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Buprenorphine hydrochloride - Generic Drug Details

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Buprenorphine hydrochloride is the generic ingredient in nine branded drugs marketed by Indivior Inc, Actavis Elizabeth, Ethypharm, Luitpold, West-ward Pharms Int, Endo Pharms Inc, Roxane, Hospira, Braeburn Pharms Inc, Barr, Sun Pharm Inds Ltd, Mylan Pharms Inc, Sandoz Inc, Par Sterile Products, Kremers Urban Pharms, Ethypharm Usa Corp, Amneal Pharms, Biodelivery Sci Intl, Orexo Us Inc, and Teva Pharms Usa, and is included in twenty-six NDAs. There are fourteen patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

This ingredient has sixty-six patent family members in twenty-two 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:14
Applicants:20
NDAs:26
Drug Master File Entries: see list28
Suppliers / Packaging: see list21
Formulation / Manufacturing:see details
Drug Prices:see low prices

Pharmacology for Ingredient: buprenorphine hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Indivior Inc
SUBOXONE
buprenorphine hydrochloride; naloxone hydrochloride
FILM;BUCCAL, SUBLINGUAL022410-002Aug 30, 2010RXNo8,603,514► subscribeY ► subscribe
Endo Pharms Inc
BELBUCA
buprenorphine hydrochloride
FILM;BUCCAL207932-006Oct 23, 2015RXNo8,147,866► subscribeY ► subscribe
Biodelivery Sci Intl
BUNAVAIL
buprenorphine hydrochloride; naloxone hydrochloride
FILM;BUCCAL205637-001Jun 6, 2014RXNo7,579,019► subscribe ► subscribe
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Expired Orange Book Patents for Generic Ingredient: buprenorphine hydrochloride

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Endo Pharms Inc
BELBUCA
buprenorphine hydrochloride
FILM;BUCCAL207932-004Oct 23, 20156,159,498► subscribe
Endo Pharms Inc
BELBUCA
buprenorphine hydrochloride
FILM;BUCCAL207932-007Oct 23, 20156,159,498► subscribe
Endo Pharms Inc
BELBUCA
buprenorphine hydrochloride
FILM;BUCCAL207932-005Oct 23, 20156,159,498► 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
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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
Japan2005325140► subscribe
Canada2487577► subscribe
Australia4757497► 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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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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