Patents whose numbers are in italics have been extended under 35 USC 156. All expiration dates include applicable Sec. 156 and pediatric (PED) extensions.
Products tagged as GENERIC have had a generic equivalent approved for at least one strength of the product.
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6899699 DP* Automatic injection device with reset feature Claim Types: Device; Method of administration Pat. Sub. Date(s): 002: Oct 25, 2017 | Jan 2, 2022 | |
| Pat. No. 8672898 DP* Automatic injection device with reset feature Claim Types: Device Pat. Sub. Date(s): 002: Oct 25, 2017 | Jan 2, 2022 | |
| Pat. No. 9486588 DP* Automatic injection device with reset feature Claim Types: Device Pat. Sub. Date(s): 002: Oct 25, 2017 | Jan 2, 2022 | |
| Pat. No. 8579869 DP* Needle mounting system and a method for mounting a needle assembly Claim Types: Device Pat. Sub. Date(s): 002: Apr 3, 2019 | Jun 30, 2023 | |
| Pat. No. 7762994 DP* Needle mounting system and a method for mounting a needle assembly Claim Types: Device Pat. Sub. Date(s): 002: Apr 3, 2019 | May 23, 2024 | |
| Pat. No. 8684969 DP* Injection device with torsion spring and rotatable display Claim Types: Device Pat. Sub. Date(s): 002: Oct 25, 2017 | Oct 20, 2025 | |
| Pat. No. 9108002 DP* Automatic injection device with a top release mechanism Claim Types: Device Pat. Sub. Date(s): 002: Oct 25, 2017 | Jan 20, 2026 | |
| Pat. No. 9457154 DP* Injection device with an end of dose feedback mechanism Claim Types: Device Pat. Sub. Date(s): 002: Oct 25, 2017 | Jan 20, 2026 | |
| Pat. No. 9616180 DP* Automatic injection device with a top release mechanism Claim Types: Device Pat. Sub. Date(s): 002: Aug 17, 2018 | Jan 20, 2026 | |
| Pat. No. 9861757 DP* Injection device with an end of dose feedback mechanism Claim Types: Device Pat. Sub. Date(s): 002: Aug 17, 2018 | Jan 20, 2026 | |
| Pat. No. 10357616 DP* Injection device with an end of dose feedback mechanism Claim Types: Device Pat. Sub. Date(s): 002: Aug 8, 2019 | Jan 20, 2026 | |
| Pat. No. 10376652 DP* Automatic injection device with a top release mechanism Claim Types: Device Pat. Sub. Date(s): 002: Sep 13, 2019 | Jan 20, 2026 | |
| Pat. No. 8920383 DP* Dose mechanism for an injection device for limiting a dose setting corresponding to the amount of medicament left Claim Types: Device Pat. Sub. Date(s): 002: Oct 25, 2017 | Jul 17, 2026 | |
| Pat. No. 9775953 DP* Dose mechanism for an injection device for limiting a dose setting corresponding to the amount of medicament left Claim Types: Device Pat. Sub. Date(s): 002: Nov 13, 2017 | Jul 17, 2026 | |
| Pat. No. 10220155 DP* Syringe device with a dose limiting mechanism and an additional safety mechanism Claim Types: Device Pat. Sub. Date(s): 002: Mar 29, 2019 | Jul 17, 2026 | |
| Pat. No. RE46363 DP* Dial-down mechanism for wind-up pen Claim Types: Device; Method of use Pat. Sub. Date(s): 002: Apr 3, 2019 | Aug 3, 2026 | |
| Pat. No. 9687611 DP* Injection device with torsion spring and rotatable display Claim Types: Device Pat. Sub. Date(s): 002: Oct 25, 2017 | Feb 27, 2027 | |
| Pat. No. 8324157 DP* Preparation comprising insulin, nicotinamide and an amino acid Claim Types: Formulation Pat. Sub. Date(s): 002: Oct 25, 2017 | Jun 25, 2030 | |
| Pat. No. 9132239 DP* Dial-down mechanism for wind-up pen Claim Types: Device Pat. Sub. Date(s): 002: Oct 25, 2017 | Feb 1, 2032 | |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NP - New product | Sep 29, 2020 | |
| Exclusivity Code: NPP - New patient population | Dec 19, 2022 |
NORDITROPIN FLEXPRO (INJECTABLE) (INJECTION) SOMATROPIN
Drug Classes: recombinant human growth hormone
NDA Applicant: NOVO NORDISK INC NDA No.: 021148 Prod. No.: 008 RX (5MG/1.5ML); 009 RX (10MG/1.5ML); 010 RX (15MG/1.5ML); 011 RX (30MG/3ML)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6899699 DP* Automatic injection device with reset feature Claim Types: Device; Method of administration Pat. Sub. Date(s): 008: Nov 28, 2012; 009: None; 010: None; 011: Jun 19, 2015 | Jan 2, 2022 | |
| Pat. No. 8672898 DP* Automatic injection device with reset feature Claim Types: Device Pat. Sub. Date(s): 008: Apr 15, 2014; 009: Apr 15, 2014; 010: Apr 15, 2014; 011: Jun 19, 2015 | Jan 2, 2022 | |
| Pat. No. 9486588 DP* Automatic injection device with reset feature Claim Types: Device Pat. Sub. Date(s): All strengths: Dec 8, 2016 | Jan 2, 2022 | |
| Pat. No. 8579869 DP* Needle mounting system and a method for mounting a needle assembly Claim Types: Device Pat. Sub. Date(s): All strengths: Jan 23, 2019 | Jun 30, 2023 | |
| Pat. No. 7762994 DP* Needle mounting system and a method for mounting a needle assembly Claim Types: Device Pat. Sub. Date(s): All strengths: Jan 23, 2019 | May 23, 2024 | |
| Pat. No. 8684969 DP* Injection device with torsion spring and rotatable display Claim Types: Device Pat. Sub. Date(s): 008: Apr 15, 2014; 009: Apr 15, 2014; 010: Apr 15, 2014; 011: Jun 19, 2015 | Oct 20, 2025 | |
| Pat. No. 9108002 DP* Automatic injection device with a top release mechanism Claim Types: Device Pat. Sub. Date(s): All strengths: Sep 17, 2015 | Jan 20, 2026 | |
| Pat. No. 9616180 DP* Automatic injection device with a top release mechanism Claim Types: Device Pat. Sub. Date(s): All strengths: Aug 21, 2018 | Jan 20, 2026 | |
| Pat. No. 9861757 DP* Injection device with an end of dose feedback mechanism Claim Types: Device Pat. Sub. Date(s): All strengths: Aug 21, 2018 | Jan 20, 2026 | |
| Pat. No. 10357616 DP* Injection device with an end of dose feedback mechanism Claim Types: Device Pat. Sub. Date(s): All strengths: Aug 14, 2019 | Jan 20, 2026 | |
| Pat. No. 10376652 DP* Automatic injection device with a top release mechanism Claim Types: Device Pat. Sub. Date(s): All strengths: Sep 13, 2019 | Jan 20, 2026 | |
| Pat. No. 8920383 DP* Dose mechanism for an injection device for limiting a dose setting corresponding to the amount of medicament left Claim Types: Device Pat. Sub. Date(s): All strengths: Feb 6, 2015 | Jul 17, 2026 | |
| Pat. No. 9775953 DP* Dose mechanism for an injection device for limiting a dose setting corresponding to the amount of medicament left Claim Types: Device Pat. Sub. Date(s): All strengths: Nov 13, 2017 | Jul 17, 2026 | |
| Pat. No. 10220155 DP* Syringe device with a dose limiting mechanism and an additional safety mechanism Claim Types: Device Pat. Sub. Date(s): All strengths: Mar 29, 2019 | Jul 17, 2026 | |
| Pat. No. RE46363 DP* Dial-down mechanism for wind-up pen Claim Types: Device; Method of use Pat. Sub. Date(s): All strengths: May 10, 2017 | Aug 3, 2026 | |
| Pat. No. 9687611 DP* Injection device with torsion spring and rotatable display Claim Types: Device Pat. Sub. Date(s): All strengths: Sep 6, 2017 | Feb 27, 2027 | |
| Pat. No. 9457154 DP* Injection device with an end of dose feedback mechanism Claim Types: Device Pat. Sub. Date(s): All strengths: Oct 18, 2016 | Sep 27, 2027 | |
| Pat. No. 9132239 DP* Dial-down mechanism for wind-up pen Claim Types: Device Pat. Sub. Date(s): All strengths: Sep 17, 2015 | Feb 1, 2032 |
NOVOLOG FLEXTOUCH (INJECTABLE) (SUBCUTANEOUS) INSULIN ASPART RECOMBINANT
Drug Classes: insulin analog
NDA Applicant: NOVO NORDISK INC NDA No.: 020986 Prod. No.: 005 DISC (300 UNITS/3ML (100 UNITS/ML))
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6899699 DP* Automatic injection device with reset feature Claim Types: Device; Method of administration Pat. Sub. Date(s): 005: Mar 10, 2014 | Jan 2, 2022 | |
| Pat. No. 8672898 DP* Automatic injection device with reset feature Claim Types: Device Pat. Sub. Date(s): 005: Apr 16, 2014 | Jan 2, 2022 | |
| Pat. No. 9486588 DP* Automatic injection device with reset feature Claim Types: Device Pat. Sub. Date(s): 005: Dec 7, 2016 | Jan 2, 2022 | |
| Pat. No. 8579869 DP* Needle mounting system and a method for mounting a needle assembly Claim Types: Device Pat. Sub. Date(s): 005: Jan 25, 2019 | Jun 30, 2023 | |
| Pat. No. 7762994 DP* Needle mounting system and a method for mounting a needle assembly Claim Types: Device Pat. Sub. Date(s): 005: Jan 25, 2019 | May 23, 2024 | |
| Pat. No. 8684969 DP* Injection device with torsion spring and rotatable display Claim Types: Device Pat. Sub. Date(s): 005: Apr 16, 2014 | Oct 20, 2025 | |
| Pat. No. 9108002 DP* Automatic injection device with a top release mechanism Claim Types: Device Pat. Sub. Date(s): 005: Sep 16, 2015 | Jan 20, 2026 | |
| Pat. No. 9616180 DP* Automatic injection device with a top release mechanism Claim Types: Device Pat. Sub. Date(s): 005: Aug 30, 2018 | Jan 20, 2026 | |
| Pat. No. 9861757 DP* Injection device with an end of dose feedback mechanism Claim Types: Device Pat. Sub. Date(s): 005: Aug 30, 2018 | Jan 20, 2026 | |
| Pat. No. 10357616 DP* Injection device with an end of dose feedback mechanism Claim Types: Device Pat. Sub. Date(s): 005: Aug 19, 2019 | Jan 20, 2026 | |
| Pat. No. 10376652 DP* Automatic injection device with a top release mechanism Claim Types: Device Pat. Sub. Date(s): 005: Sep 13, 2019 | Jan 20, 2026 | |
| Pat. No. 8920383 DP* Dose mechanism for an injection device for limiting a dose setting corresponding to the amount of medicament left Claim Types: Device Pat. Sub. Date(s): 005: Feb 9, 2015 | Jul 17, 2026 | |
| Pat. No. 9775953 DP* Dose mechanism for an injection device for limiting a dose setting corresponding to the amount of medicament left Claim Types: Device Pat. Sub. Date(s): 005: Nov 16, 2017 | Jul 17, 2026 | |
| Pat. No. 10220155 DP* Syringe device with a dose limiting mechanism and an additional safety mechanism Claim Types: Device Pat. Sub. Date(s): 005: Apr 2, 2019 | Jul 17, 2026 | |
| Pat. No. RE46363 DP* Dial-down mechanism for wind-up pen Claim Types: Device; Method of use Pat. Sub. Date(s): 005: May 10, 2017 | Aug 3, 2026 | |
| Pat. No. 9687611 DP* Injection device with torsion spring and rotatable display Claim Types: Device Pat. Sub. Date(s): 005: Sep 7, 2017 | Feb 27, 2027 | |
| Pat. No. 9457154 DP* Injection device with an end of dose feedback mechanism Claim Types: Device Pat. Sub. Date(s): 005: Oct 26, 2016 | Sep 27, 2027 | |
| Pat. No. 9132239 DP* Dial-down mechanism for wind-up pen Claim Types: Device Pat. Sub. Date(s): 005: Sep 16, 2015 | Feb 1, 2032 |
OZEMPIC (SOLUTION) (SUBCUTANEOUS) SEMAGLUTIDE
Drug Classes: glucagon-like peptide-1 (GLP-1) receptor agonist
NDA Applicant: NOVO NDA No.: 209637 Prod. No.: 001 RX (2MG/1.5ML (1.34MG/ML))
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6899699 DP* Automatic injection device with reset feature Claim Types: Device; Method of administration Pat. Sub. Date(s): 001: Dec 20, 2017 | Jan 2, 2022 | |
| Pat. No. 8672898 DP* Automatic injection device with reset feature Claim Types: Device Pat. Sub. Date(s): 001: Dec 20, 2017 | Jan 2, 2022 | |
| Pat. No. 9486588 DP* Automatic injection device with reset feature Claim Types: Device Pat. Sub. Date(s): 001: Dec 20, 2017 | Jan 2, 2022 | |
| Pat. No. 8579869 DP* Needle mounting system and a method for mounting a needle assembly Claim Types: Device Pat. Sub. Date(s): 001: Dec 20, 2017 | Jun 30, 2023 | |
| Pat. No. 7762994 DP* Needle mounting system and a method for mounting a needle assembly Claim Types: Device Pat. Sub. Date(s): 001: Dec 20, 2017 | May 23, 2024 | |
| Pat. No. 8114833 DP* Propylene glycol-containing peptide formulations which are optimal for production and for use in injection devices Claim Types: Formulation; Process Pat. Sub. Date(s): 001: Dec 20, 2017 | Aug 13, 2025 | |
| Pat. No. 8684969 DP* Injection device with torsion spring and rotatable display Claim Types: Device Pat. Sub. Date(s): 001: Dec 20, 2017 | Oct 20, 2025 | |
| Pat. No. 9108002 DP* Automatic injection device with a top release mechanism Claim Types: Device Pat. Sub. Date(s): 001: Dec 20, 2017 | Jan 20, 2026 | |
| Pat. No. 9616180 DP* Automatic injection device with a top release mechanism Claim Types: Device Pat. Sub. Date(s): 001: Aug 17, 2018 | Jan 20, 2026 | |
| Pat. No. 9861757 DP* Injection device with an end of dose feedback mechanism Claim Types: Device Pat. Sub. Date(s): 001: Aug 17, 2018 | Jan 20, 2026 | |
| Pat. No. 10357616 DP* Injection device with an end of dose feedback mechanism Claim Types: Device Pat. Sub. Date(s): 001: Aug 8, 2019 | Jan 20, 2026 | |
| Pat. No. 10376652 DP* Automatic injection device with a top release mechanism Claim Types: Device Pat. Sub. Date(s): 001: Sep 13, 2019 | Jan 20, 2026 | |
| Pat. No. 8536122 DS* DP* Acylated GLP-1 compounds Claim Types: Compound; Composition; Method of use Pat. Sub. Date(s): 001: Dec 20, 2017 | Mar 20, 2026 | U-2202: OZEMPIC is indicated as an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus |
| Pat. No. 8920383 DP* Dose mechanism for an injection device for limiting a dose setting corresponding to the amount of medicament left Claim Types: Device Pat. Sub. Date(s): 001: Dec 20, 2017 | Jul 17, 2026 | |
| Pat. No. 9775953 DP* Dose mechanism for an injection device for limiting a dose setting corresponding to the amount of medicament left Claim Types: Device Pat. Sub. Date(s): 001: Dec 20, 2017 | Jul 17, 2026 | |
| Pat. No. 10220155 DP* Syringe device with a dose limiting mechanism and an additional safety mechanism Claim Types: Device Pat. Sub. Date(s): 001: Apr 4, 2019 | Jul 17, 2026 | |
| Pat. No. RE46363 DP* Dial-down mechanism for wind-up pen Claim Types: Device; Method of use Pat. Sub. Date(s): 001: Dec 20, 2017 | Aug 3, 2026 | |
| Pat. No. 9687611 DP* Injection device with torsion spring and rotatable display Claim Types: Device Pat. Sub. Date(s): 001: Dec 20, 2017 | Feb 27, 2027 | |
| Pat. No. 9457154 DP* Injection device with an end of dose feedback mechanism Claim Types: Device Pat. Sub. Date(s): 001: Dec 20, 2017 | Sep 27, 2027 | |
| Pat. No. 8129343 DS* DP* Acylated GLP-1 compounds Claim Types: Compound; Composition; Method of use Pat. Sub. Date(s): 001: Dec 20, 2017 | Jan 29, 2029 | U-2202: OZEMPIC is indicated as an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus |
| Pat. No. 9132239 DP* Dial-down mechanism for wind-up pen Claim Types: Device Pat. Sub. Date(s): 001: Dec 20, 2017 | Feb 1, 2032 | |
| Pat. No. 10335462 Use of long-acting GLP-1 peptides Claim Types: Method of use Pat. Sub. Date(s): 001: Jul 25, 2019 | Jun 21, 2033 | U-2580: A method of treating Type 2 diabetes comprising administering semaglutide once weekly in a amount of 1.0 mg to a subject in need thereof |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NCE - New chemical entity | Dec 5, 2022 |
RYZODEG 70/30 (SOLUTION) (SUBCUTANEOUS) INSULIN ASPART; INSULIN DEGLUDEC
Drug Classes: insulin analog
NDA Applicant: NOVO NDA No.: 203313 Prod. No.: 001 DISC (90 UNITS/3ML;210 UNITS/3ML (30 UNITS/ML;70 UNITS/ML))
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6899699 DP* Automatic injection device with reset feature Claim Types: Device; Method of administration Pat. Sub. Date(s): 001: Sep 28, 2015 | Jan 2, 2022 | |
| Pat. No. 8672898 DP* Automatic injection device with reset feature Claim Types: Device Pat. Sub. Date(s): 001: Sep 28, 2015 | Jan 2, 2022 | |
| Pat. No. 9486588 DP* Automatic injection device with reset feature Claim Types: Device Pat. Sub. Date(s): 001: Dec 8, 2016 | Jan 2, 2022 | |
| Pat. No. 8579869 DP* Needle mounting system and a method for mounting a needle assembly Claim Types: Device Pat. Sub. Date(s): 001: Jan 23, 2019 | Jun 30, 2023 | |
| Pat. No. 7762994 DP* Needle mounting system and a method for mounting a needle assembly Claim Types: Device Pat. Sub. Date(s): 001: Jan 23, 2019 | May 23, 2024 | |
| Pat. No. 8684969 DP* Injection device with torsion spring and rotatable display Claim Types: Device Pat. Sub. Date(s): 001: Sep 28, 2015 | Oct 20, 2025 | |
| Pat. No. 9108002 DP* Automatic injection device with a top release mechanism Claim Types: Device Pat. Sub. Date(s): 001: Sep 28, 2015 | Jan 20, 2026 | |
| Pat. No. 9616180 DP* Automatic injection device with a top release mechanism Claim Types: Device Pat. Sub. Date(s): 001: Aug 29, 2018 | Jan 20, 2026 | |
| Pat. No. 9861757 DP* Injection device with an end of dose feedback mechanism Claim Types: Device Pat. Sub. Date(s): 001: Aug 29, 2018 | Jan 20, 2026 | |
| Pat. No. 10357616 DP* Injection device with an end of dose feedback mechanism Claim Types: Device Pat. Sub. Date(s): 001: Aug 8, 2019 | Jan 20, 2026 | |
| Pat. No. 10376652 DP* Automatic injection device with a top release mechanism Claim Types: Device Pat. Sub. Date(s): 001: Sep 13, 2019 | Jan 20, 2026 | |
| Pat. No. 8920383 DP* Dose mechanism for an injection device for limiting a dose setting corresponding to the amount of medicament left Claim Types: Device Pat. Sub. Date(s): 001: Sep 28, 2015 | Jul 17, 2026 | |
| Pat. No. 9775953 DP* Dose mechanism for an injection device for limiting a dose setting corresponding to the amount of medicament left Claim Types: Device Pat. Sub. Date(s): 001: Nov 14, 2017 | Jul 17, 2026 | |
| Pat. No. 10220155 DP* Syringe device with a dose limiting mechanism and an additional safety mechanism Claim Types: Device Pat. Sub. Date(s): 001: Apr 2, 2019 | Jul 17, 2026 | |
| Pat. No. RE46363 DP* Dial-down mechanism for wind-up pen Claim Types: Device; Method of use Pat. Sub. Date(s): 001: May 10, 2017 | Aug 3, 2026 | |
| Pat. No. 9687611 DP* Injection device with torsion spring and rotatable display Claim Types: Device Pat. Sub. Date(s): 001: Sep 8, 2017 | Feb 27, 2027 | |
| Pat. No. 9457154 DP* Injection device with an end of dose feedback mechanism Claim Types: Device Pat. Sub. Date(s): 001: Oct 25, 2016 | Sep 27, 2027 | |
| Pat. No. 7615532 DS* DP* [Extended 1802 days (4.9 years)] Insulin derivatives Claim Types: Compound; Composition Pat. Sub. Date(s): 001: Sep 28, 2015 | Jun 28, 2029 | |
| Pat. No. 9132239 DP* Dial-down mechanism for wind-up pen Claim Types: Device Pat. Sub. Date(s): 001: Sep 28, 2015 | Feb 1, 2032 | |
| Pat. No. 9884094 Method of treating diabetes mellitus Claim Types: Method of use Pat. Sub. Date(s): 001: Mar 6, 2018 | May 1, 2033 | U-2238: Method of improving glycemic control in patients with diabetes mellitus by administering a mixture of insulin degludec and insulin aspart during or around the time of the largest meal of the day |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NCE - New chemical entity | Sep 25, 2020 | |
| Exclusivity Code: NPP - New patient population | Dec 16, 2019 |
TRESIBA (SOLUTION) (SUBCUTANEOUS) INSULIN DEGLUDEC
Drug Classes: insulin analog
NDA Applicant: NOVO NDA No.: 203314 Prod. No.: 001 RX (300 UNITS/3ML (100 UNITS/ML)); 002 RX (600 UNITS/3ML (200 UNITS/ML))
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6899699 DP* Automatic injection device with reset feature Claim Types: Device; Method of administration Pat. Sub. Date(s): All strengths: Sep 28, 2015 | Jan 2, 2022 | |
| Pat. No. 8672898 DP* Automatic injection device with reset feature Claim Types: Device Pat. Sub. Date(s): All strengths: Sep 28, 2015 | Jan 2, 2022 | |
| Pat. No. 9486588 DP* Automatic injection device with reset feature Claim Types: Device Pat. Sub. Date(s): All strengths: Dec 8, 2016 | Jan 2, 2022 | |
| Pat. No. 8579869 DP* Needle mounting system and a method for mounting a needle assembly Claim Types: Device Pat. Sub. Date(s): All strengths: Jan 23, 2019 | Jun 30, 2023 | |
| Pat. No. 7762994 DP* Needle mounting system and a method for mounting a needle assembly Claim Types: Device Pat. Sub. Date(s): All strengths: Jan 23, 2019 | May 23, 2024 | |
| Pat. No. 8684969 DP* Injection device with torsion spring and rotatable display Claim Types: Device Pat. Sub. Date(s): All strengths: Sep 28, 2015 | Oct 20, 2025 | |
| Pat. No. 9108002 DP* Automatic injection device with a top release mechanism Claim Types: Device Pat. Sub. Date(s): All strengths: Sep 28, 2015 | Jan 20, 2026 | |
| Pat. No. 9616180 DP* Automatic injection device with a top release mechanism Claim Types: Device Pat. Sub. Date(s): All strengths: Aug 29, 2018 | Jan 20, 2026 | |
| Pat. No. 9861757 DP* Injection device with an end of dose feedback mechanism Claim Types: Device Pat. Sub. Date(s): All strengths: Aug 29, 2018 | Jan 20, 2026 | |
| Pat. No. 10357616 DP* Injection device with an end of dose feedback mechanism Claim Types: Device Pat. Sub. Date(s): All strengths: Aug 15, 2019 | Jan 20, 2026 | |
| Pat. No. 10376652 DP* Automatic injection device with a top release mechanism Claim Types: Device Pat. Sub. Date(s): All strengths: Sep 13, 2019 | Jan 20, 2026 | |
| Pat. No. 8920383 DP* Dose mechanism for an injection device for limiting a dose setting corresponding to the amount of medicament left Claim Types: Device Pat. Sub. Date(s): All strengths: Sep 28, 2015 | Jul 17, 2026 | |
| Pat. No. 9775953 DP* Dose mechanism for an injection device for limiting a dose setting corresponding to the amount of medicament left Claim Types: Device Pat. Sub. Date(s): All strengths: Nov 14, 2017 | Jul 17, 2026 | |
| Pat. No. 10220155 DP* Syringe device with a dose limiting mechanism and an additional safety mechanism Claim Types: Device Pat. Sub. Date(s): All strengths: Apr 2, 2019 | Jul 17, 2026 | |
| Pat. No. RE46363 DP* Dial-down mechanism for wind-up pen Claim Types: Device; Method of use Pat. Sub. Date(s): All strengths: May 10, 2017 | Aug 3, 2026 | |
| Pat. No. 9687611 DP* Injection device with torsion spring and rotatable display Claim Types: Device Pat. Sub. Date(s): All strengths: Sep 8, 2017 | Feb 27, 2027 | |
| Pat. No. 9457154 DP* Injection device with an end of dose feedback mechanism Claim Types: Device Pat. Sub. Date(s): All strengths: Oct 25, 2016 | Sep 27, 2027 | |
| Pat. No. 7615532 DS* DP* [Extended 1802 days (4.9 years)] Insulin derivatives Claim Types: Compound; Composition Pat. Sub. Date(s): All strengths: Sep 28, 2015 | Jun 28, 2029 | |
| Pat. No. 9132239 DP* Dial-down mechanism for wind-up pen Claim Types: Device Pat. Sub. Date(s): All strengths: Sep 28, 2015 | Feb 1, 2032 | |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NCE - New chemical entity | Sep 25, 2020 | |
| Exclusivity Code: NPP - New patient population | Dec 16, 2019 |
XULTOPHY 100/3.6 (SOLUTION) (SUBCUTANEOUS) INSULIN DEGLUDEC; LIRAGLUTIDE
Drug Classes: insulin analog; glucagon-like peptide-1 (GLP-1) receptor agonist
NDA Applicant: NOVO NDA No.: 208583 Prod. No.: 001 RX (300 UNITS/3ML;10.8MG/3ML (100 UNITS/ML;3.6MG/ML))
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6899699 DP* Automatic injection device with reset feature Claim Types: Device; Method of administration Pat. Sub. Date(s): 001: Dec 9, 2016 | Jan 2, 2022 | |
| Pat. No. 8672898 DP* Automatic injection device with reset feature Claim Types: Device Pat. Sub. Date(s): 001: Dec 9, 2016 | Jan 2, 2022 | |
| Pat. No. 9486588 DP* Automatic injection device with reset feature Claim Types: Device Pat. Sub. Date(s): 001: Dec 9, 2016 | Jan 2, 2022 | |
| Pat. No. 8846618 DS* DP* Stable formulation of modified GLP-1 Claim Types: Formulation; Process Pat. Sub. Date(s): 001: Dec 9, 2016 | Dec 27, 2022 *PED | |
| Pat. No. 6268343 DS* DP* [Extended 5 years] Derivatives of GLP-1 analogs Claim Types: Compound; Composition; Formulation; Method of use Pat. Sub. Date(s): 001: Dec 9, 2016 | Feb 22, 2023 *PED | |
| Pat. No. 8579869 DP* Needle mounting system and a method for mounting a needle assembly Claim Types: Device Pat. Sub. Date(s): 001: Jan 23, 2019 | Dec 30, 2023 *PED | |
| Pat. No. 7762994 DP* Needle mounting system and a method for mounting a needle assembly Claim Types: Device Pat. Sub. Date(s): 001: Jan 23, 2019 | Nov 23, 2024 *PED | |
| Pat. No. 8684969 DP* Injection device with torsion spring and rotatable display Claim Types: Device Pat. Sub. Date(s): 001: Dec 9, 2016 | Oct 20, 2025 | |
| Pat. No. 9108002 DP* Automatic injection device with a top release mechanism Claim Types: Device Pat. Sub. Date(s): 001: Dec 9, 2016 | Jan 20, 2026 | |
| Pat. No. 9616180 DP* Automatic injection device with a top release mechanism Claim Types: Device Pat. Sub. Date(s): 001: Aug 17, 2018 | Jan 20, 2026 | |
| Pat. No. 9861757 DP* Injection device with an end of dose feedback mechanism Claim Types: Device Pat. Sub. Date(s): 001: Aug 17, 2018 | Jan 20, 2026 | |
| Pat. No. 10357616 DP* Injection device with an end of dose feedback mechanism Claim Types: Device Pat. Sub. Date(s): 001: Aug 8, 2019 | Jan 20, 2026 | |
| Pat. No. 10376652 DP* Automatic injection device with a top release mechanism Claim Types: Device Pat. Sub. Date(s): 001: Sep 13, 2019 | Jan 20, 2026 | |
| Pat. No. 8920383 DP* Dose mechanism for an injection device for limiting a dose setting corresponding to the amount of medicament left Claim Types: Device Pat. Sub. Date(s): 001: Dec 9, 2016 | Jul 17, 2026 | |
| Pat. No. 9775953 DP* Dose mechanism for an injection device for limiting a dose setting corresponding to the amount of medicament left Claim Types: Device Pat. Sub. Date(s): 001: Nov 14, 2017 | Jul 17, 2026 | |
| Pat. No. 10220155 DP* Syringe device with a dose limiting mechanism and an additional safety mechanism Claim Types: Device Pat. Sub. Date(s): 001: Mar 29, 2019 | Jul 17, 2026 | |
| Pat. No. RE46363 DP* Dial-down mechanism for wind-up pen Claim Types: Device; Method of use Pat. Sub. Date(s): 001: May 10, 2017 | Aug 3, 2026 | |
| Pat. No. 9687611 DP* Injection device with torsion spring and rotatable display Claim Types: Device Pat. Sub. Date(s): 001: Sep 8, 2017 | Feb 27, 2027 | |
| Pat. No. 9457154 DP* Injection device with an end of dose feedback mechanism Claim Types: Device Pat. Sub. Date(s): 001: Dec 9, 2016 | Sep 27, 2027 | |
| Pat. No. 8937042 DP* Pharmaceutical compositions comprising GLP-1 peptides or extendin-4 and a basal insulin peptide Claim Types: Formulation Pat. Sub. Date(s): 001: Dec 9, 2016 | May 5, 2029 | |
