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Generated: September 25, 2017

DrugPatentWatch Database Preview

Buprenorphine - Generic Drug Details

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

Buprenorphine
is the generic ingredient in ten branded drugs marketed by Purdue Pharma Lp, 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-eight NDAs. There are twenty-one patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

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

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

Summary for Generic Name: buprenorphine

Tradenames:10
Patents:21
Applicants:20
NDAs:28
Drug Master File Entries: see list28
Suppliers / Packagers: see list4
Bulk Api Vendors: see list9
Clinical Trials: see list347
Patent Applications: see list6,330
Therapeutic Class:Analgesics
Formulation / Manufacturing:see details
Drug Prices:see low prices
DailyMed Link:buprenorphine at DailyMed

Pharmacology for Ingredient: buprenorphine

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Sun Pharm Inds Ltd
BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE
buprenorphine hydrochloride; naloxone hydrochloride
TABLET;SUBLINGUAL201633-001Aug 5, 2016ABRXNoNo► Subscribe► Subscribe► Subscribe
Bdsi
BELBUCA
buprenorphine hydrochloride
FILM;BUCCAL207932-004Oct 23, 2015RXYesNo► Subscribe► Subscribe► Subscribe
Indivior Inc
SUBUTEX
buprenorphine hydrochloride
TABLET;SUBLINGUAL020732-002Oct 8, 2002DISCNYesNo► Subscribe► Subscribe► Subscribe
Orexo Us Inc
ZUBSOLV
buprenorphine hydrochloride; naloxone hydrochloride
TABLET;SUBLINGUAL204242-004Dec 11, 2014RXYesYes► Subscribe► SubscribeY ► Subscribe
Indivior Inc
SUBOXONE
buprenorphine hydrochloride; naloxone hydrochloride
FILM;BUCCAL, SUBLINGUAL022410-002Aug 30, 2010RXYesNo► Subscribe► SubscribeY ► Subscribe
Bdsi
BELBUCA
buprenorphine hydrochloride
FILM;BUCCAL207932-006Oct 23, 2015RXYesNo► Subscribe► Subscribe► Subscribe
Orexo Us Inc
ZUBSOLV
buprenorphine hydrochloride; naloxone hydrochloride
TABLET;SUBLINGUAL204242-001Jul 3, 2013RXYesNo► Subscribe► SubscribeY ► Subscribe
Teva Pharms Usa
BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE
buprenorphine hydrochloride; naloxone hydrochloride
TABLET;SUBLINGUAL091149-002Sep 8, 2014ABRXNoNo► Subscribe► Subscribe► Subscribe
Orexo Us Inc
ZUBSOLV
buprenorphine hydrochloride; naloxone hydrochloride
TABLET;SUBLINGUAL204242-003Dec 11, 2014RXYesNo► Subscribe► SubscribeY ► Subscribe
Orexo Us Inc
ZUBSOLV
buprenorphine hydrochloride; naloxone hydrochloride
TABLET;SUBLINGUAL204242-004Dec 11, 2014RXYesYes► Subscribe► SubscribeY ► Subscribe
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Expired Orange Book Patents for Generic Ingredient: buprenorphine

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Purdue Pharma Lp
BUTRANS
buprenorphine
FILM, EXTENDED RELEASE;TRANSDERMAL021306-003Jun 30, 2010► Subscribe► Subscribe
Purdue Pharma Lp
BUTRANS
buprenorphine
FILM, EXTENDED RELEASE;TRANSDERMAL021306-001Jun 30, 2010► Subscribe► Subscribe
Purdue Pharma Lp
BUTRANS
buprenorphine
FILM, EXTENDED RELEASE;TRANSDERMAL021306-003Jun 30, 2010► Subscribe► Subscribe
Purdue Pharma Lp
BUTRANS
buprenorphine
FILM, EXTENDED RELEASE;TRANSDERMAL021306-004Jul 25, 2013► Subscribe► Subscribe
Purdue Pharma Lp
BUTRANS
buprenorphine
FILM, EXTENDED RELEASE;TRANSDERMAL021306-001Jun 30, 2010► Subscribe► Subscribe
Purdue Pharma Lp
BUTRANS
buprenorphine
FILM, EXTENDED RELEASE;TRANSDERMAL021306-005Jun 30, 2014► Subscribe► Subscribe
Purdue Pharma Lp
BUTRANS
buprenorphine
FILM, EXTENDED RELEASE;TRANSDERMAL021306-005Jun 30, 2014► Subscribe► Subscribe
Purdue Pharma Lp
BUTRANS
buprenorphine
FILM, EXTENDED RELEASE;TRANSDERMAL021306-002Jun 30, 2010► Subscribe► Subscribe
Purdue Pharma Lp
BUTRANS
buprenorphine
FILM, EXTENDED RELEASE;TRANSDERMAL021306-004Jul 25, 2013► Subscribe► Subscribe
Purdue Pharma Lp
BUTRANS
buprenorphine
FILM, EXTENDED RELEASE;TRANSDERMAL021306-003Jun 30, 2010► Subscribe► Subscribe
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Non-Orange Book Patents for Generic Ingredient: buprenorphine

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
5,968,547 Method of providing sustained analgesia with buprenorphine► Subscribe
6,344,212 Method of providing sustained analgesia with buprenorphine► Subscribe
6,231,886 Methods of providing sustained treatment with opioids► 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

Country Document Number Estimated Expiration
Norway322515► Subscribe
Norway20120563► Subscribe
Czech Republic9903009► Subscribe
Germany05011213► Subscribe
Hungary1200599► Subscribe
World Intellectual Property Organization (WIPO)9836728► Subscribe
Hungary0002342► Subscribe
Norway329734► Subscribe
Portugal1570823► Subscribe
Australia2004218685► 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:

Fuji
Baxter
QuintilesIMS
Merck
Express Scripts
Teva
Julphar
Chinese Patent Office
Daiichi Sankyo
Dow

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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