.

Pharmaceutical Business Intelligence

  • Analyze global market entry opportunities
  • Find generic sources and suppliers
  • Formulary management

► Plans and Pricing

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

How our clients use DrugPatentWatch

DrugPatentWatch Database Preview

Buprenorphine - Generic Drug Details

« Back to Dashboard

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

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, 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 nineteen patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Buprenorphine has sixty-seven patent family members in twenty countries.

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

Summary for Generic Name: buprenorphine

Tradenames:10
Patents:19
Applicants:19
NDAs:27
Drug Master File Entries: see list28
Suppliers / Packagers: see list3
Bulk Api Vendors: see list9
Clinical Trials: see list139
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 Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Orexo Us Inc
ZUBSOLV
buprenorphine hydrochloride; naloxone hydrochloride
TABLET;SUBLINGUAL204242-001Jul 3, 2013RXYesNo8,658,198► SubscribeY ► Subscribe
Orexo Us Inc
ZUBSOLV
buprenorphine hydrochloride; naloxone hydrochloride
TABLET;SUBLINGUAL204242-002Jul 3, 2013RXYesNo► Subscribe► Subscribe
Orexo Us Inc
ZUBSOLV
buprenorphine hydrochloride; naloxone hydrochloride
TABLET;SUBLINGUAL204242-006Oct 4, 2016RXYesNo8,940,330► SubscribeY ► Subscribe
Orexo Us Inc
ZUBSOLV
buprenorphine hydrochloride; naloxone hydrochloride
TABLET;SUBLINGUAL204242-001Jul 3, 2013RXYesNo8,940,330► SubscribeY ► Subscribe
Bdsi
BUNAVAIL
buprenorphine hydrochloride; naloxone hydrochloride
FILM;BUCCAL205637-001Jun 6, 2014RXYesNo► 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.

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, 20105,240,711► Subscribe
Purdue Pharma Lp
BUTRANS
buprenorphine
FILM, EXTENDED RELEASE;TRANSDERMAL021306-003Jun 30, 20106,344,211► Subscribe
Purdue Pharma Lp
BUTRANS
buprenorphine
FILM, EXTENDED RELEASE;TRANSDERMAL021306-001Jun 30, 20105,240,711► Subscribe
Purdue Pharma Lp
BUTRANS
buprenorphine
FILM, EXTENDED RELEASE;TRANSDERMAL021306-003Jun 30, 20106,264,980► Subscribe
Purdue Pharma Lp
BUTRANS
buprenorphine
FILM, EXTENDED RELEASE;TRANSDERMAL021306-005Jun 30, 20146,264,980► 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
6,231,886 Methods of providing sustained treatment with opioids► Subscribe
6,344,212 Method of providing sustained analgesia with buprenorphine► 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
Norway332248► Subscribe
Germany05011213► Subscribe
Japan2000511936► Subscribe
Australia743071► Subscribe
Portugal1731152► 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

How our clients use DrugPatentWatch

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.

`abc