| Pat. No. 7615532 DS* DP* [Extended 1802 days (4.9 years)] Insulin derivatives Claim Types: Compound; Composition Pat. Sub. Date(s): 001: Dec 9, 2016 | Jun 28, 2029 | |
| Pat. No. 9132239 DP* Dial-down mechanism for wind-up pen Claim Types: Device Pat. Sub. Date(s): 001: Dec 9, 2016 | Feb 1, 2032 | |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: M - Miscellaneous | Aug 8, 2022 | M-242: Information added to the labeling regarding the efficacy and safety of insulin degludec/liraglutide vs insulin glargine in pts w/ Type 2 diabetes inadequately controlled on SGLT2i with or without oral antidiabetic therapies |
| Exclusivity Code: NC - New combination | Nov 21, 2019 | |
| Exclusivity Code: NCE - New chemical entity | Sep 25, 2020 |
BAQSIMI (POWDER) (NASAL) GLUCAGON
Drug Classes: glucagon-like peptide-1 (GLP-1) receptor agonist; antihypoglycemic agent; gastrointestinal motility inhibitor; glucagon-like peptide-2 (GLP-2) analog
NDA Applicant: ELI LILLY AND CO NDA No.: 210134 Prod. No.: 001 RX (3MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6938798 DP* Fluid or powdery product dispensing device Claim Types: Device Pat. Sub. Date(s): 001: Aug 23, 2019 | Jan 3, 2022 | |
| Pat. No. 10213487 DP* Nasal powder formulation for treatment of hypoglycemia Claim Types: Formulation; Process; Device; Method of use Pat. Sub. Date(s): 001: Aug 23, 2019 | Feb 16, 2036 | U-2604: Treatment of severe hypoglycemia in patients with diabetes |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NP - New product | Jul 24, 2022 |
GIVLAARI (SOLUTION) (SUBCUTANEOUS) GIVOSIRAN SODIUM
NDA Applicant: ALNYLAM PHARMS INC NDA No.: 212194 Prod. No.: 001 RX (EQ 189MG BASE/ML (EQ 189MG BASE/ML))
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8546143 DS* Compositions and methods for inhibiting expression of a target gene Claim Types: Compound; Method of use Pat. Sub. Date(s): 001: Dec 12, 2019 | Jan 9, 2022 | U-2672: Treatment of acute hepatic porphyria |
| Pat. No. 9708610 DS* DP* Compositions comprising alternating 2'-modified nucleosides for use in gene modulation Claim Types: Composition; Method of use Pat. Sub. Date(s): 001: Dec 12, 2019 | Jan 1, 2024 | U-2672: Treatment of acute hepatic porphyria |
| Pat. No. 9708615 DS* Therapeutic compositions Claim Types: Compound Pat. Sub. Date(s): 001: Dec 12, 2019 | Mar 8, 2024 | |
| Pat. No. 10273477 DS* Therapeutic compositions Claim Types: Compound Pat. Sub. Date(s): 001: Dec 12, 2019 | Mar 8, 2024 | |
| Pat. No. 9150605 DS* DP* Compositions comprising alternating 2'-modified nucleosides for use in gene modulation Claim Types: Composition Pat. Sub. Date(s): 001: Dec 12, 2019 | Aug 28, 2025 | |
| Pat. No. 10131907 DS* DP* Glycoconjugates of RNA interference agents Claim Types: Composition; Process; Method of use Pat. Sub. Date(s): 001: Dec 12, 2019 | Aug 24, 2028 | U-2672: Treatment of acute hepatic porphyria |
| Pat. No. 8828956 DS* DP* Carbohydrate conjugates as delivery agents for oligonucleotides Claim Types: Compound; Composition; Method of use Pat. Sub. Date(s): 001: Dec 12, 2019 | Dec 4, 2028 | U-2672: Treatment of acute hepatic porphyria |
| Pat. No. 8106022 DS* DP* Carbohydrate conjugates as delivery agents for oligonucleotides Claim Types: Compound; Composition Pat. Sub. Date(s): 001: Dec 12, 2019 | Dec 12, 2029 | U-2672: Treatment of acute hepatic porphyria |
| Pat. No. 9631193 Compositions and methods for inhibiting expression of the ALAS1 gene Claim Types: Method of use Pat. Sub. Date(s): 001: Dec 12, 2019 | Mar 15, 2033 | U-2672: Treatment of acute hepatic porphyria |
| Pat. No. 10125364 DS* DP* Compositions and methods for inhibiting expression of the ALAS1 gene Claim Types: Compound; Isolated cell containing the compound; Composition; Method of use; Intermediate Pat. Sub. Date(s): 001: Dec 12, 2019 | Mar 15, 2033 | U-2672: Treatment of acute hepatic porphyria |
| Pat. No. 9133461 DS* DP* Compositions and methods for inhibiting expression of the ALAS1 gene Claim Types: Compound; Composition; Isolated cell containing the compound;; Method of use Pat. Sub. Date(s): 001: Dec 12, 2019 | May 14, 2033 | U-2672: Treatment of acute hepatic porphyria |
| Pat. No. 10119143 DS* DP* Compositions and methods for inhibiting expression of the ALAS1 gene Claim Types: Compound; Isolated cell contaiing the compound; Composition; Method of use; New polymorph, salt or hydrate Pat. Sub. Date(s): 001: Dec 12, 2019 | Oct 3, 2034 | U-2672: Treatment of acute hepatic porphyria |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NCE - New chemical entity | Nov 20, 2024 | |
| Exclusivity Code: ODE - Orphan drug exclusivity | Nov 20, 2026 | ODE-273: Indicated for the treatment of adults with acute hepatic porphyria (AHP) |
ALPHAGAN P (SOLUTION/DROPS) (OPHTHALMIC) BRIMONIDINE TARTRATE
Drug Classes: alpha adrenergic agonist
NDA Applicant: ALLERGAN NDA No.: 021262 Prod. No.: 001 RX (0.15%)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6562873 Compositions containing therapeutically active components having enhanced solubility Claim Types: Formulation Pat. Sub. Date(s): 001: None | Jan 10, 2022 *PED | |
| Pat. No. 9295641 Compositions containing alpha-2-adrenergic agonist components Claim Types: Method of use Pat. Sub. Date(s): 001: Apr 28, 2016 | Jan 10, 2022 *PED | U-1833: Reduction of elevated intraocular pressure in patients with open angle glaucoma or ocular hypertension |
| Pat. No. 6627210 DP* Compositions containing .alpha.-2-adrenergic agonist components Claim Types: Formulation Pat. Sub. Date(s): 001: None | Jan 18, 2022 *PED | |
| Pat. No. 6673337 DP* Compositions containing alpha-2-adrenergic agonist components Claim Types: Formulation Pat. Sub. Date(s): 001: None | Jan 26, 2022 *PED | |
| Pat. No. 6641834 DP* Compositions containing alpha-2-adrenergic agonist components Claim Types: Formulation Pat. Sub. Date(s): 001: None | Jan 28, 2022 *PED |
ADVIL PM (CAPSULE) (ORAL) DIPHENHYDRAMINE HYDROCHLORIDE; IBUPROFEN [GENERIC OTC]
Drug Classes: histamine-1 (H1) receptor antagonist; nonsteroidal anti-inflammatory drug
NDA Applicant: GLAXOSMITHKLINE NDA No.: 021393 Prod. No.: 001 OTC (25MG;EQ 200MG FREE ACID AND POTASSIUM SALT)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8883849 Treatment of sleep disturbances Claim Types: Method of use Pat. Sub. Date(s): 001: Dec 9, 2014 | Jan 17, 2022 | U-1618: A method of treating a patient suffering from a pain associated sleep disturbance comprising administering a liquid composition formulated inside a soft gel capsule, as claimed, to the patient |
| Pat. No. 9155718 DP* Treatment of sleep disturbances Claim Types: Formulation Pat. Sub. Date(s): 001: Nov 10, 2015 | Jan 17, 2022 |
GILOTRIF (TABLET) (ORAL) AFATINIB DIMALEATE
Drug Classes: kinase inhibitor
NDA Applicant: BOEHRINGER INGELHEIM NDA No.: 201292 Prod. No.: 001 RX (EQ 20MG BASE); 002 RX (EQ 30MG BASE)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. RE43431 DS* Quinazoline derivatives and pharmaceutical compositions containing them Claim Types: Compound Pat. Sub. Date(s): All strengths: Aug 1, 2013 | Jan 22, 2022 | |
| Pat. No. 9539258 Quinazoline derivatives for the treatment of cancer diseases Claim Types: Method of use Pat. Sub. Date(s): All strengths: Feb 2, 2017 | Nov 9, 2026 | U-1950: Treatment of patients with advanced (metastatic) non-small cell lung cancer whose disease progressed during or after platinum-based chemotherapy |
| Pat. No. 8426586 DS* Process for preparing amino crotonyl compounds Claim Types: New polymorph, salt or hydrate; Process Pat. Sub. Date(s): All strengths: Aug 1, 2013 | Oct 10, 2029 | |
| Pat. No. 8545884 DP* Solid pharmaceutical formulations comprising BIBW 2992 Claim Types: Intermediate; Formulation; Process; Product-by-process Pat. Sub. Date(s): All strengths: Oct 28, 2013 | Dec 19, 2029 | |
| Pat. No. 10004743 DP* Process for drying of BIBW2992, of its salts and of solid pharmaceutical formulations comprising this active ingredient Claim Types: Formulation Pat. Sub. Date(s): All strengths: Aug 2, 2018 | Jul 5, 2030 | |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: I - New Indication | Jan 12, 2021 | I-763: Treatment of patients with metastatic non-small cell lung cancer whose tumors have non-resistant epidermal growth factor receptor mutations as detected by an FDA-approved test |
| Exclusivity Code: ODE - Orphan drug exclusivity | Apr 15, 2023 | ODE-115: Treatment of patients with metastatic, squamous, non-small cell lung cancer progressing after platinum-based chemotherapy |
| Exclusivity Code: ODE - Orphan drug exclusivity | Jan 12, 2025 | ODE-230: First-line treatment of metastatic nonsmall cell lung cancer whose tumors have non-resistant epidermal growth factor mutations other than exon 19 deletions or exon 21 (L858R) substitution mutations as detected by an FDA-approved test |
| Exclusivity Code: ODE - Orphan drug exclusivity | Jul 12, 2020 | ODE-50: First-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations as detected by an FDA-approved test. |
GILOTRIF (TABLET) (ORAL) AFATINIB DIMALEATE
Drug Classes: kinase inhibitor
NDA Applicant: BOEHRINGER INGELHEIM NDA No.: 201292 Prod. No.: 003 RX (EQ 40MG BASE)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. RE43431 DS* Quinazoline derivatives and pharmaceutical compositions containing them Claim Types: Compound Pat. Sub. Date(s): 003: Aug 1, 2013 | Jan 22, 2022 | |
| Pat. No. 9539258 Quinazoline derivatives for the treatment of cancer diseases Claim Types: Method of use Pat. Sub. Date(s): 003: Feb 2, 2017 | Nov 9, 2026 | U-1950: Treatment of patients with advanced (metastatic) non-small cell lung cancer whose disease progressed during or after platinum-based chemotherapy |
| Pat. No. 8426586 DS* Process for preparing amino crotonyl compounds Claim Types: New polymorph, salt or hydrate; Process Pat. Sub. Date(s): 003: Aug 1, 2013 | Oct 10, 2029 | |
| Pat. No. 8545884 DP* Solid pharmaceutical formulations comprising BIBW 2992 Claim Types: Intermediate; Formulation; Process; Product-by-process Pat. Sub. Date(s): 003: Oct 28, 2013 | Dec 19, 2029 | |
| Pat. No. 10004743 DP* Process for drying of BIBW2992, of its salts and of solid pharmaceutical formulations comprising this active ingredient Claim Types: Formulation Pat. Sub. Date(s): 003: Aug 2, 2018 | Jul 5, 2030 | |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: I - New Indication | Apr 15, 2019 | I-730: New indication for the treatment of patients with metastatic, squamous, non-small cell lung cancer progressing after platinum-based chemotherapy |
| Exclusivity Code: I - New Indication | Jan 12, 2021 | I-763: Treatment of patients with metastatic non-small cell lung cancer whose tumors have non-resistant epidermal growth factor receptor mutations as detected by an FDA-approved test |
| Exclusivity Code: ODE - Orphan drug exclusivity | Apr 15, 2023 | ODE-115: Treatment of patients with metastatic, squamous, non-small cell lung cancer progressing after platinum-based chemotherapy |
| Exclusivity Code: ODE - Orphan drug exclusivity | Jan 12, 2025 | ODE-230: First-line treatment of metastatic nonsmall cell lung cancer whose tumors have non-resistant epidermal growth factor mutations other than exon 19 deletions or exon 21 (L858R) substitution mutations as detected by an FDA-approved test |
| Exclusivity Code: ODE - Orphan drug exclusivity | Jul 12, 2020 | ODE-50: First-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations as detected by an FDA-approved test. |
ESBRIET (TABLET) (ORAL) PIRFENIDONE
Drug Classes: pyridone
NDA Applicant: GENENTECH INC NDA No.: 208780 Prod. No.: 001 RX (267MG); 003 RX (801MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 9561217 DP* Pharmaceutical composition containing as an active ingredient 5-methyl-1-phenyl-2-(1H)-pyridone Claim Types: Formulation Pat. Sub. Date(s): All strengths: Feb 10, 2017 | Jan 25, 2022 | |
| Pat. No. 8383150 DP* Granulate formulation of pirfenidone and pharmaceutically acceptable excipients Claim Types: Formulation; Method of use Pat. Sub. Date(s): All strengths: Feb 10, 2017 | Sep 22, 2026 | U-2361: Method of administering a granulate formulation of 5-methyl-1-phenyl-2-(1h)-pyridone as recited in claim 1, to treat idiopathic pulmonary fibrosis |
| Pat. No. 7767700 Method of providing pirfenidone therapy to a patient Claim Types: Method of administration; Method of improving a treatment Pat. Sub. Date(s): All strengths: Feb 10, 2017 | Dec 18, 2027 | U-2080: Pirfenidone dose escalation regimen for treatment of IPF as 801 mg/day for days 1-7 of the regimen, 1602 mg/day for days 8-14 of the regimen, and 2403 mg/day for at least day 15 of the regimen |
| Pat. No. 8420674 Method of providing pirfenidone therapy to a patient Claim Types: Drug in a container; Method of administration Pat. Sub. Date(s): All strengths: Feb 10, 2017 | Dec 18, 2027 | U-2079: Pirfenidone dose escalation regimen for treatment of fibrosis as 801 mg/day for days 1-7 of the regimen, 1602 mg/day for days 8-14 of the regimen, and 2403 mg/day for at least day 15 of the regimen |
| Pat. No. 7566729 Modifying pirfenidone treatment for patients with atypical liver function Claim Types: Method of administration Pat. Sub. Date(s): All strengths: Feb 10, 2017 | Apr 22, 2029 | U-2077: Dosage modification following grade 2 abnormality in liver function biomarker after pirfenidone administration, by administering sub-2400 mg/day dose then full day daily dose in treatment of IPF U-2078: Dosage modification following grade 2 abnormality in liver function biomarker after pirfenidone administration, by discontinuing pirfenidone until biomarkers are within limits, then sub-2400mg/day dose, then full daily dose in treatment of IPF |
| Pat. No. 7635707 Pirfenidone treatment for patients with atypical liver function Claim Types: Method of administration Pat. Sub. Date(s): All strengths: Feb 10, 2017 | Apr 22, 2029 | U-2072: Full daily dosing following grade 2 abnormality in liver function biomarker after pirfenidone administration in treatment of IPF U-2073: Dosage modification following grade 2 abnormality in liver function biomarker after pirfenidone administration, by discontinuing pirfenidone until biomarkers are within normal limits, followed by administering full daily dose in treatment of IPF U-2074: Dosing 1602 mg/day pirfenidone following grade 2 abnormality in liver function biomarker after pirfenidone administration in treatment of IPF U-2075: Dosage modification following grade 2 abnormality in liver function biomarker after pirfenidone administration, by discontinuing pirfenidone until biomarkers are within normal limits followed by administering 1602 mg/day in treatment of IPF U-2076: Dosage modification following grade 2 abnormality in liver function biomarker after pirfenidone administration, by administering 801 mg/day followed by administering 1602 mg/day in treatment of IPF U-2083: Dosage modification following grade 2 abnormality in liver function biomarker after pirfenidone administration, by discontinuing pirfenidone until biomarkers are within normal limits, followed by 801 mg/day, dose, then 1602 mg/day in treatment of IPF |
| Pat. No. 8592462 Pirfenidone treatment for patients with atypical liver function Claim Types: Method of administration Pat. Sub. Date(s): All strengths: Feb 10, 2017 | Apr 22, 2029 | U-2055: Dosing of at least 1600 mg/day following grade 2 liver abnormality in biomarker ast and/or alt after pirfenidone administration in treatment of IPF U-2056: Dosage modification following grade 2 abnormality in biomarker ast and/or alt after pirfenidone administration, by administering sub-1600 mg/day, following by administering at least 1600 mg/day in treatment of IPF U-2057: Dosing 2403 mg/day pirfenidone following grade 2 abnormality in biomarker ast and/or alt after pirfenidone administration in treatment of IPF U-2058: Dosage modification following grade 2 abnormality in biomarker ast and/or alt after pirfenidone administration, by administering sub-2400mg/day dose, followed by administering 2403mg/day in treatment of IPF U-2059: Dosage modification following grade 2 abnormality in biomarker ast and/or alt after pirfenidone administration, by discontinuing pirfenidone until biomarkers of liver function are within normal limits, followed by full daily dose in treatment of IPF U-2060: Dosage modification following grade 2 abnormality in biomarker ast and/or alt after pirfenidone administration, by discontinuing pirfenidone until biomarkers of liver function are within normal limits, then at least 1600mg/day in treatment of IPF U-2061: Dosing of at least 1600 mg/day following grade 2 abnormality in liver function biomarker after pirfenidone administration in treatment of IPF U-2062: Dosage modification following grade 2 abnormality in liver function biomarker after pirfenidone administration, by administering sub-1600 mg/day dose, followed by administering at least 1600 mg/day dose in treatment of IPF U-2063: Dosage modification following grade 2 abnormality in liver function biomarker after pirfenidone administration, by discontinuing pirfenidone until biomarkers are within normal limits, followed by administering at least 1600 mg/day in treatment of IPF |
| Pat. No. 8609701 Pirfenidone treatment for patients with atypical liver function Claim Types: Method of administration Pat. Sub. Date(s): All strengths: Feb 10, 2017 | Apr 22, 2029 | U-2064: Dosing at least 1602 mg/day following grade 2 abnormality in liver function biomarker alt or ast after pirfenidone administration U-2065: Full daily dosing following grade 2 abnormality in liver function biomarker alt or ast after pirfenidone administration U-2066: Dosage modification following grade 2 abnormality in liver function biomarker alt or ast after pirfenidone administration, by administering sub-2400 mg/day dose, followed by full daily dose U-2067: Dosage modification following grade 2 abnormality in liver function biomarker alt or ast after pirfenidone administration, by discontinuing pirfenidone, followed by administering at least 1602 mg/day U-2068: Dosage modification following grade 2 abnormality in liver function biomarker alt or ast after pirfenidone administration, by discontinuing pirfenidone until biomarkers of liver function are within normal limits, followed by full daily dose U-2069: Dosage modification following grade 2 abnormality in liver function biomarker alt or ast after pirfenidone administration, by administering a sub-1600 mg/day dose, followed by administering at least 1602 mg/day U-2070: Dosage modification following grade 2 abnormality in biomarker alt or ast after pirfenidone administration, by discontinuing pirfenidone until biomarkers of liver function are within normal limits, then sub-1600 mg/day, then at least 1602 mg/day |
| Pat. No. 7816383 Methods of administering pirfenidone therapy Claim Types: Method of administration Pat. Sub. Date(s): All strengths: Feb 10, 2017 | Jan 8, 2030 | U-2042: Discontinuing administration of fluvoxamine to avoid drug interactions with pirfenidone and then administering pirfenidone U-2050: Administering pirfenidone while avoiding co-administration of fluvoxamine to avoid drug interactions with pirfenidone |
| Pat. No. 7910610 Methods of administering pirfenidone therapy Claim Types: Method of administration Pat. Sub. Date(s): All strengths: Feb 10, 2017 | Jan 8, 2030 | U-2048: Administering pirfenidone while avoiding co-administration of a strong CYP1A2 inhibitor to avoid drug interactions with pirfenidone U-2049: Discontinuing administration of a strong CYP1A2 inhibitor to avoid drug interactions with pirfenidone and then administering pirfenidone |
| Pat. No. 8013002 Methods of administering pirfenidone therapy Claim Types: Method of administration Pat. Sub. Date(s): All strengths: Feb 10, 2017 | Jan 8, 2030 | U-2047: Administering pirfenidone concurrently with fluvoxamine, the pirfenidone at a dose of about 801 mg/day to reduce drug interactions with fluvoxamine U-2082: Modifying pirfenidone administration from a dose of about 2400 mg/day downward by about 1600 mg/day while co-administering fluvoxamine to reduce drug interactions with fluvoxamine |
| Pat. No. 8084475 Pirfenidone therapy and inducers of cytochrome P450 Claim Types: Method of administration Pat. Sub. Date(s): All strengths: Feb 10, 2017 | Jan 8, 2030 | U-2052: Discontinuing administration of a strong CYP1A2 inducer to avoid reduced pirfenidone efficacy and then administering pirfenidone U-2054: Administering pirfenidone while avoiding concomitant administration of a strong inducer of CYP1A2 to avoid reduced pirfenidone efficacy |
| Pat. No. 8318780 Methods of administering pirfenidone therapy Claim Types: Method of administration Pat. Sub. Date(s): All strengths: Feb 10, 2017 | Jan 8, 2030 | U-2046: Administering pirfenidone while avoiding concomitant use of a CYP1A2 inhibitor that is a moderate to strong inhibitor of both CYP1A2 and another CYP enzyme selected from CYP2C9, CYP2C19, AND CYP2D6 U-2081: Discontinuing use of a CYP1A2 inhibitor that is a moderate to strong inhibitor of both CYP1A2 and another CYP enzyme selected from CYP2C9, CYP2C19, and CYP2D6 and then administering pirfenidone |
| Pat. No. 8648098 Pirfenidone therapy and inducers of cytochrome P450 Claim Types: Method of improving a treatment Pat. Sub. Date(s): All strengths: Feb 10, 2017 | Jan 8, 2030 | U-2051: Discontinuing smoking to avoid reduced pirfenidone efficacy and then administering pirfenidone U-2052: Discontinuing administration of a strong CYP1A2 inducer to avoid reduced pirfenidone efficacy and then administering pirfenidone |
| Pat. No. 8754109 Pirfenidone therapy and inducers of cytochrome P450 Claim Types: Method of improving a treatment Pat. Sub. Date(s): All strengths: Feb 10, 2017 | Jan 8, 2030 | U-2053: Administering pirfenidone while avoiding concomitant administration of a strong inducer of CYP1A2, including cigarette smoke, to avoid reduced pirfenidone efficacy |
| Pat. No. 8778947 Methods of administering pirfenidone therapy Claim Types: Method of administration Pat. Sub. Date(s): All strengths: Feb 10, 2017 | Aug 30, 2033 | U-2044: Dose reduction of pirfenidone by about one half during concurrent administration of ciprofloxacin at a dose of 750 mg twice daily (1500 mg/day) to reduce drug interactions in treatment of a fibrotic, inflammatory, or autoimmune disorder U-2045: Administration of pirfenidone and avoiding concurrent administration of ciprofloxacin at a dose of 750 mg to reduce drug interactions in treatment of a fibrotic, inflammatory, or autoimmune disorder |
| Pat. No. 10188637 DP* Granulate formulation of 5-methyl-1-phenyl-2-(1H)-pyridone and method of making the same Claim Types: Formulation Pat. Sub. Date(s): All strengths: Feb 25, 2019 | Mar 28, 2037 | |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NCE - New chemical entity | Oct 15, 2019 | |
| Exclusivity Code: ODE - Orphan drug exclusivity | Oct 15, 2021 | ODE-77: Treatment of idiopathic pulmonary fibrosis |
ESBRIET (TABLET) (ORAL) PIRFENIDONE
Drug Classes: pyridone
NDA Applicant: GENENTECH INC NDA No.: 208780 Prod. No.: 002 DISC (534MG**)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 9561217 DP* Pharmaceutical composition containing as an active ingredient 5-methyl-1-phenyl-2-(1H)-pyridone Claim Types: Formulation Pat. Sub. Date(s): 002: Mar 8, 2018 | Jan 25, 2022 | |
| Pat. No. 8383150 DP* Granulate formulation of pirfenidone and pharmaceutically acceptable excipients Claim Types: Formulation; Method of use Pat. Sub. Date(s): 002: Mar 8, 2018 | Sep 22, 2026 | U-2361: Method of administering a granulate formulation of 5-methyl-1-phenyl-2-(1h)-pyridone as recited in claim 1, to treat idiopathic pulmonary fibrosis |
| Pat. No. 7767700 Method of providing pirfenidone therapy to a patient Claim Types: Method of administration; Method of improving a treatment Pat. Sub. Date(s): 002: Mar 8, 2018 | Dec 18, 2027 | U-2080: Pirfenidone dose escalation regimen for treatment of IPF as 801 mg/day for days 1-7 of the regimen, 1602 mg/day for days 8-14 of the regimen, and 2403 mg/day for at least day 15 of the regimen |
| Pat. No. 8420674 Method of providing pirfenidone therapy to a patient Claim Types: Drug in a container; Method of administration Pat. Sub. Date(s): 002: Mar 8, 2018 | Dec 18, 2027 | U-2079: Pirfenidone dose escalation regimen for treatment of fibrosis as 801 mg/day for days 1-7 of the regimen, 1602 mg/day for days 8-14 of the regimen, and 2403 mg/day for at least day 15 of the regimen |
| Pat. No. 7566729 Modifying pirfenidone treatment for patients with atypical liver function Claim Types: Method of administration Pat. Sub. Date(s): 002: Mar 8, 2018 | Apr 22, 2029 | U-2269: Dosage modification following grade 2 abnormality in liver function biomarker after pirfenidone administration, by administering sub-2400mg/day dose then full daily dose in treatment of IPF U-2270: Dosage modification following grade 2 abnormality in liver function biomarker after pirfenidone administration, by discontinuing pirfenidone until biomarkers are within normal limits, then sub-2400mg/day dose, then full daily dose in treatment of IPF |
