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. 6956026 Use of exendins for the reduction of food intake Claim Types: Method of use | Jan 7, 2018 | U-1074: Use of exenatide may result in reduction in body weight U-1623: Use of exenatide may result in reduction in appetite. U-687: Reducing food intake in a subject with Type 2 diabetes by administering an exendin, such as exendin-4 |
| Pat. No. 7741269 Exendins and exendin agonists for weight reduction and obesity Claim Types: Method of use | Jan 7, 2018 | U-1074: Use of exenatide may result in reduction in body weight U-1108: Treating Type 2 diabetes mellitus with exenatide by stimulating insulin release U-653: Stimulating insulin release by administering exenatide |
| Pat. No. 6872700 Methods for glucagon suppression Claim Types: Method of use | Jan 14, 2020 | U-654: Lowering plasma glucagon in a subject in need thereof, including one with Type 2 diabetes, by administering an exendin or analog, such as exendin-4 |
| Pat. No. 6902744 DP* Exendin agonist formulations and methods of administration thereof Claim Types: Formulation | Jan 14, 2020 |
FOLLISTIM AQ (INJECTABLE) (SUBCUTANEOUS) FOLLITROPIN ALFA/BETA
Drug Classes: gonadotropin
NDA Applicant: ORGANON USA INC NDA No.: 021211 Prod. No.: 001 RX (300 IU/0.36ML); 002 RX (600 IU/0.72ML); 004 RX (900 IU/1.08ML) NDA No.: 021211 Prod. No.: 003 DISC (150 IU/0.18ML)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 5929028 DP* Liquid gonadotropin containing formulations Claim Types: Drug in a container; Process; Method of use | Jan 14, 2018 | U-1366: Treatment of infertility through induction of ovulation and pregnancy to anovulatory infertile women U-567: Method of treating infertility |
| Pat. No. 7446090 DP* FSH formulation Claim Types: Drug in a container; Formulation; Process | Aug 23, 2019 | |
| Pat. No. 7563763 FSH and FSH variant formulations, products and methods Claim Types: Method of administration; Method of use; Kit | Aug 23, 2019 | U-1183: A method for administering follicle stimulating hormone (FSH) for ovarian follicle or testicular stimulation in the human U-1367: Method of administering FSH for the treatment of infertility through induction of ovulation and pregnancy in anovulatory infertile women U-993: Method of treating infertility |
FOLLISTIM AQ (INJECTABLE) (SUBCUTANEOUS) FOLLITROPIN ALFA/BETA
Drug Classes: gonadotropin
NDA Applicant: ORGANON USA INC NDA No.: 021273 Prod. No.: 001 DISC (75 IU/0.5ML); 002 DISC (150 IU/0.5ML)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 5929028 DP* Liquid gonadotropin containing formulations Claim Types: Drug in a container; Process; Method of use | Jan 14, 2018 | U-1366: Treatment of infertility through induction of ovulation and pregnancy to anovulatory infertile women |
ULTIVA (INJECTABLE) (INJECTION) REMIFENTANIL HYDROCHLORIDE [GENERIC AP]
Drug Classes: opioid agonist
NDA Applicant: MYLAN INSTITUTIONAL NDA No.: 020630 Prod. No.: 001 RX (EQ 1MG BASE/VIAL); 002 RX (EQ 2MG BASE/VIAL); 003 RX (EQ 5MG BASE/VIAL)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 5866591 DP* Stable formulations of remifentanil Claim Types: Formulation | Mar 10, 2018 *PED |
NEUTREXIN (INJECTABLE) (INJECTION) TRIMETREXATE GLUCURONATE
NDA Applicant: MEDIMMUNE ONCOLOGY NDA No.: 020326 Prod. No.: 001 DISC (EQ 25MG BASE/VIAL); 002 DISC (EQ 200MG BASE/VIAL)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6017922 Thermally stable trimetrexates and processes for producing the same Claim Types: New polymorph, salt or hydrate; Composition | May 18, 2018 |
VFEND (INJECTABLE) (IV (INFUSION)) VORICONAZOLE [GENERIC AP]
Drug Classes: azole antifungal
NDA Applicant: PF PRISM CV NDA No.: 021267 Prod. No.: 001 RX (200MG/VIAL)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6632803 DP* Pharmaceutical formulations containing voriconazole Claim Types: Formulation; Product-by-process | Jun 2, 2018 |
GANIRELIX ACETATE (INJECTABLE) (INJECTION) GANIRELIX ACETATE
