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Last Updated: October 17, 2019

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SUBOXONE Drug Profile

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When do Suboxone patents expire, and when can generic versions of Suboxone launch?

Suboxone is a drug marketed by Indivior Inc and is included in two NDAs. There are seven patents protecting this drug and three Paragraph IV challenges.

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

The generic ingredient in SUBOXONE 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.

Drug patent expirations by year for SUBOXONE
Drug Prices for SUBOXONE

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Drug Sales Revenue Trends for SUBOXONE

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Recent Clinical Trials for SUBOXONE

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SponsorPhase
Massachusetts General HospitalPhase 4
The EMMES CorporationPhase 3
Theresa Winhusen, PhDPhase 3

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Recent Litigation for SUBOXONE

Identify potential future generic entrants

District Court Litigation
Case NameDate
United States v. Indivior Inc.2019-04-09
Indivior Inc. v. Aveva Drug Delivery Systems, Inc.2019-03-22
Indivior Inc. v. Actavis Laboratories UT, Inc.2018-04-03

See all SUBOXONE litigation

PTAB Litigation
PetitionerDate
Dr. Reddy's Laboratories S.A.2018-11-13
Dr. Reddy’s Laboratories S.A.2018-11-13
Dr. Reddy’s Laboratories, Inc.2017-06-12

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Pharmacology for SUBOXONE

US Patents and Regulatory Information for SUBOXONE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Indivior Inc SUBOXONE buprenorphine hydrochloride; naloxone hydrochloride FILM;BUCCAL, SUBLINGUAL 022410-004 Aug 10, 2012 AB RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Indivior Inc SUBOXONE buprenorphine hydrochloride; naloxone hydrochloride TABLET;SUBLINGUAL 020733-001 Oct 8, 2002 DISCN Yes No   Start Trial   Start Trial   Start Trial
Indivior Inc SUBOXONE buprenorphine hydrochloride; naloxone hydrochloride FILM;BUCCAL, SUBLINGUAL 022410-001 Aug 30, 2010 AB 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
Paragraph IV (Patent) Challenges for SUBOXONE
Drugname Dosage Strength RLD Date
➤ Subscribe Sulingual Film 12 mg/3 mg ➤ Subscribe   Start Trial
➤ Subscribe Sublingual Film 2 mg/0.5 mg and 8 mg/2 mg ➤ Subscribe   Start Trial
➤ Subscribe Sublingual Film 4 mg/1 mg ➤ Subscribe   Start Trial

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