➤ Get the DrugPatentWatch Daily Briefing

Get Daily Updates on Generic Entry, Litigation, Biosimilars, and more …

Serving leading biopharmaceutical companies globally:

Merck
Express Scripts
Colorcon
McKinsey
McKesson
Dow

Last Updated: July 5, 2020

DrugPatentWatch Database Preview

Buprenorphine hydrochloride; naloxone hydrochloride - Generic Drug Details

» See Plans and Pricing

« Back to Dashboard

What are the generic sources for buprenorphine hydrochloride; naloxone hydrochloride and what is the scope of freedom to operate?

Buprenorphine hydrochloride; naloxone hydrochloride is the generic ingredient in five branded drugs marketed by Bdsi, Alvogen Pine Brook, Dr Reddys Labs Sa, Mylan Technologies, Indivior Inc, Teva Pharms Usa, Actavis Elizabeth, Amneal Pharms, Ethypharm Usa Corp, Hikma, Lannett Co Inc, Rhodes Pharms, Specgx Llc, Sun Pharm, and Orexo Us Inc, and is included in nineteen NDAs. There are seventeen patents protecting this compound and nine Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Buprenorphine hydrochloride; naloxone hydrochloride has three hundred and forty-seven patent family members in thirty-seven countries.

There are twenty-nine drug master file entries for buprenorphine hydrochloride; naloxone hydrochloride. Eighteen suppliers are listed for this compound. There is one tentative approval for this compound.

Recent Clinical Trials for buprenorphine hydrochloride; naloxone hydrochloride

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
NYU Langone HealthPhase 4
Emergency Medicine FoundationPhase 4
Ohio State UniversityPhase 4

See all buprenorphine hydrochloride; naloxone hydrochloride clinical trials

Generic filers with tentative approvals for BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE
Applicant Application No. Strength Dosage Form
  Start Trial  Start TrialEQ 8MG BASE;EQ 2MG BASEFILM;BUCCAL, SUBLINGUAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for buprenorphine hydrochloride; naloxone hydrochloride
Paragraph IV (Patent) Challenges for BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE

US Patents and Regulatory Information for 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
Bdsi BUNAVAIL buprenorphine hydrochloride; naloxone hydrochloride FILM;BUCCAL 205637-003 Jun 6, 2014 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Ethypharm Usa Corp BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE buprenorphine hydrochloride; naloxone hydrochloride TABLET;SUBLINGUAL 204431-002 Oct 16, 2015 AB RX No No   Start Trial   Start Trial   Start Trial
Indivior Inc SUBOXONE buprenorphine hydrochloride; naloxone hydrochloride FILM;BUCCAL, SUBLINGUAL 022410-003 Aug 10, 2012 AB RX Yes No   Start Trial   Start Trial Y   Start Trial
Mylan Technologies BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE buprenorphine hydrochloride; naloxone hydrochloride FILM;BUCCAL, SUBLINGUAL 211785-001 Apr 17, 2020 AB RX No No   Start Trial   Start Trial   Start Trial
Amneal Pharms BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE buprenorphine hydrochloride; naloxone hydrochloride TABLET;SUBLINGUAL 203136-002 Feb 22, 2013 AB RX No No   Start Trial   Start Trial   Start Trial
Dr Reddys Labs Sa BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE buprenorphine hydrochloride; naloxone hydrochloride FILM;BUCCAL, SUBLINGUAL 205299-002 Jun 14, 2018 AB RX No No   Start Trial   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for buprenorphine hydrochloride; naloxone hydrochloride

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

Merck
Express Scripts
Colorcon
McKinsey
McKesson
Dow

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 verification 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.