Drug Classes: gonadotropin releasing hormone (GnRH) antagonist
NDA Applicant: ORGANON USA INC NDA No.: 021057 Prod. No.: 001 RX (EQ 250MCG BASE/0.5ML)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6653286 Gonadotropin releasing hormone antagonist Claim Types: Method of use | Jun 16, 2018 | U-1354: Inhibition of premature LH surges in women undergoing controlled ovarian hyperstimulation with FSH |
APIDRA (INJECTABLE) (IV (INFUSION), 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)); 002 RX (300 UNITS/3ML (100 UNITS/ML))
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6221633 DS* DP* Insulin derivatives having a rapid onset of action Claim Types: Compound; Process; Composition; Intermediate | Jun 18, 2018 | U-471: Method of treating a patient suffering from diabetes mellitus |
| Pat. No. 7452860 DP* Zinc-free and low-zinc insulin preparations having improved stability Claim Types: Formulation | Mar 22, 2022 | |
| Pat. No. 7696162 DP* Zinc-free and low-zinc insulin preparations having improved stability Claim Types: Formulation; Method of use | 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 | 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. 6221633 DS* DP* Insulin derivatives having a rapid onset of action Claim Types: Compound; Process; Composition; Intermediate | Jun 18, 2018 | U-471: Method of treating a patient suffering from diabetes mellitus |
| Pat. No. 7452860 DP* Zinc-free and low-zinc insulin preparations having improved stability Claim Types: Formulation | Mar 22, 2022 | |
| Pat. No. 7696162 DP* Zinc-free and low-zinc insulin preparations having improved stability Claim Types: Formulation; Method of use | 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 | Jan 25, 2023 | U-471: Method of treating a patient suffering from diabetes mellitus |
| Pat. No. 8603044 DP* Pen-type injector Claim Types: Device | Mar 2, 2024 | |
| Pat. No. 9233211 DP* Relating to a pen-type injector Claim Types: Device | Mar 2, 2024 | |
| Pat. No. 9408979 DP* Pen-type injector Claim Types: Device | Mar 2, 2024 | |
| Pat. No. 9526844 DP* Pen-type injector Claim Types: Device | Mar 2, 2024 | |
| Pat. No. 9604008 DP* Drive mechanisms suitable for use in drug delivery devices Claim Types: Device | Mar 2, 2024 | |
| Pat. No. 9610409 DP* Drive mechanisms suitable for use in drug delivery devices Claim Types: Device | Mar 2, 2024 | |
| Pat. No. 9775954 DP* Pen-type injector Claim Types: Device | Mar 2, 2024 | |
| Pat. No. 9827379 DP* Drive mechanisms suitable for use in drug delivery devices Claim Types: Device; Method of administration | 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 | Mar 3, 2024 | |
| Pat. No. 9011391 Pen-type injector Claim Types: Method of use | 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 | Jun 5, 2024 | |
| Pat. No. 9604009 DP* Drive mechanisms suitable for use in drug delivery devices Claim Types: Device | Aug 16, 2024 | |
| Pat. No. 9533105 DP* Drive mechanisms suitable for use in drug delivery devices Claim Types: Device | Aug 17, 2024 | |
| Pat. No. 9623189 DP* Relating to drive mechanisms suitable for use in drug delivery devices Claim Types: Device | Aug 19, 2024 | |
| Pat. No. 9561331 DP* Drive mechanisms suitable for use in drug delivery devices Claim Types: Device | Aug 28, 2024 | |
| Pat. No. 8512297 DP* Pen-type injector Claim Types: Device | Sep 15, 2024 | |
| Pat. No. 8679069 DP* Pen-type injector Claim Types: Device | Apr 12, 2025 | |
| Pat. No. 7918833 DP* Pen-type injector Claim Types: Device | Sep 23, 2027 | |
| Pat. No. 9717852 DP* Cartridge holder and pen-type injector Claim Types: Device | Apr 8, 2033 |
ZITHROMAX (INJECTABLE) (INJECTION) AZITHROMYCIN [GENERIC AP]
Drug Classes: macrolide antimicrobial
NDA Applicant: PFIZER NDA No.: 050733 Prod. No.: 001 RX (EQ 500MG BASE/VIAL)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6268489 DS* Azithromycin dihydrate Claim Types: New polymorph, salt or hydrate; Process | Jul 31, 2018 |
