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Last Updated: May 26, 2022

BUTRANS Drug Patent Profile


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When do Butrans patents expire, and what generic alternatives are available?

Butrans is a drug marketed by Purdue Pharma Lp and is included in one NDA.

The generic ingredient in BUTRANS is buprenorphine. There are twenty-nine drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the buprenorphine profile page.

Drug patent expirations by year for BUTRANS
Drug Prices for BUTRANS

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Drug Sales Revenue Trends for BUTRANS

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Recent Clinical Trials for BUTRANS

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Massachusetts General HospitalPhase 4
Purdue Pharma LPPhase 1
Purdue Pharma LPPhase 2

See all BUTRANS clinical trials

Paragraph IV (Patent) Challenges for BUTRANS
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
BUTRANS Transdermal System buprenorphine 15 mcg/hr 021306 1 2013-12-16
BUTRANS Transdermal System buprenorphine 5 mcg/hr 10 mcg/hr 20 mcg/hr 021306 1 2013-06-06

US Patents and Regulatory Information for BUTRANS

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Purdue Pharma Lp BUTRANS buprenorphine FILM, EXTENDED RELEASE;TRANSDERMAL 021306-001 Jun 30, 2010 AB RX Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Purdue Pharma Lp BUTRANS buprenorphine FILM, EXTENDED RELEASE;TRANSDERMAL 021306-004 Jul 25, 2013 AB RX Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Purdue Pharma Lp BUTRANS buprenorphine FILM, EXTENDED RELEASE;TRANSDERMAL 021306-005 Jun 30, 2014 AB RX Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Purdue Pharma Lp BUTRANS buprenorphine FILM, EXTENDED RELEASE;TRANSDERMAL 021306-002 Jun 30, 2010 AB RX Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Purdue Pharma Lp BUTRANS buprenorphine FILM, EXTENDED RELEASE;TRANSDERMAL 021306-003 Jun 30, 2010 AB RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for BUTRANS

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Purdue Pharma Lp BUTRANS buprenorphine FILM, EXTENDED RELEASE;TRANSDERMAL 021306-003 Jun 30, 2010 See Plans and Pricing See Plans and Pricing
Purdue Pharma Lp BUTRANS buprenorphine FILM, EXTENDED RELEASE;TRANSDERMAL 021306-002 Jun 30, 2010 See Plans and Pricing See Plans and Pricing
Purdue Pharma Lp BUTRANS buprenorphine FILM, EXTENDED RELEASE;TRANSDERMAL 021306-001 Jun 30, 2010 See Plans and Pricing See Plans and Pricing
Purdue Pharma Lp BUTRANS buprenorphine FILM, EXTENDED RELEASE;TRANSDERMAL 021306-001 Jun 30, 2010 See Plans and Pricing See Plans and Pricing
Purdue Pharma Lp BUTRANS buprenorphine FILM, EXTENDED RELEASE;TRANSDERMAL 021306-003 Jun 30, 2010 See Plans and Pricing See Plans and Pricing
Purdue Pharma Lp BUTRANS buprenorphine FILM, EXTENDED RELEASE;TRANSDERMAL 021306-004 Jul 25, 2013 See Plans and Pricing See Plans and Pricing
Purdue Pharma Lp BUTRANS buprenorphine FILM, EXTENDED RELEASE;TRANSDERMAL 021306-001 Jun 30, 2010 See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for BUTRANS

See the table below for patents covering BUTRANS around the world.

Country Patent Number Title Estimated Expiration
Japan H0818984 See Plans and Pricing
Croatia P930675 PROCESS FOR THE PREPARATION OF TRANSDERMAL THERAPEUTIC SYSTEM WITH BUPRENORPHINE AS AN ACTIVE SUBSTANCE See Plans and Pricing
Japan H03193732 PERCUTANEOUS MEDICAL SYSTEM HAVING BUPRENORPHINE AS ACTIVE SUBSTANCE See Plans and Pricing
Canada 2030178 DISPOSITIF THERAPEUTIQUE TRANSDERMIQUE FAISANT APPEL A LA BUPRENORPHINE COMME COMPOSANT ACTIF (TRANSDERMAL THERAPEUTIC SYSTEM COMPRISING AS ACTIVE COMPONENT BUPRENORPHINE) See Plans and Pricing
Hungary T55643 See Plans and Pricing
Denmark 0792145 See Plans and Pricing
Denmark 0964677 See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

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Serving leading biopharmaceutical companies globally:

Merck
Moodys
McKinsey
McKesson
Johnson and Johnson
Mallinckrodt

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