| Pat. No. 7635707 Pirfenidone treatment for patients with atypical liver function Claim Types: Method of administration Pat. Sub. Date(s): 002: Mar 8, 2018 | Apr 22, 2029 | U-2072: Full daily dosing following grade 2 abnormality in liver function biomarker after pirfenidone administration in treatment of IPF U-2073: Dosage modification following grade 2 abnormality in liver function biomarker after pirfenidone administration, by discontinuing pirfenidone until biomarkers are within normal limits, followed by administering full daily dose in treatment of IPF U-2074: Dosing 1602 mg/day pirfenidone following grade 2 abnormality in liver function biomarker after pirfenidone administration in treatment of IPF U-2075: Dosage modification following grade 2 abnormality in liver function biomarker after pirfenidone administration, by discontinuing pirfenidone until biomarkers are within normal limits followed by administering 1602 mg/day in treatment of IPF U-2076: Dosage modification following grade 2 abnormality in liver function biomarker after pirfenidone administration, by administering 801 mg/day followed by administering 1602 mg/day in treatment of IPF U-2083: Dosage modification following grade 2 abnormality in liver function biomarker after pirfenidone administration, by discontinuing pirfenidone until biomarkers are within normal limits, followed by 801 mg/day, dose, then 1602 mg/day in treatment of IPF |
| Pat. No. 8592462 Pirfenidone treatment for patients with atypical liver function Claim Types: Method of administration Pat. Sub. Date(s): 002: Mar 8, 2018 | Apr 22, 2029 | U-2055: Dosing of at least 1600 mg/day following grade 2 liver abnormality in biomarker ast and/or alt after pirfenidone administration in treatment of IPF U-2056: Dosage modification following grade 2 abnormality in biomarker ast and/or alt after pirfenidone administration, by administering sub-1600 mg/day, following by administering at least 1600 mg/day in treatment of IPF U-2057: Dosing 2403 mg/day pirfenidone following grade 2 abnormality in biomarker ast and/or alt after pirfenidone administration in treatment of IPF U-2058: Dosage modification following grade 2 abnormality in biomarker ast and/or alt after pirfenidone administration, by administering sub-2400mg/day dose, followed by administering 2403mg/day in treatment of IPF U-2059: Dosage modification following grade 2 abnormality in biomarker ast and/or alt after pirfenidone administration, by discontinuing pirfenidone until biomarkers of liver function are within normal limits, followed by full daily dose in treatment of IPF U-2060: Dosage modification following grade 2 abnormality in biomarker ast and/or alt after pirfenidone administration, by discontinuing pirfenidone until biomarkers of liver function are within normal limits, then at least 1600mg/day in treatment of IPF U-2061: Dosing of at least 1600 mg/day following grade 2 abnormality in liver function biomarker after pirfenidone administration in treatment of IPF U-2062: Dosage modification following grade 2 abnormality in liver function biomarker after pirfenidone administration, by administering sub-1600 mg/day dose, followed by administering at least 1600 mg/day dose in treatment of IPF U-2063: Dosage modification following grade 2 abnormality in liver function biomarker after pirfenidone administration, by discontinuing pirfenidone until biomarkers are within normal limits, followed by administering at least 1600 mg/day in treatment of IPF |
| Pat. No. 8609701 Pirfenidone treatment for patients with atypical liver function Claim Types: Method of administration Pat. Sub. Date(s): 002: Mar 8, 2018 | Apr 22, 2029 | U-2064: Dosing at least 1602 mg/day following grade 2 abnormality in liver function biomarker alt or ast after pirfenidone administration U-2065: Full daily dosing following grade 2 abnormality in liver function biomarker alt or ast after pirfenidone administration U-2066: Dosage modification following grade 2 abnormality in liver function biomarker alt or ast after pirfenidone administration, by administering sub-2400 mg/day dose, followed by full daily dose U-2067: Dosage modification following grade 2 abnormality in liver function biomarker alt or ast after pirfenidone administration, by discontinuing pirfenidone, followed by administering at least 1602 mg/day U-2068: Dosage modification following grade 2 abnormality in liver function biomarker alt or ast after pirfenidone administration, by discontinuing pirfenidone until biomarkers of liver function are within normal limits, followed by full daily dose U-2069: Dosage modification following grade 2 abnormality in liver function biomarker alt or ast after pirfenidone administration, by administering a sub-1600 mg/day dose, followed by administering at least 1602 mg/day U-2070: Dosage modification following grade 2 abnormality in biomarker alt or ast after pirfenidone administration, by discontinuing pirfenidone until biomarkers of liver function are within normal limits, then sub-1600 mg/day, then at least 1602 mg/day |
| Pat. No. 7816383 Methods of administering pirfenidone therapy Claim Types: Method of administration Pat. Sub. Date(s): 002: Mar 8, 2018 | Jan 8, 2030 | U-2042: Discontinuing administration of fluvoxamine to avoid drug interactions with pirfenidone and then administering pirfenidone U-2050: Administering pirfenidone while avoiding co-administration of fluvoxamine to avoid drug interactions with pirfenidone |
| Pat. No. 7910610 Methods of administering pirfenidone therapy Claim Types: Method of administration Pat. Sub. Date(s): 002: Mar 8, 2018 | Jan 8, 2030 | U-2048: Administering pirfenidone while avoiding co-administration of a strong CYP1A2 inhibitor to avoid drug interactions with pirfenidone U-2049: Discontinuing administration of a strong CYP1A2 inhibitor to avoid drug interactions with pirfenidone and then administering pirfenidone |
| Pat. No. 8013002 Methods of administering pirfenidone therapy Claim Types: Method of administration Pat. Sub. Date(s): 002: Mar 8, 2018 | Jan 8, 2030 | U-2047: Administering pirfenidone concurrently with fluvoxamine, the pirfenidone at a dose of about 801 mg/day to reduce drug interactions with fluvoxamine U-2082: Modifying pirfenidone administration from a dose of about 2400 mg/day downward by about 1600 mg/day while co-administering fluvoxamine to reduce drug interactions with fluvoxamine |
| Pat. No. 8084475 Pirfenidone therapy and inducers of cytochrome P450 Claim Types: Method of administration Pat. Sub. Date(s): 002: Mar 8, 2018 | Jan 8, 2030 | U-2054: Administering pirfenidone while avoiding concomitant administration of a strong inducer of CYP1A2 to avoid reduced pirfenidone efficacy U-2268: Discontinuing a strong CYP1A2 inducer to avoid reduced pirfenidone efficacy and then administering pirfenidone |
| Pat. No. 8318780 Methods of administering pirfenidone therapy Claim Types: Method of administration Pat. Sub. Date(s): 002: Mar 8, 2018 | Jan 8, 2030 | U-2046: Administering pirfenidone while avoiding concomitant use of a CYP1A2 inhibitor that is a moderate to strong inhibitor of both CYP1A2 and another CYP enzyme selected from CYP2C9, CYP2C19, AND CYP2D6 U-2081: Discontinuing use of a CYP1A2 inhibitor that is a moderate to strong inhibitor of both CYP1A2 and another CYP enzyme selected from CYP2C9, CYP2C19, and CYP2D6 and then administering pirfenidone |
| Pat. No. 8648098 Pirfenidone therapy and inducers of cytochrome P450 Claim Types: Method of improving a treatment Pat. Sub. Date(s): 002: Mar 8, 2018 | Jan 8, 2030 | U-2051: Discontinuing smoking to avoid reduced pirfenidone efficacy and then administering pirfenidone U-2052: Discontinuing administration of a strong CYP1A2 inducer to avoid reduced pirfenidone efficacy and then administering pirfenidone |
| Pat. No. 8754109 Pirfenidone therapy and inducers of cytochrome P450 Claim Types: Method of improving a treatment Pat. Sub. Date(s): 002: Mar 8, 2018 | Jan 8, 2030 | U-2053: Administering pirfenidone while avoiding concomitant administration of a strong inducer of CYP1A2, including cigarette smoke, to avoid reduced pirfenidone efficacy |
| Pat. No. 8778947 Methods of administering pirfenidone therapy Claim Types: Method of administration Pat. Sub. Date(s): 002: Mar 8, 2018 | Aug 30, 2033 | U-2044: Dose reduction of pirfenidone by about one half during concurrent administration of ciprofloxacin at a dose of 750 mg twice daily (1500 mg/day) to reduce drug interactions in treatment of a fibrotic, inflammatory, or autoimmune disorder U-2045: Administration of pirfenidone and avoiding concurrent administration of ciprofloxacin at a dose of 750 mg to reduce drug interactions in treatment of a fibrotic, inflammatory, or autoimmune disorder |
| Pat. No. 10188637 DP* Granulate formulation of 5-methyl-1-phenyl-2-(1H)-pyridone and method of making the same Claim Types: Formulation Pat. Sub. Date(s): 002: Feb 25, 2019 | Mar 28, 2037 | |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NCE - New chemical entity | Oct 15, 2019 | |
| Exclusivity Code: ODE - Orphan drug exclusivity | Oct 15, 2021 | ODE-77: Treatment of idiopathic pulmonary fibrosis |
ABILIFY (TABLET) (ORAL) ARIPIPRAZOLE [GENERIC AB]
Drug Classes: atypical antipsychotic
NDA Applicant: OTSUKA NDA No.: 021436 Prod. No.: 001 RX (10MG); 002 RX (15MG); 003 RX (20MG); 004 RX (30MG); 005 RX (5MG); 006 RX (2MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7053092 5-HT1a receptor subtype agonist Claim Types: Method of use Pat. Sub. Date(s): All strengths: None | Jan 28, 2022 | U-839: Treatment of major depressive disorder (MDD) |
| Pat. No. 9089567 Method of treating cognitive impairments and schizophrenias Claim Types: Method of use Pat. Sub. Date(s): All strengths: Aug 26, 2015 | Jan 28, 2022 | U-543: Treatment of schizophrenia |
| Pat. No. 8642600 Method of treating autism Claim Types: Method of use Pat. Sub. Date(s): All strengths: Mar 5, 2014 | Jul 28, 2022 *PED | U-1492: Treatment of irritability associated with autistic disorder |
| Pat. No. 9359302 DS* DP* Low hygroscopic aripiprazole drug substance and processes for the preparation thereof Claim Types: New polymorph, salt or hydrate; Process; Product-by-process; Composition; Method of use; Kit; Formulation Pat. Sub. Date(s): All strengths: Jun 30, 2016 | Sep 25, 2022 | U-1859: Treatment of schizophrenia, acute treatment of manic and mixed episodes associated with bipolar I disorder, adjunctive treatment of major depressive disorder, and treatment of irritability associated with autistic disorder |
| Pat. No. 8580796 DS* Low hygroscopic aripiprazole drug substance and processes for the preparation thereof Claim Types: New polymorph, salt or hydrate Pat. Sub. Date(s): All strengths: None | Mar 25, 2023 *PED | |
| Pat. No. 8642760 DS* Low hygroscopic aripiprazole drug substance and processes for the preparation thereof Claim Types: Compound Pat. Sub. Date(s): All strengths: Mar 5, 2014 | Mar 25, 2023 *PED | |
| Pat. No. 9387182 Carbostyril derivatives and serotonin reuptake inhibitors for treatment of mood disorders Claim Types: Formulation; Method of use Pat. Sub. Date(s): All strengths: Aug 2, 2016 | Dec 25, 2023 | U-1529: Adjunctive treatment of major depressive disorder (MDD) |
| Pat. No. 8017615 DP* Low hygroscopic aripiprazole drug substance and processes for the preparation thereof Claim Types: Composition; Product-by-process; Process Pat. Sub. Date(s): All strengths: None | Dec 16, 2024 *PED | |
| Pat. No. 9125939 Carbostyril derivatives and mood stabilizers for treating mood disorders Claim Types: Method of use Pat. Sub. Date(s): All strengths: Oct 7, 2015 | Jul 28, 2026 | U-1749: Acute treatment of manic and mixed episodes associated with bipolar I disorder |
| Pat. No. 8759350 Carbostyril derivatives and serotonin reuptake inhibitors for treatment of mood disorders Claim Types: Formulation; Method of use Pat. Sub. Date(s): All strengths: Jul 22, 2014 | Mar 2, 2027 | U-1529: Adjunctive treatment of major depressive disorder (MDD) |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: ODE - Orphan drug exclusivity | Dec 12, 2021 | ODE-80: Treatment of pediatric patients with Tourette's |
ABILIFY (SOLUTION) (ORAL) ARIPIPRAZOLE
Drug Classes: atypical antipsychotic
NDA Applicant: OTSUKA NDA No.: 021713 Prod. No.: 001 DISC (1MG/ML**)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7053092 5-HT1a receptor subtype agonist Claim Types: Method of use Pat. Sub. Date(s): 001: None | Jan 28, 2022 | U-839: Treatment of major depressive disorder (MDD) |
| Pat. No. 8642600 Method of treating autism Claim Types: Method of use Pat. Sub. Date(s): 001: Mar 5, 2014 | Jul 28, 2022 *PED | U-1492: Treatment of irritability associated with autistic disorder |
| Pat. No. 6977257 DP* Aripiprazole oral solution Claim Types: Formulation Pat. Sub. Date(s): 001: None | Oct 24, 2022 *PED | |
| Pat. No. 9387182 Carbostyril derivatives and serotonin reuptake inhibitors for treatment of mood disorders Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Aug 2, 2016 | Dec 25, 2023 | U-1529: Adjunctive treatment of major depressive disorder (MDD) |
| Pat. No. 8759350 Carbostyril derivatives and serotonin reuptake inhibitors for treatment of mood disorders Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Jul 22, 2014 | Mar 2, 2027 | U-1529: Adjunctive treatment of major depressive disorder (MDD) |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: ODE - Orphan drug exclusivity | Dec 12, 2021 | ODE-80: Treatment of pediatric patients with Tourette's |
ABILIFY MAINTENA KIT (FOR SUSPENSION, EXTENDED RELEASE) (INTRAMUSCULAR) ARIPIPRAZOLE
Drug Classes: atypical antipsychotic
NDA Applicant: OTSUKA PHARM CO LTD NDA No.: 202971 Prod. No.: 001 RX (300MG/VIAL); 002 RX (400MG/VIAL); 003 RX (300MG); 004 RX (400MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 9089567 Method of treating cognitive impairments and schizophrenias Claim Types: Method of use Pat. Sub. Date(s): All strengths: Aug 26, 2015 | Jan 28, 2022 | U-543: Treatment of schizophrenia |
| Pat. No. 8993761 DS* Low hygroscopic aripiprazole drug substance and processes for the preparation thereof Claim Types: New polymorph, salt or hydrate; Process Pat. Sub. Date(s): All strengths: Apr 28, 2015 | Sep 25, 2022 | |
| Pat. No. 8338428 DP* Methods for administering aripiprazole Claim Types: Formulation; Method of administration Pat. Sub. Date(s): All strengths: None | Aug 6, 2023 | U-1633: Use of aripiprazole in extended release injectable suspension in treating acute episodes of schizophrenia U-543: Treatment of schizophrenia |
| Pat. No. 8759351 DP* Methods for administering aripiprazole Claim Types: Formulation; Method of use Pat. Sub. Date(s): All strengths: Jul 22, 2014 | Aug 6, 2023 | U-1530: Use of aripiprazole in extended release injectable suspension U-1633: Use of aripiprazole in extended release injectable suspension in treating acute episodes of schizophrenia |
| Pat. No. 7807680 DP* Controlled release sterile injectable aripiprazole formulation and method Claim Types: Formulation; Process Pat. Sub. Date(s): 001: None; 002: None; 003: None; 004: Oct 29, 2014 | Oct 19, 2024 | |
| Pat. No. 8030313 Controlled release sterile injectable aripiprazole formulation and method Claim Types: Method of use Pat. Sub. Date(s): All strengths: None | Oct 19, 2024 | U-1632: Treatment of schizophrenia, with efficacy in treating acute episodes of schizophrenia U-543: Treatment of schizophrenia |
| Pat. No. 8722679 DP* Controlled release sterile injectable aripiprazole formulation and method Claim Types: Formulation Pat. Sub. Date(s): 001: Jun 9, 2014; 002: Jun 9, 2014; 003: None; 004: Oct 29, 2014 | Oct 19, 2024 | |
| Pat. No. 8338427 DP* Methods for administering aripiprazole Claim Types: Formulation; Method of administration Pat. Sub. Date(s): All strengths: None | Mar 15, 2025 | U-1633: Use of aripiprazole in extended release injectable suspension in treating acute episodes of schizophrenia U-543: Treatment of schizophrenia |
| Pat. No. 8399469 DS* Low hygroscopic aripiprazole drug substance and processes for the preparation thereof Claim Types: New polymorph, salt or hydrate; Process Pat. Sub. Date(s): 001: Apr 15, 2013; 002: None; 003: None; 004: Oct 29, 2014 | Jun 29, 2025 | |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: I - New Indication | Jul 27, 2020 | I-746: New indication of maintenance monotherapy treatment of bipolar I disorder in adults |
ABILIFY MYCITE KIT (TABLET) (ORAL) ARIPIPRAZOLE [Has competitive generic]
Drug Classes: atypical antipsychotic
NDA Applicant: OTSUKA PHARM CO LTD NDA No.: 207202 Prod. No.: 001 RX (2MG); 002 RX (5MG); 003 RX (10MG); 004 RX (15MG); 005 RX (20MG); 006 RX (30MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7053092 5-HT1a receptor subtype agonist Claim Types: Method of use Pat. Sub. Date(s): All strengths: Dec 12, 2017 | Jan 28, 2022 | U-1529: Adjunctive treatment of major depressive disorder (MDD) |
| Pat. No. 9089567 Method of treating cognitive impairments and schizophrenias Claim Types: Method of use Pat. Sub. Date(s): All strengths: Dec 12, 2017 | Jan 28, 2022 | U-543: Treatment of schizophrenia |
| Pat. No. 8580796 DS* Low hygroscopic aripiprazole drug substance and processes for the preparation thereof Claim Types: New polymorph, salt or hydrate Pat. Sub. Date(s): All strengths: Dec 12, 2017 | Sep 25, 2022 | |
| Pat. No. 8642760 DS* Low hygroscopic aripiprazole drug substance and processes for the preparation thereof Claim Types: Compound Pat. Sub. Date(s): All strengths: Dec 12, 2017 | Sep 25, 2022 | |
| Pat. No. 9359302 DS* DP* Low hygroscopic aripiprazole drug substance and processes for the preparation thereof Claim Types: New polymorph, salt or hydrate; Process; Product-by-process; Composition; Method of use; Kit; Formulation Pat. Sub. Date(s): All strengths: Dec 12, 2017 | Sep 25, 2022 | U-1529: Adjunctive treatment of major depressive disorder (MDD) U-1749: Acute treatment of manic and mixed episodes associated with bipolar I disorder U-543: Treatment of schizophrenia |
| Pat. No. 9387182 Carbostyril derivatives and serotonin reuptake inhibitors for treatment of mood disorders Claim Types: Formulation; Method of use Pat. Sub. Date(s): All strengths: Dec 12, 2017 | Dec 25, 2023 | U-1529: Adjunctive treatment of major depressive disorder (MDD) |
| Pat. No. 8017615 DP* Low hygroscopic aripiprazole drug substance and processes for the preparation thereof Claim Types: Composition; Product-by-process; Process Pat. Sub. Date(s): All strengths: Dec 12, 2017 | Jun 16, 2024 | |
| Pat. No. 9125939 Carbostyril derivatives and mood stabilizers for treating mood disorders Claim Types: Method of use Pat. Sub. Date(s): All strengths: Dec 12, 2017 | Jul 28, 2026 | U-1749: Acute treatment of manic and mixed episodes associated with bipolar I disorder |
| Pat. No. 7978064 DP* Communication system with partial power source Claim Types: Device; Process Pat. Sub. Date(s): All strengths: Dec 12, 2017 | Sep 14, 2026 | |
| Pat. No. 8759350 Carbostyril derivatives and serotonin reuptake inhibitors for treatment of mood disorders Claim Types: Formulation; Method of use Pat. Sub. Date(s): All strengths: Dec 12, 2017 | Mar 2, 2027 | U-1529: Adjunctive treatment of major depressive disorder (MDD) |
| Pat. No. 9444503 DP* Active signal processing personal health signal receivers Claim Types: Device; Method of use Pat. Sub. Date(s): All strengths: Dec 12, 2017 | Nov 19, 2027 | U-2169: Method of using a receiver to identify a signal from a tablet embedded with a sensor that communicates information through the body of a patient |
| Pat. No. 9119554 DP* Pharma-informatics system Claim Types: Device; Process Pat. Sub. Date(s): All strengths: Dec 12, 2017 | Dec 16, 2028 | |
| Pat. No. 9060708 DP* Multi-mode communication ingestible event markers and systems, and methods of using the same Claim Types: Device Pat. Sub. Date(s): All strengths: Dec 12, 2017 | Mar 5, 2029 | |
| Pat. No. 9258035 DP* Multi-mode communication ingestible event markers and systems, and methods of using the same Claim Types: Device Pat. Sub. Date(s): All strengths: Dec 12, 2017 | Mar 5, 2029 | |
| Pat. No. 8674825 DP* Pharma-informatics system Claim Types: Device; Method of use Pat. Sub. Date(s): All strengths: Dec 12, 2017 | Apr 9, 2029 | U-2170: Method of using a receiver to receive a signal from a tablet embedded with a sensor that communicates information through the body of a patient |
| Pat. No. 10441194 DP* Ingestible event marker systems Claim Types: Device Pat. Sub. Date(s): All strengths: Nov 1, 2019 | May 12, 2029 | |
| Pat. No. 8956288 DP* In-body power source having high surface area electrode Claim Types: Device; Method-of-use; Process Pat. Sub. Date(s): All strengths: Dec 12, 2017 | Jul 6, 2029 | U-2167: Method of using a tablet embedded with a sensor that communicates information via a signal through the body of a patient to a receiver |
| Pat. No. 8945005 DP* Controlled activation ingestible identifier Claim Types: Device; Method of use Pat. Sub. Date(s): All strengths: Dec 12, 2017 | Aug 19, 2029 | U-2167: Method of using a tablet embedded with a sensor that communicates information via a signal through the body of a patient to a receiver |
| Pat. No. 9433371 DP* In-body device with virtual dipole signal amplification Claim Types: Device Pat. Sub. Date(s): All strengths: Dec 12, 2017 | Sep 15, 2029 | |
| Pat. No. 8718193 DP* Active signal processing personal health signal receivers Claim Types: Device Pat. Sub. Date(s): All strengths: Dec 12, 2017 | Dec 5, 2029 | |
| Pat. No. 9149577 DP* Body-associated receiver and method Claim Types: Device Pat. Sub. Date(s): All strengths: Dec 12, 2017 | Dec 15, 2029 | |
| Pat. No. 8847766 DP* Pharma-informatics system Claim Types: Device; Method of use Pat. Sub. Date(s): All strengths: Dec 12, 2017 | Mar 29, 2030 | U-2167: Method of using a tablet embedded with a sensor that communicates information via a signal through the body of a patient to a receiver |
| Pat. No. 8545402 DP* Highly reliable ingestible event markers and methods for using the same Claim Types: Device Pat. Sub. Date(s): All strengths: Dec 12, 2017 | Apr 27, 2030 | |
| Pat. No. 8114021 DP* Body-associated receiver and method Claim Types: Device Pat. Sub. Date(s): All strengths: Dec 12, 2017 | Jun 21, 2030 | |
| Pat. No. 9941931 DP* System for supply chain management Claim Types: Device Pat. Sub. Date(s): All strengths: May 7, 2018 | Nov 4, 2030 | |
| Pat. No. 8961412 DP* In-body device with virtual dipole signal amplification Claim Types: Device Pat. Sub. Date(s): All strengths: Dec 12, 2017 | Nov 17, 2030 | |
| Pat. No. 8258962 DP* Multi-mode communication ingestible event markers and systems, and methods of using the same Claim Types: Device Pat. Sub. Date(s): All strengths: Dec 12, 2017 | Nov 25, 2030 | |
| Pat. No. 8547248 DP* Implantable zero-wire communications system Claim Types: Device; Method of use; Kit Pat. Sub. Date(s): All strengths: Dec 12, 2017 | Dec 18, 2030 | U-2167: Method of using a tablet embedded with a sensor that communicates information via a signal through the body of a patient to a receiver |
| Pat. No. 9320455 DP* Highly reliable ingestible event markers and methods for using the same Claim Types: Device Pat. Sub. Date(s): All strengths: Dec 12, 2017 | Dec 15, 2031 | |
| Pat. No. 9577864 DP* Method and apparatus for use with received electromagnetic signal at a frequency not known exactly in advance Claim Types: Method of use Pat. Sub. Date(s): All strengths: Dec 12, 2017 | Oct 3, 2033 | U-2169: Method of using a receiver to identify a signal from a tablet embedded with a sensor that communicates information through the body of a patient |
| Pat. No. 9268909 DP* Apparatus, system, and method to adaptively optimize power dissipation and broadcast power in a power source for a communication device Claim Types: Method of use Pat. Sub. Date(s): All strengths: Dec 12, 2017 | Oct 15, 2033 | U-2168: Method of using a logic circuit to stabilize battery voltage supplied to a sensor embedded with a tablet and that communicates information via a signal through the body of a patient to a receiver |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: I - New Indication | Jul 27, 2020 | I-746: New indication of maintenance monotherapy treatment of bipolar I disorder in adults |
VEMLIDY (TABLET) (ORAL) TENOFOVIR ALAFENAMIDE FUMARATE
Drug Classes: HBV nucleoside analog reverse transcriptase inhibitor (HBV- NRTI); HIV nucleoside analog reverse transcriptase inhibitor (HIV-1 NRTI)
NDA Applicant: GILEAD SCIENCES INC NDA No.: 208464 Prod. No.: 001 RX (EQ 25MG BASE)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7803788 Prodrugs of phosphonate nucoleotide analogues Claim Types: Method of use Pat. Sub. Date(s): 001: Nov 28, 2016 | Feb 2, 2022 | U-999: Treatment of chronic hepatitis B in adult patients |
| Pat. No. 7390791 DS* DP* Prodrugs of phosphonate nucleotide analogues Claim Types: Compound; Composition; Formulation Pat. Sub. Date(s): 001: Nov 28, 2016 | May 7, 2022 | |
| Pat. No. 8754065 DS* DP* Tenofovir alafenamide hemifumarate Claim Types: Compound; New polymorph, salt or hydrate; Composition; Method of use; Process Pat. Sub. Date(s): 001: Nov 28, 2016 | Aug 15, 2032 | U-999: Treatment of chronic hepatitis B in adult patients |
| Pat. No. 9296769 DS* DP* Tenofovir alafenamide hemifumarate Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Nov 28, 2016 | Aug 15, 2032 | U-999: Treatment of chronic hepatitis B in adult patients |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NCE - New chemical entity | Nov 5, 2020 | |
| Exclusivity Code: NP - New product | Nov 11, 2019 |
SUBOXONE (FILM) (BUCCAL, SUBLINGUAL) BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE [GENERIC AB]
Drug Classes: partial opioid agonist; opioid antagonist
NDA Applicant: INDIVIOR INC NDA No.: 022410 Prod. No.: 001 RX (EQ 2MG BASE;EQ 0.5MG BASE); 002 RX (EQ 8MG BASE;EQ 2MG BASE); 003 RX (EQ 4MG BASE;EQ 1MG BASE); 004 RX (EQ 12MG BASE;EQ 3MG BASE)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 9855221 DP* Uniform films for rapid-dissolve dosage form incorporating anti-tacking compositions Claim Types: Formulation Pat. Sub. Date(s): All strengths: Jan 3, 2018 | Feb 14, 2022 | |
