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Last Updated: April 20, 2024

Details for New Drug Application (NDA): 022272

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NDA 022272 describes OXYCONTIN, which is a drug marketed by Purdue Pharma Lp and is included in one NDA. It is available from three suppliers. There are sixteen patents protecting this drug and seven Paragraph IV challenges. Additional details are available on the OXYCONTIN profile page.

The generic ingredient in OXYCONTIN is oxycodone hydrochloride. There are nineteen drug master file entries for this compound. Forty-two suppliers are listed for this compound. Additional details are available on the oxycodone hydrochloride profile page.

Summary for 022272

Tradename:	OXYCONTIN
Applicant:	Purdue Pharma Lp
Ingredient:	oxycodone hydrochloride
Patents:	16
Formulation / Manufacturing:	see details

Pharmacology for NDA: 022272

Mechanism of Action	Full Opioid Agonists

Suppliers and Packaging for NDA: 022272

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
OXYCONTIN	oxycodone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	022272	NDA AUTHORIZED GENERIC	Teva Pharmaceuticals USA, Inc.	0093-5731	0093-5731-01	100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0093-5731-01)
OXYCONTIN	oxycodone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	022272	NDA AUTHORIZED GENERIC	Teva Pharmaceuticals USA, Inc.	0093-5732	0093-5732-01	100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0093-5732-01)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET, EXTENDED RELEASE;ORAL			Strength	10MG
Approval Date:	Apr 5, 2010	TE:		RLD:	Yes
Patent:	⤷ Try a Trial	Patent Expiration:	Mar 30, 2025	Product Flag?		Substance Flag?	Y	Delist Request?
Patent:	⤷ Try a Trial	Patent Expiration:	Mar 30, 2025	Product Flag?		Substance Flag?	Y	Delist Request?
Patent:	⤷ Try a Trial	Patent Expiration:	Aug 24, 2027	Product Flag?	Y	Substance Flag?		Delist Request?

Expired US Patents for NDA 022272

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Purdue Pharma Lp	OXYCONTIN	oxycodone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	022272-004	Apr 5, 2010	⤷ Try a Trial	⤷ Try a Trial
Purdue Pharma Lp	OXYCONTIN	oxycodone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	022272-001	Apr 5, 2010	⤷ Try a Trial	⤷ Try a Trial
Purdue Pharma Lp	OXYCONTIN	oxycodone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	022272-001	Apr 5, 2010	⤷ Try a Trial	⤷ Try a Trial
Purdue Pharma Lp	OXYCONTIN	oxycodone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	022272-007	Apr 5, 2010	⤷ Try a Trial	⤷ Try a Trial
Purdue Pharma Lp	OXYCONTIN	oxycodone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	022272-002	Apr 5, 2010	⤷ Try a Trial	⤷ Try a Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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