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Serving leading biopharmaceutical companies globally:

Teva
McKesson
Healthtrust
US Department of Justice
Federal Trade Commission
Boehringer Ingelheim
Covington
Cipla
Colorcon
AstraZeneca

Generated: January 23, 2018

DrugPatentWatch Database Preview

BUNAVAIL Drug Profile

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Which patents cover Bunavail, and what generic alternatives are available?

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

This drug has ninety-four patent family members in twenty-nine countries.

The generic ingredient in BUNAVAIL is buprenorphine hydrochloride; naloxone hydrochloride. There are twenty-nine 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 BUNAVAIL
International Patents:94
US Patents:6
Applicants:1
NDAs:1
Suppliers / Packagers: 1
Clinical Trials: 1
Formulation / Manufacturing:see details
Drug Prices:see details
DailyMed Link:BUNAVAIL at DailyMed
Drug patent expirations by year for BUNAVAIL
Pharmacology for BUNAVAIL

US Patents and Regulatory Information for BUNAVAIL

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Bdsi BUNAVAIL buprenorphine hydrochloride; naloxone hydrochloride FILM;BUCCAL 205637-001 Jun 6, 2014 RX Yes No ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Bdsi BUNAVAIL buprenorphine hydrochloride; naloxone hydrochloride FILM;BUCCAL 205637-003 Jun 6, 2014 RX Yes Yes ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Bdsi BUNAVAIL buprenorphine hydrochloride; naloxone hydrochloride FILM;BUCCAL 205637-001 Jun 6, 2014 RX Yes No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Bdsi BUNAVAIL buprenorphine hydrochloride; naloxone hydrochloride FILM;BUCCAL 205637-001 Jun 6, 2014 RX Yes No ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Bdsi BUNAVAIL buprenorphine hydrochloride; naloxone hydrochloride FILM;BUCCAL 205637-002 Jun 6, 2014 RX Yes No ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Bdsi BUNAVAIL buprenorphine hydrochloride; naloxone hydrochloride FILM;BUCCAL 205637-003 Jun 6, 2014 RX Yes Yes ➤ Subscribe ➤ Subscribe ➤ Subscribe
Bdsi BUNAVAIL buprenorphine hydrochloride; naloxone hydrochloride FILM;BUCCAL 205637-002 Jun 6, 2014 RX Yes No ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Bdsi BUNAVAIL buprenorphine hydrochloride; naloxone hydrochloride FILM;BUCCAL 205637-003 Jun 6, 2014 RX Yes Yes ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Bdsi BUNAVAIL buprenorphine hydrochloride; naloxone hydrochloride FILM;BUCCAL 205637-003 Jun 6, 2014 RX Yes Yes ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Bdsi BUNAVAIL buprenorphine hydrochloride; naloxone hydrochloride FILM;BUCCAL 205637-002 Jun 6, 2014 RX Yes No ➤ Subscribe ➤ Subscribe ➤ Subscribe
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 BUNAVAIL

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

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Paragraph IV (Patent) Challenges for BUNAVAIL
Drugname Dosage Strength RLD Submissiondate
➤ Subscribe Buccal Film 2.1mg/0.3 mg and 4.2 mg/0.7 mg ➤ Subscribe 11/23/2016
➤ Subscribe Buccal Film 6.3 mg/1 mg ➤ Subscribe 12/21/2015

Non-Orange Book US Patents for 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
9,597,288 Transmucosal delivery devices with enhanced uptake ➤ Subscribe
Patent No. Title Estimated Patent Expiration

This preview shows a limited data set. Subscribe for full access, or try a Free Trial

International Patents for BUNAVAIL

For more information try a trial or see the plans and pricing

Serving leading biopharmaceutical companies globally:

Healthtrust
Moodys
Johnson and Johnson
Chinese Patent Office
US Department of Justice
McKinsey
Cerilliant
Covington
Baxter

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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