| Pat. No. 9931305 DP* Uniform films for rapid dissolve dosage form incorporating taste-masking compositions Claim Types: Formulation Pat. Sub. Date(s): All strengths: Apr 3, 2018 | Feb 14, 2022 | |
| Pat. No. 10285910 DP* Sublingual and buccal film compositions Claim Types: Formulation Pat. Sub. Date(s): All strengths: Jun 7, 2019 | Oct 11, 2022 | |
| Pat. No. 8017150 DP* Polyethylene oxide-based films and drug delivery systems made therefrom Claim Types: Formulation Pat. Sub. Date(s): 001: Oct 4, 2011; 002: None; 003: None; 004: None | Feb 13, 2023 | |
| Pat. No. 8603514 DP* Uniform films for rapid dissolve dosage form incorporating taste-masking compositions Claim Types: Formulation Pat. Sub. Date(s): All strengths: None | Apr 3, 2024 | U-1464: Treatment of opioid dependence/sublingual or buccal application |
| Pat. No. 9687454 DP* Sublingual and buccal film compositions Claim Types: Formulation; Method of use Pat. Sub. Date(s): All strengths: Jul 14, 2017 | Aug 7, 2029 | U-1464: Treatment of opioid dependence/sublingual or buccal application |
| Pat. No. 8475832 DP* Sublingual and buccal film compositions Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Jul 3, 2013; 002: None; 003: None; 004: None | Mar 26, 2030 | U-1411: This drug is administered by sublingual route to humans for maintenance treatment of opioid dependence |
LEVOXYL (TABLET) (ORAL) LEVOTHYROXINE SODIUM [Has competitive generic]
Drug Classes: L-thyroxine (T4)
NDA Applicant: KING PHARMS NDA No.: 021301 Prod. No.: 001 RX (0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium); 002 RX (0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium); 003 RX (0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium); 004 RX (0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium); 005 RX (0.1MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium); 006 RX (0.112MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium); 007 RX (0.125MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium); 008 RX (0.137MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium); 009 RX (0.15MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium); 010 RX (0.175MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium); 011 RX (0.2MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium) NDA No.: 021301 Prod. No.: 012 DISC (0.3MG**)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6555581 Levothyroxine compositions and methods Claim Types: Formulation Pat. Sub. Date(s): All strengths: None | Feb 15, 2022 | |
| Pat. No. 7067148 DP* Stabilized pharmaceutical and thyroid hormone compositions and method of preparation Claim Types: Formulation; Process Pat. Sub. Date(s): All strengths: None | Feb 15, 2022 | |
| Pat. No. 7101569 Methods of administering levothyroxine pharmaceutical compositions Claim Types: Method of use Pat. Sub. Date(s): All strengths: None | Oct 2, 2023 | U-759: Method of use of administering levothyroxine |
PREVACID IV (INJECTABLE) (INTRAVENOUS) LANSOPRAZOLE
Drug Classes: proton pump inhibitor
NDA Applicant: TAKEDA PHARMS NA NDA No.: 021566 Prod. No.: 001 DISC (30MG/VIAL**)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7396841 DP* Injections Claim Types: Formulation; Process; Method of use Pat. Sub. Date(s): 001: None | Feb 17, 2022 *PED | U-947: When patients are unable to take the oral formulations, PREVACID IV, for injection is indicated as an alternative for the short-term treatment (up to 7 days) of all grades of erosive esophagitis |
METROGEL (GEL) (TOPICAL) METRONIDAZOLE [GENERIC AB]
Drug Classes: nitroimidazole antimicrobial
NDA Applicant: GALDERMA LABS LP NDA No.: 021789 Prod. No.: 001 RX (1%)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6881726 DP* Aqueous compositions containing metronidazole Claim Types: Formulation; Drug in a container; Process; Product-by-process; Method of use Pat. Sub. Date(s): 001: None | Feb 21, 2022 | U-743: Once a day topical treatment of the inflammatory lesions of rosacea |
| Pat. No. 7348317 DP* Aqueous compositions containing metronidazole Claim Types: Method of use; Kit; Formulation; Process Pat. Sub. Date(s): 001: None | Feb 21, 2022 | U-743: Once a day topical treatment of the inflammatory lesions of rosacea |
OCALIVA (TABLET) (ORAL) OBETICHOLIC ACID
Drug Classes: farnesoid X receptor (FXR) agonist
NDA Applicant: INTERCEPT PHARMS INC NDA No.: 207999 Prod. No.: 001 RX (5MG); 002 RX (10MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8058267 Steroids as agonists for FXR Claim Types: Method of use Pat. Sub. Date(s): All strengths: Jun 22, 2016 | Feb 21, 2022 | U-1854: Treatment of primary biliary cholangitis (PBC) |
| Pat. No. 8377916 Steroids as agonists for FXR Claim Types: Method of use Pat. Sub. Date(s): All strengths: Jun 22, 2016 | Feb 21, 2022 | U-1854: Treatment of primary biliary cholangitis (PBC) |
| Pat. No. 7138390 DS* DP* Steroids as agonists for FXR Claim Types: Compound; Formulation; Method of use Pat. Sub. Date(s): All strengths: Jun 22, 2016 | Nov 16, 2022 | |
| Pat. No. 9238673 DP* Preparation and uses of obeticholic acid Claim Types: Composition Pat. Sub. Date(s): All strengths: Jun 22, 2016 | Jun 17, 2033 | |
| Pat. No. 10174073 DS* Preparation and uses of obeticholic acid Claim Types: Product-by-process Pat. Sub. Date(s): All strengths: Jan 15, 2019 | Jun 17, 2033 | |
| Pat. No. 10047117 Preparation and uses of obeticholic acid Claim Types: Method of use Pat. Sub. Date(s): All strengths: Nov 14, 2018 | Sep 6, 2033 | U-1854: Treatment of primary biliary cholangitis (PBC) |
| Pat. No. 10052337 DP* Compositions of obeticholic acid and methods of use Claim Types: Formulation; Process Pat. Sub. Date(s): All strengths: Nov 8, 2018 | Apr 26, 2036 | |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NCE - New chemical entity | May 27, 2021 | |
| Exclusivity Code: ODE - Orphan drug exclusivity | May 27, 2023 | ODE-119: Treatment of primary biliary cholangitis (PBC) in combination with ursodeoxycholic acid (udca) in adults with an inadequate response to udca, or as monotherapy in adults unable to tolerate udca |
PEPCID AC (TABLET, CHEWABLE) (ORAL) FAMOTIDINE
Drug Classes: histamine-2 (H2) receptor antagonist
NDA Applicant: J AND J CONSUMER INC NDA No.: 020801 Prod. No.: 002 OTC (20MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6814978 DP* Process for preparing a soft tablet Claim Types: Formulation; Process Pat. Sub. Date(s): 002: None | Feb 26, 2022 *PED |
PEPCID COMPLETE (TABLET, CHEWABLE) (ORAL) CALCIUM CARBONATE; FAMOTIDINE; MAGNESIUM HYDROXIDE [GENERIC OTC]
Drug Classes: histamine-2 (H2) receptor antagonist
NDA Applicant: J AND J CONSUMER INC NDA No.: 020958 Prod. No.: 001 OTC (800MG;10MG;165MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6814978 DP* Process for preparing a soft tablet Claim Types: Formulation; Process Pat. Sub. Date(s): 001: None | Feb 26, 2022 *PED |
PRISTIQ (TABLET, EXTENDED RELEASE) (ORAL) DESVENLAFAXINE SUCCINATE [GENERIC AB]
Drug Classes: serotonin and norepinephrine reuptake inhibitor (SNRI)
NDA Applicant: PF PRISM CV NDA No.: 021992 Prod. No.: 001 RX (EQ 50MG BASE); 002 RX (EQ 100MG BASE); 003 RX (EQ 25MG BASE)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6673838 DS* [Extended 18 days (0 years)] Succinate salt of O-desmethyl-venlafaxine Claim Types: Compound; New polymorph, salt or hydrate; Composition; Formulation; Method of use Pat. Sub. Date(s): 001: None; 002: None; 003: Feb 2, 2015 | Mar 1, 2022 | U-1364: Maintenance treatment of major depressive disorder (MDD) U-860: For the approved uses and conditions of use, including depression |
| Pat. No. 8269040 DS* Derivatives of venlafaxine and methods of preparing and using the same Claim Types: Compound Pat. Sub. Date(s): 001: None; 002: None; 003: Feb 2, 2015 | Jul 5, 2027 | |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: M - Miscellaneous | Feb 6, 2021 | M-222: Addition of data based on the assessment of safety and efficacy in pediatric patients with major depressive disorder to fulfill postmarketing study requirement 1229-1 |
FUSILEV (POWDER; SOLUTION) (INTRAVENOUS) LEVOLEUCOVORIN CALCIUM [GENERIC AP]
Drug Classes: folate analog
NDA Applicant: ACROTECH NDA No.: 020140 Prod. No.: 001 RX (EQ 50MG BASE/VIAL) NDA No.: 020140 Prod. No.: 002 DISC (EQ 175MG BASE/17.5ML (EQ 10MG BASE/ML)**); 003 DISC (EQ 250MG BASE/25ML (EQ 10MG BASE/ML)**)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6500829 DS* DP* [Extended 797 days (2.2 years)] Substantially pure diastereoisomers of tetrahydrofolate derivatives Claim Types: Formulation Pat. Sub. Date(s): 001: None; 002: May 9, 2011; 003: May 9, 2011 | Mar 7, 2022 |
VIMPAT (TABLET) (ORAL) LACOSAMIDE
Drug Classes: antiepileptic drug (AED)
NDA Applicant: UCB INC NDA No.: 022253 Prod. No.: 001 RX (50MG); 002 RX (100MG); 003 RX (150MG); 004 RX (200MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. RE38551 DS* DP* [Extended 5 years] Anticonvulsant enantiomeric amino acid derivatives Claim Types: Compound; Composition; Method of use Pat. Sub. Date(s): All strengths: None | Mar 17, 2022 | U-1567: Method of treating, as initial loading dose for monotherapy or adjunctive therapy, partial onset-seizures in a patient with epilepsy aged 17 years or older U-2140: Method of treating partial onset seizures in patients 4 years of age and older |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NPP - New patient population | Nov 3, 2020 |
VIMPAT (SOLUTION) (INTRAVENOUS) LACOSAMIDE
Drug Classes: antiepileptic drug (AED)
NDA Applicant: UCB INC NDA No.: 022254 Prod. No.: 001 RX (200MG/20ML (10MG/ML))
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. RE38551 DS* DP* [Extended 5 years] Anticonvulsant enantiomeric amino acid derivatives Claim Types: Compound; Composition; Method of use Pat. Sub. Date(s): 001: None | Mar 17, 2022 | U-1565: Method of treating, as initial loading dose for monotherapy or adjunctive therapy, partial onset-seizures in a patient with epilepsy aged 17 years or older when oral administration is temporarily not feasible U-1568: Method of treating, as monotherapy or adjunctive therapy, partial-onset seizures in a patient with epilepsy aged 17 years and older when oral administration is temporarily not feasible |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: M - Miscellaneous | Nov 3, 2020 | M-217: Incorporation of the labeling revisions provided for in NDA 022253/S-039 and NDA 022255/S-022 into the lacosamide injection labeling |
VIMPAT (SOLUTION) (ORAL) LACOSAMIDE
Drug Classes: antiepileptic drug (AED)
NDA Applicant: UCB INC NDA No.: 022255 Prod. No.: 001 RX (10MG/ML)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. RE38551 DS* DP* [Extended 5 years] Anticonvulsant enantiomeric amino acid derivatives Claim Types: Compound; Composition; Method of use Pat. Sub. Date(s): 001: None | Mar 17, 2022 | U-1567: Method of treating, as initial loading dose for monotherapy or adjunctive therapy, partial onset-seizures in a patient with epilepsy aged 17 years or older U-2140: Method of treating partial onset seizures in patients 4 years of age and older |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NPP - New patient population | Nov 3, 2020 |
APIDRA (INJECTABLE) (INTRAVENOUS, SUBCUTANEOUS) INSULIN GLULISINE RECOMBINANT
Drug Classes: insulin analog
NDA Applicant: SANOFI AVENTIS US NDA No.: 021629 Prod. No.: 001 RX (1000 UNITS/10ML (100 UNITS/ML)) NDA No.: 021629 Prod. No.: 002 DISC (300 UNITS/3ML (100 UNITS/ML))
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7452860 DP* Zinc-free and low-zinc insulin preparations having improved stability Claim Types: Formulation Pat. Sub. Date(s): All strengths: None | Mar 22, 2022 | |
| Pat. No. 7696162 DP* Zinc-free and low-zinc insulin preparations having improved stability Claim Types: Formulation; Method of use Pat. Sub. Date(s): All strengths: None | Mar 22, 2022 | U-471: Method of treating a patient suffering from diabetes mellitus |
| Pat. No. 6960561 DP* Zinc-free and low-zinc insulin preparations having improved stability Claim Types: Formulation; Process Pat. Sub. Date(s): All strengths: None | Jan 25, 2023 | U-471: Method of treating a patient suffering from diabetes mellitus |
APIDRA SOLOSTAR (INJECTABLE) (SUBCUTANEOUS) INSULIN GLULISINE RECOMBINANT
Drug Classes: insulin analog
NDA Applicant: SANOFI AVENTIS US NDA No.: 021629 Prod. No.: 003 RX (300 UNITS/3ML)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7452860 DP* Zinc-free and low-zinc insulin preparations having improved stability Claim Types: Formulation Pat. Sub. Date(s): 003: None | Mar 22, 2022 | |
| Pat. No. 7696162 DP* Zinc-free and low-zinc insulin preparations having improved stability Claim Types: Formulation; Method of use Pat. Sub. Date(s): 003: None | Mar 22, 2022 | U-471: Method of treating a patient suffering from diabetes mellitus |
| Pat. No. 6960561 DP* Zinc-free and low-zinc insulin preparations having improved stability Claim Types: Formulation; Process Pat. Sub. Date(s): 003: None | Jan 25, 2023 | U-471: Method of treating a patient suffering from diabetes mellitus |
| Pat. No. 8603044 DP* Pen-type injector Claim Types: Device Pat. Sub. Date(s): 003: Jan 6, 2014 | Mar 2, 2024 | |
| Pat. No. 9233211 DP* Relating to a pen-type injector Claim Types: Device Pat. Sub. Date(s): 003: Jan 13, 2016 | Mar 2, 2024 | |
| Pat. No. 9408979 DP* Pen-type injector Claim Types: Device Pat. Sub. Date(s): 003: Sep 15, 2016 | Mar 2, 2024 | |
| Pat. No. 9526844 DP* Pen-type injector Claim Types: Device Pat. Sub. Date(s): 003: Dec 27, 2016 | Mar 2, 2024 | |
| Pat. No. 9604008 DP* Drive mechanisms suitable for use in drug delivery devices Claim Types: Device Pat. Sub. Date(s): 003: Mar 28, 2017 | Mar 2, 2024 | |
| Pat. No. 9610409 DP* Drive mechanisms suitable for use in drug delivery devices Claim Types: Device Pat. Sub. Date(s): 003: Apr 4, 2017 | Mar 2, 2024 | |
| Pat. No. 9775954 DP* Pen-type injector Claim Types: Device Pat. Sub. Date(s): 003: Oct 3, 2017 | Mar 2, 2024 | |
| Pat. No. 9827379 DP* Drive mechanisms suitable for use in drug delivery devices Claim Types: Device; Method of administration Pat. Sub. Date(s): 003: Nov 28, 2017 | Mar 2, 2024 | U-2146: Improvement in glycemic control in diabetes mellitus patients by use of a pen injector with a rotating drive sleeve |
| Pat. No. 8556864 DP* Drive mechanisms suitable for use in drug delivery devices Claim Types: Device Pat. Sub. Date(s): 003: Nov 6, 2013 | Mar 3, 2024 | |
| Pat. No. 9011391 Pen-type injector Claim Types: Method of use Pat. Sub. Date(s): 003: May 1, 2015 | Mar 26, 2024 | U-1832: Improvement in glycemic control in diabetes mellitus patients by use of a pen injector with a threaded drive sleeve |
| Pat. No. 8992486 DP* Pen-type injector Claim Types: Device Pat. Sub. Date(s): 003: Apr 9, 2015 | Jun 5, 2024 | |
| Pat. No. 9604009 DP* Drive mechanisms suitable for use in drug delivery devices Claim Types: Device Pat. Sub. Date(s): 003: Mar 28, 2017 | Aug 16, 2024 | |
| Pat. No. 9533105 DP* Drive mechanisms suitable for use in drug delivery devices Claim Types: Device Pat. Sub. Date(s): 003: Jan 3, 2017 | Aug 17, 2024 | |
| Pat. No. 9623189 DP* Relating to drive mechanisms suitable for use in drug delivery devices Claim Types: Device Pat. Sub. Date(s): 003: Apr 18, 2017 | Aug 19, 2024 | |
| Pat. No. 9561331 DP* Drive mechanisms suitable for use in drug delivery devices Claim Types: Device Pat. Sub. Date(s): 003: Feb 7, 2017 | Aug 28, 2024 | |
| Pat. No. 8512297 DP* Pen-type injector Claim Types: Device Pat. Sub. Date(s): 003: Aug 21, 2013 | Sep 15, 2024 | |
| Pat. No. 8679069 DP* Pen-type injector Claim Types: Device Pat. Sub. Date(s): 003: Mar 25, 2014 | Apr 12, 2025 | |
| Pat. No. 7918833 DP* Pen-type injector Claim Types: Device Pat. Sub. Date(s): 003: None | Sep 23, 2027 | |
| Pat. No. 9717852 DP* Cartridge holder and pen-type injector Claim Types: Device Pat. Sub. Date(s): 003: Jul 11, 2018 | Apr 8, 2033 |
SPIRIVA (POWDER) (INHALATION) TIOTROPIUM BROMIDE
Drug Classes: anticholinergic
NDA Applicant: BOEHRINGER INGELHEIM NDA No.: 021395 Prod. No.: 001 RX (EQ 0.018MG BASE/INH)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6777423 DS* DP* Crystalline tiotropium bromide monohydrate, processes for the preparation thereof, and pharmaceutical compositions Claim Types: New polymorph, salt or hydrate; Process Pat. Sub. Date(s): 001: None | Mar 24, 2022 *PED | |
| Pat. No. 6908928 DS* DP* Crystalline tiotropium bromide monohydrate, processes for the preparation thereof,and pharmaceutical compositions Claim Types: Composition; Product-by-process; Method of use Pat. Sub. Date(s): 001: None | Mar 24, 2022 *PED | U-566: For the long-term, once-daily, maintenance treatment of bronchospasm associated with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema U-762: Treatment of chronic obstructive pulmonary disease |
| Pat. No. 7309707 DS* DP* Crystalline micronisate, process for the manufacture thereof and use thereof for the preparation of a medicament Claim Types: New polymorph, salt or hydrate; Process Pat. Sub. Date(s): 001: None | Mar 24, 2022 *PED | |
| Pat. No. 7642268 DS* DP* Crystalline micronisate, process for the manufacture thereof and use thereof for the preparation of a medicament Claim Types: Composition; Formulation Pat. Sub. Date(s): 001: None | Mar 24, 2022 *PED | |
| Pat. No. RE38912 DP* Process for preparing powder formulations Claim Types: Product-by-process; Process Pat. Sub. Date(s): 001: None | Apr 11, 2022 *PED | |
| Pat. No. 7070800 DP* Inhalable powder containing tiotropium Claim Types: Formulation; Process; Method of use Pat. Sub. Date(s): 001: None | Jul 22, 2022 *PED | U-566: For the long-term, once-daily, maintenance treatment of bronchospasm associated with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema |
| Pat. No. 8022082 DP* Method for the administration of an anticholinergic by inhalation Claim Types: Method of administration; Kit Pat. Sub. Date(s): 001: Oct 24, 2011 | Jul 19, 2026 *PED | U-1186: Administration of an inhalable powder comprising tiotropium via device |
| Pat. No. 7694676 DP* Dry powder inhaler Claim Types: Device Pat. Sub. Date(s): 001: Jun 13, 2011 | Sep 12, 2027 *PED | |
| Pat. No. 9010323 DP* Inhaler and sieve for an inhaler Claim Types: Device Pat. Sub. Date(s): 001: Apr 20, 2017 | Apr 19, 2030 |
TRULANCE (TABLET) (ORAL) PLECANATIDE
Drug Classes: guanylate cyclase-C agonist
NDA Applicant: SALIX NDA No.: 208745 Prod. No.: 001 RX (3MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8637451 Guanylate cyclase receptor agonists for the treatment of tissue inflammation and carcinogenesis Claim Types: Method of use Pat. Sub. Date(s): 001: Feb 14, 2017 | Mar 28, 2022 | U-1964: Elevation of intracellular cGMP resulting in increased intestinal fluid and accelerated transit |
| Pat. No. 7799897 DS* Guanylate cyclase receptor agonists for the treatment of tissue inflammation and carcinogenesis Claim Types: Compound; Composition; Formulation Pat. Sub. Date(s): 001: Feb 14, 2017 | Jun 9, 2022 | |
| Pat. No. 7041786 DS* Guanylate cyclase receptor agonists for the treatment of tissue inflammation and carcinogenesis Claim Types: Compound; Formulation Pat. Sub. Date(s): 001: Feb 14, 2017 | Mar 25, 2023 | |
| Pat. No. 9610321 Formulations of guanylate cyclase C agonists and methods of use Claim Types: Method of use Pat. Sub. Date(s): 001: May 1, 2017 | Sep 15, 2031 | U-1999: Chronic idiopathic constipation U-2230: Irritable bowel syndrome with constipation |
| Pat. No. 9919024 Formulations of guanylate cyclase C agonists and methods of use Claim Types: Method of use Pat. Sub. Date(s): 001: Apr 10, 2018 | Sep 15, 2031 | U-1999: Chronic idiopathic constipation U-2230: Irritable bowel syndrome with constipation |
| Pat. No. 9925231 DP* Formulations of guanylate cyclase C agonists and methods of use Claim Types: Formulation Pat. Sub. Date(s): 001: Apr 10, 2018 | Sep 15, 2031 | |
| Pat. No. 9616097 DP* Formulations of guanylate cyclase C agonists and methods of use Claim Types: Formulation Pat. Sub. Date(s): 001: May 1, 2017 | Jul 2, 2032 | |
| Pat. No. 10011637 DS* Ultra-pure agonists of guanylate cyclase C, method of making and using same Claim Types: Formulation; Process Pat. Sub. Date(s): 001: Jul 19, 2018 | Jun 5, 2034 | |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: I - New Indication | Jan 24, 2021 | I-764: Treatment in adult patients for irritable bowel syndrome with constipation (IBS-C) |
| Exclusivity Code: NCE - New chemical entity | Jan 19, 2022 |
ARESTIN (POWDER, EXTENDED RELEASE) (DENTAL) MINOCYCLINE HYDROCHLORIDE
Drug Classes: tetracycline-class drug
NDA Applicant: ORAPHARMA NDA No.: 050781 Prod. No.: 001 RX (EQ 1MG BASE)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6682348 DP* Dispensing apparatus and cartridge Claim Types: Device; Method of use Pat. Sub. Date(s): 001: May 24, 2012 | Mar 29, 2022 | |
| Pat. No. 7699609 DP* Dispensing apparatus and cartridge with deformable tip Claim Types: Device Pat. Sub. Date(s): 001: Mar 26, 2015 | Mar 29, 2022 |
ORACEA (CAPSULE) (ORAL) DOXYCYCLINE
Drug Classes: tetracycline-class drug
NDA Applicant: GALDERMA LABS LP NDA No.: 050805 Prod. No.: 001 RX (40MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7211267 Methods of treating acne Claim Types: Method of use Pat. Sub. Date(s): 001: None | Apr 5, 2022 | U-925: Treatment of only inflammatory lesions (papules and pustules) of rosacea |
| Pat. No. 7232572 Methods of treating rosacea Claim Types: Method of use Pat. Sub. Date(s): 001: None | Apr 5, 2022 | U-925: Treatment of only inflammatory lesions (papules and pustules) of rosacea |
| Pat. No. 8603506 Methods of treating acne Claim Types: Method of use Pat. Sub. Date(s): 001: None | Apr 5, 2022 | U-1063: Treatment of only inflammatory lesions (papules and pustules) of rosacea |
| Pat. No. 9241946 Methods of treating acne Claim Types: Method of use Pat. Sub. Date(s): 001: Feb 3, 2016 | Apr 5, 2022 | U-1063: Treatment of only inflammatory lesions (papules and pustules) of rosacea |
| Pat. No. 10058564 Methods of treating acne Claim Types: Method of use Pat. Sub. Date(s): 001: Sep 25, 2018 | Apr 5, 2022 | U-1063: Treatment of only inflammatory lesions (papules and pustules) of rosacea |
| Pat. No. 8394405 DP* Once daily formulations of tetracyclines Claim Types: Formulation; Method of use; Process Pat. Sub. Date(s): 001: Mar 25, 2013 | Apr 7, 2024 | U-925: Treatment of only inflammatory lesions (papules and pustules) of rosacea |
| Pat. No. 8394406 DP* Once daily formulations of tetracyclines Claim Types: Formulation; Method of use; Process Pat. Sub. Date(s): 001: Mar 25, 2013 | Apr 7, 2024 | U-925: Treatment of only inflammatory lesions (papules and pustules) of rosacea |
| Pat. No. 8470364 DP* Once daily formulations of tetracyclines Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Jun 26, 2013 | Apr 7, 2024 | U-925: Treatment of only inflammatory lesions (papules and pustules) of rosacea |
| Pat. No. 8709478 Once daily formulations of tetracyclines Claim Types: Method of use Pat. Sub. Date(s): 001: Apr 30, 2014 | Apr 7, 2024 | U-1063: Treatment of only inflammatory lesions (papules and pustules) of rosacea |
| Pat. No. 8206740 DP* Once daily formulations of tetracyclines Claim Types: Formulation; Method of use; Process Pat. Sub. Date(s): 001: None | Dec 24, 2025 | U-925: Treatment of only inflammatory lesions (papules and pustules) of rosacea |
| Pat. No. 7749532 DP* Once daily formulations of tetracyclines Claim Types: Formulation; Method of use; Process Pat. Sub. Date(s): 001: None | Dec 19, 2027 | U-1063: Treatment of only inflammatory lesions (papules and pustules) of rosacea |
CONZIP (CAPSULE, EXTENDED RELEASE) (ORAL) TRAMADOL HYDROCHLORIDE
Drug Classes: opioid agonist
NDA Applicant: CIPHER PHARMS INC NDA No.: 022370 Prod. No.: 001 RX (100MG); 002 RX (200MG); 003 RX (300MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7858118 DP* Extended release composition containing Tramadol Claim Types: Formulation; Method of use Pat. Sub. Date(s): All strengths: None | Apr 11, 2022 | U-1104: Use of tramadol for the management of moderate to moderately severe chronic pain |
WELCHOL (BAR, CHEWABLE) (ORAL) COLESEVELAM HYDROCHLORIDE
Drug Classes: bile acid sequestrant
NDA Applicant: DAIICHI SANKYO INC NDA No.: 210895 Prod. No.: 001 RX (3.75GM)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7229613 Method for lowering serum glucose Claim Types: Method of use Pat. Sub. Date(s): 001: May 2, 2019 | Apr 17, 2022 | U-2516: A method for reducing serum glucose levels in adults with Type 2 diabetes mellitus |
COMBIGAN (SOLUTION/DROPS) (OPHTHALMIC) BRIMONIDINE TARTRATE; TIMOLOL MALEATE
Drug Classes: alpha adrenergic agonist; beta-adrenergic receptor inhibitor
NDA Applicant: ALLERGAN NDA No.: 021398 Prod. No.: 001 RX (0.2%;EQ 0.5% BASE)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7030149 Combination of brimonidine timolol for topical ophthalmic use Claim Types: Method of use Pat. Sub. Date(s): 001: None | Apr 19, 2022 | U-849: Reduction of elevated intraocular pressure (IOP) in patients with glaucoma or ocular hypertension who require adjunctive or replacement therapy due to inadequately controlled IOP. dose is one drop of COMBIGAN in the affected eye twice daily |
| Pat. No. 7320976 Combination of brimonidine and timolol for topical ophthalmic use Claim Types: Method of use Pat. Sub. Date(s): 001: None | Apr 19, 2022 | U-849: Reduction of elevated intraocular pressure (IOP) in patients with glaucoma or ocular hypertension who require adjunctive or replacement therapy due to inadequately controlled IOP. dose is one drop of COMBIGAN in the affected eye twice daily |
