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Serving 500+ biopharmaceutical companies globally:

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Generated: June 23, 2017

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 Indivior Inc, Actavis Elizabeth, Kremers Urban Pharms, West-ward Pharms Int, Ethypharm Usa Corp, Sun Pharm Inds Ltd, Amneal Pharms, Bdsi, Orexo Us Inc, and Teva Pharms Usa, and is included in eleven NDAs. There are sixteen patents protecting this compound and seven Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

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

There are twenty-eight drug master file entries for buprenorphine hydrochloride; naloxone hydrochloride. Twenty-one suppliers are listed for this compound.

Summary for Generic Name: buprenorphine hydrochloride; naloxone hydrochloride

Tradenames:4
Patents:16
Applicants:10
NDAs:11
Drug Master File Entries: see list28
Suppliers / Packagers: see list21
Clinical Trials: see list2,686
Drug Prices:see low prices
DailyMed Link:buprenorphine hydrochloride; naloxone hydrochloride at DailyMed

Pharmacology for Ingredient: 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
Orexo Us Inc
ZUBSOLV
buprenorphine hydrochloride; naloxone hydrochloride
TABLET;SUBLINGUAL204242-006Oct 4, 2016RXYesNo8,658,198► SubscribeY ► Subscribe
Orexo Us Inc
ZUBSOLV
buprenorphine hydrochloride; naloxone hydrochloride
TABLET;SUBLINGUAL204242-004Dec 11, 2014RXYesYes8,470,361► SubscribeY ► Subscribe
Orexo Us Inc
ZUBSOLV
buprenorphine hydrochloride; naloxone hydrochloride
TABLET;SUBLINGUAL204242-004Dec 11, 2014RXYesYes8,940,330► SubscribeY ► Subscribe
Orexo Us Inc
ZUBSOLV
buprenorphine hydrochloride; naloxone hydrochloride
TABLET;SUBLINGUAL204242-001Jul 3, 2013RXYesNo9,439,900► SubscribeY ► Subscribe
Bdsi
BUNAVAIL
buprenorphine hydrochloride; naloxone hydrochloride
FILM;BUCCAL205637-001Jun 6, 2014RXYesNo9,655,843► SubscribeY ► Subscribe
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Expired Orange Book Patents for Generic Ingredient: buprenorphine hydrochloride; naloxone hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Bdsi
BUNAVAIL
buprenorphine hydrochloride; naloxone hydrochloride
FILM;BUCCAL205637-003Jun 6, 20146,159,498► Subscribe
Bdsi
BUNAVAIL
buprenorphine hydrochloride; naloxone hydrochloride
FILM;BUCCAL205637-001Jun 6, 20146,159,498► Subscribe
Bdsi
BUNAVAIL
buprenorphine hydrochloride; naloxone hydrochloride
FILM;BUCCAL205637-002Jun 6, 20146,159,498► Subscribe
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Non-Orange Book Patents for Generic Ingredient: 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
7,666,337Polyethylene oxide-based films and drug delivery systems made therefrom► Subscribe
8,906,277Process for manufacturing a resulting pharmaceutical film► Subscribe
7,897,080Polyethylene-oxide based films and drug delivery systems made therefrom► Subscribe
7,910,031Process for forming an ingestible thin film with non-self-aggregating uniform heterogeneity► Subscribe
2,016,206,639► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.

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International Patent Family for Ingredient: buprenorphine hydrochloride; naloxone hydrochloride

Country Document Number Estimated Expiration
World Intellectual Property Organization (WIPO)2007067494► Subscribe
Japan2011050394► Subscribe
New Zealand594545► Subscribe
China101346135► Subscribe
Bulgaria65502► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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Supplementary Protection Certificates for Tradename: BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2015000006Germany► SubscribePRODUCT NAME: ZOLPIDEM UND PHARMAZEUTISCH VERTRAEGLICHE SALZE DAVON; NAT. REGISTRATION NO/DATE: 83439.00.00 83440.00.00 20120725 FIRST REGISTRATION: BELGIEN BE424286 BE424295 20120718
00714Netherlands► SubscribePRODUCT NAME: ZOLPIDEM EN FARMACEUTISCH AANVAARDBARE ZOUTEN DAARVAN; NAT. REGISTRATION NO/DATE: RVG 108438 - 439 20130624; FIRST REGISTRATION: BE424286BE424295 2012180718
636Luxembourg► SubscribePRODUCT NAME: ZOLPIDEM ET SES SELS PHARMACEUTIQUEMENT ACCEPTABLES
4Finland► Subscribe
2015 00004Denmark► SubscribePRODUCT 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
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For more information try a trial or see the database preview and plans and pricing

Serving 500+ biopharmaceutical companies globally:

AstraZeneca
Accenture
Healthtrust
McKinsey
Julphar
Colorcon
QuintilesIMS
Medtronic
Boehringer Ingelheim
Covington

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.

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