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Serving hundreds of leading biopharmaceutical companies globally:

Colorcon
Cerilliant
Harvard Business School
Dow
Mallinckrodt
Medtronic
QuintilesIMS
Farmers Insurance
Baxter

Generated: December 14, 2018

DrugPatentWatch Database Preview

OPANA ER Drug Profile

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Which patents cover Opana Er, and what generic alternatives are available?

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

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 ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Endo Pharms OPANA ER oxymorphone hydrochloride TABLET, EXTENDED RELEASE;ORAL 201655-004 Dec 9, 2011 DISCN Yes No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Endo Pharms OPANA ER oxymorphone hydrochloride TABLET, EXTENDED RELEASE;ORAL 201655-005 Dec 9, 2011 DISCN Yes No ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Endo Pharms OPANA ER oxymorphone hydrochloride TABLET, EXTENDED RELEASE;ORAL 201655-006 Dec 9, 2011 DISCN Yes No ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
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 021610-004 Jun 22, 2006 ➤ Sign Up ➤ Sign Up
Endo Pharms OPANA ER oxymorphone hydrochloride TABLET, EXTENDED RELEASE;ORAL 021610-007 Feb 29, 2008 ➤ Sign Up ➤ Sign Up
Endo Pharms OPANA ER oxymorphone hydrochloride TABLET, EXTENDED RELEASE;ORAL 021610-002 Jun 22, 2006 ➤ Sign Up ➤ Sign Up
Endo Pharms OPANA ER oxymorphone hydrochloride TABLET, EXTENDED RELEASE;ORAL 021610-004 Jun 22, 2006 ➤ Sign Up ➤ Sign Up
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 ➤ Sign Up
➤ Subscribe Extended-release Tablets 20 mg, 30 mg, 40 mg ➤ Subscribe ➤ Sign Up
➤ Subscribe Extended-release Tablets 7.5 mg, 10 mg, and 15 mg ➤ Subscribe ➤ Sign Up
➤ Subscribe Extended-release Tablets 30 mg ➤ Subscribe ➤ Sign Up
➤ Subscribe Extended-release Tablets 7.5 mg and 15 mg ➤ Subscribe ➤ Sign Up
➤ Subscribe Extended-release Tablets 5 mg, 10 mg, 20 mg and 40 mg ➤ Subscribe ➤ Sign Up

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Serving hundreds of leading biopharmaceutical companies globally:

Colorcon
Cerilliant
Harvard Business School
Dow
Mallinckrodt
Medtronic
QuintilesIMS
Farmers Insurance
Baxter

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