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Serving leading biopharmaceutical companies globally:

Deloitte
Moodys
Johnson and Johnson
US Army
McKinsey
Covington
Express Scripts
Chubb
Baxter
McKesson

Generated: January 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 five suppliers. There are four patents protecting this drug and two Paragraph IV challenges. 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:4
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 0093-3600-40 4 POUCH in 1 CARTON (0093-3600-40) > 1 PATCH in 1 POUCH (0093-3600-21) > 168 h in 1 PATCH
BUTRANS buprenorphine FILM, EXTENDED RELEASE;TRANSDERMAL 021306 NDA AUTHORIZED GENERIC Teva Pharmaceuticals USA, Inc. 0093-3601 0093-3601-40 4 POUCH in 1 CARTON (0093-3601-40) > 1 PATCH in 1 POUCH (0093-3601-21) > 168 h in 1 PATCH

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:FILM, EXTENDED RELEASE;TRANSDERMALStrength5MCG/HR
Approval Date:Jun 30, 2010TE:RLD:Yes
Patent:➤ SubscribePatent Expiration:Sep 29, 2017Product 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:➤ SubscribePatent Expiration:Sep 29, 2017Product 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:➤ SubscribePatent Expiration:Sep 29, 2017Product Flag?Substance Flag?Delist Request?
Patented Use:THE MANAGEMENT OF MODERATE TO SEVERE CHRONIC PAIN IN PATIENTS REQUIRING A CONTINUOUS, AROUND-THE-CLOCK OPIOID ANALGESIC FOR AN EXTENDED PERIOD OF TIME

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 021306-004 Jul 25, 2013 ➤ Subscribe ➤ Subscribe
Purdue Pharma Lp BUTRANS buprenorphine FILM, EXTENDED RELEASE;TRANSDERMAL 021306-003 Jun 30, 2010 ➤ Subscribe ➤ Subscribe
Purdue Pharma Lp BUTRANS buprenorphine FILM, EXTENDED RELEASE;TRANSDERMAL 021306-005 Jun 30, 2014 ➤ Subscribe ➤ Subscribe
Purdue Pharma Lp BUTRANS buprenorphine FILM, EXTENDED RELEASE;TRANSDERMAL 021306-004 Jul 25, 2013 ➤ Subscribe ➤ Subscribe
Purdue Pharma Lp BUTRANS buprenorphine FILM, EXTENDED RELEASE;TRANSDERMAL 021306-001 Jun 30, 2010 ➤ Subscribe ➤ Subscribe
Purdue Pharma Lp BUTRANS buprenorphine FILM, EXTENDED RELEASE;TRANSDERMAL 021306-003 Jun 30, 2010 ➤ Subscribe ➤ Subscribe
Purdue Pharma Lp BUTRANS buprenorphine FILM, EXTENDED RELEASE;TRANSDERMAL 021306-005 Jun 30, 2014 ➤ Subscribe ➤ Subscribe
Purdue Pharma Lp BUTRANS buprenorphine FILM, EXTENDED RELEASE;TRANSDERMAL 021306-002 Jun 30, 2010 ➤ Subscribe ➤ Subscribe
Purdue Pharma Lp BUTRANS buprenorphine FILM, EXTENDED RELEASE;TRANSDERMAL 021306-004 Jul 25, 2013 ➤ Subscribe ➤ Subscribe
Purdue Pharma Lp BUTRANS buprenorphine FILM, EXTENDED RELEASE;TRANSDERMAL 021306-003 Jun 30, 2010 ➤ Subscribe ➤ Subscribe
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Serving leading biopharmaceutical companies globally:

Merck
Johnson and Johnson
Chinese Patent Office
Moodys
Medtronic
Boehringer Ingelheim
Healthtrust
McKesson
Cipla

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