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Serving hundreds of leading biopharmaceutical companies globally:

QuintilesIMS
Farmers Insurance
Boehringer Ingelheim
Chinese Patent Office
Queensland Health
Chubb
Dow
Colorcon
Cipla

Generated: April 22, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 021306

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NDA 021306 describes BUTRANS, which is a drug marketed by Purdue Pharma Lp and is included in one NDA. It is available from four suppliers. Additional details are available on the BUTRANS profile page.

The generic ingredient in BUTRANS is buprenorphine. There are twenty-nine drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the buprenorphine profile page.
Summary for 021306
Tradename:BUTRANS
Applicant:Purdue Pharma Lp
Ingredient:buprenorphine
Patents:0
Therapeutic Class:Analgesics
Formulation / Manufacturing:see details
Pharmacology for NDA: 021306
Mechanism of ActionPartial Opioid Agonists
Medical Subject Heading (MeSH) Categories for 021306
Suppliers and Packaging for NDA: 021306
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
BUTRANS buprenorphine FILM, EXTENDED RELEASE;TRANSDERMAL 021306 NDA AUTHORIZED GENERIC Teva Pharmaceuticals USA, Inc. 0093-3600 N 0093-3600-40
BUTRANS buprenorphine FILM, EXTENDED RELEASE;TRANSDERMAL 021306 NDA AUTHORIZED GENERIC Teva Pharmaceuticals USA, Inc. 0093-3601 N 0093-3601-40

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:FILM, EXTENDED RELEASE;TRANSDERMALStrength5MCG/HR
Approval Date:Jun 30, 2010TE:RLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:FILM, EXTENDED RELEASE;TRANSDERMALStrength10MCG/HR
Approval Date:Jun 30, 2010TE:RLD:Yes

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:FILM, EXTENDED RELEASE;TRANSDERMALStrength20MCG/HR
Approval Date:Jun 30, 2010TE:RLD:Yes

Expired US Patents for NDA 021306

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Purdue Pharma Lp BUTRANS buprenorphine FILM, EXTENDED RELEASE;TRANSDERMAL 021306-001 Jun 30, 2010 ➤ Sign Up ➤ Sign Up
Purdue Pharma Lp BUTRANS buprenorphine FILM, EXTENDED RELEASE;TRANSDERMAL 021306-001 Jun 30, 2010 ➤ Sign Up ➤ Sign Up
Purdue Pharma Lp BUTRANS buprenorphine FILM, EXTENDED RELEASE;TRANSDERMAL 021306-002 Jun 30, 2010 ➤ Sign Up ➤ Sign Up
Purdue Pharma Lp BUTRANS buprenorphine FILM, EXTENDED RELEASE;TRANSDERMAL 021306-001 Jun 30, 2010 ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Serving hundreds of leading biopharmaceutical companies globally:

Citi
Medtronic
Daiichi Sankyo
AstraZeneca
Express Scripts
Dow
Fuji
Healthtrust
Teva

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