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Buprenorphine hydrochloride - Generic Drug Details

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What are the generic drug sources, and freedom to operate, for buprenorphine hydrochloride?

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, 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-six NDAs. There are fifteen patents protecting this compound and three Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

This ingredient has sixty-nine patent family members in twenty-six countries.

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

Summary for Generic Name: buprenorphine hydrochloride

Tradenames:9
Patents:16
Applicants:18
NDAs:26
Drug Master File Entries: see list28
Suppliers / Packagers: see list22
Bulk Api Vendors: see list21
Clinical Trials: see list1,116
Patent Applications: see list686
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 Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Bdsi
BUNAVAIL
buprenorphine hydrochloride; naloxone hydrochloride
FILM;BUCCAL205637-003Jun 6, 2014RXYesYes► Subscribe► Subscribe
Braeburn Pharms Inc
PROBUPHINE
buprenorphine hydrochloride
IMPLANT;IMPLANTATION204442-001May 26, 2016RXYesYes7,736,665► Subscribe ► Subscribe
Indivior Inc
SUBOXONE
buprenorphine hydrochloride; naloxone hydrochloride
FILM;BUCCAL, SUBLINGUAL022410-003Aug 10, 2012RXYesNo8,475,832► SubscribeY ► Subscribe
Bdsi
BUNAVAIL
buprenorphine hydrochloride; naloxone hydrochloride
FILM;BUCCAL205637-003Jun 6, 2014RXYesYes7,579,019► Subscribe ► Subscribe
Orexo Us Inc
ZUBSOLV
buprenorphine hydrochloride; naloxone hydrochloride
TABLET;SUBLINGUAL204242-002Jul 3, 2013RXYesNo8,470,361► 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;BUCCAL207932-007Oct 23, 20156,159,498► Subscribe
Bdsi
BELBUCA
buprenorphine hydrochloride
FILM;BUCCAL207932-006Oct 23, 20156,159,498► Subscribe
Bdsi
BELBUCA
buprenorphine hydrochloride
FILM;BUCCAL207932-003Oct 23, 20156,159,498► Subscribe
Bdsi
BELBUCA
buprenorphine hydrochloride
FILM;BUCCAL207932-001Oct 23, 20156,159,498► Subscribe
Bdsi
BELBUCA
buprenorphine hydrochloride
FILM;BUCCAL207932-002Oct 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
Spain2577390► Subscribe
Israel220722► Subscribe
Japan3964465► Subscribe
South Korea101329496► Subscribe
Australia2003240493► 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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