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Last Updated: October 11, 2024

OPANA ER Drug Patent Profile


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When do Opana Er patents expire, and what generic alternatives are available?

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

This drug has two hundred and four 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. Nine suppliers are listed for this compound. Additional details are available on the oxymorphone hydrochloride profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Opana Er

A generic version of OPANA ER was approved as oxymorphone hydrochloride by IMPAX LABS on June 14th, 2010.

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Summary for OPANA ER
International Patents:204
US Patents:5
Applicants:2
NDAs:2
Raw Ingredient (Bulk) Api Vendors: 11
Patent Applications: 850
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for OPANA ER
What excipients (inactive ingredients) are in OPANA ER?OPANA ER excipients list
DailyMed Link:OPANA ER at DailyMed
Drug patent expirations by year for OPANA ER
Paragraph IV (Patent) Challenges for OPANA ER
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
OPANA ER Extended-release Tablets oxymorphone hydrochloride 20 mg, 30 mg and 40 mg 201655 1 2012-04-03
OPANA ER Extended-release Tablets oxymorphone hydrochloride 5 mg 201655 1 2012-03-26
OPANA ER Extended-release Tablets oxymorphone hydrochloride 7.5 mg, 10 mg, and 15 mg 201655 1 2012-03-23

US Patents and Regulatory Information for OPANA ER

OPANA ER is protected by six US patents.

Patents protecting OPANA ER

Method for making analgesics
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Abuse-proofed dosage form
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Abuse-proof dosage form
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Method of treating pain utilizing controlled release oxymorphone pharmaceutical compositions and instruction on dosing for renal impairment
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: DOSE MODIFICATION FOR RENAL IMPAIRMENT

Method of treating pain utilizing controlled release oxymorphone pharmaceutical compositions and instruction on dosing for renal impairment
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: METHOD OF ADMINISTRATION OF CONTROLLED RELEASE OXYMORPHONE

Process for preparing morphinan-6-one products with low levels of .alpha.,.beta.-unsaturated ketone compounds
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

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 201655-006 Dec 9, 2011 DISCN Yes 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 Y ⤷  Sign Up
Endo Pharms OPANA ER oxymorphone hydrochloride TABLET, EXTENDED RELEASE;ORAL 201655-007 Dec 9, 2011 DISCN Yes No ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Endo Pharms OPANA ER oxymorphone hydrochloride TABLET, EXTENDED RELEASE;ORAL 201655-007 Dec 9, 2011 DISCN Yes No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Endo Pharms OPANA ER oxymorphone hydrochloride TABLET, EXTENDED RELEASE;ORAL 201655-003 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

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 201655-006 Dec 9, 2011 ⤷  Sign Up ⤷  Sign Up
Endo Pharms OPANA ER oxymorphone hydrochloride TABLET, EXTENDED RELEASE;ORAL 201655-002 Dec 9, 2011 ⤷  Sign Up ⤷  Sign Up
Endo Operations OPANA ER oxymorphone hydrochloride TABLET, EXTENDED RELEASE;ORAL 021610-005 Feb 29, 2008 ⤷  Sign Up ⤷  Sign Up
Endo Pharms OPANA ER oxymorphone hydrochloride TABLET, EXTENDED RELEASE;ORAL 201655-002 Dec 9, 2011 ⤷  Sign Up ⤷  Sign Up
Endo Pharms OPANA ER oxymorphone hydrochloride TABLET, EXTENDED RELEASE;ORAL 201655-001 Dec 9, 2011 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for OPANA ER

See the table below for patents covering OPANA ER around the world.

Country Patent Number Title Estimated Expiration
Israel 143642 ⤷  Sign Up
Russian Federation 2010119291 СТОЙКАЯ К РАЗРУШЕНИЮ ЛЕКАРСТВЕННАЯ ФОРМА С ЗАМЕДЛЕННЫМ ВЫСВОБОЖДЕНИЕМ ОКСИКОДОНА ГИДРОХЛОРИДА ⤷  Sign Up
Brazil PI0413361 forma de dosagem protegida contra abusos ⤷  Sign Up
Norway 338235 ⤷  Sign Up
Mexico 9204352 TABLETAS DE VERAPAMIL DE LIBERACION CONTROLADA ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

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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 verification 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.