EXPAREL (INJECTABLE, LIPOSOMAL) (INJECTION) BUPIVACAINE
Drug Classes: amide local anesthetic
NDA Applicant: PACIRA PHARMS INC NDA No.: 022496 Prod. No.: 001 RX (133MG/10ML (13.3MG/ML))
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8182835 DP* Sustained-release liposomal anesthetic compositions Claim Types: Product-by-process; Method of administration; Method of use | Sep 18, 2018 | U-1246: Single dose administration into the surgical site to produce postsurgical analgesia |
| Pat. No. 8834921 DP* Sustained-release liposomal anesthetic compositions Claim Types: Formulation; Method of use; Process | Sep 18, 2018 | U-1587: Single-dose infiltration into the surgical site to produce postsurgical analgesia. |
| Pat. No. 9585838 DP* Production of multivesicular liposomes Claim Types: Product-by-process; Process | Dec 24, 2021 | |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: I - New Indication | Apr 6, 2021 | I-771: Revision of the indication section of the package insert regarding an interscalene brachial plexus nerve block to produce postsurgical regional analgesia |
EXPAREL (INJECTABLE, LIPOSOMAL) (INJECTION) BUPIVACAINE
Drug Classes: amide local anesthetic
NDA Applicant: PACIRA PHARMS INC NDA No.: 022496 Prod. No.: 002 RX (266MG/20ML (13.3MG/ML))
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8182835 DP* Sustained-release liposomal anesthetic compositions Claim Types: Product-by-process; Method of administration; Method of use | Sep 18, 2018 | U-1246: Single dose administration into the surgical site to produce postsurgical analgesia |
| Pat. No. 8834921 DP* Sustained-release liposomal anesthetic compositions Claim Types: Formulation; Method of use; Process | Sep 18, 2018 | U-1587: Single-dose infiltration into the surgical site to produce postsurgical analgesia. |
| Pat. No. 9205052 Sustained-release liposomal anesthetic compositions Claim Types: Method of use; Method of administration | Sep 18, 2018 | U-1246: Single dose administration into the surgical site to produce postsurgical analgesia |
| Pat. No. 9585838 DP* Production of multivesicular liposomes Claim Types: Product-by-process; Process | Dec 24, 2021 | |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: I - New Indication | Apr 6, 2021 | I-771: Revision of the indication section of the package insert regarding an interscalene brachial plexus nerve block to produce postsurgical regional analgesia |
ELIGARD (INJECTABLE) (SUBCUTANEOUS) LEUPROLIDE ACETATE
Drug Classes: gonadotropin releasing hormone (GnRH) agonist
NDA Applicant: TOLMAR THERAP NDA No.: 021343 Prod. No.: 001 RX (7.5MG/VIAL)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6565874 DP* Polymeric delivery formulations of leuprolide with improved efficacy Claim Types: Formulation; Process; Method of use; Kit | Oct 28, 2018 | U-801: Method of treating cancer |
| Pat. No. 6773714 DP* Polymeric delivery formulations of leuprolide with improved efficacy Claim Types: Formulation; Product-by-process; Method of use; Process; Kit | Oct 28, 2018 | U-801: Method of treating cancer |
| Pat. No. 9254307 DS* DP* Polymeric delivery formulations of leuprolide with improved efficacy Claim Types: Formulation; Method of use | Oct 28, 2018 | |
| Pat. No. 6626870 DP* Stoppering method to maintain sterility Claim Types: Device; Process | Mar 27, 2020 |
ELIGARD (INJECTABLE) (SUBCUTANEOUS) LEUPROLIDE ACETATE
Drug Classes: gonadotropin releasing hormone (GnRH) agonist
NDA Applicant: TOLMAR THERAP NDA No.: 021379 Prod. No.: 001 RX (22.5MG/VIAL)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6565874 DP* Polymeric delivery formulations of leuprolide with improved efficacy Claim Types: Formulation; Process; Method of use; Kit | Oct 28, 2018 | U-801: Method of treating cancer |
| Pat. No. 6773714 DP* Polymeric delivery formulations of leuprolide with improved efficacy Claim Types: Formulation; Product-by-process; Method of use; Process; Kit | Oct 28, 2018 | U-801: Method of treating cancer |
