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Last Updated: July 18, 2024

BELBUCA Drug Patent Profile


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Which patents cover Belbuca, and when can generic versions of Belbuca launch?

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

This drug has seventy-six patent family members in twenty-seven countries.

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

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Drug patent expirations by year for BELBUCA
Drug Prices for BELBUCA

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Recent Clinical Trials for BELBUCA

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

SponsorPhase
Carolinas Pain InstitutePhase 4
BioDelivery Sciences InternationalPhase 4
Medical College of WisconsinPhase 2

See all BELBUCA clinical trials

Pharmacology for BELBUCA
Drug ClassPartial Opioid Agonist
Mechanism of ActionPartial Opioid Agonists
Paragraph IV (Patent) Challenges for BELBUCA
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
BELBUCA Buccal Film buprenorphine hydrochloride 75 mcg and 150 mcg 207932 1 2016-10-24
BELBUCA Buccal Film buprenorphine hydrochloride 300 mcg, 450 mcg, 600 mcg and 750 mcg 207932 1 2016-10-04
BELBUCA Buccal Film buprenorphine hydrochloride 900 mcg 207932 1 2016-09-12

US Patents and Regulatory Information for BELBUCA

BELBUCA is protected by three US patents.

Patents protecting BELBUCA

Transmucosal delivery devices with enhanced uptake
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: TREATMENT OF PAIN BY TRANSMUCOSAL DELIVERY OF BUPRENORPHINE

Transmucosal delivery devices with enhanced uptake
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE

Transmucosal drug delivery devices for use in chronic pain relief
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Bdsi BELBUCA buprenorphine hydrochloride FILM;BUCCAL 207932-001 Oct 23, 2015 RX Yes No ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Bdsi BELBUCA buprenorphine hydrochloride FILM;BUCCAL 207932-006 Oct 23, 2015 RX Yes No ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Bdsi BELBUCA buprenorphine hydrochloride FILM;BUCCAL 207932-003 Oct 23, 2015 RX Yes No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Bdsi BELBUCA buprenorphine hydrochloride FILM;BUCCAL 207932-002 Oct 23, 2015 RX Yes No ⤷  Sign Up ⤷  Sign Up ⤷  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 BELBUCA

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Bdsi BELBUCA buprenorphine hydrochloride FILM;BUCCAL 207932-004 Oct 23, 2015 ⤷  Sign Up ⤷  Sign Up
Bdsi BELBUCA buprenorphine hydrochloride FILM;BUCCAL 207932-007 Oct 23, 2015 ⤷  Sign Up ⤷  Sign Up
Bdsi BELBUCA buprenorphine hydrochloride FILM;BUCCAL 207932-004 Oct 23, 2015 ⤷  Sign Up ⤷  Sign Up
Bdsi BELBUCA buprenorphine hydrochloride FILM;BUCCAL 207932-001 Oct 23, 2015 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for BELBUCA

See the table below for patents covering BELBUCA around the world.

Country Patent Number Title Estimated Expiration
Russian Federation 2504377 СПОСОБ ТРАНСМУКОЗАЛЬНОЙ ДОСТАВКИ ЛЕКАРСТВА, СРЕДСТВО ТРАНСМУКОЗАЛЬНОЙ ДОСТАВКИ ЛЕКАРСТВА (ВАРИАНТЫ) И СПОСОБ ЛЕЧЕНИЯ БОЛИ (METHOD FOR TRANSMUCOSAL DRUG DELIVERY, AGENT FOR TRANSMUCOSAL DRUG DELIVERY (VERSIONS) AND METHOD FOR PAIN MANAGEMENT) ⤷  Sign Up
Norway 20200273 Transmukosal leveringsanordning med forøket opptak ⤷  Sign Up
Denmark 0973497 ⤷  Sign Up
Japan 6255349 ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

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