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Last Updated: October 19, 2019

DrugPatentWatch Database Preview

OPANA ER Drug Profile

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Which patents cover Opana Er, and when can generic versions of Opana Er launch?

Opana Er is a drug marketed by Endo Pharms and is included in two NDAs. There are ten patents protecting this drug and six Paragraph IV challenges.

This drug has two hundred and forty-five patent family members in thirty-two countries.

The generic ingredient in OPANA ER is oxymorphone hydrochloride. There are nine drug master file entries for this compound. Thirteen suppliers are listed for this compound. Additional details are available on the oxymorphone hydrochloride profile page.

Drug patent expirations by year for OPANA ER
Recent Litigation for OPANA ER

Identify potential future generic entrants

District Court Litigation
Case NameDate
Purdue Pharma L.P. v. Ascent Pharmaceuticals, Inc.2018-01-11
Purdue Pharma L.P. v. Amneal Pharmaceuticals, LLC2018-01-03
Purdue Pharma L.P. v. Kashiv Pharma, LLC2018-01-03

See all OPANA ER litigation

PTAB Litigation
PetitionerDate
Amneal Pharmaceuticals, LLC2014-08-22
Amneal Pharmaceuticals, LLC2014-01-16
Amneal Pharmaceuticals, LLC2013-11-18

See all OPANA ER litigation

Pharmacology for OPANA ER
Drug ClassOpioid Agonist
Mechanism of ActionFull Opioid Agonists
Synonyms for OPANA ER
(5alpha)-4,5-Epoxy-3,14-dihydroxy-17-methylmorphinan-6-one hydrochloride
357-07-3
4,5-alpha-Epoxy-3,14-dihydroxy-17-methylmorphinan-6-one hydrochloride
4,5alpha-Epoxy-3,14-dihydroxy-17-methylmorphinan-6-one hydrochloride
5Y2EI94NBC
76-41-5 (Parent)
AKOS027326705
BCGJBQBWUGVESK-KCTCKCTRSA-N
C17H19NO4.HCl
CHEBI:7866
CHEMBL1200794
D00844
DTXSID10189214
EINECS 206-610-5
LS-92124
Morphinan-6-one, 3,14-dihydroxy-4,5-alpha-epoxy-17-methyl-, hydrochloride
Morphinan-6-one, 4,5-epoxy-3,14-dihydroxy-17-methyl-, hydrochloride, (5alpha)-
Numorphan (TN)
Opana (TN)
Oxymorphinone hydrochloride
Oxymorphone HCl
OXYMORPHONE HYDROCHLORIDE
Oxymorphone hydrochloride (USP)
Oxymorphone hydrochloride [USAN]
Oxymorphone hydrochloride [USP]
SCHEMBL41770
UNII-5Y2EI94NBC

US Patents and Regulatory Information for OPANA ER

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Endo Pharms OPANA ER oxymorphone hydrochloride TABLET, EXTENDED RELEASE;ORAL 021610-003 Jun 22, 2006 DISCN No No   Start Trial   Start Trial Y   Start Trial
Endo Pharms OPANA ER oxymorphone hydrochloride TABLET, EXTENDED RELEASE;ORAL 201655-004 Dec 9, 2011 DISCN Yes No   Start Trial   Start Trial   Start Trial
Endo Pharms OPANA ER oxymorphone hydrochloride TABLET, EXTENDED RELEASE;ORAL 201655-005 Dec 9, 2011 DISCN Yes No   Start Trial   Start Trial Y   Start Trial
Endo Pharms OPANA ER oxymorphone hydrochloride TABLET, EXTENDED RELEASE;ORAL 201655-006 Dec 9, 2011 DISCN Yes No   Start Trial   Start Trial Y   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for OPANA ER

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Endo Pharms OPANA ER oxymorphone hydrochloride TABLET, EXTENDED RELEASE;ORAL 021610-005 Feb 29, 2008   Start Trial   Start Trial
Endo Pharms OPANA ER oxymorphone hydrochloride TABLET, EXTENDED RELEASE;ORAL 021610-007 Feb 29, 2008   Start Trial   Start Trial
Endo Pharms OPANA ER oxymorphone hydrochloride TABLET, EXTENDED RELEASE;ORAL 021610-003 Jun 22, 2006   Start Trial   Start Trial
Endo Pharms OPANA ER oxymorphone hydrochloride TABLET, EXTENDED RELEASE;ORAL 021610-003 Jun 22, 2006   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration
Paragraph IV (Patent) Challenges for OPANA ER
Drugname Dosage Strength RLD Date
➤ Subscribe Extended-release Tablets 7.5 mg, 10 mg, and 15 mg ➤ Subscribe   Start Trial
➤ Subscribe Extended-release Tablets 5 mg ➤ Subscribe   Start Trial
➤ Subscribe Extended-release Tablets 20 mg, 30 mg, 40 mg ➤ Subscribe   Start Trial
➤ Subscribe Extended-release Tablets 30 mg ➤ Subscribe   Start Trial
➤ Subscribe Extended-release Tablets 7.5 mg and 15 mg ➤ Subscribe   Start Trial
➤ Subscribe Extended-release Tablets 5 mg, 10 mg, 20 mg and 40 mg ➤ Subscribe   Start Trial

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

McKinsey
Boehringer Ingelheim
Medtronic
Harvard Business School
Baxter
Merck

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