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Generated: April 26, 2017

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Buprenorphine hydrochloride - Generic Drug Details

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

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

Buprenorphine hydrochloride has sixty-nine patent family members in twenty-six countries.

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

Summary for Generic Name: buprenorphine hydrochloride

Drug Master File Entries: see list28
Suppliers / Packagers: see list23
Bulk Api Vendors: see list21
Clinical Trials: see list1,116
Patent Applications: see list1,028
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 TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Sun Pharm Inds Ltd
buprenorphine hydrochloride
TABLET;SUBLINGUAL201760-001Jan 29, 2016ABRXNoNo► Subscribe► Subscribe
buprenorphine hydrochloride
FILM;BUCCAL207932-004Oct 23, 2015RXYesNo6,159,498► SubscribeY ► Subscribe
buprenorphine hydrochloride
FILM;BUCCAL207932-003Oct 23, 2015RXYesNo6,159,498► SubscribeY ► Subscribe
buprenorphine hydrochloride; naloxone hydrochloride
FILM;BUCCAL205637-002Jun 6, 2014RXYesNo6,159,498► SubscribeY ► Subscribe
buprenorphine hydrochloride
FILM;BUCCAL207932-002Oct 23, 2015RXYesNo7,579,019► Subscribe ► Subscribe
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