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Last Updated: March 26, 2026

Details for New Drug Application (NDA): 201655

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NDA 201655 describes OPANA ER, which is a drug marketed by Endo Operations and Endo Pharms and is included in two NDAs. There are three 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 201655

Tradename:	OPANA ER
Applicant:	Endo Pharms
Ingredient:	oxymorphone hydrochloride
Patents:	3

Medical Subject Heading (MeSH) Categories for 201655

Adjuvants, Anesthesia
Analgesics, Opioid
Narcotics

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET, EXTENDED RELEASE;ORAL			Strength	5MG
Approval Date:	Dec 9, 2011	TE:		RLD:	Yes
Patent:	⤷ Start Trial	Patent Expiration:	Jul 10, 2029	Product Flag?		Substance Flag?	Y	Delist Request?
Patent:	⤷ Start Trial	Patent Expiration:	Jun 21, 2027	Product Flag?		Substance Flag?		Delist Request?
Patented Use:	METHOD OF ADMINISTRATION OF CONTROLLED RELEASE OXYMORPHONE
Patent:	⤷ Start Trial	Patent Expiration:	Nov 22, 2029	Product Flag?		Substance Flag?	Y	Delist Request?

Expired US Patents for NDA 201655

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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	201655-006	Dec 9, 2011	⤷ Start Trial	⤷ Start Trial
Endo Pharms	OPANA ER	oxymorphone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	201655-002	Dec 9, 2011	⤷ Start Trial	⤷ Start Trial
Endo Pharms	OPANA ER	oxymorphone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	201655-006	Dec 9, 2011	⤷ Start Trial	⤷ Start Trial
Endo Pharms	OPANA ER	oxymorphone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	201655-007	Dec 9, 2011	⤷ Start Trial	⤷ Start Trial
Endo Pharms	OPANA ER	oxymorphone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	201655-003	Dec 9, 2011	⤷ Start Trial	⤷ Start Trial
Endo Pharms	OPANA ER	oxymorphone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	201655-007	Dec 9, 2011	⤷ Start Trial	⤷ Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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