| Pat. No. 7642258 DS* DP* Combination of brimonidine and timolol for topical ophthalmic use Claim Types: Formulation; Kit Pat. Sub. Date(s): 001: None | Apr 19, 2022 | U-1024: Reduction of elevated intraocular pressure in patients with glaucoma or ocular hypertension who require adjunctive or replacement therapy due to inadequately controlled IOP |
| Pat. No. 8133890 Combination of brimonidine and timolol for topical ophthalmic use Claim Types: Method of use Pat. Sub. Date(s): 001: Apr 2, 2012 | Apr 19, 2022 | U-1235: Reduction of elevated intraocular pressure in patients with glaucoma or ocular hypertension |
| Pat. No. 8354409 DP* Combination of brimonidine and timolol for topical ophthalmic use Claim Types: Formulation; Method of administration; Method of use Pat. Sub. Date(s): 001: Mar 27, 2013 | Apr 19, 2022 | U-1371: Reduction of intraocular pressure in patients with elevated intraocular pressure or glaucoma |
| Pat. No. 8748425 DP* Combination of brimonidine and timolol for topical ophthalmic use Claim Types: Method of use Pat. Sub. Date(s): 001: Jul 7, 2014 | Apr 19, 2022 | U-1524: Reduction of elevated intraocular pressure |
| Pat. No. 9474751 DP* Combination of brimonidine and timolol for topical ophthalmic use Claim Types: Method of use Pat. Sub. Date(s): 001: Oct 25, 2016 | Apr 19, 2022 | U-1524: Reduction of elevated intraocular pressure |
| Pat. No. 9770453 DP* Combination of brimonidine and timolol for topical ophthalmic use Claim Types: Method of use Pat. Sub. Date(s): 001: Oct 12, 2017 | Apr 19, 2022 | U-2131: Reduction of elevated intraocular pressure (IOP) in patients with glaucoma or ocular hypertension, with comparable efficacy, and a reduction in specified adverse events, compared to brimonidine 0.2% tid |
| Pat. No. 9907801 DP* Combination of brimonidine and timolol for topical ophthalmic use Claim Types: Method of use Pat. Sub. Date(s): 001: Mar 7, 2018 | Apr 19, 2022 | U-2239: Reduction of elevated intraocular pressure (IOP) in patients with glaucoma or ocular hypertension, with a reduction in specified adverse events, compared to brimonidine 0.2% tid |
| Pat. No. 9907802 DP* Combination of brimonidine and timolol for topical ophthalmic use Claim Types: Method of use Pat. Sub. Date(s): 001: Mar 7, 2018 | Apr 19, 2022 | U-2240: Reduction of elevated intraocular pressure (IOP) in patients with glaucoma or ocular hypertension, with comparable efficacy to brimonidine 0.2% tid |
| Pat. No. 7323463 DP* DLR* Combination of brimonidine and timolol for topical ophthalmic use Claim Types: Formulation; Drug in a container Pat. Sub. Date(s): 001: None | Jan 19, 2023 |
CERDELGA (CAPSULE) (ORAL) ELIGLUSTAT TARTRATE
Drug Classes: glucosylceramide synthase inhibitor
NDA Applicant: GENZYME CORP NDA No.: 205494 Prod. No.: 001 RX (EQ 84MG BASE)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6916802 DS* Amino ceramide-like compounds and therapeutic methods of use Claim Types: Compound; Method of use Pat. Sub. Date(s): 001: Sep 15, 2014 | Apr 29, 2022 | U-1571: Treatment of Gaucher disease type 1 |
| Pat. No. 7253185 DP* Amino ceramide-like compounds and therapeutic methods of use Claim Types: Composition Pat. Sub. Date(s): 001: May 10, 2018 | Apr 29, 2022 | |
| Pat. No. 7615573 Synthesis of UDP-glucose: N-acylsphingosine glucosyltransferase inhibitors Claim Types: Method of use Pat. Sub. Date(s): 001: Oct 21, 2014 | Apr 29, 2022 | U-1571: Treatment of Gaucher disease type 1 |
| Pat. No. 7196205 DS* [Extended 1519 days (4.2 years)] Synthesis of UDP-glucose: N-acylsphingosine glucosyltransferase inhibitors Claim Types: Compound Pat. Sub. Date(s): 001: Oct 21, 2014 | Jun 26, 2026 | |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NCE - New chemical entity | Aug 19, 2019 | |
| Exclusivity Code: ODE - Orphan drug exclusivity | Aug 19, 2021 | ODE-73: Long-term treatment of adult patients with gaucher disease type 1 who are cyp2d6 extensive metabolizers (EMs), intermediate metabolizers (IMs), or poor metabolizers (PMs) as detected by an FDA-cleared test. |
LYNPARZA (CAPSULE) (ORAL) OLAPARIB
Drug Classes: poly (ADP-ribose) polymerase (PARP) inhibitor
NDA Applicant: ASTRAZENECA PHARMS NDA No.: 206162 Prod. No.: 001 RX (50MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7151102 DS* DP* Phthalazinone derivatives Claim Types: Compound; Composition Pat. Sub. Date(s): 001: Jan 15, 2015 | Apr 29, 2022 | |
| Pat. No. 8912187 Phthalazinone derivatives Claim Types: Method of use Pat. Sub. Date(s): 001: Jan 15, 2015 | Mar 12, 2024 | U-1634: Treatment of BRCA mutated ovarian cancer using PARP inhibitor |
| Pat. No. 7449464 DS* DP* Phthalazinone derivatives Claim Types: Compound; Composition Pat. Sub. Date(s): 001: Jan 15, 2015 | Oct 11, 2024 | |
| Pat. No. 7981889 DS* DP* Phthalazinone derivatives Claim Types: Compound; Composition Pat. Sub. Date(s): 001: Jan 15, 2015 | Oct 11, 2024 | |
| Pat. No. 8143241 DNA damage repair inhibitors for treatment of cancer Claim Types: Method of use Pat. Sub. Date(s): 001: Jan 15, 2015 | Aug 12, 2027 | U-1634: Treatment of BRCA mutated ovarian cancer using PARP inhibitor |
| Pat. No. 8247416 DS* Phthalazinone derivative Claim Types: New polymorph, salt or hydrate; Process Pat. Sub. Date(s): 001: Jan 15, 2015 | Sep 24, 2028 | |
| Pat. No. 8859562 Use of RNAI inhibiting PARP activity for the manufacture of a medicament for the treatment of cancer Claim Types: Method of use Pat. Sub. Date(s): 001: Jan 15, 2015 | Aug 4, 2031 | U-1634: Treatment of BRCA mutated ovarian cancer using PARP inhibitor |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NCE - New chemical entity | Dec 19, 2019 | |
| Exclusivity Code: ODE - Orphan drug exclusivity | Dec 19, 2021 | ODE-83: Use of as monotherapy for patients with deleterious or suspected deleterious germline brca mutated (as detected by an FDA-approved test) advanced ovarian cancer who have been treated with three or more prior lines of chemotherapy |
LYNPARZA (TABLET) (ORAL) OLAPARIB
Drug Classes: poly (ADP-ribose) polymerase (PARP) inhibitor
NDA Applicant: ASTRAZENECA PHARMS NDA No.: 208558 Prod. No.: 001 RX (100MG); 002 RX (150MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7151102 DS* DP* Phthalazinone derivatives Claim Types: Compound; Composition Pat. Sub. Date(s): All strengths: Sep 15, 2017 | Apr 29, 2022 | |
| Pat. No. 8912187 Phthalazinone derivatives Claim Types: Method of use Pat. Sub. Date(s): All strengths: Sep 15, 2017 | Mar 12, 2024 | U-2101: Maintenance treatment of recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer, who are in a complete or partial response to platinum-based chemotherapy U-2480: Maintenance treatment of GBRCA- or SBRCA-mutated advanced epithelial ovarian, fallopian tube or primary peritoneal cancer who are in a complete or partial response to first-line platinum-based chemotherapy U-2481: Treatment of deleterious or suspected deleterious germline BRCA-mutated advanced ovarian cancer who have been treated with three or more prior lines of chemotherapy U-2482: Treatment of HR-negative, HER-2 negative, GBRCA-mutated metastatic breast cancer, who have been treated with chemotherapy in the neoadjuvant, adjuvant, or metastatic setting U-2483: Treatment of HR-positive, HER-2 negative, gbrca-mutated metastatic breast cancer, who have been treated with chemotherapy in the neoadjuvant, adjuvant, or metastatic setting, and with endocrine therapy or are inappropriate for endocrine therapy |
| Pat. No. 7449464 DS* DP* Phthalazinone derivatives Claim Types: Compound; Composition Pat. Sub. Date(s): All strengths: Sep 15, 2017 | Oct 11, 2024 | |
| Pat. No. 7981889 DS* DP* Phthalazinone derivatives Claim Types: Compound; Composition Pat. Sub. Date(s): All strengths: Sep 15, 2017 | Oct 11, 2024 | |
| Pat. No. 8143241 DNA damage repair inhibitors for treatment of cancer Claim Types: Method of use Pat. Sub. Date(s): All strengths: Sep 15, 2017 | Aug 12, 2027 | U-2101: Maintenance treatment of recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer, who are in a complete or partial response to platinum-based chemotherapy U-2103: Maintenance treatment of BRCA-mutated recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer, who are in a complete or partial response to platinum-based chemotherapy U-2480: Maintenance treatment of GBRCA- or SBRCA-mutated advanced epithelial ovarian, fallopian tube or primary peritoneal cancer who are in a complete or partial response to first-line platinum-based chemotherapy U-2481: Treatment of deleterious or suspected deleterious germline BRCA-mutated advanced ovarian cancer who have been treated with three or more prior lines of chemotherapy U-2482: Treatment of HR-negative, HER-2 negative, GBRCA-mutated metastatic breast cancer, who have been treated with chemotherapy in the neoadjuvant, adjuvant, or metastatic setting U-2483: Treatment of HR-positive, HER-2 negative, gbrca-mutated metastatic breast cancer, who have been treated with chemotherapy in the neoadjuvant, adjuvant, or metastatic setting, and with endocrine therapy or are inappropriate for endocrine therapy |
| Pat. No. 8475842 DP* Immediate release pharmaceutical formulation of 4-[3-(4-cyclopropanecarbonyl-piperazine-1-carbonyl)-4-fluoro-benzyl]-2H-p- hthalazin-1-one Claim Types: Formulation Pat. Sub. Date(s): All strengths: Sep 15, 2017 | Dec 31, 2029 | |
| Pat. No. 8859562 Use of RNAI inhibiting PARP activity for the manufacture of a medicament for the treatment of cancer Claim Types: Method of use Pat. Sub. Date(s): All strengths: Sep 15, 2017 | Aug 4, 2031 | U-2101: Maintenance treatment of recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer, who are in a complete or partial response to platinum-based chemotherapy U-2480: Maintenance treatment of GBRCA- or SBRCA-mutated advanced epithelial ovarian, fallopian tube or primary peritoneal cancer who are in a complete or partial response to first-line platinum-based chemotherapy U-2481: Treatment of deleterious or suspected deleterious germline BRCA-mutated advanced ovarian cancer who have been treated with three or more prior lines of chemotherapy U-2482: Treatment of HR-negative, HER-2 negative, GBRCA-mutated metastatic breast cancer, who have been treated with chemotherapy in the neoadjuvant, adjuvant, or metastatic setting U-2483: Treatment of HR-positive, HER-2 negative, gbrca-mutated metastatic breast cancer, who have been treated with chemotherapy in the neoadjuvant, adjuvant, or metastatic setting, and with endocrine therapy or are inappropriate for endocrine therapy |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: I - New Indication | Jan 12, 2021 | I-762: Treatment of deleterious or suspected deleterious germline BRCA-mutated, human epidermal growth factor receptor 2-negative metastatic breast cancer who have been treated with chemotherapy in the neoadjuvant, adjuvant or metastatic setting |
| Exclusivity Code: I - New Indication | Dec 19, 2021 | I-776: Firstline maintenance tx in pts w/ deleterious or suspected deleterious germline, somatic BRCA-mutated advanced epithelial ovarian, fallopian tube or primary peritoneal CA who are in complete or partial response to firstline platinum-based chemotherapy |
| Exclusivity Code: I - New Indication | Dec 27, 2022 | I-818: Maintenance treatment of adult patients with deleterious or suspected deleterious gbrcam metastatic pancreatic adenocarcinoma whose disease has not progressed on at least 16 weeks of a first-line platinum-based chemotherapy regimen |
| Exclusivity Code: NCE - New chemical entity | Dec 19, 2019 | |
| Exclusivity Code: NP - New product | Aug 17, 2020 | |
| Exclusivity Code: ODE - Orphan drug exclusivity | Aug 17, 2024 | ODE-180: Maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer, who are in a complete or partial response to platinum-based chemotherapy |
| Exclusivity Code: ODE - Orphan drug exclusivity | Aug 17, 2024 | ODE-181: Treatment of adult patients with deleterious or suspected deleterious germline brca-mutated advanced ovarian cancer who have been treated with three or more prior lines of chemotherapy |
| Exclusivity Code: ODE - Orphan drug exclusivity | Dec 19, 2025 | ODE-226: Maintenance treatment of adults with deleterious or suspected deleterious germline or somatic BRCA-mutated advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer in complete or partial response to first-line platinum-based chemotherapy |
| Exclusivity Code: ODE - Orphan drug exclusivity | Dec 19, 2021 | ODE-83: Use of as monotherapy for patients with deleterious or suspected deleterious germline brca mutated (as detected by an FDA-approved test) advanced ovarian cancer who have been treated with three or more prior lines of chemotherapy |
NEXTERONE (INJECTABLE) (INJECTION) AMIODARONE HYDROCHLORIDE
Drug Classes: antiarrhythmic
NDA Applicant: BAXTER HLTHCARE NDA No.: 022325 Prod. No.: 002 RX (150MG/100ML (1.5MG/ML)); 003 RX (360MG/200ML (1.8MG/ML)) NDA No.: 022325 Prod. No.: 001 DISC (50MG/ML**)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6869939 DP* Formulations containing amiodarone and sulfoalkyl ether cyclodextrin Claim Types: Formulation; Process Pat. Sub. Date(s): All strengths: None | May 4, 2022 | |
| Pat. No. 7635773 DP* Sulfoalkyl ether cyclodextrin compositions Claim Types: Formulation; Process Pat. Sub. Date(s): All strengths: None | Mar 13, 2029 |
EPIDIOLEX (SOLUTION) (ORAL) CANNABIDIOL
NDA Applicant: GW RES LTD NDA No.: 210365 Prod. No.: 001 RX (100MG/ML)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 10195159 DS* Processes and apparatus for extraction of active substances and enriched extracts from natural products Claim Types: Formulation Pat. Sub. Date(s): 001: Jun 26, 2019 | May 7, 2022 | |
| Pat. No. 9949937 Use of cannabinoids in the treatment of epilepsy Claim Types: Method of use Pat. Sub. Date(s): 001: Oct 25, 2018 | Jun 17, 2035 | U-2421: Use in combination with clobazam for the treatment of seizures in patients with dravet syndrome |
| Pat. No. 9956183 Use of cannabinoids in the treatment of epilepsy Claim Types: Method of use Pat. Sub. Date(s): 001: Oct 25, 2018 | Jun 17, 2035 | U-2422: Use in combination with clobazam for the treatment of seizures in patients with lennox gastaut syndrome who have been previously treated with clobazam U-2423: Use in combination with clobazam for the treatment of seizures in patients with dravet syndrome who have been previously treated with clobazam |
| Pat. No. 9956184 Use of cannabinoids in the treatment of epilepsy Claim Types: Method of use Pat. Sub. Date(s): 001: Oct 25, 2018 | Jun 17, 2035 | U-2424: Use in combination with clobazam for treatment of seizures in patients with lennox gastaut syndrome |
| Pat. No. 9956185 Use of cannabinoids in the treatment of epilepsy Claim Types: Method of use Pat. Sub. Date(s): 001: Oct 25, 2018 | Jun 17, 2035 | U-2425: Use for the treatment of convulsive seizures in patients with Dravet Syndrome |
| Pat. No. 9956186 Use of cannabinoids in the treatment of epilepsy Claim Types: Method of use Pat. Sub. Date(s): 001: Oct 25, 2018 | Jun 17, 2035 | U-2426: Use for the treatment of convulsive seizures in patients with Lennox Gastaut Syndrome |
| Pat. No. 10092525 Use of cannabinoids in the treatment of epilepsy Claim Types: Method of use Pat. Sub. Date(s): 001: Oct 25, 2018 | Jun 17, 2035 | U-2427: Use for the treatment of drop seizures in patients with Dravet Syndrome |
| Pat. No. 10111840 Use of cannabinoids in the treatment of epilepsy Claim Types: Method of use Pat. Sub. Date(s): 001: Nov 27, 2018 | Jun 17, 2035 | U-2442: Use for the treatment of atonic seizures in patients with Lennox-Gastaut syndrome U-2443: Use for the treatment of atonic seizures in patients with Dravet syndrome |
| Pat. No. 10137095 Use of cannabinoids in the treatment of epilepsy Claim Types: Method of use Pat. Sub. Date(s): 001: Dec 17, 2018 | Jun 17, 2035 | U-2454: Use for the treatment of drop seizures in patients with Lennox-Gastaut Syndrome U-2455: Use in combination with clobazam for treatment of drop seizures in patients with Lennox Gastaut Syndrome |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NCE - New chemical entity | Sep 28, 2023 | |
| Exclusivity Code: ODE - Orphan drug exclusivity | Sep 28, 2025 | ODE-216: Indicated for the treatment of seizures associated with Lennox-Gastaut Syndrome (LGS) or Dravet Syndrome (DS) in patients 2 years of age and older |
TARGINIQ (TABLET, EXTENDED RELEASE) (ORAL) NALOXONE HYDROCHLORIDE; OXYCODONE HYDROCHLORIDE
Drug Classes: opioid antagonist; opioid agonist
NDA Applicant: PURDUE PHARMA LP NDA No.: 205777 Prod. No.: 001 DISC (5MG;10MG); 002 DISC (10MG;20MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8969369 DP* Abuse-resistant controlled-release opioid dosage form Claim Types: Formulation; Method of use Pat. Sub. Date(s): All strengths: Mar 3, 2015 | May 10, 2022 | U-1556: Management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. |
| Pat. No. 9056051 DP* Abuse-resistant controlled-release opioid dosage form Claim Types: Formulation; Method of use Pat. Sub. Date(s): All strengths: Jun 30, 2015 | May 10, 2022 | U-1556: Management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. |
| Pat. No. 9084729 DP* Abuse-resistant controlled-release opioid dosage form Claim Types: Formulation; Method of use Pat. Sub. Date(s): All strengths: Jul 22, 2015 | May 10, 2022 | U-1556: Management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. |
| Pat. No. 9161937 DP* Abuse-resistant controlled-release opioid dosage form Claim Types: Formulation; Method of use Pat. Sub. Date(s): All strengths: Oct 27, 2015 | May 10, 2022 | U-1556: Management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. |
| Pat. No. 9168252 DP* Abuse-resistant controlled-release opioid dosage form Claim Types: Formulation Pat. Sub. Date(s): All strengths: Oct 27, 2015 | May 10, 2022 | U-1556: Management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. |
| Pat. No. 9283216 DP* Abuse-resistant controlled-release opioid dosage form Claim Types: Formulation; Method of use Pat. Sub. Date(s): All strengths: Mar 15, 2016 | May 10, 2022 | U-1819: Management of pain severe enough to require daily, around-the-clock, long term opioid treatment and for which alternative treatment options are inadequate |
| Pat. No. 9283221 DP* Abuse-resistant controlled-release opioid dosage form Claim Types: Formulation Pat. Sub. Date(s): All strengths: Mar 15, 2016 | May 10, 2022 | U-1819: Management of pain severe enough to require daily, around-the-clock, long term opioid treatment and for which alternative treatment options are inadequate |
| Pat. No. 9345701 DP* Abuse-resistant controlled-release opioid dosage form Claim Types: Formulation; Method of use Pat. Sub. Date(s): All strengths: May 24, 2016 | May 10, 2022 | U-1819: Management of pain severe enough to require daily, around-the-clock, long term opioid treatment and for which alternative treatment options are inadequate |
| Pat. No. 9511066 Abuse-resistant controlled-release opioid dosage form Claim Types: Method of use Pat. Sub. Date(s): All strengths: Dec 6, 2016 | May 10, 2022 | U-1921: Management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate by providing an abuse-deterrent oral controlled release combination drug product |
| Pat. No. 8846090 DP* Matrix for sustained, invariant and independent release of active compounds Claim Types: Formulation Pat. Sub. Date(s): All strengths: Sep 30, 2014 | Apr 4, 2023 | |
| Pat. No. 8846091 DP* Matrix for sustained, invariant and independent release of active compounds Claim Types: Formulation Pat. Sub. Date(s): All strengths: Sep 30, 2014 | Apr 4, 2023 | |
| Pat. No. 9555000 DP* Pharmaceutical preparation containing oxycodone and naloxone Claim Types: Formulation; Method of use Pat. Sub. Date(s): All strengths: Feb 1, 2017 | Apr 4, 2023 | U-1556: Management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. |
| Pat. No. 9907793 DP* Pharmaceutical preparation containing oxycodone and naloxone Claim Types: Formulation; Method of use Pat. Sub. Date(s): All strengths: Mar 6, 2018 | Apr 4, 2023 | U-1556: Management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. |
| Pat. No. 9073933 DS* Oxycodone hydrochloride having less than 25 PPM 14-hydroxycodeinone Claim Types: Formulation; Process Pat. Sub. Date(s): All strengths: Aug 3, 2015 | Mar 30, 2025 | |
| Pat. No. 9522919 DS* DP* Oxycodone compositions Claim Types: Formulation Pat. Sub. Date(s): All strengths: Dec 20, 2016 | Mar 30, 2025 |
TARGINIQ (TABLET, EXTENDED RELEASE) (ORAL) NALOXONE HYDROCHLORIDE; OXYCODONE HYDROCHLORIDE
Drug Classes: opioid antagonist; opioid agonist
NDA Applicant: PURDUE PHARMA LP NDA No.: 205777 Prod. No.: 003 DISC (20MG;40MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8969369 DP* Abuse-resistant controlled-release opioid dosage form Claim Types: Formulation; Method of use Pat. Sub. Date(s): 003: Mar 3, 2015 | May 10, 2022 | U-1556: Management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. |
| Pat. No. 9056051 DP* Abuse-resistant controlled-release opioid dosage form Claim Types: Formulation; Method of use Pat. Sub. Date(s): 003: Jun 30, 2015 | May 10, 2022 | U-1556: Management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. |
| Pat. No. 9084729 DP* Abuse-resistant controlled-release opioid dosage form Claim Types: Formulation; Method of use Pat. Sub. Date(s): 003: Jul 22, 2015 | May 10, 2022 | U-1556: Management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. |
| Pat. No. 9161937 DP* Abuse-resistant controlled-release opioid dosage form Claim Types: Formulation; Method of use Pat. Sub. Date(s): 003: Oct 27, 2015 | May 10, 2022 | U-1556: Management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. |
| Pat. No. 9168252 DP* Abuse-resistant controlled-release opioid dosage form Claim Types: Formulation Pat. Sub. Date(s): 003: Oct 27, 2015 | May 10, 2022 | U-1556: Management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. |
| Pat. No. 9283216 DP* Abuse-resistant controlled-release opioid dosage form Claim Types: Formulation; Method of use Pat. Sub. Date(s): 003: Mar 15, 2016 | May 10, 2022 | U-1819: Management of pain severe enough to require daily, around-the-clock, long term opioid treatment and for which alternative treatment options are inadequate |
| Pat. No. 9283221 DP* Abuse-resistant controlled-release opioid dosage form Claim Types: Formulation Pat. Sub. Date(s): 003: Mar 15, 2016 | May 10, 2022 | U-1819: Management of pain severe enough to require daily, around-the-clock, long term opioid treatment and for which alternative treatment options are inadequate |
| Pat. No. 9345701 DP* Abuse-resistant controlled-release opioid dosage form Claim Types: Formulation; Method of use Pat. Sub. Date(s): 003: May 24, 2016 | May 10, 2022 | U-1819: Management of pain severe enough to require daily, around-the-clock, long term opioid treatment and for which alternative treatment options are inadequate |
| Pat. No. 9511066 Abuse-resistant controlled-release opioid dosage form Claim Types: Method of use Pat. Sub. Date(s): 003: Dec 6, 2016 | May 10, 2022 | U-1921: Management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate by providing an abuse-deterrent oral controlled release combination drug product |
| Pat. No. 8846090 DP* Matrix for sustained, invariant and independent release of active compounds Claim Types: Formulation Pat. Sub. Date(s): 003: Sep 30, 2014 | Apr 4, 2023 | |
| Pat. No. 8846091 DP* Matrix for sustained, invariant and independent release of active compounds Claim Types: Formulation Pat. Sub. Date(s): 003: Sep 30, 2014 | Apr 4, 2023 | |
| Pat. No. 9073933 DS* Oxycodone hydrochloride having less than 25 PPM 14-hydroxycodeinone Claim Types: Formulation; Process Pat. Sub. Date(s): 003: Aug 3, 2015 | Mar 30, 2025 | |
| Pat. No. 9522919 DS* DP* Oxycodone compositions Claim Types: Formulation Pat. Sub. Date(s): 003: Dec 20, 2016 | Mar 30, 2025 |
PROTONIX IV (INJECTABLE) (IV (INFUSION)) PANTOPRAZOLE SODIUM [GENERIC AP]
Drug Classes: proton pump inhibitor
NDA Applicant: WYETH PHARMS NDA No.: 020988 Prod. No.: 001 RX (EQ 40MG BASE/VIAL)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6780881 DP* Freeze-dried pantoprazole preparation and pantoprazole injection Claim Types: Formulation; Process Pat. Sub. Date(s): 001: None | May 17, 2022 *PED | |
| Pat. No. 7351723 DP* Freeze-dried pantoprazole preparation and pantoprazole injection Claim Types: Composition Pat. Sub. Date(s): 001: None | May 17, 2022 *PED | |
| Pat. No. 8754108 DP* Freeze-dried pantoprazole preparation and pantoprazole injection Claim Types: Formulation Pat. Sub. Date(s): 001: None | May 17, 2022 *PED |
ALIMTA (POWDER) (INTRAVENOUS) PEMETREXED DISODIUM
Drug Classes: folate analog metabolic inhibitor
NDA Applicant: LILLY NDA No.: 021462 Prod. No.: 001 RX (EQ 500MG BASE/VIAL); 002 RX (EQ 100MG BASE/VIAL)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7772209 Antifolate combination therapies Claim Types: Method of administration Pat. Sub. Date(s): All strengths: None | May 24, 2022 *PED | U-1296: Use of Pemetrexed with prior and/or repeated vitamin B12 and folic acid administration |
RYTARY (CAPSULE, EXTENDED RELEASE) (ORAL) CARBIDOPA; LEVODOPA
Drug Classes: aromatic amino acid decarboxylation inhibitor
