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OPANA

NDA

OXYMORPHONE HYDROCHLORIDE | N011707 | ENDO PHARMACEUTICALS INC

2 strengths0 unique patents0 unique exclusivities

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

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

1 petition from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Endo Pharmaceuticals, Inc. - Citizen Petition FDA-2010-P-0243 · 3 docket documents Endo Pharmaceuticals Inc. filed this citizen petition on May 13, 2010, under section 505(q) of the Federal Food, Drug, and Cosmetic Act requesting that the FDA publicly announce its position that new NDAs and ANDAs referencing Opana or Opana ER (oxymorphone hydrochloride tablets and extended-release	505(q)	2010-05-18	Partially Denied	—

Source: Regulations.gov. FDA citizen petitions matched by application number.

Clinical Trials

24 trials from ClinicalTrials.gov, 18 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Bioavailability of Oxymorphone Hydrochloride 40 mg Extended Release Tablets Under Fasted Conditions NCT00857428	Phase 1	Completed	Sandoz	50	2007-11 → 2007-12
Efficacy and Safety of Oxymorphone Extended Release in Opioid-Experienced Patients With Chronic Non-Malignant Pain NCT00226421	Phase 3	Completed	Endo USA Inc., a Keenova Therapeutics Company	120	2004-10 → 2005-08
Oxymorphone Extended Release in Patients With Cancer or Neuropathic Pain NCT00911261	Phase 3	Completed	Endo USA Inc., a Keenova Therapeutics Company	223	2003-08 → 2005-05
Real-time Decision Support for Postoperative Nausea and Vomiting (PONV) Prophylaxis NCT02625181	N/A	Completed	Vanderbilt University	27,034	2016-07 → 2017-11-30
Effect of Extended-release Oxymorphone Taken With or Without Food on Cognitive Functioning NCT00930943	Phase 4	Completed	MedVadis Research Corporation	30	2009-05 → 2009-11
Post-operative Efficacy and Safety Study NCT00904085	Phase 3	Completed	Endo USA Inc., a Keenova Therapeutics Company	122	2003-04 → 2003-06
Efficacy and Safety of Oxmorphone Extended Release in Chronic Non-malignant Pain NCT00225797	Phase 3	Completed	Endo USA Inc., a Keenova Therapeutics Company	160	2004-11 → 2005-07
Study to Compare Oxymorphone Extended-Release (Opana ER) Versus Oxycodone Controlled-Release (Oxycontin)NCT00955110	Phase 4	Completed	Endo USA Inc., a Keenova Therapeutics Company	78	2009-06 → 2009-09
Bioavailability of Oxymorphone Hydrochloride 40 mg Extended Release Tablets Under Fed Conditions NCT00857142	Phase 1	Completed	Sandoz	32	2007-11 → 2007-12
Oxymorphone Extended Release (ER) in Opioid-Naive Patients With Chronic Pain NCT00911287	Phase 3	Completed	Endo USA Inc., a Keenova Therapeutics Company	129	2003-06 → 2004-03

Source: ClinicalTrials.gov. Trials matched by ingredient name.

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

3 letters from Drugs@FDA

Date	Submission	Document
Oct 8, 2019	SUPPL -37	View Letter (PDF)
Dec 19, 2016	SUPPL -36	View Letter (PDF)
Oct 23, 2006	SUPPL -31	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

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#001 — 1.5MG/ML

0 patents0 exclusivities▴

INJECTABLE;INJECTION | Approved: Approved Prior to Jan 1, 1982

No patent or exclusivity listings for this strength.

#002 — 1MG/ML

RLD

0 patents0 exclusivities▾

INJECTABLE;INJECTION | Approved: Approved Prior to Jan 1, 1982