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 two suppliers. There are fifteen 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. Thirty-seven 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:	15

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	Purdue Pharma LP	59011-410	59011-410-10	100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (59011-410-10)
OXYCONTIN	oxycodone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	022272	NDA	Purdue Pharma LP	59011-410	59011-410-20	2 BLISTER PACK in 1 CARTON (59011-410-20) / 10 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK

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:	11,304,908	Patent Expiration:	Aug 24, 2027	Product Flag?	Y	Substance Flag?		Delist Request?
Patent:	11,304,909	Patent Expiration:	Aug 24, 2027	Product Flag?		Substance Flag?		Delist Request?
Patented Use:	MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE
Patent:	11,964,056	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	10,130,591	⤷ Start Trial
Purdue Pharma Lp	OXYCONTIN	oxycodone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	022272-007	Apr 5, 2010	8,337,888	⤷ Start Trial
Purdue Pharma Lp	OXYCONTIN	oxycodone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	022272-002	Apr 5, 2010	9,060,976	⤷ Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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