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OPANA ER

NDA

OXYMORPHONE HYDROCHLORIDE | N021610 | ENDO OPERATIONS LTD

7 strengths2 unique patents0 unique exclusivities

Patent Timeline

2 unique patents by expiration date

Expiring < 1yr (1)Active (1)Today

2027

2028

2029

2030

Today

8808737

Jun. 21, 2027

8871779

Nov. 22, 2029

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

2 cases on OB patents from PACER

Case	Court	Filed	Status	Judge
Endo Pharmaceuticals Inc. v. Sandoz Inc. 1:2013cv03287 3 patentsANDA 90565, 20-4321oxymorphone hydrochloride	S.D.N.Y.	2013-05-15	Terminated 2013-10-18	—
Endo Pharmaceuticals Inc. v. Roxane Laboratories, Inc. 1:2013cv03288 3 patentsANDA 020822oxymorphone hydrochloride	S.D.N.Y.	2013-05-15	Terminated 2016-06-29	—

Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

API Supply Chain2 active DMFs4 inactive

2 active API suppliers hold Drug Master Files for this ingredient. Limited supplier base — potential supply chain risk.

SPECGX LLCOXYMORPHONE HYDROCHLORIDE USP

DMF 145021999

NORAMCO LLCOXYMORPHONE HYDROCHLORIDE DRUG SUBSTANCE

DMF 228162009

DIOSYNTH INCInactiveOXYMORPHONE HYDROCHLORIDE

DMF 74511988

MALLINCKRODT CHEMICAL INCInactiveOXYMORPHONE HYDROCHLORIDE

DMF 91091991

SIEGFRIED USA INCInactiveOXYMORPHONE HYDROCHLORIDE USP

DMF 234032009

SIEGFRIED USA LLCInactiveOXYMORPHONE HYDROCHLORIDE USP (LOW ABUK IMPURITY)

DMF 256282011

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

22 letters from Drugs@FDA

Date	Submission	Document
Nov 4, 2024	SUPPL -32	View Letter (PDF)
Dec 19, 2023	SUPPL -31	View Letter (PDF)
May 2, 2022	SUPPL -30	View Letter (PDF)
Mar 5, 2021	SUPPL -28	View Letter (PDF)
Oct 8, 2019	SUPPL -27	View Letter (PDF)
Oct 1, 2018	SUPPL -25	View Letter (PDF)
Oct 1, 2018	SUPPL -26	View Letter (PDF)
May 30, 2017	SUPPL -24	View Letter (PDF)
Dec 20, 2016	SUPPL -22	View Letter (PDF)
Oct 4, 2016	SUPPL -23	View Letter (PDF)
Apr 22, 2016	SUPPL -21	View Letter (PDF)
Jul 6, 2015	SUPPL -20	View Letter (PDF)
Aug 20, 2014	SUPPL -19	View Letter (PDF)
Apr 17, 2014	SUPPL -18	View Letter (PDF)
Apr 18, 2013	SUPPL -14	View Letter (PDF)
Jul 13, 2012	SUPPL -13	View Letter (PDF)
Jul 11, 2012	SUPPL -12	View Letter (PDF)
Oct 12, 2010	SUPPL -9	View Letter (PDF)
Mar 5, 2008	SUPPL -6	View Letter (PDF)
Jan 18, 2008	SUPPL -5	View Letter (PDF)
Jul 16, 2007	SUPPL -3	View Letter (PDF)
Aug 7, 2006	SUPPL -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (7)

Sort:

#001 — 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

2 patents0 exclusivities▴

TABLET, EXTENDED RELEASE;ORAL | Approved: Jun 22, 2006

Patents (2)

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
8808737	Jun 21, 2027	—	—	—		—
8871779	Nov 22, 2029	—	Yes	—	—	—

#002 — 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

2 patents0 exclusivities▾

TABLET, EXTENDED RELEASE;ORAL | Approved: Jun 22, 2006

#003 — 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

2 patents0 exclusivities▾

TABLET, EXTENDED RELEASE;ORAL | Approved: Jun 22, 2006

#004 — 40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

2 patents0 exclusivities▾

TABLET, EXTENDED RELEASE;ORAL | Approved: Jun 22, 2006

#005 — 7.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

2 patents0 exclusivities▾

TABLET, EXTENDED RELEASE;ORAL | Approved: Feb 29, 2008

#006 — 15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

2 patents0 exclusivities▾

TABLET, EXTENDED RELEASE;ORAL | Approved: Feb 29, 2008

#007 — 30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

2 patents0 exclusivities▾

TABLET, EXTENDED RELEASE;ORAL | Approved: Feb 29, 2008