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Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
Healthtrust
US Department of Justice
Colorcon
Express Scripts
Accenture
Citi
Fuji
Federal Trade Commission
Queensland Health

Generated: October 21, 2017

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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 Indivior Inc, Actavis Elizabeth, Ethypharm, Luitpold, West-ward Pharms Int, Bdsi, Hospira, Braeburn Pharms Inc, Barr, Sun Pharm Inds Ltd, Mylan Pharms Inc, Rhodes Pharms, Sandoz Inc, Par Sterile Products, Kremers Urban Pharms, Ethypharm Usa Corp, Amneal Pharms, Orexo Us Inc, and Teva Pharms Usa, and is included in twenty-seven 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 Generic Name: buprenorphine hydrochloride

US Patents:17
Tradenames:9
Applicants:19
NDAs:27
Drug Master File Entries: see list29
Suppliers / Packagers: see list22
Bulk Api Vendors: see list21
Clinical Trials: see list2,615
Patent Applications: see list1,063
Formulation / Manufacturing:see details
Drug Prices:see low prices
DailyMed Link:buprenorphine hydrochloride at DailyMed

Pharmacology for Ingredient: 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;SUBLINGUAL204242-002Jul 3, 2013RXYesNo► Subscribe► SubscribeY ► Subscribe
Orexo Us Inc
ZUBSOLV
buprenorphine hydrochloride; naloxone hydrochloride
TABLET;SUBLINGUAL204242-005Jun 4, 2015RXYesNo► Subscribe► SubscribeY ► Subscribe
West-ward Pharms Int
BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE
buprenorphine hydrochloride; naloxone hydrochloride
TABLET;SUBLINGUAL203326-002Jun 27, 2014ABRXNoNo► Subscribe► Subscribe► Subscribe
Ethypharm Usa Corp
BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE
buprenorphine hydrochloride; naloxone hydrochloride
TABLET;SUBLINGUAL204431-002Oct 16, 2015ABRXNoNo► Subscribe► Subscribe► Subscribe
Orexo Us Inc
ZUBSOLV
buprenorphine hydrochloride; naloxone hydrochloride
TABLET;SUBLINGUAL204242-001Jul 3, 2013RXYesNo► Subscribe► Subscribe► Subscribe
Bdsi
BUNAVAIL
buprenorphine hydrochloride; naloxone hydrochloride
FILM;BUCCAL205637-001Jun 6, 2014RXYesNo► Subscribe► Subscribe ► Subscribe
Amneal Pharms
BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE
buprenorphine hydrochloride; naloxone hydrochloride
TABLET;SUBLINGUAL203136-002Feb 22, 2013ABRXNoNo► Subscribe► Subscribe► Subscribe
Actavis Elizabeth
BUPRENORPHINE HYDROCHLORIDE
buprenorphine hydrochloride
TABLET;SUBLINGUAL090819-002Feb 19, 2015ABRXNoNo► Subscribe► Subscribe► Subscribe
Orexo Us Inc
ZUBSOLV
buprenorphine hydrochloride; naloxone hydrochloride
TABLET;SUBLINGUAL204242-004Dec 11, 2014RXYesYes► Subscribe► SubscribeY ► Subscribe
Orexo Us Inc
ZUBSOLV
buprenorphine hydrochloride; naloxone hydrochloride
TABLET;SUBLINGUAL204242-002Jul 3, 2013RXYesNo► Subscribe► Subscribe ► Subscribe
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Expired Orange Book Patents for Generic Ingredient: buprenorphine hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Bdsi
BELBUCA
buprenorphine hydrochloride
FILM;BUCCAL207932-007Oct 23, 2015► Subscribe► Subscribe
Bdsi
BELBUCA
buprenorphine hydrochloride
FILM;BUCCAL207932-001Oct 23, 2015► Subscribe► Subscribe
Bdsi
BELBUCA
buprenorphine hydrochloride
FILM;BUCCAL207932-006Oct 23, 2015► Subscribe► Subscribe
Bdsi
BELBUCA
buprenorphine hydrochloride
FILM;BUCCAL207932-004Oct 23, 2015► Subscribe► Subscribe
Bdsi
BELBUCA
buprenorphine hydrochloride
FILM;BUCCAL207932-002Oct 23, 2015► Subscribe► Subscribe
Bdsi
BELBUCA
buprenorphine hydrochloride
FILM;BUCCAL207932-005Oct 23, 2015► Subscribe► Subscribe
Bdsi
BELBUCA
buprenorphine hydrochloride
FILM;BUCCAL207932-003Oct 23, 2015► Subscribe► Subscribe
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Non-Orange Book Patents for Generic Ingredient: 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
9,597,288Transmucosal delivery devices with enhanced uptake► Subscribe
5,800,832 Bioerodable film for delivery of pharmaceutical compounds to mucosal surfaces► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.

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International Patent Family for Ingredient: buprenorphine hydrochloride

Country Document Number Estimated Expiration
Russian Federation2504377► Subscribe
Japan2005528422► Subscribe
Poland2054031► Subscribe
Canada2658585► Subscribe
Australia2007275581► Subscribe
Australia3892401► Subscribe
South Africa200900485► Subscribe
Serbia54764► Subscribe
Japan2009544619► Subscribe
Canada2487577► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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Serving leading biopharmaceutical companies globally:

US Army
Covington
Mallinckrodt
Fish and Richardson
Citi
AstraZeneca
Baxter
Federal Trade Commission
Cantor Fitzgerald
Cerilliant

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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