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Last Updated: May 19, 2022

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-two 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-two 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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: MAINTENANCE TREATMENT OF OPIOID DEPENDENCE

Abuse-resistant mucoadhesive devices for delivery of buprenorphine
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Abuse resistant transmucosal drug delivery device
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Transmucosal delivery devices with enhanced uptake
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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 See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Bdsi BUNAVAIL buprenorphine hydrochloride; naloxone hydrochloride FILM;BUCCAL 205637-002 Jun 6, 2014 DISCN Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Bdsi BUNAVAIL buprenorphine hydrochloride; naloxone hydrochloride FILM;BUCCAL 205637-001 Jun 6, 2014 DISCN Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Bdsi BUNAVAIL buprenorphine hydrochloride; naloxone hydrochloride FILM;BUCCAL 205637-003 Jun 6, 2014 DISCN Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
>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: See Plans and Pricing

Brazil

Patent: 0619806
Estimated Expiration: See Plans and Pricing

Canada

Patent: 29046
Estimated Expiration: See Plans and Pricing

China

Patent: 1330903
Estimated Expiration: See Plans and Pricing

European Patent Office

Patent: 68539
Estimated Expiration: See Plans and Pricing

Japan

Patent: 86151
Estimated Expiration: See Plans and Pricing

Patent: 09519347
Estimated Expiration: See Plans and Pricing

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
Hong Kong 1193566 吸收增強的經粘膜遞送裝置 (TRANSMUCOSAL DELIVERY DEVICES WITH ENHANCED UPTAKE) See Plans and Pricing
Mexico 2009000745 DISPOSITIVOS DE SUMINISTRO TRANSMUCOSA CON ADMISION MEJORADA. (TRANSMUCOSAL DELIVERY DEVICES WITH ENHANCED UPTAKE.) See Plans and Pricing
Denmark 0973497 See Plans and Pricing
European Patent Office 3067044 DISPOSITIFS D'ADMINISTRATION TRANSMUQUEUSE AVEC ABSORPTION ACCRUE (TRANSMUCOSAL DELIVERY DEVICES WITH ENHANCED UPTAKE) See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

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