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BUNAVAIL Drug Profile

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Which patents cover Bunavail, and what substitute generic drugs are available?

Bunavail is a drug marketed by Bdsi and is included in one NDA. There are five patents protecting this drug and one Paragraph IV challenge.

This drug has eighty-one patent family members in twenty-eight countries.

The generic ingredient in BUNAVAIL is buprenorphine hydrochloride; naloxone hydrochloride. There are twenty-eight drug master file entries for this compound. Twenty-one suppliers are listed for this compound. Additional details are available on the buprenorphine hydrochloride; naloxone hydrochloride profile page.

Summary for Tradename: BUNAVAIL

Patents:5
Applicants:1
NDAs:1
Suppliers / Packagers: see list1
Clinical Trials: see list1
Formulation / Manufacturing:see details
Drug Prices:see details
DailyMed Link:BUNAVAIL at DailyMed

Pharmacology for Tradename: BUNAVAIL

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Bdsi
BUNAVAIL
buprenorphine hydrochloride; naloxone hydrochloride
FILM;BUCCAL205637-001Jun 6, 2014RXYesNo8,147,866► SubscribeY ► Subscribe
Bdsi
BUNAVAIL
buprenorphine hydrochloride; naloxone hydrochloride
FILM;BUCCAL205637-003Jun 6, 2014RXYesYes► Subscribe► Subscribe
Bdsi
BUNAVAIL
buprenorphine hydrochloride; naloxone hydrochloride
FILM;BUCCAL205637-002Jun 6, 2014RXYesNo7,579,019► Subscribe ► Subscribe
Bdsi
BUNAVAIL
buprenorphine hydrochloride; naloxone hydrochloride
FILM;BUCCAL205637-001Jun 6, 2014RXYesNo8,703,177► SubscribeY ► Subscribe
Bdsi
BUNAVAIL
buprenorphine hydrochloride; naloxone hydrochloride
FILM;BUCCAL205637-002Jun 6, 2014RXYesNo► Subscribe► Subscribe
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Expired Patents for Tradename: BUNAVAIL

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;BUCCAL205637-002Jun 6, 20146,159,498► Subscribe
Bdsi
BUNAVAIL
buprenorphine hydrochloride; naloxone hydrochloride
FILM;BUCCAL205637-001Jun 6, 20146,159,498► Subscribe
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Paragraph IV activity for: BUNAVAIL

Drugname Dosage Strength RLD Submissiondate
buprenorphine and naloxoneBuccal Film6.3 mg/1 mgBunavail12/21/2015

Non-Orange Book Patents for Tradename: BUNAVAIL

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
5,800,832 Bioerodable film for delivery of pharmaceutical compounds to mucosal surfaces► 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 Tradename: BUNAVAIL

Country Document Number Estimated Expiration
New Zealand574361► Subscribe
Germany69923675► Subscribe
Mexico2009000745► Subscribe
European Patent Office2054031► Subscribe
Japan5586151► 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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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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