| Pat. No. 8486455 DS* DP* Polymeric delivery formulations of leuprolide with improved efficacy Claim Types: Formulation; Method of use | Oct 28, 2018 | |
| Pat. No. 9283282 DS* DP* Sustained release polymer Claim Types: Formulation | Oct 28, 2018 | |
| Pat. No. 6626870 DP* Stoppering method to maintain sterility Claim Types: Device; Process | Mar 27, 2020 | |
| Pat. No. 8840916 DP* Sustained release polymer Claim Types: Compound | Nov 13, 2020 | |
| Pat. No. 9539333 DS* DP* Sustained release polymer Claim Types: Intermediate; Formulation; Method of use | Nov 13, 2020 | U-621: Method of treating cancer |
| Pat. No. 8470359 DS* DP* Sustained release polymer Claim Types: Formulation; Method of use | Oct 15, 2023 | U-621: Method of treating cancer |
ELIGARD (INJECTABLE) (SUBCUTANEOUS) LEUPROLIDE ACETATE
Drug Classes: gonadotropin releasing hormone (GnRH) agonist
NDA Applicant: TOLMAR THERAP NDA No.: 021488 Prod. No.: 001 RX (30MG/VIAL)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6565874 DP* Polymeric delivery formulations of leuprolide with improved efficacy Claim Types: Formulation; Process; Method of use; Kit | Oct 28, 2018 | U-801: Method of treating cancer |
| Pat. No. 6773714 DP* Polymeric delivery formulations of leuprolide with improved efficacy Claim Types: Formulation; Product-by-process; Method of use; Process; Kit | Oct 28, 2018 | U-801: Method of treating cancer |
| Pat. No. 8486455 DS* DP* Polymeric delivery formulations of leuprolide with improved efficacy Claim Types: Formulation; Method of use | Oct 28, 2018 | |
| Pat. No. 9283282 DS* DP* Sustained release polymer Claim Types: Formulation | Oct 28, 2018 | |
| Pat. No. 6626870 DP* Stoppering method to maintain sterility Claim Types: Device; Process | Mar 27, 2020 | |
| Pat. No. 8840916 DP* Sustained release polymer Claim Types: Compound | Nov 13, 2020 | |
| Pat. No. 9539333 DS* DP* Sustained release polymer Claim Types: Intermediate; Formulation; Method of use | Nov 13, 2020 | U-621: Method of treating cancer |
| Pat. No. 8470359 DS* DP* Sustained release polymer Claim Types: Formulation; Method of use | Oct 15, 2023 | U-621: Method of treating cancer |
ELIGARD (INJECTABLE) (SUBCUTANEOUS) LEUPROLIDE ACETATE
Drug Classes: gonadotropin releasing hormone (GnRH) agonist
NDA Applicant: TOLMAR THERAP NDA No.: 021731 Prod. No.: 001 RX (45MG/VIAL)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6565874 DP* Polymeric delivery formulations of leuprolide with improved efficacy Claim Types: Formulation; Process; Method of use; Kit | Oct 28, 2018 | U-621: Method of treating cancer |
| Pat. No. 6773714 Polymeric delivery formulations of leuprolide with improved efficacy Claim Types: Formulation; Product-by-process; Method of use; Process; Kit | Oct 28, 2018 | U-621: Method of treating cancer |
| Pat. No. 8486455 DS* DP* Polymeric delivery formulations of leuprolide with improved efficacy Claim Types: Formulation; Method of use | Oct 28, 2018 | |
| Pat. No. 9283282 DS* DP* Sustained release polymer Claim Types: Formulation | Oct 28, 2018 | |
| Pat. No. 6626870 DP* Stoppering method to maintain sterility Claim Types: Device; Process | Mar 27, 2020 | |
| Pat. No. 8840916 DP* Sustained release polymer Claim Types: Compound | Nov 13, 2020 | |
| Pat. No. 9539333 DS* DP* Sustained release polymer Claim Types: Intermediate; Formulation; Method of use | Nov 13, 2020 | U-621: Method of treating cancer |
| Pat. No. 9914802 DS* DP* Sustained release polymer Claim Types: Method of use; Process; Formulation | Nov 13, 2020 | U-1666: Palliative treatment of prostate cancer |
| Pat. No. 8470359 DS* DP* Sustained release polymer Claim Types: Formulation; Method of use | Oct 15, 2023 | U-621: Method of treating cancer |
TRISENOX (INJECTABLE) (INJECTION) ARSENIC TRIOXIDE
