Orange Book Companion
Orange Book Champion: HYSINGLA

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)
PatentsExpirationPatented Use
Pat. No. 6733783 DP* Controlled release hydrocodone formulations
Claim Types: Formulation; Method of use; Process
Oct 30, 2021U-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, 2023U-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, 2031U-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, 2020U-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, 2027U-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, 2027U-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, 2027U-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, 2027U-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, 2020U-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, 2020U-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 


DS*=Drug Substance; DP*=Drug Product - patent submitted for the product after Aug. 18, 2003.
Last edited: 22 September 2018
2001-2018 Bruce A. Pokras, All rights reserved worldwide