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Harvard Business School

Last Updated: November 22, 2019

DrugPatentWatch Database Preview

BUNAVAIL Drug Profile

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Which patents cover Bunavail, and what generic alternatives are available?

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

This drug has one hundred and one patent family members in twenty-nine countries.

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

Drug patent expirations by year for BUNAVAIL
Drug Prices for BUNAVAIL

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Recent Clinical Trials for BUNAVAIL

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SponsorPhase
Indivior Inc.Phase 4
BioDelivery Sciences InternationalPhase 3

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Recent Litigation for BUNAVAIL

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District Court Litigation
Case NameDate
BIODELIVERY SCIENCES INTERNATIONAL, INC. v. CHEMO RESEARCH, S.L.2019-03-15
BioDelivery Sciences International, Inc. v. Chemo Research, S.L.2019-03-01
BioDelivery Sciences International, Inc. v. Alvogen Pb Research & Development LLC2018-09-07

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PTAB Litigation
PetitionerDate
MONOSOL RX, LLC2014-01-22

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Pharmacology for BUNAVAIL
Synonyms for BUNAVAIL
352020-56-5
Buprenorphine / Naloxone
Buprenorphine and Naloxone
Buprenorphine hydrochloride and naloxone hydrochloride
Buprenorphine mixture with Naloxone
Buprenorphine-Naloxone
buprenorphine-naloxone combination
Buprenorphine, Naloxone Drug Combination
DTXSID50188706
Naloxone-Buprenorphine
Zubsolv
Paragraph IV (Patent) Challenges for BUNAVAIL
Tradename Dosage Ingredient NDA Submissiondate
BUNAVAIL FILM;BUCCAL buprenorphine hydrochloride; naloxone hydrochloride 205637 2016-11-23
BUNAVAIL FILM;BUCCAL buprenorphine hydrochloride; naloxone hydrochloride 205637 2015-12-21

US Patents and Regulatory Information for BUNAVAIL

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 RX Yes No   Start Trial   Start Trial Y   Start Trial
Bdsi BUNAVAIL buprenorphine hydrochloride; naloxone hydrochloride FILM;BUCCAL 205637-002 Jun 6, 2014 RX Yes No   Start Trial   Start Trial Y   Start Trial
Bdsi BUNAVAIL buprenorphine hydrochloride; naloxone hydrochloride FILM;BUCCAL 205637-001 Jun 6, 2014 RX Yes No   Start Trial   Start Trial Y   Start Trial
Bdsi BUNAVAIL buprenorphine hydrochloride; naloxone hydrochloride FILM;BUCCAL 205637-003 Jun 6, 2014 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Bdsi BUNAVAIL buprenorphine hydrochloride; naloxone hydrochloride FILM;BUCCAL 205637-002 Jun 6, 2014 RX Yes No   Start Trial   Start Trial Y   Start Trial
Bdsi BUNAVAIL buprenorphine hydrochloride; naloxone hydrochloride FILM;BUCCAL 205637-003 Jun 6, 2014 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Bdsi BUNAVAIL buprenorphine hydrochloride; naloxone hydrochloride FILM;BUCCAL 205637-001 Jun 6, 2014 RX Yes No   Start Trial   Start Trial Y   Start 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

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Bdsi BUNAVAIL buprenorphine hydrochloride; naloxone hydrochloride FILM;BUCCAL 205637-001 Jun 6, 2014   Start Trial   Start Trial
Bdsi BUNAVAIL buprenorphine hydrochloride; naloxone hydrochloride FILM;BUCCAL 205637-003 Jun 6, 2014   Start Trial   Start Trial
Bdsi BUNAVAIL buprenorphine hydrochloride; naloxone hydrochloride FILM;BUCCAL 205637-002 Jun 6, 2014   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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Serving leading biopharmaceutical companies globally:

McKesson
McKinsey
Johnson and Johnson
Medtronic
Moodys
Dow

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