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Serving hundreds of leading biopharmaceutical companies globally:

Chubb
Cipla
Fuji
Daiichi Sankyo
Harvard Business School
Fish and Richardson
Colorcon
Express Scripts
UBS

Generated: May 23, 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. Fifteen 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 021610-002 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 021610-001 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 Submissiondate
➤ Subscribe Extended-release Tablets 7.5 mg, 10 mg, and 15 mg ➤ Subscribe 2012-03-23
➤ Subscribe Extended-release Tablets 5 mg ➤ Subscribe 2012-03-26
➤ Subscribe Extended-release Tablets 20 mg, 30 mg, 40 mg ➤ Subscribe 2012-04-03
➤ Subscribe Extended-release Tablets 30 mg ➤ Subscribe 2008-06-12
➤ Subscribe Extended-release Tablets 7.5 mg and 15 mg ➤ Subscribe 2008-05-29
➤ Subscribe Extended-release Tablets 5 mg, 10 mg, 20 mg and 40 mg ➤ Subscribe 2007-11-23

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
8,323,889 Process for the production of an abuse-proofed solid dosage form ➤ Try a Free Trial
9,820,982 Oxymorphone controlled release formulations ➤ Try a Free Trial
9,629,807 Abuse-proofed dosage form ➤ Try a Free Trial
8,748,611 Processes for preparing morphinan-6-one products with low levels of alpha beta-unsaturated compounds ➤ Try a Free Trial
Patent No. Title Estimated Patent Expiration

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Serving hundreds of leading biopharmaceutical companies globally:

Cantor Fitzgerald
Moodys
Colorcon
Baxter
Johnson and Johnson
Mallinckrodt
Queensland Health
Fish and Richardson
Merck

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.