NDA Applicant: IMPAX LABS INC NDA No.: 203312 Prod. No.: 001 RX (23.75MG;95MG); 002 RX (36.25MG;145MG); 003 RX (48.75MG;195MG); 004 RX (61.25MG;245MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7094427 DP* DLR* Combination immediate release controlled release levodopa/carbidopa dosage forms Claim Types: Formulation; Method of use Pat. Sub. Date(s): All strengths: Jan 27, 2015 | May 29, 2022 | U-1645: Treatment of Parkinson's disease, post-encephalitic parkinsonism, and parkinsonism that may follow carbon monoxide intoxication or manganese intoxication |
| Pat. No. 8377474 DP* Controlled release formulations of levodopa and uses thereof Claim Types: Formulation; Method of use Pat. Sub. Date(s): All strengths: Jan 27, 2015 | Dec 26, 2028 | U-1645: Treatment of Parkinson's disease, post-encephalitic parkinsonism, and parkinsonism that may follow carbon monoxide intoxication or manganese intoxication U-219: Treatment of Parkinson's disease |
| Pat. No. 8454998 DP* Controlled release formulations of levodopa and uses thereof Claim Types: Method of use Pat. Sub. Date(s): All strengths: Jan 27, 2015 | Dec 26, 2028 | U-1645: Treatment of Parkinson's disease, post-encephalitic parkinsonism, and parkinsonism that may follow carbon monoxide intoxication or manganese intoxication U-1646: Treatment of post-encephalitic Parkinsonism, and Parkinsonism that may follow carbon monoxide intoxication or manganese intoxication U-1647: Treatment of Parkinsonism that may follow carbon monoxide intoxication or manganese intoxication U-1649: Treatment of post-encephalitic Parkinsonism U-219: Treatment of Parkinson's disease |
| Pat. No. 8557283 DP* Controlled release formulations of levodopa and uses thereof Claim Types: Method of use Pat. Sub. Date(s): All strengths: Jan 27, 2015 | Dec 26, 2028 | U-1645: Treatment of Parkinson's disease, post-encephalitic parkinsonism, and parkinsonism that may follow carbon monoxide intoxication or manganese intoxication U-219: Treatment of Parkinson's disease |
| Pat. No. 9089607 DP* Controlled release formulations of levodopa and uses thereof Claim Types: Formulation; Method of use Pat. Sub. Date(s): All strengths: Aug 10, 2015 | Dec 26, 2028 | U-1645: Treatment of Parkinson's disease, post-encephalitic parkinsonism, and parkinsonism that may follow carbon monoxide intoxication or manganese intoxication U-1720: Method of providing a therapeutically effective and stable median blood plasma level of levodopa |
| Pat. No. 9089608 DP* Controlled release formulations of levodopa and uses thereof Claim Types: Formulation Pat. Sub. Date(s): All strengths: Aug 10, 2015 | Dec 26, 2028 | |
| Pat. No. 9463246 DP* Controlled release formulations of levodopa and uses thereof Claim Types: Method of administration Pat. Sub. Date(s): All strengths: Oct 12, 2016 | Dec 26, 2028 | U-219: Treatment of Parkinson's disease |
| Pat. No. 9533046 DP* Controlled release formulations of levodopa and uses thereof Claim Types: Method of administration Pat. Sub. Date(s): All strengths: Jan 11, 2017 | Dec 26, 2028 | U-219: Treatment of Parkinson's disease |
| Pat. No. 9901640 DP* Controlled release formulations of levodopa and uses thereof Claim Types: Formulation; Method of use Pat. Sub. Date(s): All strengths: Feb 28, 2018 | Dec 26, 2028 | U-219: Treatment of Parkinson's disease |
ADVIL PM (TABLET) (ORAL) DIPHENHYDRAMINE CITRATE; IBUPROFEN [GENERIC OTC]
Drug Classes: histamine-1 (H1) receptor antagonist; nonsteroidal anti-inflammatory drug
NDA Applicant: GLAXOSMITHKLINE NDA No.: 021394 Prod. No.: 001 OTC (38MG;200MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8263647 DP* Treatment of sleep disturbances Claim Types: Formulation Pat. Sub. Date(s): 001: None | May 30, 2022 |
VIMOVO (TABLET, DELAYED RELEASE) (ORAL) ESOMEPRAZOLE MAGNESIUM; NAPROXEN
Drug Classes: proton pump inhibitor; nonsteroidal anti-inflammatory drug
NDA Applicant: HORIZON NDA No.: 022511 Prod. No.: 001 RX (EQ 20MG BASE;500MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8557285 DP* Pharmaceutical compositions for the coordinated delivery of NSAIDs Claim Types: Formulation Pat. Sub. Date(s): 001: Oct 29, 2013 | May 31, 2022 | |
| Pat. No. 8852636 DP* Pharmaceutical compositions for the coordinated delivery of NSAIDs Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Oct 29, 2014 | May 31, 2022 | U-1052: Relief of signs and symptoms of arthritis and risk-reduction of NSAID-associated gastric ulcer |
| Pat. No. 8858996 DP* Pharmaceutical compositions for the coordinated delivery of NSAIDS Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Oct 29, 2014 | May 31, 2022 | U-1052: Relief of signs and symptoms of arthritis and risk-reduction of NSAID-associated gastric ulcer |
| Pat. No. 9161920 Pharmaceutical compositions for the coordinated delivery of NSAIDs Claim Types: Method of use Pat. Sub. Date(s): 001: Nov 12, 2015 | May 31, 2022 | U-1760: Risk-reduction of nsaid gastric ulcer in patients requiring chronic nsaid treatment |
| Pat. No. 9198888 Pharmaceutical compositions for the coordinated delivery of NSAIDs Claim Types: Formulation Pat. Sub. Date(s): 001: Dec 17, 2015 | May 31, 2022 | U-1781: Risk-reduction of NSAID-associated gastric ulcer in patients requiring NSAID treatment |
| Pat. No. 9345695 DP* Pharmaceutical compositions for the coordinated delivery of NSAIDs Claim Types: Formulation Pat. Sub. Date(s): 001: Jun 23, 2016 | May 31, 2022 | |
| Pat. No. 9707181 DP* Pharmaceutical compositions for the coordinated delivery of NSAIDs Claim Types: Formulation Pat. Sub. Date(s): 001: Aug 17, 2017 | May 31, 2022 | |
| Pat. No. 6926907 DP* Pharmaceutical compositions for the coordinated delivery of NSAIDs Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: None | Feb 28, 2023 | U-1052: Relief of signs and symptoms of arthritis and risk-reduction of NSAID-associated gastric ulcer |
| Pat. No. 9393208 Method for delivering a pharmaceutical composition to patient in need thereof Claim Types: Method of administration Pat. Sub. Date(s): 001: Aug 17, 2016 | Sep 3, 2029 | U-1781: Risk-reduction of NSAID-associated gastric ulcer in patients requiring NSAID treatment |
| Pat. No. 9220698 Method for delivering a pharmaceutical composition to patient in need thereof Claim Types: Method of use; Method of administration Pat. Sub. Date(s): 001: Jan 28, 2016 | Mar 10, 2031 | U-1781: Risk-reduction of NSAID-associated gastric ulcer in patients requiring NSAID treatment |
| Pat. No. 8945621 Method for treating a patient at risk for developing an NSAID-associated ulcer Claim Types: Method of use; Method of administration Pat. Sub. Date(s): 001: Mar 2, 2015 | Oct 17, 2031 | U-1661: Risk-reduction of NSAID-associated gastric ulcers in patients also taking low dose aspirin |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NPP - New patient population | Jul 6, 2020 |
VIMOVO (TABLET, DELAYED RELEASE) (ORAL) ESOMEPRAZOLE MAGNESIUM; NAPROXEN
Drug Classes: proton pump inhibitor; nonsteroidal anti-inflammatory drug
NDA Applicant: HORIZON NDA No.: 022511 Prod. No.: 002 RX (EQ 20MG BASE;375MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8557285 DP* Pharmaceutical compositions for the coordinated delivery of NSAIDs Claim Types: Formulation Pat. Sub. Date(s): 002: Oct 29, 2013 | May 31, 2022 | |
| Pat. No. 8852636 DP* Pharmaceutical compositions for the coordinated delivery of NSAIDs Claim Types: Formulation; Method of use Pat. Sub. Date(s): 002: Oct 29, 2014 | May 31, 2022 | U-1052: Relief of signs and symptoms of arthritis and risk-reduction of NSAID-associated gastric ulcer |
| Pat. No. 8858996 DP* Pharmaceutical compositions for the coordinated delivery of NSAIDS Claim Types: Formulation; Method of use Pat. Sub. Date(s): 002: Oct 29, 2014 | May 31, 2022 | U-1052: Relief of signs and symptoms of arthritis and risk-reduction of NSAID-associated gastric ulcer |
| Pat. No. 9161920 Pharmaceutical compositions for the coordinated delivery of NSAIDs Claim Types: Method of use Pat. Sub. Date(s): 002: Nov 12, 2015 | May 31, 2022 | U-1760: Risk-reduction of nsaid gastric ulcer in patients requiring chronic nsaid treatment |
| Pat. No. 9198888 Pharmaceutical compositions for the coordinated delivery of NSAIDs Claim Types: Formulation Pat. Sub. Date(s): 002: Dec 17, 2015 | May 31, 2022 | U-1781: Risk-reduction of NSAID-associated gastric ulcer in patients requiring NSAID treatment |
| Pat. No. 9345695 DP* Pharmaceutical compositions for the coordinated delivery of NSAIDs Claim Types: Formulation Pat. Sub. Date(s): 002: Jun 23, 2016 | May 31, 2022 | |
| Pat. No. 9707181 DP* Pharmaceutical compositions for the coordinated delivery of NSAIDs Claim Types: Formulation Pat. Sub. Date(s): 002: Aug 17, 2017 | May 31, 2022 | |
| Pat. No. 6926907 DP* Pharmaceutical compositions for the coordinated delivery of NSAIDs Claim Types: Formulation; Method of use Pat. Sub. Date(s): 002: None | Feb 28, 2023 | U-1052: Relief of signs and symptoms of arthritis and risk-reduction of NSAID-associated gastric ulcer |
| Pat. No. 9393208 Method for delivering a pharmaceutical composition to patient in need thereof Claim Types: Method of administration Pat. Sub. Date(s): 002: Aug 17, 2016 | Sep 3, 2029 | U-1781: Risk-reduction of NSAID-associated gastric ulcer in patients requiring NSAID treatment |
| Pat. No. 8945621 Method for treating a patient at risk for developing an NSAID-associated ulcer Claim Types: Method of use; Method of administration Pat. Sub. Date(s): 002: Mar 2, 2015 | Oct 17, 2031 | U-1661: Risk-reduction of NSAID-associated gastric ulcers in patients also taking low dose aspirin |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NPP - New patient population | Jul 6, 2020 |
YOSPRALA (TABLET, DELAYED RELEASE) (ORAL) ASPIRIN; OMEPRAZOLE
Drug Classes: anti-platelet agent; nonsteroidal anti-inflammatory drug; proton pump inhibitor
NDA Applicant: GENUS LIFESCIENCES NDA No.: 205103 Prod. No.: 001 RX (81MG;40MG); 002 RX (325MG;40MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 9364439 DP* Pharmaceutical compositions for the coordinated delivery of NSAIDs Claim Types: Formulation; Method of use Pat. Sub. Date(s): All strengths: Oct 14, 2016 | May 31, 2022 | U-1902: Treatment or secondary prevention of cardiovascular disease, cardiovascular events, or cerebrovascular events and risk-reduction of aspirin-associated gastric ulcers |
| Pat. No. 6926907 DP* Pharmaceutical compositions for the coordinated delivery of NSAIDs Claim Types: Formulation; Method of use Pat. Sub. Date(s): All strengths: Oct 14, 2016 | Feb 28, 2023 | U-1902: Treatment or secondary prevention of cardiovascular disease, cardiovascular events, or cerebrovascular events and risk-reduction of aspirin-associated gastric ulcers |
| Pat. No. 8206741 DP* Pharmaceutical compositions for the coordinated delivery of NSAIDs Claim Types: Formulation; Method of use Pat. Sub. Date(s): All strengths: Oct 14, 2016 | Feb 28, 2023 | U-1902: Treatment or secondary prevention of cardiovascular disease, cardiovascular events, or cerebrovascular events and risk-reduction of aspirin-associated gastric ulcers |
| Pat. No. 9987231 Compositions and methods for delivery of omeprazole plus acetylsalicylic acid Claim Types: Method of administration Pat. Sub. Date(s): All strengths: Jul 3, 2018 | Jan 2, 2033 | U-2324: For secondary prevention of cardiovascular and cerebrovascular events in patients at risk of developing aspirin-associated gastric ulcers |
| Pat. No. 9539214 Compositions and methods for delivery of omeprazole plus acetylsalicylic acid Claim Types: Method of use Pat. Sub. Date(s): All strengths: Jan 27, 2017 | Mar 13, 2033 | U-1902: Treatment or secondary prevention of cardiovascular disease, cardiovascular events, or cerebrovascular events and risk-reduction of aspirin-associated gastric ulcers |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NC - New combination | Sep 14, 2019 |
MYTESI (TABLET, DELAYED RELEASE) (ORAL) CROFELEMER
Drug Classes: antidiarrheal
NDA Applicant: NAPO PHARMS INC NDA No.: 202292 Prod. No.: 001 RX (125MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7341744 DP* [Extended 1075 days (2.9 years)] Method of treating secretory diarrhea with enteric formulations of proanthocyanidin polymer Claim Types: Method of use Pat. Sub. Date(s): 001: None | Jun 2, 2022 | U-1319: Symptomatic relief of non-infectious diarrhea |
| Pat. No. 8962680 Methods and compositions for treating HIV-associated diarrhea Claim Types: Method of use Pat. Sub. Date(s): 001: Feb 24, 2015 | Oct 31, 2031 | U-1319: Symptomatic relief of non-infectious diarrhea |
| Pat. No. 9585868 Methods and compositions for treating HIV-associated diarrhea Claim Types: Method of administration Pat. Sub. Date(s): 001: Jul 24, 2017 | Oct 31, 2031 | U-1319: Symptomatic relief of non-infectious diarrhea |
ESKATA (SOLUTION) (TOPICAL) HYDROGEN PEROXIDE
Drug Classes: aldehyde dehydrogenase inhibitor; isocitrate dehydrogenase-2 inhibitor
NDA Applicant: ACLARIS NDA No.: 209305 Prod. No.: 001 DISC (40%)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7381427 Seborrheic keratosis treatment Claim Types: Method of use Pat. Sub. Date(s): 001: Jan 3, 2018 | Jun 8, 2022 | U-2205: Treatment of seborrheic keratoses that are raised |
| Pat. No. 9980983 Peroxide formulations and methods and applicators for using the same Claim Types: Method of use Pat. Sub. Date(s): 001: Jun 18, 2018 | Apr 21, 2035 | U-2205: Treatment of seborrheic keratoses that are raised |
| Pat. No. 10098910 DP* Peroxide formulations and methods and applicators for using the same Claim Types: Device; Method of use Pat. Sub. Date(s): 001: Oct 25, 2018 | Apr 21, 2035 | U-2205: Treatment of seborrheic keratoses that are raised |
| Pat. No. 9675639 DP* Peroxide formulations and methods and applicators for using the same Claim Types: Formulation; Method of use; Method of administration Pat. Sub. Date(s): 001: Jan 3, 2018 | Jul 4, 2035 | U-2205: Treatment of seborrheic keratoses that are raised |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NP - New product | Dec 14, 2020 |
RYANODEX (FOR SUSPENSION) (INTRAVENOUS) DANTROLENE SODIUM
Drug Classes: skeletal muscle relaxant
NDA Applicant: EAGLE PHARMS NDA No.: 205579 Prod. No.: 001 RX (250MG/VIAL)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 9884044 DP* Treatment using dantrolene Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Feb 6, 2018 | Jun 13, 2022 | U-1546: For use in the treatment of malignant hyperthermia in conjunction with appropriate supportive measures and for the prevention of malignant hyperthermia in patients at high risk. |
| Pat. No. 8110225 DP* Treatment using dantrolene Claim Types: Formulation; Process Pat. Sub. Date(s): 001: Jul 28, 2014 | Dec 24, 2022 | |
| Pat. No. 8604072 DP* Treatment using dantrolene Claim Types: Method of use Pat. Sub. Date(s): 001: Jul 28, 2014 | Dec 24, 2022 | |
| Pat. No. 8685460 Treatment using dantrolene Claim Types: Method of use Pat. Sub. Date(s): 001: Aug 8, 2014 | Feb 15, 2023 | U-1546: For use in the treatment of malignant hyperthermia in conjunction with appropriate supportive measures and for the prevention of malignant hyperthermia in patients at high risk. |
| Pat. No. 7758890 DP* Treatment using dantrolene Claim Types: Formulation Pat. Sub. Date(s): 001: Jul 28, 2014 | Jul 1, 2025 | |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: ODE - Orphan drug exclusivity | Jul 22, 2021 | ODE-69: Treatment of malignant hyperthermia in conjunction with appropriate supportive measures and for the prevention of malignant hyperthermia in patients at high risk |
BETHKIS (SOLUTION) (INHALATION) TOBRAMYCIN
Drug Classes: aminoglycoside antibacterial
NDA Applicant: CHIESI USA INC NDA No.: 201820 Prod. No.: 001 RX (300MG/4ML)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7939502 Optimised formulation of tobramycin for aerosolization Claim Types: Method of use Pat. Sub. Date(s): 001: Jan 30, 2013 | Jun 14, 2022 | U-1324: Management of cystic fibrosis patients |
| Pat. No. 6987094 DP* Optimized formulation of tobramycin for aerosolization Claim Types: Formulation; Process Pat. Sub. Date(s): 001: Jan 30, 2013 | Sep 22, 2022 | |
| Pat. No. 7696178 DP* Optimised formulation of tobramycin for aerosolization Claim Types: Formulation; Process Pat. Sub. Date(s): 001: Jan 30, 2013 | Sep 22, 2022 |
STIVARGA (TABLET) (ORAL) REGORAFENIB
Drug Classes: kinase inhibitor
NDA Applicant: BAYER HLTHCARE NDA No.: 203085 Prod. No.: 001 RX (40MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7351834 DS* [Extended 898 days (2.5 years)] .omega.-Carboxyaryl substituted diphenyl ureas as raf kinase inhibitors Claim Types: Compound; New polymorph, salt or hydrate Pat. Sub. Date(s): 001: Oct 23, 2012 | Jun 28, 2022 | |
| Pat. No. 8680124 Treatment of cancers with acquired resistance to kit inhibitors Claim Types: Method of use Pat. Sub. Date(s): 001: Apr 21, 2014 | Jun 2, 2030 | U-1506: Treatment of patients with gastrointestinal stromal tumor (GIST), including but not limited to patients previously treated with imatinib and patients with GIST having resistance to a KIT tyrosine kinase inhibitor |
| Pat. No. 8637553 DS* DP* Fluoro substituted omega-carboxyaryl diphenyl urea for the treatment and prevention of diseases and conditions Claim Types: Compound; Composition Pat. Sub. Date(s): 001: Feb 21, 2014 | Feb 16, 2031 | |
| Pat. No. 9458107 DP* Process for the preparation of 4-{4-[({[4 chloro-3-(trifluoromethyl)-phenyl]amino}carbonyl)amino]-3-fluorphenoxy-N-- ethylpyridie-carboxamide, its salts and monohydrate Claim Types: Formulation; New polymorph, salt or hydrate Pat. Sub. Date(s): 001: Nov 2, 2016 | Apr 8, 2031 | |
| Pat. No. 9957232 DS* 4-[4-({[4-chloro-3-(trifluoromethyl)phenyl]carbamoyl}amino)-3-fluorophenox- y]-N-methylpyridine-2-carboxamide monohydrate Claim Types: Compound; Composition; Method of use; Formulation; New polymorph, salt or hydrate Pat. Sub. Date(s): 001: May 30, 2018 | Jul 9, 2032 | |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: I - New Indication | Apr 27, 2020 | I-744: Treatment of patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib |
| Exclusivity Code: ODE - Orphan drug exclusivity | Apr 27, 2024 | ODE-139: Treatment of patients with hepatocellular carcinoma (HCC or liver cancer) who have been previously treated with the drug sorafenib. |
| Exclusivity Code: ODE - Orphan drug exclusivity | Feb 25, 2020 | ODE-44: Treatment of patients with locally advanced, unresectable or metastatic gastrointestinal stromal tumor (gist) who have been previously treated with imatinib mesylate and sunitinib malate. |
LUSEDRA (SOLUTION) (INTRAVENOUS) FOSPROPOFOL DISODIUM
NDA Applicant: EISAI INC NDA No.: 022244 Prod. No.: 001 DISC (1050MG/30ML (35MG/ML))
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6204257 DS* DP* [Extended 1424 days (3.9 years)] Water soluble prodrugs of hindered alcohols Claim Types: Compound; Composition; Process; Method of use Pat. Sub. Date(s): 001: None | Jul 1, 2022 | U-945: Sedative-hypnotic agent indicated for monitored anesthesia care (MAC) sedation |
SAXENDA (SOLUTION) (SUBCUTANEOUS) LIRAGLUTIDE RECOMBINANT
Drug Classes: glucagon-like peptide-1 (GLP-1) receptor agonist
NDA Applicant: NOVO NDA No.: 206321 Prod. No.: 001 RX (18MG/3ML (6MG/ML))
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6899699 DP* Automatic injection device with reset feature Claim Types: Device; Method of administration Pat. Sub. Date(s): 001: Jan 21, 2015 | Jul 1, 2022 *PED | |
| Pat. No. 8672898 DP* Automatic injection device with reset feature Claim Types: Device Pat. Sub. Date(s): 001: Jan 21, 2015 | Jul 2, 2022 *PED | |
| Pat. No. 9486588 DP* Automatic injection device with reset feature Claim Types: Device Pat. Sub. Date(s): 001: Dec 7, 2016 | Jul 2, 2022 *PED | |
| Pat. No. 8846618 DP* Stable formulation of modified GLP-1 Claim Types: Formulation; Process Pat. Sub. Date(s): 001: Mar 17, 2015 | Dec 27, 2022 *PED | |
| Pat. No. 6268343 DS* DP* [Extended 5 years] Derivatives of GLP-1 analogs Claim Types: Compound; Composition; Formulation; Method of use Pat. Sub. Date(s): 001: Jan 21, 2015 | Feb 22, 2023 *PED | U-1255: Method for chronic weight management by treating obesity |
| Pat. No. 8579869 DP* Needle mounting system and a method for mounting a needle assembly Claim Types: Device Pat. Sub. Date(s): 001: Jan 23, 2019 | Dec 30, 2023 *PED | |
| Pat. No. 7762994 DP* Needle mounting system and a method for mounting a needle assembly Claim Types: Device Pat. Sub. Date(s): 001: Jan 23, 2019 | Nov 23, 2024 *PED | |
| Pat. No. 10357616 DP* Injection device with an end of dose feedback mechanism Claim Types: Device Pat. Sub. Date(s): 001: Aug 8, 2019 | Jan 20, 2026 | |
| Pat. No. 10376652 DP* Automatic injection device with a top release mechanism Claim Types: Device Pat. Sub. Date(s): 001: Sep 13, 2019 | Jan 20, 2026 | |
| Pat. No. 8114833 DP* Propylene glycol-containing peptide formulations which are optimal for production and for use in injection devices Claim Types: Formulation; Process Pat. Sub. Date(s): 001: Jan 21, 2015 | Feb 13, 2026 *PED | |
| Pat. No. 8684969 DP* Injection device with torsion spring and rotatable display Claim Types: Device Pat. Sub. Date(s): 001: Jan 21, 2015 | Apr 20, 2026 *PED | |
| Pat. No. 9616180 DP* Automatic injection device with a top release mechanism Claim Types: Device Pat. Sub. Date(s): 001: Aug 23, 2018 | Jul 20, 2026 *PED | |
| Pat. No. 9861757 DP* Injection device with an end of dose feedback mechanism Claim Types: Device Pat. Sub. Date(s): 001: Aug 23, 2018 | Jul 20, 2026 *PED | |
| Pat. No. 9108002 DP* Automatic injection device with a top release mechanism Claim Types: Device Pat. Sub. Date(s): 001: Sep 18, 2015 | Jul 26, 2026 *PED | |
| Pat. No. 8920383 DP* Dose mechanism for an injection device for limiting a dose setting corresponding to the amount of medicament left Claim Types: Device Pat. Sub. Date(s): 001: Feb 5, 2015 | Jan 17, 2027 *PED | |
| Pat. No. 9775953 DP* Dose mechanism for an injection device for limiting a dose setting corresponding to the amount of medicament left Claim Types: Device Pat. Sub. Date(s): 001: Nov 13, 2017 | Jan 17, 2027 *PED | |
| Pat. No. 10220155 DP* Syringe device with a dose limiting mechanism and an additional safety mechanism Claim Types: Device Pat. Sub. Date(s): 001: Apr 1, 2019 | Jan 17, 2027 *PED | |
| Pat. No. RE46363 DP* Dial-down mechanism for wind-up pen Claim Types: Device; Method of use Pat. Sub. Date(s): 001: May 10, 2017 | Feb 3, 2027 *PED | |
| Pat. No. 9687611 DP* Injection device with torsion spring and rotatable display Claim Types: Device Pat. Sub. Date(s): 001: Sep 6, 2017 | Aug 27, 2027 *PED | |
| Pat. No. 9457154 DP* Injection device with an end of dose feedback mechanism Claim Types: Device Pat. Sub. Date(s): 001: Oct 26, 2016 | Mar 27, 2028 *PED | |
| Pat. No. 9132239 DP* Dial-down mechanism for wind-up pen Claim Types: Device Pat. Sub. Date(s): 001: Sep 18, 2015 | Aug 1, 2032 *PED | |
| Pat. No. 9968659 Liraglutide in cardiovascular conditions Claim Types: Method of use Pat. Sub. Date(s): 001: Nov 16, 2018 | Jul 9, 2037 *PED | U-2438: Cardiovascular outcomes trial of liraglutide 1.8 mg in patients with Type 2 diabetes and cardiovascular disease |
ULESFIA (LOTION) (TOPICAL) BENZYL ALCOHOL
Drug Classes: pediculicide; benzylamine antifungal
NDA Applicant: SHIONOGI INC NDA No.: 022129 Prod. No.: 001 DISC (5%)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6793931 DP* Ectoparasite asphyxiator compositions and methods for their applications Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: None | Jul 11, 2022 | U-970: Topical treatment of lice infestations |
| Pat. No. 7294342 Ectoparasite asphyxiator compositions and methods for their application Claim Types: Method of use Pat. Sub. Date(s): 001: None | May 19, 2024 | U-970: Topical treatment of lice infestations |
FOLOTYN (SOLUTION) (INTRAVENOUS) PRALATREXATE
Drug Classes: folate analog metabolic inhibitor
NDA Applicant: ACROTECH NDA No.: 022468 Prod. No.: 001 RX (20MG/ML (20MG/ML)); 002 RX (40MG/2ML (20MG/ML))
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6028071 DS* DP* [Extended 5 years] Purified compositions of 10-propargyl-10-deazaaminopterin and methods of using same in the treatment of tumors Claim Types: Compound; Composition; Method of use; Formulation Pat. Sub. Date(s): All strengths: None | Jul 16, 2022 | U-1004: Treatment of patients with relapsed or refractory peripheral T-cell lymphoma |
| Pat. No. 7622470 Treatment of T-cell lymphoma using 10-propargyl-10-deazaaminopterin Claim Types: Method of use Pat. Sub. Date(s): All strengths: None | May 31, 2025 | U-1015: Treatment of patients with relapsed or refractory peripheral T-cell lymphoma |
| Pat. No. 8299078 Treatment of T-cell lymphoma using 10-propargyl-10-deazaaminopterin Claim Types: Method of use Pat. Sub. Date(s): 001: Dec 19, 2012; 002: None | May 31, 2025 | U-1004: Treatment of patients with relapsed or refractory peripheral T-cell lymphoma |
AXID (SOLUTION) (ORAL) NIZATIDINE
Drug Classes: histamine-2 (H2) receptor antagonist
NDA Applicant: BRAINTREE NDA No.: 021494 Prod. No.: 001 DISC (15MG/ML**)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6930119 DP* Liquid pharmaceutical composition Claim Types: Formulation Pat. Sub. Date(s): 001: None | Jul 17, 2022 |
VELCADE (INJECTABLE) (INTRAVENOUS, SUBCUTANEOUS) BORTEZOMIB
Drug Classes: proteasome inhibitor
NDA Applicant: MILLENNIUM PHARMS NDA No.: 021602 Prod. No.: 001 RX (3.5MG/VIAL)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6713446 DS* DP* Formulation of boronic acid compounds Claim Types: Compound; Formulation; Process; Product-by-process Pat. Sub. Date(s): 001: None | Jul 25, 2022 *PED | |
