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Last Updated: March 18, 2024

BUNAVAIL Drug Patent Profile


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When do Bunavail patents expire, and what generic alternatives are available?

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

This drug has eighty-three patent family members in twenty-six countries.

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

Paragraph IV (Patent) Challenges for BUNAVAIL
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
BUNAVAIL Buccal Film buprenorphine hydrochloride; naloxone hydrochloride 2.1 mg/0.3 mg and 4.2 mg/0.7 mg 205637 1 2016-11-23
BUNAVAIL Buccal Film buprenorphine hydrochloride; naloxone hydrochloride 6.3 mg/1 mg 205637 1 2015-12-21

US Patents and Regulatory Information for BUNAVAIL

BUNAVAIL is protected by four US patents.

Patents protecting BUNAVAIL

Transmucosal delivery devices with enhanced uptake
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: MAINTENANCE TREATMENT OF OPIOID DEPENDENCE

Abuse-resistant mucoadhesive devices for delivery of buprenorphine
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Abuse resistant transmucosal drug delivery device
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Transmucosal delivery devices with enhanced uptake
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF OPIOID DEPENDENCE

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

Expired US Patents for BUNAVAIL

International Patents for BUNAVAIL

When does loss-of-exclusivity occur for BUNAVAIL?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Australia

Patent: 06326377
Estimated Expiration: ⤷  Try a Trial

Brazil

Patent: 0619806
Estimated Expiration: ⤷  Try a Trial

Canada

Patent: 29046
Estimated Expiration: ⤷  Try a Trial

China

Patent: 1330903
Estimated Expiration: ⤷  Try a Trial

European Patent Office

Patent: 68539
Estimated Expiration: ⤷  Try a Trial

Japan

Patent: 86151
Estimated Expiration: ⤷  Try a Trial

Patent: 09519347
Estimated Expiration: ⤷  Try a Trial

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering BUNAVAIL around the world.

Country Patent Number Title Estimated Expiration
Japan 2019108362 ブプレノルフィンの乱用抵抗性粘膜付着性送達デバイス (ABUSE-RESISTANT MUCOADHESIVE DEVICES FOR DELIVERY OF BUPRENORPHINE) ⤷  Try a Trial
Eurasian Patent Organization 201991223 НЕ ВЫЗЫВАЮЩИЕ ЗАВИСИМОСТЬ МУКОАДГЕЗИВНЫЕ УСТРОЙСТВА ДЛЯ ДОСТАВКИ БУПРЕНОРФИНА ⤷  Try a Trial
Denmark 0973497 ⤷  Try a Trial
China 103889508 Abuse-resistant mucoadhesive devices for delivery of buprenorphine ⤷  Try a Trial
South Korea 101329496 ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

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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 verification 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.