NDA Applicant: CEPHALON NDA No.: 021248 Prod. No.: 001 DISC (1MG/ML)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6723351 Process for producing arsenic trioxide formulations and methods for treating cancer using arsenic trioxide or melarsoprol Claim Types: Method of use | Nov 10, 2018 | U-2204: Treating patients with acute promyelocytic leukemia (APL) who are refractory to, or have relapsed from, retinoid and anthracycline chemotherapy, and whose APL is characterized by the presence of the t(15;17) translocation or PML/RAR-alpha gene expression U-2229: In combination with tretinoin, treating adults and pediatric patients 1 year and older with newly-diagnosed low-risk acute promyelocytic leukemia (APL) characterized by the presence of the t(15;17) translocation or PML/RAR-A gene expression U-573: Treatment of acute promyelogenous leukemia (APL) |
| Pat. No. 6855339 Process for producing arsenic trioxide formulations and methods for treating cancer using arsenic trioxide or melarsoprol Claim Types: Method of use | Nov 10, 2018 | U-2204: Treating patients with acute promyelocytic leukemia (APL) who are refractory to, or have relapsed from, retinoid and anthracycline chemotherapy, and whose APL is characterized by the presence of the t(15;17) translocation or PML/RAR-alpha gene expression U-2229: In combination with tretinoin, treating adults and pediatric patients 1 year and older with newly-diagnosed low-risk acute promyelocytic leukemia (APL) characterized by the presence of the t(15;17) translocation or PML/RAR-A gene expression U-617: Treatment of acute promyelogenous leukemia (APL) |
| Pat. No. 6861076 Process for producing arsenic trioxide formulations and methods for treating cancer using arsenic trioxide or melarsoprol Claim Types: Method of use | Nov 10, 2018 | U-2204: Treating patients with acute promyelocytic leukemia (APL) who are refractory to, or have relapsed from, retinoid and anthracycline chemotherapy, and whose APL is characterized by the presence of the t(15;17) translocation or PML/RAR-alpha gene expression U-2229: In combination with tretinoin, treating adults and pediatric patients 1 year and older with newly-diagnosed low-risk acute promyelocytic leukemia (APL) characterized by the presence of the t(15;17) translocation or PML/RAR-A gene expression U-617: Treatment of acute promyelogenous leukemia (APL) |
| Pat. No. 6884439 Process for producing arsenic trioxide formulations and methods for treatingcancer using arsenic trioxide or melarsoprol Claim Types: Method of use | Nov 10, 2018 | U-2204: Treating patients with acute promyelocytic leukemia (APL) who are refractory to, or have relapsed from, retinoid and anthracycline chemotherapy, and whose APL is characterized by the presence of the t(15;17) translocation or PML/RAR-alpha gene expression U-2229: In combination with tretinoin, treating adults and pediatric patients 1 year and older with newly-diagnosed low-risk acute promyelocytic leukemia (APL) characterized by the presence of the t(15;17) translocation or PML/RAR-A gene expression U-651: Treatment of acute promyelocytic leukemia (APL) |
| Pat. No. 6982096 Process for producing arsenic trioxide formulations and methods for treating cancer using arsenic trioxide or melarsoprol Claim Types: Method of use | Nov 10, 2018 | U-2204: Treating patients with acute promyelocytic leukemia (APL) who are refractory to, or have relapsed from, retinoid and anthracycline chemotherapy, and whose APL is characterized by the presence of the t(15;17) translocation or PML/RAR-alpha gene expression U-2229: In combination with tretinoin, treating adults and pediatric patients 1 year and older with newly-diagnosed low-risk acute promyelocytic leukemia (APL) characterized by the presence of the t(15;17) translocation or PML/RAR-A gene expression U-651: Treatment of acute promyelocytic leukemia (APL) |
