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NDA

OXYMORPHONE HYDROCHLORIDE | N201655 | ENDO PHARMACEUTICALS INC

7 strengths3 unique patents0 unique exclusivities

Patent Timeline

3 unique patents by expiration date

Expiring < 1yr (1)Active (2)TodayIPRPTAB Challenge

2027

2028

2029

2030

Today

7851482

Jul. 10, 2029IPR

8808737

Jun. 21, 2027

8871779

Nov. 22, 2029

PTAB Proceedings

1 challenge on OB patents at the Patent Trial and Appeal Board

Trial #	Patent	Type	Petitioner	Status	Filed	Decision
IPR2014-00160	7851482	IPR	Amneal Pharmaceuticals, LLC	Terminated-Settled	2013-11-18	—

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

10 cases on OB patents from PACER

Case	Court	Filed	Status	Judge
Endo Pharmaceuticals Inc. et al v. Actavis LLC, et al. 1:2014cv01381 3 patentsANDA 79-046, 20-3930oxymorphone hydrochloride	D. Del.	2014-11-07	Terminated 2019-06-21	—
Endo Pharmaceuticals Inc. et al v Sun Pharmaceutical Laboratories Ltd. et al 1:2014cv01386 2 patentsANDA 203506, 204527oxymorphone hydrochloride	D. Del.	2014-11-07	Terminated 2018-09-04	—
Endo Pharmaceuticals Inc. et al v. Teva Pharmaceuticals USA Inc. et al 1:2014cv01389 2 patentsANDA 204324oxymorphone hydrochloride	D. Del.	2014-11-07	Terminated 2019-05-20	—
Endo Pharmaceuticals Inc. et al v. Actavis Inc. et al 1:2013cv00436 6 patentsANDA 20-3930oxymorphone hydrochloride	S.D.N.Y.	2013-01-18	Terminated 2016-06-29	—
Endo Pharmaceuticals Inc. et al v. IMPAX Laboratories, Inc. 1:2013cv00435 6 patentsANDA 20-4211oxymorphone hydrochloride	S.D.N.Y.	2013-01-18	Terminated 2016-06-29	—
Endo Pharmaceuticals Inc. et al v. Par Pharmaceutical Companies, Inc. et al 1:2012cv09261 6 patentsANDA 20-4340oxymorphone hydrochloride	S.D.N.Y.	2012-12-19	Terminated 2015-01-15	—
Endo Pharmaceuticals Inc. v. Actavis Inc. et al 1:2012cv08985 3 patentsANDA 79-046oxymorphone hydrochloride	S.D.N.Y.	2012-12-11	Terminated 2016-06-29	—
Endo Pharmaceuticals Inc. et al v. Sandoz Inc. 1:2012cv08318 5 patentsANDA 20-4321oxymorphone hydrochloride	S.D.N.Y.	2012-11-14	Terminated 2015-03-23	—
Endo Pharmaceuticals Inc. et al v. Impax Laboratories, Inc. et al 1:2012cv08317 5 patentsANDA 20-4334oxymorphone hydrochloride	S.D.N.Y.	2012-11-14	Terminated 2016-06-29	—
Endo Pharmaceuticals Inc. et al v. Amneal Pharmaceuticals, LLC et al 1:2012cv08115 2 patentsANDA 20-4294oxymorphone hydrochloride	S.D.N.Y.	2012-11-07	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

15 letters from Drugs@FDA

Date	Submission	Document
Oct 9, 2019	SUPPL -26	View Letter (PDF)
Oct 1, 2018	SUPPL -25	View Letter (PDF)
Oct 1, 2018	SUPPL -24	View Letter (PDF)
May 31, 2017	SUPPL -23	View Letter (PDF)
Dec 21, 2016	SUPPL -21	View Letter (PDF)
Oct 3, 2016	SUPPL -22	View Letter (PDF)
Apr 22, 2016	SUPPL -20	View Letter (PDF)
Jul 7, 2015	SUPPL -17	View Letter (PDF)
Jan 29, 2015	SUPPL -16	View Letter (PDF)
Aug 20, 2014	SUPPL -15	View Letter (PDF)
Apr 17, 2014	SUPPL -12	View Letter (PDF)
Apr 18, 2013	SUPPL -5	View Letter (PDF)
Jan 16, 2013	SUPPL -4	View Letter (PDF)
Jul 11, 2012	SUPPL -2	View Letter (PDF)
Dec 9, 2011	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

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#001 — 5MG

RLD

3 patents0 exclusivities▴