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 eighteen 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-five 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:	18

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:	⤷ Sign Up	Patent Expiration:	Mar 30, 2025	Product Flag?		Substance Flag?	Y	Delist Request?
Patent:	⤷ Sign Up	Patent Expiration:	Mar 30, 2025	Product Flag?		Substance Flag?	Y	Delist Request?
Patent:	⤷ Sign Up	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	022272-003	Apr 5, 2010	⤷ Sign Up	⤷ Sign Up
Purdue Pharma Lp	OXYCONTIN	oxycodone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	022272-005	Apr 5, 2010	⤷ Sign Up	⤷ Sign Up
Purdue Pharma Lp	OXYCONTIN	oxycodone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	022272-002	Apr 5, 2010	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.