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Last Updated: September 25, 2022

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-five 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.

Drug patent expirations by year for BELBUCA
Drug Prices for BELBUCA

See drug prices for BELBUCA

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
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATEMENT OF PAIN BY TRANSMUCOSAL DELIVERY OF BUPRENORPHINE

Transmucosal delivery devices with enhanced uptake
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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 See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Bdsi BELBUCA buprenorphine hydrochloride FILM;BUCCAL 207932-006 Oct 23, 2015 RX Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Bdsi BELBUCA buprenorphine hydrochloride FILM;BUCCAL 207932-003 Oct 23, 2015 RX Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Bdsi BELBUCA buprenorphine hydrochloride FILM;BUCCAL 207932-002 Oct 23, 2015 RX Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Bdsi BELBUCA buprenorphine hydrochloride FILM;BUCCAL 207932-004 Oct 23, 2015 RX Yes No See Plans and Pricing See Plans and Pricing 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 BELBUCA

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Bdsi BELBUCA buprenorphine hydrochloride FILM;BUCCAL 207932-007 Oct 23, 2015 See Plans and Pricing See Plans and Pricing
Bdsi BELBUCA buprenorphine hydrochloride FILM;BUCCAL 207932-006 Oct 23, 2015 See Plans and Pricing See Plans and Pricing
Bdsi BELBUCA buprenorphine hydrochloride FILM;BUCCAL 207932-001 Oct 23, 2015 See Plans and Pricing See Plans and Pricing
Bdsi BELBUCA buprenorphine hydrochloride FILM;BUCCAL 207932-004 Oct 23, 2015 See Plans and Pricing See Plans and Pricing
Bdsi BELBUCA buprenorphine hydrochloride FILM;BUCCAL 207932-007 Oct 23, 2015 See Plans and Pricing See Plans and Pricing
>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 2009106177 СПОСОБ ТРАНСМУКОЗАЛЬНОЙ ДОСТАВКИ ЛЕКАРСТВ, СРЕДСТВО ДЛЯ ЕГО ОСУЩЕСТВЛЕНИЯ (ВАРИАНТЫ) И СПОСОБ ЛЕЧЕНИЯ БОЛИ See Plans and Pricing
Japan 2013151549 TRANSMUCOSAL DELIVERY DEVICE WITH ENHANCED UPTAKE See Plans and Pricing
Brazil 112014015329 dispositivos de liberação de droga transmucosa para uso em alívio de dor crônica See Plans and Pricing
Ukraine 118540 ПРИСТРОЇ ДЛЯ ТРАНСМУКОЗАЛЬНОЇ ДОСТАВКИ ЛІКІВ ДЛЯ ЗАСТОСУВАННЯ У ПОЛЕГШЕННІ ХРОНІЧНОГО БОЛЮ (TRANSMUCOSAL DRUG DELIVERY DEVICES FOR USE IN CHRONIC PAIN RELIEF) See Plans and Pricing
Spain 2237104 See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

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Serving leading biopharmaceutical companies globally:

Baxter
McKinsey
Merck
Boehringer Ingelheim
Colorcon
Medtronic

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.