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Last Updated: June 3, 2020

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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 seventy patent family members in twenty-six countries.

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

US ANDA Litigation and Generic Entry Outlook for Suboxone

Annual sales in 2017 were $271mm indicating the motivation for generic entry.

There have been twenty-nine patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

There is one tentative approval for the generic drug (buprenorphine hydrochloride; naloxone hydrochloride), which indicates the potential for near-term generic launch.

Indicators of Generic Entry

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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

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

SponsorPhase
Emergency Medicine FoundationPhase 4
NYU Langone HealthPhase 4
Ohio State UniversityPhase 4

See all SUBOXONE clinical trials

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. ALVOGEN PINE BROOK LLC2018-04-03

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

See all SUBOXONE litigation

Pharmacology for SUBOXONE
Paragraph IV (Patent) Challenges for SUBOXONE
Tradename Dosage Ingredient NDA Submissiondate
SUBOXONE FILM;BUCCAL, SUBLINGUAL buprenorphine hydrochloride; naloxone hydrochloride 022410 2013-05-14
SUBOXONE FILM;BUCCAL, SUBLINGUAL buprenorphine hydrochloride; naloxone hydrochloride 022410 2012-10-15
SUBOXONE TABLET;SUBLINGUAL buprenorphine hydrochloride; naloxone hydrochloride 020733 2011-06-17
SUBOXONE TABLET;SUBLINGUAL buprenorphine hydrochloride; naloxone hydrochloride 020733 2009-01-26

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
Indivior Inc SUBOXONE buprenorphine hydrochloride; naloxone hydrochloride FILM;BUCCAL, SUBLINGUAL 022410-002 Aug 30, 2010 AB RX Yes No   Start Trial   Start Trial Y   Start Trial
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
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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Serving leading biopharmaceutical companies globally:

Moodys
Medtronic
Colorcon
Harvard Business School
AstraZeneca
Dow

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