| Pat. No. 6958319 DS* DP* Formulation of boronic acid compounds Claim Types: Compound; Process; Composition Pat. Sub. Date(s): 001: None | Jul 25, 2022 *PED | |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: M - Miscellaneous | Mar 14, 2019 PED | M-165: Provides for updates to the pediatric use section based on the pediatric study report entitled, 'a Phase II pilot trial of bortezomib in combination with intensive re-induction therapy in children with relapsed acute lymphoblastic lymphoma (ll)' |
| Exclusivity Code: ODE - Orphan drug exclusivity | Apr 8, 2022 PED | ODE-76: Treatment of patients with mantle cell lymphoma who have not received at least 1 prior therapy |
ZETIA (TABLET) (ORAL) EZETIMIBE [GENERIC AB]
Drug Classes: dietary cholesterol absorption inhibitor
NDA Applicant: MSD INTL GMBH NDA No.: 021445 Prod. No.: 001 RX (10MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7030106 DP* Sterol absorption inhibitor compositions Claim Types: Formulation Pat. Sub. Date(s): 001: None | Jul 25, 2022 *PED | |
| Pat. No. 7612058 Methods for inhibiting sterol absorption Claim Types: Method of use Pat. Sub. Date(s): 001: None | Apr 30, 2026 *PED | U-1027: Reduction of elevated plasma sterol and/or stanol levels in a mammal U-1173: To reduce elevated total-c, LDL-c, apo b and non-HDL-c in patients with primary hyperlipidemia by administration of ezetimibe alone or in combination with a statin or with fenofibrate |
EVAMIST (SPRAY) (TRANSDERMAL) ESTRADIOL
Drug Classes: estrogen
NDA Applicant: PERRIGO PHARMA INTL NDA No.: 022014 Prod. No.: 001 RX (1.53MG/SPRAY)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6978945 DP* Dispensing device Claim Types: Device Pat. Sub. Date(s): 001: None | Jul 31, 2022 |
ADDYI (TABLET) (ORAL) FLIBANSERIN
NDA Applicant: SPROUT PHARMS NDA No.: 022526 Prod. No.: 001 RX (100MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7420057 DS* DP* Stable polymorph of flibanserin Claim Types: New polymorph, salt or hydrate; Composition; Product-by-process Pat. Sub. Date(s): 001: Sep 14, 2015 | Aug 1, 2022 | |
| Pat. No. 9468639 Treating sexual desire disorders with flibanserin Claim Types: Method of use Pat. Sub. Date(s): 001: Nov 8, 2016 | Oct 16, 2022 | U-1734: Use of flibanserin or a pharmaceutically acceptable acid addition salt thereof to treat hypoactive sexual desire disorder (HSDD) |
| Pat. No. 7151103 Method of treating female hypoactive sexual desire disorder with flibanserin Claim Types: Method of use Pat. Sub. Date(s): 001: Sep 14, 2015 | May 9, 2023 | U-1734: Use of flibanserin or a pharmaceutically acceptable acid addition salt thereof to treat hypoactive sexual desire disorder (HSDD) |
| Pat. No. 8227471 Treating sexual desire disorders with flibanserin Claim Types: Method of use Pat. Sub. Date(s): 001: Sep 14, 2015 | May 9, 2023 | U-1734: Use of flibanserin or a pharmaceutically acceptable acid addition salt thereof to treat hypoactive sexual desire disorder (HSDD) |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NCE - New chemical entity | Aug 18, 2020 |
MACRILEN (FOR SOLUTION) (ORAL) MACIMORELIN ACETATE
Drug Classes: growth hormone (GH) secretagogue receptor agonist
NDA Applicant: NOVO NDA No.: 205598 Prod. No.: 001 RX (EQ 60MG BASE/POUCH)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6861409 DS* DP* Growth hormone secretagogues Claim Types: Compound; Composition; Method of use Pat. Sub. Date(s): 001: Jan 19, 2018 | Aug 1, 2022 | U-2220: A method for the diagnosis of adult growth hormone deficiency by measuring the level of growth hormone after oral administration of macimorelin |
| Pat. No. 8192719 Methods and kits to diagnose growth hormone deficiency by oral administration of EP 1572 or EP 1573 compounds Claim Types: Diagnostic or surgical method; Kit Pat. Sub. Date(s): 001: Jan 19, 2018 | Oct 12, 2027 | U-2220: A method for the diagnosis of adult growth hormone deficiency by measuring the level of growth hormone after oral administration of macimorelin |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NCE - New chemical entity | Dec 20, 2022 | |
| Exclusivity Code: ODE - Orphan drug exclusivity | Dec 20, 2024 | ODE-170: For the diagnosis of adult growth hormone deficiency (AGHD) |
NUCYNTA (TABLET) (ORAL) TAPENTADOL HYDROCHLORIDE
Drug Classes: opioid agonist
NDA Applicant: DEPO NF NDA No.: 022304 Prod. No.: 001 RX (EQ 50MG BASE); 002 RX (EQ 75MG BASE); 003 RX (EQ 100MG BASE)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. RE39593 DS* DP* [Extended 1508 days (4.1 years)] 1-phenyl-3-dimethylaminopropane compounds with a pharmacological effects Claim Types: Compound; Composition; Method of use Pat. Sub. Date(s): All strengths: Jul 21, 2011 | Aug 5, 2022 | U-931: Relief of moderate to severe acute pain |
| Pat. No. 7994364 DS* DP* Crystalline forms of (-)-(1R,2R)-3-(3-dimethylamino-1-ethyl-2-methylpropyl)-phenol hydrochloride Claim Types: New polymorph, salt or hydrate; Process; Composition; Method of use Pat. Sub. Date(s): 001: Sep 2, 2011; 002: None; 003: None | Jun 27, 2025 | U-931: Relief of moderate to severe acute pain |
NUCYNTA (SOLUTION) (ORAL) TAPENTADOL HYDROCHLORIDE
Drug Classes: opioid agonist
NDA Applicant: ASSERTIO NDA No.: 203794 Prod. No.: 001 DISC (EQ 20MG BASE/ML)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. RE39593 DS* DP* [Extended 1508 days (4.1 years)] 1-phenyl-3-dimethylaminopropane compounds with a pharmacological effects Claim Types: Compound; Composition; Method of use Pat. Sub. Date(s): 001: Oct 24, 2012 | Aug 5, 2022 | U-1289: Management of moderate to severe acute pain |
| Pat. No. 7994364 DS* DP* Crystalline forms of (-)-(1R,2R)-3-(3-dimethylamino-1-ethyl-2-methylpropyl)-phenol hydrochloride Claim Types: New polymorph, salt or hydrate; Process; Composition; Method of use Pat. Sub. Date(s): 001: Oct 24, 2012 | Jun 27, 2025 | U-1289: Management of moderate to severe acute pain |
NUCYNTA ER (TABLET, EXTENDED RELEASE) (ORAL) TAPENTADOL HYDROCHLORIDE
Drug Classes: opioid agonist
NDA Applicant: DEPO NF NDA No.: 200533 Prod. No.: 001 RX (EQ 50MG BASE); 002 RX (EQ 100MG BASE); 003 RX (EQ 150MG BASE); 004 RX (EQ 200MG BASE); 005 RX (EQ 250MG BASE)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. RE39593 DS* DP* [Extended 1508 days (4.1 years)] 1-phenyl-3-dimethylaminopropane compounds with a pharmacological effects Claim Types: Compound; Composition; Method of use Pat. Sub. Date(s): 001: Sep 19, 2011; 002: None; 003: None; 004: None; 005: None | Aug 5, 2022 | U-1178: Relief of moderate to severe chronic pain U-1276: Management of neuropathic pain associated with diabetic peripheral neuropathy |
| Pat. No. 8075872 DP* Abuse-proofed dosage form Claim Types: Formulation; Process Pat. Sub. Date(s): 001: Jan 9, 2012; 002: None; 003: None; 004: None; 005: None | Nov 20, 2023 | |
| Pat. No. 8309060 DP* Abuse-proofed dosage form Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Dec 5, 2012; 002: None; 003: None; 004: None; 005: None | Nov 20, 2023 | U-1178: Relief of moderate to severe chronic pain U-1276: Management of neuropathic pain associated with diabetic peripheral neuropathy |
| Pat. No. 8420056 DP* Abuse-proofed dosage form Claim Types: Formulation; Process; Product-by-process Pat. Sub. Date(s): 001: May 2, 2013; 002: None; 003: None; 004: None; 005: None | Nov 20, 2023 | |
| Pat. No. 8114383 DP* DLR* Abuse-proofed dosage form Claim Types: Formulation Pat. Sub. Date(s): 001: Mar 14, 2012; 002: None; 003: None; 004: None; 005: None | Oct 10, 2024 | |
| Pat. No. 7994364 DS* DP* Crystalline forms of (-)-(1R,2R)-3-(3-dimethylamino-1-ethyl-2-methylpropyl)-phenol hydrochloride Claim Types: New polymorph, salt or hydrate; Process; Composition; Method of use Pat. Sub. Date(s): 001: Sep 2, 2011; 002: None; 003: None; 004: None; 005: None | Jun 27, 2025 | U-1178: Relief of moderate to severe chronic pain U-1276: Management of neuropathic pain associated with diabetic peripheral neuropathy |
| Pat. No. 8536130 Use of 1 phenyl-3-dimethylamino-propane compounds for treating neuropathic pain Claim Types: Method of use Pat. Sub. Date(s): All strengths: None | Sep 22, 2028 | U-1276: Management of neuropathic pain associated with diabetic peripheral neuropathy |
OXYCONTIN (TABLET, EXTENDED RELEASE) (ORAL) OXYCODONE HYDROCHLORIDE
Drug Classes: opioid agonist
NDA Applicant: PURDUE PHARMA LP NDA No.: 022272 Prod. No.: 001 RX (10MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 9060976 DP* DLR* Pharmaceutical formulation containing gelling agent Claim Types: Formulation Pat. Sub. Date(s): 001: Jun 23, 2015 | Aug 6, 2022 | |
| Pat. No. 9675610 DP* Abuse-proofed dosage form Claim Types: Formulation Pat. Sub. Date(s): 001: Jul 12, 2017 | Jun 16, 2023 | |
| Pat. No. 10369109 DP* Abuse-proofed dosage form Claim Types: Formulation Pat. Sub. Date(s): 001: Aug 9, 2019 | Jun 16, 2023 | |
| Pat. No. 8309060 DP* Abuse-proofed dosage form Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Nov 14, 2012 | Nov 20, 2023 | U-1556: Management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. |
| Pat. No. 10130591 DP* Abuse-proofed dosage form Claim Types: Method of use; Product-by-process Pat. Sub. Date(s): 001: Nov 27, 2018 | Nov 20, 2023 | U-1819: Management of pain severe enough to require daily, around-the-clock, long term opioid treatment and for which alternative treatment options are inadequate |
| Pat. No. 7674799 DP* DLR* Oxycodone hydrochloride having less than 25 ppm 14-hydroxycodeinone Claim Types: Formulation Pat. Sub. Date(s): 001: None | Mar 30, 2025 | |
| Pat. No. 7674800 DS* DLR* Oxycodone hydrochloride having less than 25 PPM 14-hydroxycodeinone Claim Types: Product-by-process; Process Pat. Sub. Date(s): 001: None | Mar 30, 2025 | |
| Pat. No. 7683072 DS* DLR* Oxycodone hydrochloride having less than 25 ppm 14-hydroxycodeinone Claim Types: Compound Pat. Sub. Date(s): 001: None | Mar 30, 2025 | |
| Pat. No. 9073933 DS* Oxycodone hydrochloride having less than 25 PPM 14-hydroxycodeinone Claim Types: Formulation; Process Pat. Sub. Date(s): 001: Aug 3, 2015 | Mar 30, 2025 | |
| Pat. No. 9522919 DS* DP* Oxycodone compositions Claim Types: Formulation Pat. Sub. Date(s): 001: Dec 20, 2016 | Mar 30, 2025 | |
| Pat. No. 10407434 DS* Process for preparing oxycodone compositions Claim Types: Product-by-process; Process Pat. Sub. Date(s): 001: Sep 10, 2019 | Mar 30, 2025 | |
| Pat. No. 7776314 DP* DLR* Abuse-proofed dosage system Claim Types: Formulation Pat. Sub. Date(s): 001: None | Apr 19, 2025 | |
| Pat. No. 8808741 Tamper resistant dosage forms Claim Types: Method of use Pat. Sub. Date(s): 001: Aug 19, 2014 | Aug 24, 2027 | U-1556: Management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. |
| Pat. No. 8894988 DP* Tamper resistant dosage forms Claim Types: Formulation Pat. Sub. Date(s): 001: Nov 25, 2014 | Aug 24, 2027 | |
| Pat. No. 9492389 DP* Tamper resistant dosage forms Claim Types: Product-by-process Pat. Sub. Date(s): 001: Nov 16, 2016 | Aug 24, 2027 | |
| Pat. No. 9492391 Tamper resistant dosage forms Claim Types: Method of use Pat. Sub. Date(s): 001: Nov 16, 2016 | Aug 24, 2027 | U-1556: Management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. |
| Pat. No. 9492392 DP* Tamper resistant dosage forms Claim Types: Formulation Pat. Sub. Date(s): 001: Nov 16, 2016 | Aug 24, 2027 | |
| Pat. No. 9492393 Tamper resistant dosage forms Claim Types: Method of use Pat. Sub. Date(s): 001: Nov 16, 2016 | Aug 24, 2027 | U-1556: Management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. |
| Pat. No. 9763933 DP* Tamper resistant dosage forms Claim Types: Formulation Pat. Sub. Date(s): 001: Sep 19, 2017 | Aug 24, 2027 | |
| Pat. No. 9770416 DP* Tamper resistant dosage forms Claim Types: Formulation Pat. Sub. Date(s): 001: Sep 27, 2017 | Aug 24, 2027 | |
| Pat. No. 9775808 DP* Tamper resistant dosage forms Claim Types: Formulation Pat. Sub. Date(s): 001: Oct 4, 2017 | Aug 24, 2027 | |
| Pat. No. 8894987 DP* Tamper resistant dosage forms Claim Types: Product-by-process; Process Pat. Sub. Date(s): 001: Nov 25, 2014 | Mar 29, 2030 |
KINEVAC (INJECTABLE) (INJECTION) SINCALIDE
Drug Classes: cholecystokinin (CCK) analog
NDA Applicant: BRACCO NDA No.: 017697 Prod. No.: 001 RX (0.005MG/VIAL)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6803046 DP* Sincalide formulations Claim Types: Formulation; Process; Kit; Method of use Pat. Sub. Date(s): 001: None | Aug 16, 2022 |
LEVAQUIN (SOLUTION) (ORAL) LEVOFLOXACIN [Has competitive generic]
Drug Classes: quinolone antimicrobial
NDA Applicant: JANSSEN PHARMS NDA No.: 021721 Prod. No.: 001 DISC (250MG/10ML)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6806256 DP* Taste masked liquid pharmaceutical compositions Claim Types: Formulation Pat. Sub. Date(s): 001: None | Aug 26, 2022 *PED |
ANORO ELLIPTA (POWDER) (INHALATION) UMECLIDINIUM BROMIDE; VILANTEROL TRIFENATATE
Drug Classes: anticholinergic; beta-2 adrenergic agonist
NDA Applicant: GLAXOSMITHKLINE NDA No.: 203975 Prod. No.: 001 RX (EQ 0.0625MG BASE/INH;EQ 0.025MG BASE/INH)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7776895 DP* Inhalation devices for delivering phenethanolamine derivatives for the treatment of respiratory diseases Claim Types: Device Pat. Sub. Date(s): 001: Jan 9, 2014 | Sep 11, 2022 | |
| Pat. No. RE44874 DS* DP* Phenethanolamine derivatives for treatment of respiratory diseases Claim Types: Compound; Composition; Formulation; Method of use; Process; Drug in a container Pat. Sub. Date(s): 001: May 14, 2014 | Mar 23, 2023 | U-1476: Indicated for the long-term, once-daily, maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema. |
| Pat. No. 7498440 DS* DP* Muscarinic acetylcholine receptor antagonists Claim Types: Compound; Composition Pat. Sub. Date(s): 001: Jan 9, 2014 | Apr 27, 2025 | |
| Pat. No. 8309572 Muscarinic acetylcholine receptor antagonists Claim Types: Method of use; Method of administration Pat. Sub. Date(s): 001: Jan 9, 2014 | Apr 27, 2025 | U-1476: Indicated for the long-term, once-daily, maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema. |
| Pat. No. 7439393 DS* DP* [Extended 983 days (2.7 years)] Phenethanolamine derivatives for treatment of respiratory diseases Claim Types: Compound; Composition; Formulation; Method of use Pat. Sub. Date(s): 001: Jan 9, 2014 | May 21, 2025 | U-1476: Indicated for the long-term, once-daily, maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema. |
| Pat. No. 8183257 Muscarinic acetylcholine receptor antagonists Claim Types: Method of use Pat. Sub. Date(s): 001: None | Jul 27, 2025 | U-1476: Indicated for the long-term, once-daily, maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema. |
| Pat. No. 8511304 DP* Medicament dispenser Claim Types: Device; Method of use Pat. Sub. Date(s): 001: Jan 9, 2014 | Jun 14, 2027 | U-1476: Indicated for the long-term, once-daily, maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema. |
| Pat. No. 9333310 DP* Medicament dispenser Claim Types: Device; Drug in a container Pat. Sub. Date(s): 001: May 20, 2016 | Oct 2, 2027 | |
| Pat. No. 8113199 DP* Counter for use with a medicament dispenser Claim Types: Device Pat. Sub. Date(s): 001: Jan 9, 2014 | Oct 23, 2027 | |
| Pat. No. 7488827 DS* DP* [Extended 965 days (2.6 years)] Muscarinic acetylcholine receptor antagonists Claim Types: Compound; Composition; Formulation Pat. Sub. Date(s): 001: Jan 9, 2014 | Dec 18, 2027 | |
| Pat. No. 8161968 DP* Medicament dispenser Claim Types: Device Pat. Sub. Date(s): 001: Jan 9, 2014 | Feb 5, 2028 | |
| Pat. No. 8534281 DP* Manifold for use in medicament dispenser Claim Types: Device Pat. Sub. Date(s): 001: Jan 9, 2014 | Mar 8, 2030 | |
| Pat. No. 8746242 DP* Medicament dispenser Claim Types: Device Pat. Sub. Date(s): 001: Jun 26, 2014 | Oct 11, 2030 | |
| Pat. No. 9750726 DP* Combinations of a muscarinic receptor antagonist and a beta-2 adrenoreceptor agonist Claim Types: Formulation Pat. Sub. Date(s): 001: Sep 21, 2017 | Nov 29, 2030 | |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: M - Miscellaneous | Jun 9, 2022 | M-245: Additional information added to the labeling based on safety and efficacy data from the IMPACT trial |
ORAVIG (TABLET) (BUCCAL) MICONAZOLE
Drug Classes: azole antifungal
NDA Applicant: FORTOVIA NDA No.: 022404 Prod. No.: 001 RX (50MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6916485 DP* Prolonged release bioadhesive therapeutic systems Claim Types: Formulation; Process; Method of use Pat. Sub. Date(s): 001: None | Sep 11, 2022 | U-1051: Treatment of oropharyngeal candidiasis |
| Pat. No. 7651698 Prolonged release bioadhesive therapeutic systems Claim Types: Method of use Pat. Sub. Date(s): 001: None | Sep 11, 2022 | U-1051: Treatment of oropharyngeal candidiasis |
| Pat. No. 8518442 DP* Prolonged release bioadhesive therapeutic systems Claim Types: Formulation Pat. Sub. Date(s): 001: Sep 17, 2013 | Sep 11, 2022 |
VAGIFEM (TABLET) (VAGINAL) ESTRADIOL [GENERIC AB]
Drug Classes: estrogen
NDA Applicant: NOVO NORDISK INC NDA No.: 020908 Prod. No.: 002 RX (10MCG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7018992 Hormone composition Claim Types: Method of use Pat. Sub. Date(s): 002: None | Sep 17, 2022 | U-1023: Treatment of atrophic vaginitis due to menopause |
TRINTELLIX (TABLET) (ORAL) VORTIOXETINE HYDROBROMIDE
NDA Applicant: TAKEDA PHARMS USA NDA No.: 204447 Prod. No.: 001 RX (EQ 5MG BASE); 002 RX (EQ 10MG BASE); 004 RX (EQ 20MG BASE) NDA No.: 204447 Prod. No.: 003 DISC (EQ 15MG BASE**)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8476279 DP* Phenyl-piperazine derivatives as serotonin reuptake inhibitors Claim Types: Composition; Method of use Pat. Sub. Date(s): All strengths: Oct 16, 2013 | Oct 2, 2022 | U-1439: Method of treating an affective disorder such as depression |
| Pat. No. 7144884 DS* DP* Phenyl-piperazine derivatives as serotonin reuptake inhibitors Claim Types: Compound; Composition; Method of use Pat. Sub. Date(s): All strengths: Oct 16, 2013 | Jun 17, 2026 | U-1439: Method of treating an affective disorder such as depression |
| Pat. No. 8969355 1-[2-(2,4 dimethylphenylsulfanyl)-phenyl]piperazine as a compound with combined serotonin reuptake, 5-HT3 and 5-HT1a activity for the treatment of cognitive impairment Claim Types: Method of use Pat. Sub. Date(s): All strengths: Mar 19, 2015 | Jun 15, 2027 | U-1668: Method of treating depression or major depressive disorder |
| Pat. No. 9125908 1-[2-(2,4-dimethylphenylsulfanyl)-phenyl]piperazine as a compound with combined serotonin Claim Types: Method of use Pat. Sub. Date(s): All strengths: May 24, 2018 | Jun 15, 2027 | U-2309: Use in the treatment of major depressive disorder to improve processing speed, an aspect of cognitive function |
| Pat. No. 9125909 1-[2-(2,4 dimethylphenylsulfanyl)-phenyl]piperazine as a compound with combined serotonin Claim Types: Method of use Pat. Sub. Date(s): All strengths: May 24, 2018 | Jun 15, 2027 | U-2309: Use in the treatment of major depressive disorder to improve processing speed, an aspect of cognitive function |
| Pat. No. 9125910 1-[2-(2,4 dimethylphenylsulfanyl)-phenyl]piperazine as a compound with combined serotonin reuptake, 5-HT.sub.3 and 5-HT.sub.1A activity for the treatment of cognitive impairment Claim Types: Method of use Pat. Sub. Date(s): All strengths: May 24, 2018 | Jun 15, 2027 | U-2309: Use in the treatment of major depressive disorder to improve processing speed, an aspect of cognitive function |
| Pat. No. 9227946 1-[2-(2,4 dimethylphenylsulfanyl)-phenyl]piperazine as a compound with combined serotonin reuptake, 5-HT3 and 5-HT1a activity for the treatment of cognitive impairment Claim Types: Method of use Pat. Sub. Date(s): All strengths: Jan 21, 2016 | Jun 15, 2027 | U-1668: Method of treating depression or major depressive disorder |
| Pat. No. 9861630 1-[2-(2,4-dimethylphenylsulfanyl)-phenyl]piperazine as a compound with combined serotonin reuptake, 5-HT.sub.3 and 5-HT.sub.1A activity for the treatment of cognitive impairment Claim Types: Method of use Pat. Sub. Date(s): All strengths: Jan 18, 2018 | Jun 15, 2027 | U-1668: Method of treating depression or major depressive disorder |
| Pat. No. 8722684 DS* DP* 1-[2-(2,4-dimethylphenylsulfanyl)-phenyl] piperazine as a compound with combined serotonin reuptake, 5-HT3 and 5-HT1A activity for the treatment of cognitive impairment Claim Types: New polymorph, salt or hydrate; Composition; Product-by-process; Formulation Pat. Sub. Date(s): All strengths: Jun 9, 2014 | Jun 30, 2031 | |
| Pat. No. 9278096 Therapeutic uses of compounds having combined SERT, 5-HT.sub.3 and 5-HT.sub.1A activity Claim Types: Method of use Pat. Sub. Date(s): All strengths: Nov 13, 2018 | Mar 21, 2032 | U-2436: Use in the treatment of major depressive disorder to improve treatment emergent sexual dysfunction (TESD) induced by prior serotonin reuptake inhibitor treatment |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: M - Miscellaneous | May 2, 2021 | M-227: Addition to the clinical studies section of the labeling with the subsection entitled digit symbol substitution test in major depressive disorder |
| Exclusivity Code: M - Miscellaneous | Oct 19, 2021 | M-234: Update to the prescribing information for vortioxetine on treatment-emergent sexual dysfunction comparing vortioxetine and SSRIS |
AVANDAMET (TABLET) (ORAL) METFORMIN HYDROCHLORIDE; ROSIGLITAZONE MALEATE
Drug Classes: biguanide; peroxisome proliferator-activated receptor (PPAR) gamma agonist; thiazolidinedione
NDA Applicant: SB PHARMCO NDA No.: 021410 Prod. No.: 001 DISC (500MG;EQ 1MG BASE**); 002 DISC (500MG;EQ 2MG BASE**); 003 DISC (500MG;EQ 4MG BASE**); 004 DISC (1GM;EQ 2MG BASE**); 005 DISC (1GM;EQ 4MG BASE**)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8236345 DP* Composition and use Claim Types: Formulation Pat. Sub. Date(s): 001: Aug 20, 2012; 002: None; 003: None; 004: None; 005: None | Oct 7, 2022 |
WELCHOL (TABLET) (ORAL) COLESEVELAM HYDROCHLORIDE [GENERIC AB]
Drug Classes: bile acid sequestrant
NDA Applicant: DAIICHI SANKYO NDA No.: 021176 Prod. No.: 001 RX (625MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7229613 Method for lowering serum glucose Claim Types: Method of use Pat. Sub. Date(s): 001: None | Oct 17, 2022 *PED | U-851: Treatment of Type 2 diabetes mellitus |
WELCHOL (FOR SUSPENSION) (ORAL) COLESEVELAM HYDROCHLORIDE [Has competitive generic]
Drug Classes: bile acid sequestrant
NDA Applicant: DAIICHI SANKYO NDA No.: 022362 Prod. No.: 002 RX (3.75GM/PACKET) NDA No.: 022362 Prod. No.: 001 DISC (1.875GM/PACKET)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7229613 Method for lowering serum glucose Claim Types: Method of use Pat. Sub. Date(s): All strengths: None | Oct 17, 2022 *PED | U-493: Treatment of Type 2 Diabetes Mellitus |
MOVANTIK (TABLET) (ORAL) NALOXEGOL OXALATE
Drug Classes: opioid antagonist
NDA Applicant: ASTRAZENECA PHARMS NDA No.: 204760 Prod. No.: 001 RX (EQ 12.5MG BASE); 002 RX (EQ 25MG BASE)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7662365 DS* DP* Polymer conjugates of opioid antagonists Claim Types: Composition; Compound Pat. Sub. Date(s): All strengths: Oct 14, 2014 | Oct 18, 2022 | |
| Pat. No. 8617530 Polymer conjugates of opioid antagonists Claim Types: Method of use Pat. Sub. Date(s): All strengths: Oct 14, 2014 | Oct 18, 2022 | U-1185: Treatment of opioid-induced constipation |
| Pat. No. 7056500 DP* Polymer conjugates of opioid antagonists Claim Types: Formulation; Method of use Pat. Sub. Date(s): All strengths: Jun 5, 2015 | Jun 29, 2024 | U-1185: Treatment of opioid-induced constipation |
| Pat. No. 8067431 Chemically modified small molecules Claim Types: Method of use Pat. Sub. Date(s): All strengths: Oct 14, 2014 | Dec 16, 2024 | U-1185: Treatment of opioid-induced constipation |
| Pat. No. 7786133 DS* DP* Chemically modified small molecules Claim Types: Compound; Composition Pat. Sub. Date(s): All strengths: Oct 14, 2014 | Dec 19, 2027 | |
| Pat. No. 9012469 DS* DP* Crystalline naloxol-peg conjugate Claim Types: New polymorph, salt or hydrate; Process; Composition Pat. Sub. Date(s): All strengths: May 15, 2015 | Apr 2, 2032 | |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NCE - New chemical entity | Sep 16, 2019 |
SUMAVEL DOSEPRO (INJECTABLE) (SUBCUTANEOUS) SUMATRIPTAN SUCCINATE [Has competitive generic]
Drug Classes: serotonin 5-HT1B/1D receptor agonist (triptan)
NDA Applicant: ENDO VENTURES LTD NDA No.: 022239 Prod. No.: 001 DISC (EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML))
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8343130 DP* Needleless injector Claim Types: Method of administration Pat. Sub. Date(s): 001: Jan 25, 2013 | Oct 18, 2022 | |
| Pat. No. 8241244 DP* Needleless injector drug capsule and a method for filling thereof Claim Types: Process Pat. Sub. Date(s): 001: Aug 31, 2012 | Nov 21, 2022 | |
| Pat. No. 8491524 DP* Needleless injector drug capsule and a method for filling thereof Claim Types: Device Pat. Sub. Date(s): 001: Aug 23, 2013 | Nov 21, 2022 | |
| Pat. No. 8267903 DP* Casing Claim Types: Device Pat. Sub. Date(s): 001: Oct 10, 2012 | Mar 18, 2023 | |
| Pat. No. 8118771 DP* Needleless injector drug capsule and a method for filling thereof Claim Types: Process Pat. Sub. Date(s): 001: Mar 9, 2012 | Aug 10, 2023 | |
| Pat. No. 8241243 DP* Needleless injector drug capsule and a method for filling thereof Claim Types: Device Pat. Sub. Date(s): 001: Aug 31, 2012 | Aug 10, 2023 | |
| Pat. No. 8287489 DP* Device for readying a needle free injector for delivery Claim Types: Device Pat. Sub. Date(s): 001: Nov 16, 2012 | Dec 6, 2024 | |
| Pat. No. 7901385 DP* Casing Claim Types: Device Pat. Sub. Date(s): 001: Mar 23, 2011 | Jul 31, 2026 | |
| Pat. No. 7776007 DP* Device for readying a needle free injector for delivery Claim Types: Device Pat. Sub. Date(s): 001: Mar 4, 2011 | Nov 22, 2026 |
