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Generated: April 27, 2017

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Buprenorphine hydrochloride; naloxone hydrochloride - Generic Drug Details

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

Buprenorphine hydrochloride; naloxone hydrochloride
is the generic ingredient in four branded drugs marketed by Indivior Inc, Actavis Elizabeth, Kremers Urban Pharms, West-ward Pharms Int, Ethypharm Usa Corp, Sun Pharm Inds Ltd, Amneal Pharms, Bdsi, Orexo Us Inc, and Teva Pharms Usa, and is included in eleven NDAs. There are fifteen patents protecting this compound and seven Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Buprenorphine hydrochloride; naloxone hydrochloride has two hundred and ninety-five patent family members in forty-three countries.

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

Summary for Generic Name: buprenorphine hydrochloride; naloxone hydrochloride

Drug Master File Entries: see list28
Suppliers / Packagers: see list22
Clinical Trials: see list1,162
Drug Prices:see low prices
DailyMed Link:buprenorphine hydrochloride; naloxone hydrochloride at DailyMed

Pharmacology for Ingredient: buprenorphine hydrochloride; naloxone hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Orexo Us Inc
buprenorphine hydrochloride; naloxone hydrochloride
TABLET;SUBLINGUAL204242-005Jun 4, 2015RXYesNo► Subscribe► Subscribe
Orexo Us Inc
buprenorphine hydrochloride; naloxone hydrochloride
TABLET;SUBLINGUAL204242-006Oct 4, 2016RXYesNo9,259,421► SubscribeY ► Subscribe
Orexo Us Inc
buprenorphine hydrochloride; naloxone hydrochloride
TABLET;SUBLINGUAL204242-002Jul 3, 2013RXYesNo9,259,421► SubscribeY ► Subscribe
buprenorphine hydrochloride; naloxone hydrochloride
FILM;BUCCAL205637-001Jun 6, 2014RXYesNo7,579,019► Subscribe ► Subscribe
Orexo Us Inc
buprenorphine hydrochloride; naloxone hydrochloride
TABLET;SUBLINGUAL204242-003Dec 11, 2014RXYesNo8,940,330► SubscribeY ► Subscribe
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  • Formulary management
  • Identify first generic entrants
  • Obtain formulation and manufacturing information

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