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Generated: April 24, 2019

DrugPatentWatch Database Preview

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 twelve suppliers. There are twenty 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. Fifty-three 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:20
Formulation / Manufacturing:see details
Pharmacology for NDA: 022272
Mechanism of ActionFull 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:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength10MG
Approval Date:Apr 5, 2010TE:RLD:Yes
Patent:➤ Sign UpPatent Expiration:Nov 20, 2023Product Flag?YSubstance 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:➤ Sign UpPatent Expiration:Mar 30, 2025Product Flag?YSubstance Flag?Delist Request?Y
Patent:➤ Sign UpPatent Expiration:Mar 30, 2025Product Flag?Substance Flag?YDelist Request?Y

Expired US Patents for NDA 022272

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
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 022272-005 Apr 5, 2010 ➤ Sign Up ➤ Sign Up
Purdue Pharma Lp OXYCONTIN oxycodone hydrochloride TABLET, EXTENDED RELEASE;ORAL 022272-006 Apr 5, 2010 ➤ Sign Up ➤ Sign Up
Purdue Pharma Lp OXYCONTIN oxycodone hydrochloride TABLET, EXTENDED RELEASE;ORAL 022272-001 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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