.

Deeper Knowledge, Faster

  • Find suppliers and generic API sources
  • Predict branded drug patent expiration
  • Uncover prior art in expired and abandoned patents

► See Plans & Pricing

Upgrade to enjoy subscriber-only features like email alerts and data export. See the Plans and Pricing

Serving 500+ biopharmaceutical companies globally:

Queensland Health
Argus Health
AstraZeneca
Daiichi Sankyo
Dow
Teva
Medtronic
Accenture
Cantor Fitzgerald
Federal Trade Commission

Generated: July 24, 2017

DrugPatentWatch Database Preview

Buprenorphine - Generic Drug Details

« Back to Dashboard

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 list341
Patent Applications: see list12,948
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
Indivior Inc
SUBOXONE
buprenorphine hydrochloride; naloxone hydrochloride
FILM;BUCCAL, SUBLINGUAL022410-002Aug 30, 2010RXYesNo► Subscribe► SubscribeY ► Subscribe
Orexo Us Inc
ZUBSOLV
buprenorphine hydrochloride; naloxone hydrochloride
TABLET;SUBLINGUAL204242-002Jul 3, 2013RXYesNo► Subscribe► SubscribeY ► Subscribe
Bdsi
BELBUCA
buprenorphine hydrochloride
FILM;BUCCAL207932-004Oct 23, 2015RXYesNo► Subscribe► Subscribe► Subscribe
Bdsi
BUNAVAIL
buprenorphine hydrochloride; naloxone hydrochloride
FILM;BUCCAL205637-003Jun 6, 2014RXYesYes► Subscribe► SubscribeY ► Subscribe
Bdsi
BUNAVAIL
buprenorphine hydrochloride; naloxone hydrochloride
FILM;BUCCAL205637-002Jun 6, 2014RXYesNo► Subscribe► SubscribeY ► Subscribe
This preview shows a limited data set
Subscribe for full access, or try a Trial

Export unavailable in trial.
Subscribe for complete access.

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;TRANSDERMAL021306-005Jun 30, 2014► Subscribe► Subscribe
Purdue Pharma Lp
BUTRANS
buprenorphine
FILM, EXTENDED RELEASE;TRANSDERMAL021306-003Jun 30, 2010► Subscribe► Subscribe
Purdue Pharma Lp
BUTRANS
buprenorphine
FILM, EXTENDED RELEASE;TRANSDERMAL021306-005Jun 30, 2014► Subscribe► Subscribe
Purdue Pharma Lp
BUTRANS
buprenorphine
FILM, EXTENDED RELEASE;TRANSDERMAL021306-001Jun 30, 2010► Subscribe► Subscribe
Purdue Pharma Lp
BUTRANS
buprenorphine
FILM, EXTENDED RELEASE;TRANSDERMAL021306-002Jun 30, 2010► Subscribe► Subscribe
This preview shows a limited data set
Subscribe for full access, or try a Trial

Export unavailable in trial.
Subscribe for complete access.

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
This preview shows a limited data set
Subscribe for full access, or try a Trial

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.

Export unavailable in trial.
Subscribe for complete access.

International Patent Family for Ingredient: buprenorphine

Country Document Number Estimated Expiration
Israel201437► Subscribe
Czech Republic20150477► Subscribe
HungaryP1500370► Subscribe
European Patent Office2301494► Subscribe
Portugal964677► Subscribe
This preview shows a limited data set
Subscribe for full access, or try a Trial

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.

Export unavailable in trial.
Subscribe for complete access.

« Back to Dashboard

For more information try a trial or see the database preview and plans and pricing

Serving 500+ biopharmaceutical companies globally:

Farmers Insurance
McKesson
Fuji
Medtronic
Boehringer Ingelheim
Cerilliant
UBS
QuintilesIMS
Baxter
Argus Health

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.

Copyright 2002-2017 thinkBiotech LLC
ISSN: 2162-2639

Secure SSL Encrypted Heap | Mobile and Web Analytics

Follow DrugPatentWatch:



Google
Twitter
Google Plus
botpot