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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 thirteen 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 seventeen drug master file entries for this compound. Fifty-nine suppliers are listed for this compound. There are seventeen tentative approvals for this compound. Additional details are available on the oxycodone hydrochloride profile page.

Summary for NDA: 022272

Tradename:
OXYCONTIN
Applicant:
Purdue Pharma Lp
Ingredient:
oxycodone hydrochloride
Patents:13
Therapeutic Class:Analgesics
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)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength10MG
Approval Date:Apr 5, 2010TE:RLD:No
Patent:6,488,963Patent Expiration:Jun 24, 2017Product Flag?YSubstance Flag?Delist Request?
Patent:7,674,799Patent Expiration:Mar 30, 2025Product Flag?YSubstance Flag?Delist Request?
Patent:7,674,800Patent Expiration:Mar 30, 2025Product Flag?Substance Flag?YDelist Request?

Expired Orange Book 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;ORAL022272-001Apr 5, 20105,508,042► subscribe
Purdue Pharma Lp
OXYCONTIN
oxycodone hydrochloride
TABLET, EXTENDED RELEASE;ORAL022272-003Apr 5, 20105,508,042► subscribe
Purdue Pharma Lp
OXYCONTIN
oxycodone hydrochloride
TABLET, EXTENDED RELEASE;ORAL022272-002Apr 5, 20105,508,042► subscribe
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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 verifification 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.

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