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Mallinckrodt
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Daiichi Sankyo
Accenture
McKesson
Cantor Fitzgerald
Citi
Deloitte
Farmers Insurance

Generated: July 18, 2018

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 buprenorphine hydrochloride; naloxone hydrochloride patent protection?

Buprenorphine hydrochloride; naloxone hydrochloride
is the generic ingredient in four branded drugs marketed by Bdsi, Dr Reddys Labs Sa, Mylan Technologies, Indivior Inc, Actavis Elizabeth, Amneal Pharms, Ethypharm Usa Corp, Lannett Co Inc, Specgx Llc, Sun Pharm Inds Ltd, Teva Pharms Usa, West-ward Pharms Int, and Orexo Us Inc, and is included in fifteen 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-five patent family members in forty-three countries.

There are twenty-nine drug master file entries for buprenorphine hydrochloride; naloxone hydrochloride. Twenty-three suppliers are listed for this compound.
Pharmacology 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 ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Sun Pharm Inds Ltd BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE buprenorphine hydrochloride; naloxone hydrochloride TABLET;SUBLINGUAL 201633-002 Aug 5, 2016 AB RX No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
West-ward Pharms Int BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE buprenorphine hydrochloride; naloxone hydrochloride TABLET;SUBLINGUAL 203326-002 Jun 27, 2014 AB RX No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Indivior Inc SUBOXONE buprenorphine hydrochloride; naloxone hydrochloride FILM;BUCCAL, SUBLINGUAL 022410-003 Aug 10, 2012 AB RX Yes No ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

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Expired US Patents for buprenorphine hydrochloride; naloxone hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Bdsi BUNAVAIL buprenorphine hydrochloride; naloxone hydrochloride FILM;BUCCAL 205637-002 Jun 6, 2014 ➤ Try a Free Trial ➤ Try a Free Trial
Bdsi BUNAVAIL buprenorphine hydrochloride; naloxone hydrochloride FILM;BUCCAL 205637-001 Jun 6, 2014 ➤ Try a Free Trial ➤ Try a Free Trial
Bdsi BUNAVAIL buprenorphine hydrochloride; naloxone hydrochloride FILM;BUCCAL 205637-003 Jun 6, 2014 ➤ Try a Free Trial ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Non-Orange Book US Patents for buprenorphine hydrochloride; naloxone hydrochloride

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
9,597,288 Transmucosal delivery devices with enhanced uptake ➤ Try a Free Trial
5,800,832 Bioerodable film for delivery of pharmaceutical compounds to mucosal surfaces ➤ Try a Free Trial
6,159,498 Bioerodable film for delivery of pharmaceutical compounds of mucosal surfaces ➤ Try a Free Trial
2,016,206,639 ➤ Try a Free Trial
Patent No. Title Estimated Patent Expiration

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Supplementary Protection Certificates for buprenorphine hydrochloride; naloxone hydrochloride

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
636 Luxembourg ➤ Try a Free Trial PRODUCT NAME: ZOLPIDEM ET SES SELS PHARMACEUTIQUEMENT ACCEPTABLES
2015 00004 Denmark ➤ Try a Free 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
2015000006 Germany ➤ Try a Free 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
4 Finland ➤ Try a Free Trial
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

QuintilesIMS
Cipla
Medtronic
Julphar
Deloitte
Farmers Insurance
Dow
Citi
Chinese Patent Office

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.