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Last Updated: July 19, 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-three suppliers are listed for this compound. Additional details are available on the buprenorphine hydrochloride; naloxone hydrochloride profile page.

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Drug patent expirations by year for BUNAVAIL
Drug Prices for BUNAVAIL

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Recent Clinical Trials for BUNAVAIL

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Indivior Inc.Phase 4
BioDelivery Sciences InternationalPhase 3

See all BUNAVAIL clinical trials

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: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: MAINTENANCE TREATMENT OF OPIOID DEPENDENCE

Abuse-resistant mucoadhesive devices for delivery of buprenorphine
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Abuse resistant transmucosal drug delivery device
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Transmucosal delivery devices with enhanced uptake
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
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 ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Bdsi BUNAVAIL buprenorphine hydrochloride; naloxone hydrochloride FILM;BUCCAL 205637-002 Jun 6, 2014 DISCN Yes No ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Bdsi BUNAVAIL buprenorphine hydrochloride; naloxone hydrochloride FILM;BUCCAL 205637-001 Jun 6, 2014 DISCN Yes No ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
>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

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

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
Patent: Abuse resistant transmucosal drug delivery device
Estimated Expiration: ⤷  Sign Up

Brazil

Patent: 0619806
Patent: dispositivo para fornecimento de fármacos transmucosal resistente ao abuso
Estimated Expiration: ⤷  Sign Up

Canada

Patent: 29046
Patent: DISPOSITIF RESISTANT AUX ABUS POUR L'ADMINISTRATION TRANSMUCOSALE DE MEDICAMENTS (ABUSE RESISTANT TRANSMUCOSAL DRUG DELIVERY DEVICE)
Estimated Expiration: ⤷  Sign Up

China

Patent: 1330903
Patent: Abuse resistant transmucosal drug delivery device
Estimated Expiration: ⤷  Sign Up

European Patent Office

Patent: 68539
Patent: DISPOSITIF RESISTANT AUX ABUS POUR L'ADMINISTRATION TRANSMUCOSALE DE MEDICAMENTS (ABUSE RESISTANT TRANSMUCOSAL DRUG DELIVERY DEVICE)
Estimated Expiration: ⤷  Sign Up

Japan

Patent: 86151
Estimated Expiration: ⤷  Sign Up

Patent: 09519347
Estimated Expiration: ⤷  Sign Up

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
Australia 2006326377 Abuse resistant transmucosal drug delivery device ⤷  Sign Up
Australia 3967899 ⤷  Sign Up
Norway 344719 ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

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