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Last Updated: September 20, 2024

OPANA ER Drug Patent 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 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:1
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 201655-005 Dec 9, 2011 DISCN Yes No ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Endo Pharms OPANA ER oxymorphone hydrochloride TABLET, EXTENDED RELEASE;ORAL 201655-007 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 201655-004 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 201655-002 Dec 9, 2011 ⤷  Sign Up ⤷  Sign Up
Endo Pharms OPANA ER oxymorphone hydrochloride TABLET, EXTENDED RELEASE;ORAL 201655-005 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 Pharms 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 201655-005 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
Japan H07165615 EFFECT-RETAINING TYPE HETERO DISPERSION HYDROGEL SYSTEM FOR INSOLUBLE CHEMICAL ⤷  Sign Up
Germany 69638364 ⤷  Sign Up
Chile 2004002016 FORMA DE DOSIFICACION TERMOFORMADA A PRUEBA DE ABUSO QUE CONTIENE (A) UNO O MAS PRINCIPIOS ACTIVOS SUSCEPTIBLES DE ABUSO, (B) OPCIONALMENTE SUSTANCIAS AUXILIARES, (C) AL MENOS UN POLIMERO SINTETICO O NATURAL DEFINIDO Y (D) OPCIONALMENTE AL MENOS UNA ⤷  Sign Up
Spain 2629303 ⤷  Sign Up
Portugal 1740156 ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

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