HALFLYTELY (FOR SOLUTION, TABLET, DELAYED RELEASE) (ORAL) BISACODYL; POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE
Drug Classes: stimulant laxative; osmotic laxative
NDA Applicant: BRAINTREE NDA No.: 021551 Prod. No.: 003 DISC (5MG,N/A;N/A,210GM;N/A,0.74GM;N/A,2.86GM;N/A,5.6GM**)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7291324 Method of bowel cleansing Claim Types: Method of use Pat. Sub. Date(s): 003: None | Oct 22, 2022 | U-837: Gastrointestinal lavage indicated for cleansing of the colon as a preparation for colonoscopy in adults |
SINGULAIR (GRANULE) (ORAL) MONTELUKAST SODIUM [GENERIC AB]
Drug Classes: leukotriene receptor antagonist (LTRA)
NDA Applicant: MERCK NDA No.: 021409 Prod. No.: 001 RX (EQ 4MG BASE/PACKET)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8007830 DP* Granule formation Claim Types: Formulation Pat. Sub. Date(s): 001: Sep 29, 2011 | Oct 24, 2022 |
TRI-LUMA (CREAM) (TOPICAL) FLUOCINOLONE ACETONIDE; HYDROQUINONE; TRETINOIN
Drug Classes: corticosteroid; melanin synthesis inhibitor; retinoid
NDA Applicant: GALDERMA LABS LP NDA No.: 021112 Prod. No.: 001 RX (0.01%;4%;0.05%)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8247395 DP* Topical skin care composition Claim Types: Formulation; Product-by-process Pat. Sub. Date(s): 001: Oct 5, 2012 | Oct 25, 2022 | |
| Pat. No. 8653053 DP* Topical skin care composition Claim Types: Product-by-process; Formulation Pat. Sub. Date(s): 001: Mar 14, 2014 | Oct 25, 2022 | |
| Pat. No. 7915243 DP* Topical skin care composition Claim Types: Formulation Pat. Sub. Date(s): 001: Mar 31, 2011 | Sep 8, 2023 | |
| Pat. No. 7939516 DP* Topical skin care composition Claim Types: Formulation Pat. Sub. Date(s): 001: May 17, 2011 | Sep 8, 2023 |
RYDAPT (CAPSULE) (ORAL) MIDOSTAURIN
Drug Classes: kinase inhibitor
NDA Applicant: NOVARTIS NDA No.: 207997 Prod. No.: 001 RX (25MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8222244 Staurosporine derivatives as inhibitors of FLT3 receptor tyrosine kinase activity Claim Types: Method of use Pat. Sub. Date(s): 001: May 23, 2017 | Oct 29, 2022 | U-2007: Treatment of adult patients with newly diagnosed acute myeloid leukemia (AML) who are FLT3 mutation-positive, in combination with standard cytarabine and daunorubicin induction and cytarabine consolidation chemotherapy |
| Pat. No. 7973031 Staurosporine derivatives as inhibitors of FLT3 receptor tyrosine kinase activity Claim Types: Method of use Pat. Sub. Date(s): 001: May 23, 2017 | Oct 17, 2024 | U-2007: Treatment of adult patients with newly diagnosed acute myeloid leukemia (AML) who are FLT3 mutation-positive, in combination with standard cytarabine and daunorubicin induction and cytarabine consolidation chemotherapy |
| Pat. No. 8575146 Pharmaceutical uses of staurosporine derivatives Claim Types: Method of use Pat. Sub. Date(s): 001: May 23, 2017 | Dec 2, 2030 | U-2008: Treatment of adult patients with aggressive systemic mastocytosis (asm), systemic mastocytosis with associated hematological neoplasm (SM-AHN), or mast cell leukemia (MCL) |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NCE - New chemical entity | Apr 28, 2022 | |
| Exclusivity Code: ODE - Orphan drug exclusivity | Apr 28, 2024 | ODE-140: Treatment of adult patients with aggressive systemic mastocytosis (ASM), systemic mastocytosis with associated hematological neoplasm (SM-AHN), or mast cell leukemia (MCL) |
| Exclusivity Code: ODE - Orphan drug exclusivity | Apr 28, 2024 | ODE-141: Treatment of adult patients with newly diagnosed acute myeloid leukemia (aml) that is flt3 mutation-positive as detected by an FDA approved test, in combination with standard cytarabine and daunorubicin induction and cytarabine consolidation |
HORIZANT (TABLET, EXTENDED RELEASE) (ORAL) GABAPENTIN ENACARBIL
Drug Classes: antiepileptic drug (AED)
NDA Applicant: ARBOR PHARMS LLC NDA No.: 022399 Prod. No.: 001 RX (600MG); 002 RX (300MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8048917 DS* DP* Prodrugs of GABA analogs, compositions and uses thereof Claim Types: Composition; Formulation; Method of use Pat. Sub. Date(s): 001: Nov 21, 2011; 002: Jan 5, 2012 | Nov 6, 2022 | U-1247: Management of postherpetic neuralgia (PHN) in adults |
| Pat. No. 8686034 Crystalline form of .gamma.-aminobutyric acid analog Claim Types: Method of use Pat. Sub. Date(s): All strengths: Apr 28, 2014 | Jan 24, 2025 | U-1231: Treatment of moderate-to-severe primary restless leg syndrome in adults U-1247: Management of postherpetic neuralgia (PHN) in adults |
| Pat. No. 6818787 DS* DP* [Extended 882 days (2.4 years)] Prodrugs of GABA analogs, compositions and uses thereof Claim Types: Compound Pat. Sub. Date(s): 001: Apr 19, 2011; 002: Jan 5, 2012 | Apr 6, 2025 | |
| Pat. No. 8114909 Treating or preventing restless legs syndrome using prodrugs of GABA analogs Claim Types: Method of use Pat. Sub. Date(s): 001: Mar 13, 2012; 002: None | Apr 11, 2026 | U-1231: Treatment of moderate-to-severe primary restless leg syndrome in adults |
| Pat. No. 8026279 DS* DP* Crystalline form of .gamma.-aminobutyric acid analog Claim Types: New polymorph, salt or hydrate Pat. Sub. Date(s): 001: Oct 24, 2011; 002: Jan 5, 2012 | Nov 10, 2026 | |
| Pat. No. 8795725 DP* GABA analog prodrug sustained release oral dosage forms Claim Types: Formulation; Method of use Pat. Sub. Date(s): All strengths: Aug 27, 2014 | Jun 10, 2029 | U-1231: Treatment of moderate-to-severe primary restless leg syndrome in adults U-1247: Management of postherpetic neuralgia (PHN) in adults |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: ODE - Orphan drug exclusivity | Jun 6, 2019 | ODE-25: Management of postherpetic neuralgia in adults. |
XERESE (CREAM) (TOPICAL) ACYCLOVIR; HYDROCORTISONE
Drug Classes: nucleoside analog HSV DNA polymerase inhibitor / VZV DNA polymerase inhibitor; corticosteroid
NDA Applicant: BAUSCH NDA No.: 022436 Prod. No.: 001 RX (5%;1%)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7223387 DP* Antiviral formulations comprising propylene glycol and an isopropyl alkanoic acid ester Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: None | Nov 13, 2022 | U-1006: New combination product for the early treatment of recurrent herpes labialis (cold sores) to reduce the likelihood of ulcerative cold sores and to shorten the lesion healing time in adults and adolescents (12 years of age and older) U-1484: Combination product for the early treatment of recurrent herpes labialis (cold sores) to reduce the likelihood of ulcerative cold sores and to shorten the lesion healing time in adults and children (6 years of age and older) |
XOFIGO (SOLUTION) (INTRAVENOUS) RADIUM RA-223 DICHLORIDE
Drug Classes: alpha particle-emitting radioactive therapeutic agent
NDA Applicant: BAYER HLTHCARE NDA No.: 203971 Prod. No.: 001 RX (162mCi/6ML (27mCi/ML))
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6635234 [Extended 1049 days (2.9 years)] Preparation and use of radium-223 to target calcified tissues for pain palliation, bone cancer therapy, and bone surface conditioning Claim Types: Method of use; Method of administration Pat. Sub. Date(s): 001: Jun 11, 2013 | Nov 17, 2022 | U-2271: Therapeutic treatment of patients with castration-resistant prostate cancer, symptomatic bone metastases and no known visceral metastatic disease |
AMLODIPINE BESYLATE (TABLET, ORALLY DISINTEGRATING) (ORAL) AMLODIPINE BESYLATE
Drug Classes: dihydropyridine calcium channel blocker
NDA Applicant: SYNTHON PHARMS NDA No.: 022026 Prod. No.: 001 DISC (EQ 2.5MG BASE); 002 DISC (EQ 5MG BASE); 003 DISC (EQ 10MG BASE)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6828339 DS* Amlodipine salt forms and processes for preparing them Claim Types: New polymorph, salt or hydrate; Formulation Pat. Sub. Date(s): All strengths: None | Nov 20, 2022 |
NEURONTIN (SOLUTION) (ORAL) GABAPENTIN [GENERIC AA]
Drug Classes: antiepileptic drug (AED)
NDA Applicant: PARKE DAVIS NDA No.: 021129 Prod. No.: 001 RX (250MG/5ML)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7256216 DP* Liquid pharmaceutical compositions Claim Types: Formulation Pat. Sub. Date(s): 001: None | Nov 28, 2022 *PED |
HETLIOZ (CAPSULE) (ORAL) TASIMELTEON
Drug Classes: melatonin receptor agonist
NDA Applicant: VANDA PHARMS INC NDA No.: 205677 Prod. No.: 001 RX (20MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 5856529 DS* DP* [Extended 5 years] Benzofuran and dihydrobenzofuran melatonergic agents Claim Types: Compound; Composition; Method of use Pat. Sub. Date(s): 001: None | Dec 9, 2022 | U-2149: Treatment of non-24 hour sleep-wake disorder by administering tasimelteon |
| Pat. No. RE46604 Treatment of circadian rhythm disorders Claim Types: Method of use Pat. Sub. Date(s): 001: Nov 30, 2017 | Jan 25, 2033 | U-2147: Treatment of non-24 hour sleep-wake disorder by orally administering 20mg of tasimelteon once daily before bedtime |
| Pat. No. 9060995 Treatment of circadian rhythm disorders Claim Types: Method of improving a treatment Pat. Sub. Date(s): 001: Jun 26, 2015 | Jan 25, 2033 | U-1710: Treatment of non-24-hour sleep-wake disorder by avoiding the use of tasimelteon in combination with fluvoxamine |
| Pat. No. 9539234 Treatment of circadian rhythm disorders Claim Types: Method of use Pat. Sub. Date(s): 001: Jan 11, 2017 | Jan 25, 2033 | U-1934: Treatment of non-24-hour sleep-wake disorder by avoiding the use of tasimelteon in combination with a strong CYP1A2 inhibitor |
| Pat. No. 9549913 Treatment of circadian rhythm disorders Claim Types: Method of use Pat. Sub. Date(s): 001: Jan 27, 2017 | Jan 25, 2033 | U-1486: Treatment of non-24-hour sleep-wake disorder |
| Pat. No. 9855241 Treatment of circadian rhythm disorders Claim Types: Method of use Pat. Sub. Date(s): 001: Jan 18, 2018 | Jan 25, 2033 | U-2149: Treatment of non-24 hour sleep-wake disorder by administering tasimelteon |
| Pat. No. 10149829 Treatment of circadian rhythm disorders Claim Types: Method of use Pat. Sub. Date(s): 001: Dec 27, 2018 | Jan 25, 2033 | U-2477: Treatment of non-24 hour sleep-wake disorder by avoiding the use of tasimelteon in combination with CYP1A2 strong inhibitors |
| Pat. No. 10449176 Treatment of circadian rhythm disorders Claim Types: Method of use Pat. Sub. Date(s): 001: Nov 20, 2019 | Jan 25, 2033 | U-2149: Treatment of non-24 hour sleep-wake disorder by administering tasimelteon |
| Pat. No. 9730910 Treatment of circadian rhythm disorders Claim Types: Method of administration Pat. Sub. Date(s): 001: Aug 22, 2017 | May 17, 2034 | U-2085: Treatment of non-24-hour sleep-wake disorder by avoiding the use of tasimelteon in combination with rifampin |
| Pat. No. 10071977 DS* DP* Highly purifid pharmaceutical grade tasimelteon Claim Types: Formulation; Process Pat. Sub. Date(s): 001: Sep 17, 2018 | Feb 12, 2035 | |
| Pat. No. 10376487 Method of treatment Claim Types: Method of use Pat. Sub. Date(s): 001: Sep 11, 2019 | Jul 27, 2035 | U-2615: Treatment of non-24 hour sleep-wake disorder by avoiding the administration of tasimelteon with food |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NCE - New chemical entity | Jan 31, 2019 | |
| Exclusivity Code: ODE - Orphan drug exclusivity | Jan 31, 2021 | ODE-59: Treatment of non-24-hour sleep-wake disorder |
DORYX (TABLET, DELAYED RELEASE) (ORAL) DOXYCYCLINE HYCLATE [GENERIC AB]
Drug Classes: tetracycline-class drug
NDA Applicant: MAYNE PHARMA NDA No.: 050795 Prod. No.: 001 RX (EQ 75MG BASE); 002 RX (EQ 100MG BASE); 003 RX (EQ 150MG BASE); 005 RX (EQ 200MG BASE); 006 RX (EQ 50MG BASE) NDA No.: 050795 Prod. No.: 004 DISC (EQ 80MG BASE)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6958161 DP* Modified release coated drug preparation Claim Types: Formulation; Method of administration Pat. Sub. Date(s): 001: None; 002: None; 003: None; 004: May 30, 2013; 005: None; 006: Feb 10, 2015 | Dec 15, 2022 | U-918: To treat or prevent infections caused by susceptible bacteria using delayed-release tablets consisting of doxycycline hyclate coated pellets in a tablet |
| Pat. No. 8715724 DP* Tabletting process Claim Types: Product-by-process; Process Pat. Sub. Date(s): 001: May 7, 2014; 002: May 7, 2014; 003: May 7, 2014; 004: May 7, 2014; 005: May 7, 2014; 006: Feb 10, 2015 | Feb 3, 2028 |
DORYX MPC (TABLET, DELAYED RELEASE) (ORAL) DOXYCYCLINE HYCLATE
Drug Classes: tetracycline-class drug
NDA Applicant: MAYNE PHARMA NDA No.: 050795 Prod. No.: 008 RX (EQ 120MG BASE) NDA No.: 050795 Prod. No.: 007 DISC (EQ 60MG BASE**)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6958161 DP* Modified release coated drug preparation Claim Types: Formulation; Method of administration Pat. Sub. Date(s): All strengths: May 23, 2016 | Dec 15, 2022 | U-918: To treat or prevent infections caused by susceptible bacteria using delayed-release tablets consisting of doxycycline hyclate coated pellets in a tablet |
| Pat. No. 8715724 DP* Tabletting process Claim Types: Product-by-process; Process Pat. Sub. Date(s): All strengths: May 23, 2016 | Feb 3, 2028 | |
| Pat. No. 9295652 DP* Controlled release doxycycline Claim Types: Formulation; Method of use Pat. Sub. Date(s): All strengths: May 23, 2016 | Oct 23, 2034 | U-918: To treat or prevent infections caused by susceptible bacteria using delayed-release tablets consisting of doxycycline hyclate coated pellets in a tablet |
| Pat. No. 9511031 DP* Controlled release doxycycline Claim Types: Formulation Pat. Sub. Date(s): All strengths: Jan 5, 2017 | Oct 23, 2034 | |
| Pat. No. 9446057 DP* Controlled release doxycycline Claim Types: Formulation; Method of use Pat. Sub. Date(s): All strengths: Sep 9, 2016 | Dec 23, 2034 | U-918: To treat or prevent infections caused by susceptible bacteria using delayed-release tablets consisting of doxycycline hyclate coated pellets in a tablet |
VARUBI (TABLET) (ORAL) ROLAPITANT HYDROCHLORIDE
Drug Classes: substance P/neurokinin-1 (NK-1) receptor antagonist
NDA Applicant: TERSERA THERAPS LLC NDA No.: 206500 Prod. No.: 001 RX (EQ 90MG BASE)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8796299 NK1 antagonists Claim Types: Method of use Pat. Sub. Date(s): 001: Sep 25, 2015 | Dec 17, 2022 | U-1741: Prevention of delayed nausea and vomiting associated with emetogenic cancer chemotherapy |
| Pat. No. 7049320 DS* DP* NK.sub.1 antagonists Claim Types: Compound; Composition; Method of use Pat. Sub. Date(s): 001: Sep 25, 2015 | Dec 8, 2023 | U-1741: Prevention of delayed nausea and vomiting associated with emetogenic cancer chemotherapy |
| Pat. No. 7563801 DP* Pharmaceutical formulations: salts of 8-[{1-(3,5-Bis-(trifluoromethyl)phenyl)-ethoxy}-methyl]-8-phenyl-1,7-diaz- a-spiro[4.5]decan-2-one and treatment methods using the same Claim Types: Formulation; Product-by-process Pat. Sub. Date(s): 001: Sep 25, 2015 | Apr 4, 2027 | |
| Pat. No. 7981905 Pharmaceutical formulations: salts of 8-[{1-(3,5-bis-(trifluoromethyl)phenyl)-Ethoxy}-methyl]-8-phenyl-1,7-diaz- a-spiro[4.5]decan-2-one and treatment methods using the same Claim Types: Method of use Pat. Sub. Date(s): 001: Sep 25, 2015 | Apr 4, 2027 | U-1741: Prevention of delayed nausea and vomiting associated with emetogenic cancer chemotherapy |
| Pat. No. 8178550 DS* DP* Hydrochloride salts of 8-[{1-(3,5-Bis-(trifluoromethyl)phenyl)-ethoxy)-methyl]-8-phenyl-1,7-diaz- a-spiro[4.5]decan-2-one and preparation process therefor Claim Types: New polymorph, salt or hydrate; Composition Pat. Sub. Date(s): 001: Sep 25, 2015 | Apr 4, 2027 | |
| Pat. No. 8404702 Pharmaceutical formulations:salts of 8-[1-3,5-bis-(trifluoromethyl)phenyl)-ethoxymethyl]-8-phenyl-1,7-diaza-sp- iro[4.5]decan-2-one and treatment methods using the same Claim Types: Method of use Pat. Sub. Date(s): 001: Sep 25, 2015 | Apr 4, 2027 | U-1741: Prevention of delayed nausea and vomiting associated with emetogenic cancer chemotherapy |
| Pat. No. 8470842 Hydrochloride salts of 8-[{1-(3,5-Bis-trifluoromethyl)phenyl)-ethoxy}-methyl]-8-phenyl-1,7-diaza- -spiro[4.5]decan-2-one and preparation process therefor Claim Types: Method of use Pat. Sub. Date(s): 001: Sep 25, 2015 | Jan 18, 2029 | U-1741: Prevention of delayed nausea and vomiting associated with emetogenic cancer chemotherapy |
| Pat. No. 8361500 DP* Tablet formulations containing 8-[{1-(3,5-Bis-(trifluoromethyl)phenyl)-ethoxy}-methyl]-8-phenyl-1,7-diaz- Claim Types: Formulation Pat. Sub. Date(s): 001: Sep 25, 2015 | Oct 9, 2029 | |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NCE - New chemical entity | Sep 1, 2020 |
VARUBI (EMULSION) (INTRAVENOUS) ROLAPITANT HYDROCHLORIDE
Drug Classes: substance P/neurokinin-1 (NK-1) receptor antagonist
NDA Applicant: TERSERA THERAPS LLC NDA No.: 208399 Prod. No.: 001 DISC (EQ 166.5MG BASE/92.5ML (EQ 1.8MG BASE/ML))
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8796299 NK1 antagonists Claim Types: Method of use Pat. Sub. Date(s): 001: Nov 16, 2017 | Dec 17, 2022 | U-1741: Prevention of delayed nausea and vomiting associated with emetogenic cancer chemotherapy |
| Pat. No. 7049320 DS* DP* NK.sub.1 antagonists Claim Types: Compound; Composition; Method of use Pat. Sub. Date(s): 001: Nov 16, 2017 | Dec 8, 2023 | U-1741: Prevention of delayed nausea and vomiting associated with emetogenic cancer chemotherapy |
| Pat. No. 7981905 Pharmaceutical formulations: salts of 8-[{1-(3,5-bis-(trifluoromethyl)phenyl)-Ethoxy}-methyl]-8-phenyl-1,7-diaz- a-spiro[4.5]decan-2-one and treatment methods using the same Claim Types: Method of use Pat. Sub. Date(s): 001: Nov 22, 2017 | Apr 4, 2027 | U-1741: Prevention of delayed nausea and vomiting associated with emetogenic cancer chemotherapy |
| Pat. No. 8178550 DS* DP* Hydrochloride salts of 8-[{1-(3,5-Bis-(trifluoromethyl)phenyl)-ethoxy)-methyl]-8-phenyl-1,7-diaz- a-spiro[4.5]decan-2-one and preparation process therefor Claim Types: New polymorph, salt or hydrate; Composition Pat. Sub. Date(s): 001: Nov 22, 2017 | Apr 4, 2027 | |
| Pat. No. 8404702 Pharmaceutical formulations:salts of 8-[1-3,5-bis-(trifluoromethyl)phenyl)-ethoxymethyl]-8-phenyl-1,7-diaza-sp- iro[4.5]decan-2-one and treatment methods using the same Claim Types: Method of use Pat. Sub. Date(s): 001: Nov 22, 2017 | Apr 4, 2027 | U-1741: Prevention of delayed nausea and vomiting associated with emetogenic cancer chemotherapy |
| Pat. No. 8470842 Hydrochloride salts of 8-[{1-(3,5-Bis-trifluoromethyl)phenyl)-ethoxy}-methyl]-8-phenyl-1,7-diaza- -spiro[4.5]decan-2-one and preparation process therefor Claim Types: Method of use Pat. Sub. Date(s): 001: Nov 22, 2017 | Jan 18, 2029 | U-1741: Prevention of delayed nausea and vomiting associated with emetogenic cancer chemotherapy |
| Pat. No. 9101615 Intravenous formulations of neurokinin-1 antagonists Claim Types: Method of use Pat. Sub. Date(s): 001: Nov 22, 2017 | Jul 14, 2032 | U-1741: Prevention of delayed nausea and vomiting associated with emetogenic cancer chemotherapy |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NCE - New chemical entity | Sep 1, 2020 |
ZIOPTAN (SOLUTION/DROPS) (OPHTHALMIC) TAFLUPROST [GENERIC AT]
Drug Classes: prostaglandin analog
NDA Applicant: OAK PHARMS INC NDA No.: 202514 Prod. No.: 001 RX (0.0015%)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 5886035 DS* DP* [Extended 5 years] Difluoroprostaglandin derivatives and their use Claim Types: Compound; Composition Pat. Sub. Date(s): 001: Feb 27, 2012 | Dec 18, 2022 | U-778: Reduction of elevated intraocular pressure in patients with open angle glaucoma or ocular hypertension |
| Pat. No. 9999593 DP* Method and composition for treating ocular hypertension and glaucoma Claim Types: Formulation Pat. Sub. Date(s): 001: Jul 9, 2018 | May 28, 2029 |
PATADAY (SOLUTION/DROPS) (OPHTHALMIC) OLOPATADINE HYDROCHLORIDE [GENERIC AT]
Drug Classes: histamine-1 (H1) receptor inhibitor
NDA Applicant: NOVARTIS NDA No.: 021545 Prod. No.: 001 RX (EQ 0.2% BASE)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7402609 DP* Olopatadine formulations for topical administration Claim Types: Formulation Pat. Sub. Date(s): 001: None | Dec 19, 2022 *PED | |
| Pat. No. 6995186 DP* Olopatadine formulations for topical administration Claim Types: Formulation; Process; Method of use Pat. Sub. Date(s): 001: None | May 12, 2024 *PED | U-765: Method of treating allergic conjunctivitis |
OFORTA (TABLET) (ORAL) FLUDARABINE PHOSPHATE
Drug Classes: nucleoside metabolic inhibitor
NDA Applicant: SANOFI AVENTIS US NDA No.: 022273 Prod. No.: 001 DISC (10MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7148207 DP* Oral fludara of high-purity formulation with quick release of active ingredient Claim Types: Formulation Pat. Sub. Date(s): 001: None | Dec 20, 2022 | U-944: Treatment of patients with B-cell chronic lymphocytic leukemia (CLL) |
EPIDUO (GEL) (TOPICAL) ADAPALENE; BENZOYL PEROXIDE [GENERIC AB]
Drug Classes: retinoid
NDA Applicant: GALDERMA LABS LP NDA No.: 022320 Prod. No.: 001 RX (0.1%;2.5%)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8105618 Dermatological/cosmetic gels comprising at least one retinoid and/or retinoid salt and benzoyl peroxide Claim Types: Method of use Pat. Sub. Date(s): 001: Feb 29, 2012 | Dec 23, 2022 | U-1078: Treatment of acne |
| Pat. No. 8241649 DP* Dermatological/cosmetic gels comprising at least one retinoid and/or retinoid salt and benzoyl peroxide Claim Types: Formulation; Drug in a container Pat. Sub. Date(s): 001: Aug 14, 2012 | Dec 23, 2022 | |
| Pat. No. 8809305 Administration of adapalene and benzoyl peroxide for the long-term treatment of acne vulgaris Claim Types: Method of use; Method of administration Pat. Sub. Date(s): 001: Sep 19, 2014 | Dec 23, 2022 | U-1078: Treatment of acne |
| Pat. No. 8936800 DP* Gel composition for treatment of common acne comprising a combination of benzoyl peroxide and adapalene and/or adapalene salt Claim Types: Formulation; Method of use; Drug in a container Pat. Sub. Date(s): 001: Mar 19, 2015 | Dec 23, 2022 | U-1078: Treatment of acne |
| Pat. No. 7964202 DP* Method for treatment of common acne Claim Types: Method of use; Drug in a container Pat. Sub. Date(s): 001: Jun 23, 2011 | Sep 1, 2024 | U-1078: Treatment of acne |
| Pat. No. 7820186 DP* Gel composition for once-daily treatment of common acne comprising a combination of benzoyl peroxide and adapalene and/or adapalene salt Claim Types: Formulation Pat. Sub. Date(s): 001: Nov 2, 2010 | Nov 23, 2025 | |
| Pat. No. 8445543 Combinations of adapalene and benzoyl peroxide for treating acne lesions Claim Types: Method of administration Pat. Sub. Date(s): 001: Jun 19, 2013 | Jul 12, 2027 | U-1078: Treatment of acne |
| Pat. No. 8071644 DP* Combinations of adapalene and benzoyl peroxide for treating acne lesions Claim Types: Method of use Pat. Sub. Date(s): 001: Dec 7, 2011 | Jul 18, 2027 | U-1078: Treatment of acne |
| Pat. No. 8080537 Combinations of adapalene and benzoyl peroxide for treating acne lesions Claim Types: Method of administration Pat. Sub. Date(s): 001: Dec 21, 2011 | Jul 18, 2027 | U-1078: Treatment of acne |
| Pat. No. 8129362 Combination/association of adapalene and benzoyl peroxide for treating acne lesions Claim Types: Method of use Pat. Sub. Date(s): 001: Apr 4, 2012 | Jul 18, 2027 | U-1078: Treatment of acne |
EPIDUO FORTE (GEL) (TOPICAL) ADAPALENE; BENZOYL PEROXIDE
Drug Classes: retinoid
NDA Applicant: GALDERMA LABS NDA No.: 207917 Prod. No.: 001 RX (0.3%;2.5%)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8445543 Combinations of adapalene and benzoyl peroxide for treating acne lesions Claim Types: Method of administration Pat. Sub. Date(s): 001: Jul 24, 2015 | Dec 23, 2022 | U-1078: Treatment of acne |
| Pat. No. 8785420 Combination/association of adapalene and benzoyl peroxide for treating acne lesions Claim Types: Method of use Pat. Sub. Date(s): 001: Jul 24, 2015 | Dec 23, 2022 | U-1078: Treatment of acne |
| Pat. No. 8809305 Administration of adapalene and benzoyl peroxide for the long-term treatment of acne vulgaris Claim Types: Method of use; Method of administration Pat. Sub. Date(s): 001: Jan 29, 2016 | Dec 23, 2022 | U-1078: Treatment of acne |
| Pat. No. 8936800 DP* Gel composition for treatment of common acne comprising a combination of benzoyl peroxide and adapalene and/or adapalene salt Claim Types: Formulation; Method of use; Drug in a container Pat. Sub. Date(s): 001: Jul 24, 2015 | Dec 23, 2022 | U-1078: Treatment of acne |
| Pat. No. 9814690 DP* Gel composition for treatment of common acne comprising a combination of benzoyl peroxide and adapalene and/or adapalene salt Claim Types: Formulation; Method of use; Drug in a container Pat. Sub. Date(s): 001: Dec 12, 2017 | Dec 23, 2022 | U-1078: Treatment of acne |
| Pat. No. 8703820 Administration of 6-[3-(1-adamantyl)-4-methoxyphenyl]-2-naphthoic acid for the treatment of dermatological disorders Claim Types: Method of use Pat. Sub. Date(s): 001: Jul 24, 2015 | Mar 12, 2023 | U-1078: Treatment of acne |
| Pat. No. 8729127 Administration of 6-[3-(1-adamantyl)-4-methoxyphenyl]-2-naphthoic acid for the treatment of dermatological disorders Claim Types: Method of use Pat. Sub. Date(s): 001: Jul 24, 2015 | Mar 12, 2023 | U-1078: Treatment of acne |
| Pat. No. 9381179 Administration of 6-[3-(1-adamantyl)-4-methoxyphenyl]-2-naphthoic acid for the treatment of dermatological disorders Claim Types: Method of use Pat. Sub. Date(s): 001: Aug 4, 2016 | Mar 12, 2023 | U-1078: Treatment of acne |
| Pat. No. 9387187 Administration of 6[3-(1-adamantyl)-4-methoxyphenyl]-2-naphthoic acid for the treatment of dermatological disorders Claim Types: Method of use Pat. Sub. Date(s): 001: Aug 5, 2016 | Mar 12, 2023 | U-1078: Treatment of acne |