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Generated: February 16, 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 eleven 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-four 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
Regulatory Exclusivity Expiration:Aug 13, 2018
Regulatory Exclusivity Use:NEW PATIENT POPULATION
Patent:➤ Try a Free TrialPatent 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:➤ Try a Free TrialPatent Expiration:Mar 30, 2025Product Flag?YSubstance Flag?Delist 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 022272-002 Apr 5, 2010 ➤ Try a Free Trial ➤ Try a Free Trial
Purdue Pharma Lp OXYCONTIN oxycodone hydrochloride TABLET, EXTENDED RELEASE;ORAL 022272-006 Apr 5, 2010 ➤ Try a Free Trial ➤ Try a Free Trial
Purdue Pharma Lp OXYCONTIN oxycodone hydrochloride TABLET, EXTENDED RELEASE;ORAL 022272-003 Apr 5, 2010 ➤ Try a Free Trial ➤ Try a Free Trial
Purdue Pharma Lp OXYCONTIN oxycodone hydrochloride TABLET, EXTENDED RELEASE;ORAL 022272-005 Apr 5, 2010 ➤ Try a Free Trial ➤ Try a Free Trial
Purdue Pharma Lp OXYCONTIN oxycodone hydrochloride TABLET, EXTENDED RELEASE;ORAL 022272-001 Apr 5, 2010 ➤ Try a Free Trial ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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