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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Serving leading biopharmaceutical companies globally:

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Mallinckrodt

Last Updated: November 15, 2019

DrugPatentWatch Database Preview

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 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-three 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
University of PennsylvaniaPhase 4
Prevention Point PhiladelphiaPhase 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
Indivior Inc SUBOXONE buprenorphine hydrochloride; naloxone hydrochloride FILM;BUCCAL, SUBLINGUAL 022410-001 Aug 30, 2010 AB RX Yes No   Start Trial   Start Trial Y   Start Trial
Orexo Us Inc ZUBSOLV buprenorphine hydrochloride; naloxone hydrochloride TABLET;SUBLINGUAL 204242-006 Oct 4, 2016 RX Yes No   Start Trial   Start Trial Y   Start Trial
Dr Reddys Labs Sa BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE buprenorphine hydrochloride; naloxone hydrochloride FILM;BUCCAL, SUBLINGUAL 205299-001 Jun 14, 2018 AB RX No No   Start Trial   Start Trial   Start Trial
Bdsi BUNAVAIL buprenorphine hydrochloride; naloxone hydrochloride FILM;BUCCAL 205637-001 Jun 6, 2014 RX Yes No   Start Trial   Start Trial Y   Start Trial
Indivior Inc SUBOXONE buprenorphine hydrochloride; naloxone hydrochloride FILM;BUCCAL, SUBLINGUAL 022410-001 Aug 30, 2010 AB 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 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 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 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 484 Finland   Start Trial
2236132 92636 Luxembourg   Start Trial PRODUCT NAME: ZOLPIDEM ET SES SELS PHARMACEUTIQUEMENT ACCEPTABLES
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Johnson and Johnson
Express Scripts
Medtronic
Harvard Business School
McKinsey
Mallinckrodt

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.