| Pat. No. 8273379 Process for producing arsenic trioxide formulations and methods for treating cancer using arsenic trioxide or melarsoprol Claim Types: Method of use | Nov 10, 2018 | U-1291: Treatment of acute promyelocytic leukemia (APL) in patients whose APL is characterized by the presence of the (15;17) translocation or pml/rar-alpha gene expression U-2204: Treating patients with acute promyelocytic leukemia (APL) who are refractory to, or have relapsed from, retinoid and anthracycline chemotherapy, and whose APL is characterized by the presence of the t(15;17) translocation or PML/RAR-alpha gene expression U-2229: In combination with tretinoin, treating adults and pediatric patients 1 year and older with newly-diagnosed low-risk acute promyelocytic leukemia (APL) characterized by the presence of the t(15;17) translocation or PML/RAR-A gene expression |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: ODE - Orphan drug exclusivity | Jan 12, 2025 | ODE-167: Arsenic trioxide for use in combination with tretinoin for treatment of adults with newly-diagnosed low-risk acute promyelocytic leukemia (APL) whose APL is characterized by the presence of the t(15;17) translocation or PML/RAR-alpha gene expression |
TRISENOX (INJECTABLE) (INJECTION) ARSENIC TRIOXIDE
NDA Applicant: CEPHALON NDA No.: 021248 Prod. No.: 002 RX (2MG/ML)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6723351 Process for producing arsenic trioxide formulations and methods for treating cancer using arsenic trioxide or melarsoprol Claim Types: Method of use | Nov 10, 2018 | U-2204: Treating patients with acute promyelocytic leukemia (APL) who are refractory to, or have relapsed from, retinoid and anthracycline chemotherapy, and whose APL is characterized by the presence of the t(15;17) translocation or PML/RAR-alpha gene expression U-2229: In combination with tretinoin, treating adults and pediatric patients 1 year and older with newly-diagnosed low-risk acute promyelocytic leukemia (APL) characterized by the presence of the t(15;17) translocation or PML/RAR-A gene expression |
| Pat. No. 6855339 Process for producing arsenic trioxide formulations and methods for treating cancer using arsenic trioxide or melarsoprol Claim Types: Method of use | Nov 10, 2018 | U-2204: Treating patients with acute promyelocytic leukemia (APL) who are refractory to, or have relapsed from, retinoid and anthracycline chemotherapy, and whose APL is characterized by the presence of the t(15;17) translocation or PML/RAR-alpha gene expression U-2229: In combination with tretinoin, treating adults and pediatric patients 1 year and older with newly-diagnosed low-risk acute promyelocytic leukemia (APL) characterized by the presence of the t(15;17) translocation or PML/RAR-A gene expression |
| Pat. No. 6861076 Process for producing arsenic trioxide formulations and methods for treating cancer using arsenic trioxide or melarsoprol Claim Types: Method of use | Nov 10, 2018 | U-2204: Treating patients with acute promyelocytic leukemia (APL) who are refractory to, or have relapsed from, retinoid and anthracycline chemotherapy, and whose APL is characterized by the presence of the t(15;17) translocation or PML/RAR-alpha gene expression U-2229: In combination with tretinoin, treating adults and pediatric patients 1 year and older with newly-diagnosed low-risk acute promyelocytic leukemia (APL) characterized by the presence of the t(15;17) translocation or PML/RAR-A gene expression |
| Pat. No. 6884439 Process for producing arsenic trioxide formulations and methods for treatingcancer using arsenic trioxide or melarsoprol Claim Types: Method of use | Nov 10, 2018 | U-2204: Treating patients with acute promyelocytic leukemia (APL) who are refractory to, or have relapsed from, retinoid and anthracycline chemotherapy, and whose APL is characterized by the presence of the t(15;17) translocation or PML/RAR-alpha gene expression U-2229: In combination with tretinoin, treating adults and pediatric patients 1 year and older with newly-diagnosed low-risk acute promyelocytic leukemia (APL) characterized by the presence of the t(15;17) translocation or PML/RAR-A gene expression |
