Details for New Drug Application (NDA): 021610

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NDA 021610 describes OPANA ER, which is a drug marketed by Endo Operations and Endo Pharms and is included in two NDAs. There are four patents protecting this drug and six Paragraph IV challenges. Additional details are available on the OPANA ER profile page.

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.

Summary for 021610

Tradename:	OPANA ER
Applicant:	Endo Operations
Ingredient:	oxymorphone hydrochloride
Patents:	2

Medical Subject Heading (MeSH) Categories for 021610

Adjuvants, Anesthesia
Analgesics, Opioid
Narcotics

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET, EXTENDED RELEASE;ORAL			Strength	5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Jun 22, 2006	TE:		RLD:	Yes
Patent:	8,808,737	Patent Expiration:	Jun 21, 2027	Product Flag?		Substance Flag?		Delist Request?
Patented Use:	DOSE MODIFICATION FOR RENAL IMPAIRMENT
Patent:	8,871,779	Patent Expiration:	Nov 22, 2029	Product Flag?		Substance Flag?	Y	Delist Request?

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET, EXTENDED RELEASE;ORAL			Strength	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Jun 22, 2006	TE:		RLD:	Yes
Patent:	8,808,737	Patent Expiration:	Jun 21, 2027	Product Flag?		Substance Flag?		Delist Request?
Patented Use:	DOSE MODIFICATION FOR RENAL IMPAIRMENT

Expired US Patents for NDA 021610

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Endo Operations	OPANA ER	oxymorphone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021610-004	Jun 22, 2006	8,329,216	⤷ Get Started Free
Endo Operations	OPANA ER	oxymorphone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021610-003	Jun 22, 2006	5,662,933	⤷ Get Started Free
Endo Operations	OPANA ER	oxymorphone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021610-005	Feb 29, 2008	8,309,112	⤷ Get Started Free
Endo Operations	OPANA ER	oxymorphone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021610-006	Feb 29, 2008	5,128,143	⤷ Get Started Free
Endo Operations	OPANA ER	oxymorphone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021610-002	Jun 22, 2006	5,128,143	⤷ Get Started Free
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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