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Generated: August 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 sixteen patents protecting this compound and three Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

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

There are twenty-eight drug master file entries for buprenorphine hydrochloride. Twenty-one suppliers are listed for this compound.

Summary for Generic Name: buprenorphine hydrochloride

Tradenames:9
Patents:16
Applicants:19
NDAs:27
Drug Master File Entries: see list28
Suppliers / Packagers: see list21
Bulk Api Vendors: see list21
Clinical Trials: see list2,584
Patent Applications: see list1,028
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
Rhodes Pharms
BUPRENORPHINE HYDROCHLORIDE
buprenorphine hydrochloride
TABLET;SUBLINGUAL207276-001Mar 27, 2017ABRXNoNo► Subscribe► Subscribe► Subscribe
Braeburn Pharms Inc
PROBUPHINE
buprenorphine hydrochloride
IMPLANT;IMPLANTATION204442-001May 26, 2016RXYesYes► Subscribe► Subscribe► Subscribe
Bdsi
BELBUCA
buprenorphine hydrochloride
FILM;BUCCAL207932-001Oct 23, 2015RXYesNo► Subscribe► Subscribe► Subscribe
Orexo Us Inc
ZUBSOLV
buprenorphine hydrochloride; naloxone hydrochloride
TABLET;SUBLINGUAL204242-002Jul 3, 2013RXYesNo► Subscribe► SubscribeY ► Subscribe
Bdsi
BELBUCA
buprenorphine hydrochloride
FILM;BUCCAL207932-006Oct 23, 2015RXYesNo► Subscribe► SubscribeY ► 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;BUCCAL207932-006Oct 23, 2015► Subscribe► Subscribe
Bdsi
BELBUCA
buprenorphine hydrochloride
FILM;BUCCAL207932-003Oct 23, 2015► Subscribe► Subscribe
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;BUCCAL207932-004Oct 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
5,800,832 Bioerodable film for delivery of pharmaceutical compounds to mucosal surfaces► Subscribe
9,597,288Transmucosal delivery devices with enhanced uptake► 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
World Intellectual Property Organization (WIPO)9955312► Subscribe
Japan2010270153► Subscribe
Slovenia2054031► Subscribe
Australia4757497► Subscribe
Ukraine96455► 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 500+ biopharmaceutical companies globally:

Moodys
Federal Trade Commission
Boehringer Ingelheim
US Army
Cantor Fitzgerald
McKesson
Queensland Health
AstraZeneca
Chubb
McKinsey

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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