| Pat. No. 6982096 Process for producing arsenic trioxide formulations and methods for treating cancer using arsenic trioxide or melarsoprol Claim Types: Method of use | Nov 10, 2018 | U-2204: Treating patients with acute promyelocytic leukemia (APL) who are refractory to, or have relapsed from, retinoid and anthracycline chemotherapy, and whose APL is characterized by the presence of the t(15;17) translocation or PML/RAR-alpha gene expression U-2229: In combination with tretinoin, treating adults and pediatric patients 1 year and older with newly-diagnosed low-risk acute promyelocytic leukemia (APL) characterized by the presence of the t(15;17) translocation or PML/RAR-A gene expression |
| Pat. No. 8273379 Process for producing arsenic trioxide formulations and methods for treating cancer using arsenic trioxide or melarsoprol Claim Types: Method of use | Nov 10, 2018 | U-2204: Treating patients with acute promyelocytic leukemia (APL) who are refractory to, or have relapsed from, retinoid and anthracycline chemotherapy, and whose APL is characterized by the presence of the t(15;17) translocation or PML/RAR-alpha gene expression U-2229: In combination with tretinoin, treating adults and pediatric patients 1 year and older with newly-diagnosed low-risk acute promyelocytic leukemia (APL) characterized by the presence of the t(15;17) translocation or PML/RAR-A gene expression |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: ODE - Orphan drug exclusivity | Jan 12, 2025 | ODE-167: Arsenic trioxide for use in combination with tretinoin for treatment of adults with newly-diagnosed low-risk acute promyelocytic leukemia (APL) whose APL is characterized by the presence of the t(15;17) translocation or PML/RAR-alpha gene expression |
GENOTROPIN PRESERVATIVE FREE (INJECTABLE) (INJECTION) SOMATROPIN RECOMBINANT
Drug Classes: recombinant human growth hormone
NDA Applicant: PHARMACIA AND UPJOHN NDA No.: 020280 Prod. No.: 001 RX (0.2MG/VIAL); 002 RX (0.4MG/VIAL); 003 RX (0.6MG/VIAL); 005 RX (0.8MG/VIAL); 008 RX (1MG/VIAL); 009 RX (1.2MG/VIAL)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6152897 DP* Syringe Claim Types: Device | Nov 20, 2018 |
IXEMPRA KIT (INJECTABLE) (IV (INFUSION)) IXABEPILONE
Drug Classes: microtubule inhibitor
NDA Applicant: R-PHARM US LLC NDA No.: 022065 Prod. No.: 001 RX (15MG/VIAL); 002 RX (45MG/VIAL)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7125899 DS* DP* Epothilone derivatives Claim Types: Compound; Method of use; Composition; New polymorph, salt or hydrate | Nov 26, 2018 *PED | U-957: A method of treating cancer in a patient comprising administering ixabepilone or pharmaceutical compositions comprising ixabepilone |
| Pat. No. RE41911 DS* DP* Epothilone derivatives Claim Types: Compound; Method of use; Composition | Mar 28, 2021 *PED | U-961: Method of treating breast cancer by administering ixabepilone; a method of treating a cancer responsible to microtubule stabilization by administering ixabepilone |
| Pat. No. 6670384 DP* Methods of administering epothilone analogs for the treatment of cancer Claim Types: Formulation; Method of use; Process | Jul 23, 2022 *PED | U-959: Method of treating cancer, IV admin, lyophylized ixabepilone diluted, every week or 3 weeks; lyophilized ixabepilone with solvent(dehydrated ethanol) diluted to concentration of 0.1mg/ml to 0.9mg/ml U-960: Method of treating cancer in a patient comprising intravenously administering to the patient ixabepilone diluted in a parenteral diluent |
| Pat. No. 7022330 DP* Parenteral formulation for epothilone analogs Claim Types: Product-by-process; Formulation; Method of use; Process | Jul 23, 2022 *PED | U-958: Method of treating patient comprising mixing first and second vials of product comprising lyophilized ixabepilone to provide an epothilone analog solution, diluting solution with a suitable diluent to prepare intravenous formulation for PT |
