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.
HYSINGLA (TABLET, EXTENDED RELEASE) (ORAL) HYDROCODONE BITARTRATE
Drug Classes: opioid agonist
NDA Applicant: PURDUE PHARMA LP NDA No.: 206627 Prod. No.: 001 RX (20MG); 002 RX (30MG); 003 RX (40MG); 004 RX (60MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6733783 DP* Controlled release hydrocodone formulations Claim Types: Formulation; Method of use; Process | Oct 30, 2021 | 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. 8309060 DP* Abuse-proofed dosage form Claim Types: Formulation; Method of use | 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. 8361499 DP* Controlled release hydrocodone formulations Claim Types: Formulation | Oct 30, 2021 | |
| Pat. No. 8529948 DP* Pharmaceutical formulation containing gelling agent Claim Types: Formulation | Aug 6, 2022 | |
| Pat. No. 8551520 DP* Controlled release hydrocodone Claim Types: Formulation | Oct 30, 2021 | |
| Pat. No. 8647667 DP* Controlled release hydrocodone formulations Claim Types: Formulation | Oct 30, 2021 | |
| Pat. No. 8808740 DP* Encased tamper resistant controlled release dosage forms Claim Types: Formulation; Method of use | Dec 21, 2031 | 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. 9023401 DP* Controlled release hydrocodone formulations Claim Types: Formulation | Oct 30, 2020 | |
| Pat. No. 9056052 DP* Controlled release hydrocodone formulations Claim Types: Formulation | Oct 30, 2020 | |
| Pat. No. 9060940 Controlled release hydrocodone Claim Types: Method of use; Method of administration | Oct 30, 2020 | 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. 9084816 DP* Tamper resistant dosage forms Claim Types: Formulation | Aug 24, 2027 | |
| Pat. No. 9095614 Tamper resistant dosage forms Claim Types: Method of use | 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. 9095615 DP* Tamper resistant dosage forms Claim Types: Formulation | Aug 24, 2027 | |
| Pat. No. 9198863 DP* Controlled release hydrocodone formulations Claim Types: Formulation | Oct 30, 2020 | |
| Pat. No. 9205056 DP* Controlled release hydrocodone formulations Claim Types: Formulation | Oct 30, 2020 | |
| Pat. No. 9289391 DP* Controlled release hydrocodone formulations Claim Types: Formulation | Oct 30, 2020 | |
| Pat. No. 9486412 DP* Tamper resistant dosage forms Claim Types: Product-by-process | Aug 24, 2027 | |
| Pat. No. 9486413 DP* Tamper resistant dosage forms Claim Types: Product-by-process | Aug 24, 2027 | |
| Pat. No. 9492389 DP* Tamper resistant dosage forms Claim Types: Product-by-process | Aug 24, 2027 | |
| Pat. No. 9492390 Tamper resistant dosage forms Claim Types: Method of use | 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. 9492391 Tamper resistant dosage forms Claim Types: Method of use | 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. 9517236 DP* Controlled release hydrocodone formulations Claim Types: Formulation | Oct 30, 2020 | |
| Pat. No. 9545380 Tamper resistant dosage forms Claim Types: Method of use | 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. 9572779 DP* Encased tamper resistant controlled release dosage forms Claim Types: Formulation | Dec 21, 2031 | |
| Pat. No. 9572804 DP* Controlled release hydrocodone formulations Claim Types: Formulation | Oct 30, 2020 | |
| Pat. No. 9669023 DP* Controlled release hydrocodone formulations Claim Types: Formulation | Oct 30, 2020 | |
| Pat. No. 9669024 DP* Controlled release hydrocodone formulations Claim Types: Composition; Formulation | Oct 30, 2020 | |
| Pat. No. 9675610 DP* Abuse-proofed dosage form Claim Types: Formulation | Jun 16, 2023 | |
| Pat. No. 9675611 Methods of providing analgesia Claim Types: Method of administration | Oct 30, 2020 | 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. 9682077 Methods of providing analgesia Claim Types: Method of administration | Oct 30, 2020 | 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. 9750703 DP* Encased tamper resistant controlled release dosage forms Claim Types: Formulation | Dec 21, 2031 | |
| Pat. No. 9763933 DP* Tamper resistant dosage forms Claim Types: Formulation | Aug 24, 2027 | |
| Pat. No. 9770416 DP* Tamper resistant dosage forms Claim Types: Formulation | Aug 24, 2027 | |
| Pat. No. 9775809 DP* Tamper resistant dosage forms Claim Types: Formulation | Aug 24, 2027 | |
| Pat. No. 9861584 DP* Tamper resistant controlled release dosage forms Claim Types: Formulation | Dec 21, 2031 | |
| Pat. No. 9872837 DP* Tamper resistant controlled release dosage forms Claim Types: Formulation | Dec 21, 2031 |