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Serving leading biopharmaceutical companies globally:

US Department of Justice
McKinsey
Cantor Fitzgerald
Boehringer Ingelheim
QuintilesIMS
Daiichi Sankyo
Argus Health
Citi
Fish and Richardson
Accenture

Generated: February 21, 2018

DrugPatentWatch Database Preview

Buprenorphine hydrochloride - Generic Drug Details

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

Buprenorphine hydrochloride
is the generic ingredient in nine branded drugs marketed by 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, Specgx Llc, Teva Pharms Usa, and Orexo Us Inc, and is included in twenty-eight NDAs. There are seventeen patents protecting this compound and three Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Buprenorphine hydrochloride has seventy-nine patent family members in twenty-seven countries.

There are twenty-nine drug master file entries for buprenorphine hydrochloride. Twenty-two suppliers are listed for this compound.
Summary for buprenorphine hydrochloride
Pharmacology for buprenorphine hydrochloride

US Patents and Regulatory Information for buprenorphine hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Orexo Us Inc ZUBSOLV buprenorphine hydrochloride; naloxone hydrochloride TABLET;SUBLINGUAL 204242-002 Jul 3, 2013 RX Yes No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Sun Pharm Inds Ltd BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE buprenorphine hydrochloride; naloxone hydrochloride TABLET;SUBLINGUAL 201633-002 Aug 5, 2016 AB RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Bdsi BUNAVAIL buprenorphine hydrochloride; naloxone hydrochloride FILM;BUCCAL 205637-001 Jun 6, 2014 RX Yes No ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Specgx Llc BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE buprenorphine hydrochloride; naloxone hydrochloride TABLET;SUBLINGUAL 207000-001 Dec 13, 2017 AB RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Ethypharm BUPRENORPHINE HYDROCHLORIDE buprenorphine hydrochloride TABLET;SUBLINGUAL 090622-002 Sep 24, 2010 AB RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Orexo Us Inc ZUBSOLV buprenorphine hydrochloride; naloxone hydrochloride TABLET;SUBLINGUAL 204242-004 Dec 11, 2014 RX Yes Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
Rhodes Pharms BUPRENORPHINE HYDROCHLORIDE buprenorphine hydrochloride TABLET;SUBLINGUAL 207276-001 Mar 27, 2017 AB RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Teva Pharms Usa BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE buprenorphine hydrochloride; naloxone hydrochloride TABLET;SUBLINGUAL 091149-002 Sep 8, 2014 AB RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Bdsi BUNAVAIL buprenorphine hydrochloride; naloxone hydrochloride FILM;BUCCAL 205637-003 Jun 6, 2014 RX Yes Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
Barr BUPRENORPHINE HYDROCHLORIDE buprenorphine hydrochloride TABLET;SUBLINGUAL 090360-002 May 7, 2010 AB RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
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 hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Bdsi BELBUCA buprenorphine hydrochloride FILM;BUCCAL 207932-001 Oct 23, 2015 ➤ Sign Up ➤ Sign Up
Bdsi BELBUCA buprenorphine hydrochloride FILM;BUCCAL 207932-003 Oct 23, 2015 ➤ Sign Up ➤ Sign Up
Bdsi BELBUCA buprenorphine hydrochloride FILM;BUCCAL 207932-004 Oct 23, 2015 ➤ Sign Up ➤ Sign Up
Bdsi BELBUCA buprenorphine hydrochloride FILM;BUCCAL 207932-002 Oct 23, 2015 ➤ Sign Up ➤ Sign Up
Bdsi BELBUCA buprenorphine hydrochloride FILM;BUCCAL 207932-007 Oct 23, 2015 ➤ Sign Up ➤ Sign Up
Bdsi BELBUCA buprenorphine hydrochloride FILM;BUCCAL 207932-006 Oct 23, 2015 ➤ Sign Up ➤ Sign Up
Bdsi BELBUCA buprenorphine hydrochloride FILM;BUCCAL 207932-005 Oct 23, 2015 ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Non-Orange Book US Patents for buprenorphine hydrochloride

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
9,597,288 Transmucosal delivery devices with enhanced uptake ➤ Sign Up
5,800,832 Bioerodable film for delivery of pharmaceutical compounds to mucosal surfaces ➤ Sign Up
6,159,498 Bioerodable film for delivery of pharmaceutical compounds of mucosal surfaces ➤ Sign Up
Patent No. Title Estimated Patent Expiration

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International Patents for buprenorphine hydrochloride

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Serving hundreds of leading biopharmaceutical companies globally:

Baxter
US Department of Justice
McKinsey
Colorcon
Express Scripts
Queensland Health
Fish and Richardson
Federal Trade Commission
Merck

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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