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 14^th, 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
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Abuse-proofed dosage form
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Abuse-proof dosage form
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Method of treating pain utilizing controlled release oxymorphone pharmaceutical compositions and instruction on dosing for renal impairment
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Patented Use: DOSE MODIFICATION FOR RENAL IMPAIRMENT

Process for preparing morphinan-6-one products with low levels of .alpha.,.beta.-unsaturated ketone compounds
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Glossary

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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

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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.

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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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Summary for OPANA ER

Paragraph IV (Patent) Challenges for OPANA ER

Patents protecting OPANA ER

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