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Serving hundreds of leading biopharmaceutical companies globally:

Chinese Patent Office
QuintilesIMS
Queensland Health
Teva
Cipla
Julphar

Generated: March 22, 2019

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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 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. Twelve suppliers are listed for this compound. Additional details are available on the oxymorphone hydrochloride profile page.

Drug patent expirations by year for OPANA ER
Pharmacology for OPANA ER
Drug ClassOpioid Agonist
Mechanism of ActionFull Opioid Agonists
Medical Subject Heading (MeSH) Categories for OPANA ER
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 ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Endo Pharms OPANA ER oxymorphone hydrochloride TABLET, EXTENDED RELEASE;ORAL 201655-004 Dec 9, 2011 DISCN Yes No ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Endo Pharms OPANA ER oxymorphone hydrochloride TABLET, EXTENDED RELEASE;ORAL 201655-005 Dec 9, 2011 DISCN Yes No ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Endo Pharms OPANA ER oxymorphone hydrochloride TABLET, EXTENDED RELEASE;ORAL 201655-006 Dec 9, 2011 DISCN Yes No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Endo Pharms OPANA ER oxymorphone hydrochloride TABLET, EXTENDED RELEASE;ORAL 201655-005 Dec 9, 2011 DISCN Yes No ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

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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 021610-002 Jun 22, 2006 ➤ Try a Free Trial ➤ Try a Free Trial
Endo Pharms OPANA ER oxymorphone hydrochloride TABLET, EXTENDED RELEASE;ORAL 021610-001 Jun 22, 2006 ➤ Try a Free Trial ➤ Try a Free Trial
Endo Pharms OPANA ER oxymorphone hydrochloride TABLET, EXTENDED RELEASE;ORAL 021610-004 Jun 22, 2006 ➤ Try a Free Trial ➤ Try a Free Trial
Endo Pharms OPANA ER oxymorphone hydrochloride TABLET, EXTENDED RELEASE;ORAL 021610-004 Jun 22, 2006 ➤ Try a Free Trial ➤ Try a Free Trial
Endo Pharms OPANA ER oxymorphone hydrochloride TABLET, EXTENDED RELEASE;ORAL 021610-007 Feb 29, 2008 ➤ Try a Free Trial ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Paragraph IV (Patent) Challenges for OPANA ER
Drugname Dosage Strength RLD Date
➤ Subscribe Extended-release Tablets 5 mg ➤ Subscribe ➤ Try a Free Trial
➤ Subscribe Extended-release Tablets 20 mg, 30 mg, 40 mg ➤ Subscribe ➤ Try a Free Trial
➤ Subscribe Extended-release Tablets 7.5 mg, 10 mg, and 15 mg ➤ Subscribe ➤ Try a Free Trial
➤ Subscribe Extended-release Tablets 30 mg ➤ Subscribe ➤ Try a Free Trial
➤ Subscribe Extended-release Tablets 7.5 mg and 15 mg ➤ Subscribe ➤ Try a Free Trial
➤ Subscribe Extended-release Tablets 5 mg, 10 mg, 20 mg and 40 mg ➤ Subscribe ➤ Try a Free Trial

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Serving hundreds of leading biopharmaceutical companies globally:

McKinsey
Covington
Teva
Chinese Patent Office
Merck
Medtronic

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