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Last Updated: April 18, 2024

Details for New Drug Application (NDA): 021610

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NDA 021610 describes OPANA ER, which is a drug marketed by Endo Pharms and is included in two NDAs. There are five 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. Ten suppliers are listed for this compound. Additional details are available on the oxymorphone hydrochloride profile page.

Summary for 021610

Tradename:	OPANA ER
Applicant:	Endo Pharms
Ingredient:	oxymorphone hydrochloride
Patents:	2
Formulation / Manufacturing:	see details

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TABLET, EXTENDED RELEASE;ORAL			Strength	5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons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:	⤷ Try a Trial	Patent Expiration:	Jun 21, 2027	Product Flag?		Substance Flag?		Delist Request?
Patented Use:	DOSE MODIFICATION FOR RENAL IMPAIRMENT
Patent:	⤷ Try a Trial	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TABLET, EXTENDED RELEASE;ORAL			Strength	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons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:	⤷ Try a Trial	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 Pharms	OPANA ER	oxymorphone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021610-003	Jun 22, 2006	⤷ Try a Trial	⤷ Try a Trial
Endo Pharms	OPANA ER	oxymorphone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021610-001	Jun 22, 2006	⤷ Try a Trial	⤷ Try a Trial
Endo Pharms	OPANA ER	oxymorphone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021610-003	Jun 22, 2006	⤷ Try a Trial	⤷ Try a Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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