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Serving leading biopharmaceutical companies globally:

Moodys
Farmers Insurance
McKesson
Citi
Mallinckrodt
Cipla
Fuji
Baxter
Merck
Boehringer Ingelheim

Generated: January 18, 2018

DrugPatentWatch Database Preview

Buprenorphine - Generic Drug Details

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What are the generic sources for buprenorphine and what is the scope of buprenorphine patent protection?

Buprenorphine
is the generic ingredient in ten branded drugs marketed by Purdue Pharma Lp, Bdsi, Braeburn Pharms Inc, Indivior Inc, Hospira, Luitpold, Par Sterile Products, West-ward Pharms Int, Actavis Elizabeth, Barr, Ethypharm, Mylan Pharms Inc, Rhodes Pharms, Sandoz Inc, Sun Pharm Inds Ltd, Amneal Pharms, Ethypharm Usa Corp, Kremers Urban Pharms, Teva Pharms Usa, and Orexo Us Inc, and is included in twenty-eight NDAs. There are twenty-one patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Buprenorphine has eighty-three patent family members in twenty-one countries.

There are twenty-nine drug master file entries for buprenorphine. Five suppliers are listed for this compound.
Summary for buprenorphine
Pharmacology for buprenorphine
Medical Subject Heading (MeSH) Categories for buprenorphine

US Patents and Regulatory Information for buprenorphine

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Indivior Inc SUBOXONE buprenorphine hydrochloride; naloxone hydrochloride FILM;BUCCAL, SUBLINGUAL 022410-001 Aug 30, 2010 RX Yes No ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Indivior Inc BUPRENEX buprenorphine hydrochloride INJECTABLE;INJECTION 018401-001 Approved Prior to Jan 1, 1982 AP RX Yes Yes ➤ Subscribe ➤ Subscribe ➤ Subscribe
Bdsi BUNAVAIL buprenorphine hydrochloride; naloxone hydrochloride FILM;BUCCAL 205637-001 Jun 6, 2014 RX Yes No ➤ Subscribe ➤ Subscribe ➤ Subscribe
West-ward Pharms Int BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE buprenorphine hydrochloride; naloxone hydrochloride TABLET;SUBLINGUAL 203326-002 Jun 27, 2014 AB RX No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Orexo Us Inc ZUBSOLV buprenorphine hydrochloride; naloxone hydrochloride TABLET;SUBLINGUAL 204242-002 Jul 3, 2013 RX Yes No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Bdsi BUNAVAIL buprenorphine hydrochloride; naloxone hydrochloride FILM;BUCCAL 205637-002 Jun 6, 2014 RX Yes No ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Purdue Pharma Lp BUTRANS buprenorphine FILM, EXTENDED RELEASE;TRANSDERMAL 021306-003 Jun 30, 2010 RX Yes Yes ➤ Subscribe ➤ Subscribe ➤ Subscribe
Orexo Us Inc ZUBSOLV buprenorphine hydrochloride; naloxone hydrochloride TABLET;SUBLINGUAL 204242-006 Oct 4, 2016 RX Yes No ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Bdsi BUNAVAIL buprenorphine hydrochloride; naloxone hydrochloride FILM;BUCCAL 205637-003 Jun 6, 2014 RX Yes Yes ➤ Subscribe ➤ Subscribe ➤ Subscribe
Orexo Us Inc ZUBSOLV buprenorphine hydrochloride; naloxone hydrochloride TABLET;SUBLINGUAL 204242-005 Jun 4, 2015 RX Yes No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

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Expired US Patents for buprenorphine

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 ➤ 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 021306-003 Jun 30, 2010 ➤ 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 021306-001 Jun 30, 2010 ➤ 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 021306-004 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 021306-002 Jun 30, 2010 ➤ Subscribe ➤ Subscribe
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Non-Orange Book US Patents for buprenorphine

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
5,968,547 Method of providing sustained analgesia with buprenorphine ➤ Subscribe
6,231,886 Methods of providing sustained treatment with opioids ➤ Subscribe
6,344,212 Method of providing sustained analgesia with buprenorphine ➤ Subscribe
Patent No. Title Estimated Patent Expiration

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International Patents for buprenorphine

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Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
Dow
Baxter
UBS
Mallinckrodt
Chubb
Healthtrust
Daiichi Sankyo
Covington

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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