Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Last Updated: December 14, 2019

DrugPatentWatch Database Preview

BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE - Generic Drug Details

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What are the generic drug 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, Lannett Co Inc, Specgx Llc, Sun Pharm, West-ward Pharms Int, and Orexo Us Inc, and is included in seventeen NDAs. There are eighteen 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 eighty-seven patent family members in forty-four countries.

There are twenty-nine drug master file entries for buprenorphine hydrochloride; naloxone hydrochloride. Twenty 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
Brown UniversityPhase 1
Public Health Management CorporationPhase 4
Philadelphia Department of Public HealthPhase 4

See all BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE clinical trials

Recent Litigation for BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE

Identify potential future generic entrants

District Court Litigation
Case NameDate
United States v. Indivior Inc.2019-04-09
Indivior Inc. v. Aveva Drug Delivery Systems, Inc.2019-03-22
BIODELIVERY SCIENCES INTERNATIONAL, INC. v. CHEMO RESEARCH, S.L.2019-03-15

See all BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE litigation

PTAB Litigation
PetitionerDate
Dr. Reddy's Laboratories S.A.2018-11-13
Dr. Reddy’s Laboratories S.A.2018-11-13
Dr. Reddy’s Laboratories, Inc.2017-06-12

See all BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE litigation

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
Orexo Us Inc ZUBSOLV buprenorphine hydrochloride; naloxone hydrochloride TABLET;SUBLINGUAL 204242-005 Jun 4, 2015 RX Yes No   Start Trial   Start Trial Y   Start Trial
Orexo Us Inc ZUBSOLV buprenorphine hydrochloride; naloxone hydrochloride TABLET;SUBLINGUAL 204242-005 Jun 4, 2015 RX Yes No   Start Trial   Start Trial Y   Start Trial
Teva Pharms Usa BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE buprenorphine hydrochloride; naloxone hydrochloride TABLET;SUBLINGUAL 091149-001 Sep 8, 2014 DISCN No No   Start Trial   Start Trial   Start Trial
Alvogen Pine Brook BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE buprenorphine hydrochloride; naloxone hydrochloride FILM;BUCCAL, SUBLINGUAL 205954-002 Jan 24, 2019 AB RX No No   Start Trial   Start Trial   Start Trial
Alvogen Pine Brook BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE buprenorphine hydrochloride; naloxone hydrochloride FILM;BUCCAL, SUBLINGUAL 205954-003 Jan 24, 2019 AB RX No No   Start Trial   Start Trial   Start Trial
Orexo Us Inc ZUBSOLV buprenorphine hydrochloride; naloxone hydrochloride TABLET;SUBLINGUAL 204242-005 Jun 4, 2015 RX Yes No   Start Trial   Start Trial Y   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

Supplementary Protection Certificates for BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2236132 92636 Luxembourg   Start Trial PRODUCT NAME: ZOLPIDEM ET SES SELS PHARMACEUTIQUEMENT ACCEPTABLES
2236132 122015000006 Germany   Start Trial PRODUCT NAME: ZOLPIDEM UND PHARMAZEUTISCH VERTRAEGLICHE SALZE DAVON; NAT. REGISTRATION NO/DATE: 83439.00.00 83440.00.00 20120725 FIRST REGISTRATION: BELGIEN BE424286 BE424295 20120718
2236132 484 Finland   Start Trial
2236132 300714 Netherlands   Start Trial PRODUCT NAME: ZOLPIDEM EN FARMACEUTISCH AANVAARDBARE ZOUTEN DAARVAN; NATIONAL REGISTRATION NO/DATE: RVG 108438 - 439 20160624; REGISTRATION NO/DATE: BE424286 20120718 BE424295 20120718
2236132 CA 2015 00004 Denmark   Start Trial PRODUCT NAME: ZOLPIDEM OG FARMACEUTISK ACCEPTABLE SALTE HERAF, HERUNDER ZOLPIDEMTARTRAT; NAT. REG. NO/DATE: 47607 OG 47608 20120719; FIRST REG. NO/DATE: (B BE424286 OG BE424295 20120718
2236132 C300714 Netherlands   Start Trial PRODUCT NAME: ZOLPIDEM EN FARMACEUTISCH AANVAARDBARE ZOUTEN DAARVAN; NAT. REGISTRATION NO/DATE: RVG 108438 - 439 20130624; FIRST REGISTRATION: BE424286BE424295 2012180718
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Baxter
Colorcon
Medtronic
Express Scripts
McKinsey
McKesson

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