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Serving hundreds of leading biopharmaceutical companies globally:

Citi
Merck
Cerilliant
Accenture
Argus Health
Express Scripts
Federal Trade Commission
UBS
Cantor Fitzgerald

Generated: July 22, 2018

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 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. Sixteen 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 ➤ 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 ➤ 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 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 021610-006 Feb 29, 2008 ➤ 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 021610-005 Feb 29, 2008 ➤ Try a Free Trial ➤ Try a Free Trial
Endo Pharms OPANA ER oxymorphone hydrochloride TABLET, EXTENDED RELEASE;ORAL 021610-005 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 7.5 mg, 10 mg, and 15 mg ➤ Subscribe ➤ Try a Free Trial
➤ 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 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

Non-Orange Book US Patents for OPANA ER

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
9,789,103 Method of treating pain utilizing controlled release oxymorphone pharmaceutical compositions and instruction on dosing for renal impairment ➤ Try a Free Trial
9,629,807 Abuse-proofed dosage form ➤ Try a Free Trial
9,820,982 Oxymorphone controlled release formulations ➤ Try a Free Trial
8,323,889 Process for the production of an abuse-proofed solid dosage form ➤ Try a Free Trial
Patent No. Title Estimated Patent Expiration

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Serving hundreds of leading biopharmaceutical companies globally:

Teva
US Army
Boehringer Ingelheim
Colorcon
Healthtrust
McKesson
Farmers Insurance
Fuji
Johnson and Johnson

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