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Serving hundreds of leading biopharmaceutical companies globally:

Johnson and Johnson
Moodys
Deloitte
QuintilesIMS
Healthtrust
Colorcon
Julphar
Medtronic
Accenture

Generated: September 23, 2018

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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 buprenorphine hydrochloride; naloxone hydrochloride freedom to operate?

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.

There are twenty-nine drug master file entries for buprenorphine hydrochloride; naloxone hydrochloride. Twenty-two 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
Mylan Technologies BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE buprenorphine hydrochloride; naloxone hydrochloride FILM;BUCCAL, SUBLINGUAL 207607-002 Jun 14, 2018 AB RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Orexo Us Inc ZUBSOLV buprenorphine hydrochloride; naloxone hydrochloride TABLET;SUBLINGUAL 204242-002 Jul 3, 2013 RX Yes No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Indivior Inc SUBOXONE buprenorphine hydrochloride; naloxone hydrochloride TABLET;SUBLINGUAL 020733-002 Oct 8, 2002 DISCN Yes No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Orexo Us Inc ZUBSOLV buprenorphine hydrochloride; naloxone hydrochloride TABLET;SUBLINGUAL 204242-004 Dec 11, 2014 RX Yes Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
Orexo Us Inc ZUBSOLV buprenorphine hydrochloride; naloxone hydrochloride TABLET;SUBLINGUAL 204242-004 Dec 11, 2014 RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Mylan Technologies BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE buprenorphine hydrochloride; naloxone hydrochloride FILM;BUCCAL, SUBLINGUAL 207607-001 Jun 14, 2018 AB RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
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 205637-003 Jun 6, 2014 ➤ Sign Up ➤ Sign Up
Bdsi BUNAVAIL buprenorphine hydrochloride; naloxone hydrochloride FILM;BUCCAL 205637-001 Jun 6, 2014 ➤ Sign Up ➤ Sign Up
Bdsi BUNAVAIL buprenorphine hydrochloride; naloxone hydrochloride FILM;BUCCAL 205637-002 Jun 6, 2014 ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Supplementary Protection Certificates for buprenorphine hydrochloride; naloxone hydrochloride

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2015 00004 Denmark ➤ Sign Up 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
4 Finland ➤ Sign Up
0714 Netherlands ➤ Sign Up PRODUCT NAME: ZOLPIDEM EN FARMACEUTISCH AANVAARDBARE ZOUTEN DAARVAN; NATIONAL REGISTRATION NO/DATE: RVG 108438 - 439 20160624; REGISTRATION NO/DATE: BE424286 20120718 BE424295 20120718
00714 Netherlands ➤ Sign Up PRODUCT NAME: ZOLPIDEM EN FARMACEUTISCH AANVAARDBARE ZOUTEN DAARVAN; NAT. REGISTRATION NO/DATE: RVG 108438 - 439 20130624; FIRST REGISTRATION: BE424286BE424295 2012180718
2015000006 Germany ➤ Sign Up 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
636 Luxembourg ➤ Sign Up PRODUCT NAME: ZOLPIDEM ET SES SELS PHARMACEUTIQUEMENT ACCEPTABLES
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Johnson and Johnson
Moodys
Deloitte
QuintilesIMS
Healthtrust
Colorcon
Julphar
Medtronic
Accenture

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.