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Buprenorphine hydrochloride; naloxone hydrochloride - Generic Drug Details

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Buprenorphine hydrochloride; naloxone hydrochloride is the generic ingredient in four branded drugs marketed by Indivior Inc, Actavis Elizabeth, Kremers Urban Pharms, Roxane, Ethypharm Usa Corp, Sun Pharm Inds Ltd, Amneal Pharms, Biodelivery Sci Intl, Orexo Us Inc, and Teva Pharms Usa, and is included in eleven NDAs. There are thirteen patents protecting this compound and seven Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

This ingredient has two hundred and seventy-seven patent family members in forty-three countries.

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

Summary for Generic Name: buprenorphine hydrochloride; naloxone hydrochloride

Tradenames:4
Patents:13
Applicants:10
NDAs:11
Drug Master File Entries: see list28
Suppliers / Packaging: see list19
Formulation / Manufacturing:see details
Drug Prices:see low prices

Pharmacology for Ingredient: buprenorphine hydrochloride; naloxone hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Amneal Pharms
BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE
buprenorphine hydrochloride; naloxone hydrochloride
TABLET;SUBLINGUAL203136-001Feb 22, 2013RXNo► subscribe► subscribe
Biodelivery Sci Intl
BUNAVAIL
buprenorphine hydrochloride; naloxone hydrochloride
FILM;BUCCAL205637-002Jun 6, 2014RXNo8,703,177► subscribeY ► subscribe
Orexo Us Inc
ZUBSOLV
buprenorphine hydrochloride; naloxone hydrochloride
TABLET;SUBLINGUAL204242-005Jun 4, 2015RXNo8,658,198► 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
Biodelivery Sci Intl
BUNAVAIL
buprenorphine hydrochloride; naloxone hydrochloride
FILM;BUCCAL205637-001Jun 6, 20146,159,498► subscribe
Biodelivery Sci Intl
BUNAVAIL
buprenorphine hydrochloride; naloxone hydrochloride
FILM;BUCCAL205637-003Jun 6, 20146,159,498► subscribe
Biodelivery Sci Intl
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
7,910,031Process for forming an ingestible thin film with non-self-aggregating uniform heterogeneity► subscribe
7,425,292Thin film with non-self-aggregating uniform heterogeneity and drug delivery systems made therefrom► subscribe
8,906,277Process for manufacturing a resulting pharmaceutical film► 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
South Korea20140075682► subscribe
Peru11982014► subscribe
Australia2006322050► 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
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
636Luxembourg► subscribePRODUCT NAME: ZOLPIDEM ET SES SELS PHARMACEUTIQUEMENT ACCEPTABLES
00714Netherlands► subscribePRODUCT NAME: ZOLPIDEM EN FARMACEUTISCH AANVAARDBARE ZOUTEN DAARVAN; NAT. REGISTRATION NO/DATE: RVG 108438 - 439 20130624; FIRST REGISTRATION: BE424286BE424295 2012180718
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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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