| Pat. No. RE41393 Treatment of refractory tumors using epothilone derivatives Claim Types: Method of use | Aug 8, 2022 *PED | U-961: Method of treating breast cancer by administering ixabepilone; a method of treating a cancer responsible to microtubule stabilization by administering ixabepilone |
| Pat. No. 7312237 Combination of epothilone analogs and chemotherapeutic agents for the treatment of prolilferative diseases Claim Types: Method of use | Feb 21, 2025 *PED | U-965: Use of ixabepilone in combination with capecitabine in treatment of metastasis breast cancer |
FORTEO (INJECTABLE) (SUBCUTANEOUS) TERIPARATIDE RECOMBINANT HUMAN
Drug Classes: parathyroid hormone analog
NDA Applicant: LILLY NDA No.: 021318 Prod. No.: 001 DISC (0.75MG/3ML (0.25MG/ML))
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6770623 DP* Stabilized teriparatide solutions Claim Types: Drug in a container; Method of use; Process | Dec 8, 2018 | U-597: FORTEO is indicated for the treatment of post menopausal women with osteoporosis who are at high risk for fracture |
| Pat. No. 7144861 DP* Stabilized teriparatide solutions Claim Types: Formulation; Process; Drug in a container | Dec 8, 2018 | |
| Pat. No. 7550434 DP* Stabilized teriparatide solutions Claim Types: Drug in a container; Method of use; Process | Dec 8, 2018 | U-982: A method of treating osteoporosis |
| Pat. No. 6977077 Method of increasing bone toughness and stiffness and reducing fractures Claim Types: Method of use | Aug 19, 2019 | U-597: FORTEO is indicated for the treatment of post menopausal women with osteoporosis who are at high risk for fracture |
| Pat. No. 7163684 Method of increasing bone toughness and stiffness and reducing fractures Claim Types: Method of use | Aug 19, 2019 | U-790: FORTEO is indicated for the treatment of post menopausal women with osteoporosis who are at risk for fracture. FORTEO can be used by people who have had a fracture related to osteoporosis |
| Pat. No. 7351414 Method of reducing the risk of bone fracture Claim Types: Method of use | Aug 19, 2019 | U-865: Treatment of a woman with osteoporosis and a high risk for bone fracture by reducing the risk of vertebral and nonvertebral bone fracture |
| Pat. No. 7517334 DP* Medication dispensing apparatus with spring-driven locking feature enabled by administration of final dose Claim Types: Device | Mar 25, 2025 |
FORTEO (INJECTABLE) (SUBCUTANEOUS) TERIPARATIDE RECOMBINANT HUMAN
Drug Classes: parathyroid hormone analog
NDA Applicant: LILLY NDA No.: 021318 Prod. No.: 002 RX (0.6MG/2.4ML (0.25MG/ML))
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6770623 DP* Stabilized teriparatide solutions Claim Types: Drug in a container; Method of use; Process | Dec 8, 2018 | U-982: A method of treating osteoporosis |
| Pat. No. 7144861 DP* Stabilized teriparatide solutions Claim Types: Formulation; Process; Drug in a container | Dec 8, 2018 | |
| Pat. No. 7550434 DP* Stabilized teriparatide solutions Claim Types: Drug in a container; Method of use; Process | Dec 8, 2018 | U-982: A method of treating osteoporosis |
| Pat. No. 6977077 Method of increasing bone toughness and stiffness and reducing fractures Claim Types: Method of use | Aug 19, 2019 | U-982: A method of treating osteoporosis U-994: Method of treatment of osteoporosis wherein the osteoporosis is steroid-induced |
| Pat. No. 7163684 Method of increasing bone toughness and stiffness and reducing fractures Claim Types: Method of use | Aug 19, 2019 | U-983: Method of treating osteoporosis in a post-menopausal woman at risk for fracture U-994: Method of treatment of osteoporosis wherein the osteoporosis is steroid-induced |
| Pat. No. 7351414 Method of reducing the risk of bone fracture Claim Types: Method of use | Aug 19, 2019 | U-984: Method for the treatment of a woman with osteoporosis and at risk for bone fracture U-994: Method of treatment of osteoporosis wherein the osteoporosis is steroid-induced |
| Pat. No. 7517334 DP* Medication dispensing apparatus with spring-driven locking feature enabled by administration of final dose Claim Types: Device | Mar 25, 2025 |