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Generated: May 29, 2017

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

Buprenorphine has sixty-nine 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:20
Applicants:20
NDAs:28
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 TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Bdsi
BUNAVAIL
buprenorphine hydrochloride; naloxone hydrochloride
FILM;BUCCAL205637-003Jun 6, 2014RXYesYes8,147,866► SubscribeY ► Subscribe
Orexo Us Inc
ZUBSOLV
buprenorphine hydrochloride; naloxone hydrochloride
TABLET;SUBLINGUAL204242-004Dec 11, 2014RXYesYes9,439,900► SubscribeY ► Subscribe
Indivior Inc
SUBOXONE
buprenorphine hydrochloride; naloxone hydrochloride
FILM;BUCCAL, SUBLINGUAL022410-002Aug 30, 2010RXYesNo8,475,832► SubscribeY ► Subscribe
Bdsi
BELBUCA
buprenorphine hydrochloride
FILM;BUCCAL207932-001Oct 23, 2015RXYesNo8,147,866► SubscribeY ► Subscribe
Purdue Pharma Lp
BUTRANS
buprenorphine
FILM, EXTENDED RELEASE;TRANSDERMAL021306-005Jun 30, 2014RXYesNoRE41408► Subscribe ► Subscribe
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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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