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Serving hundreds of leading biopharmaceutical companies globally:

Covington
Accenture
Fish and Richardson
Boehringer Ingelheim
Federal Trade Commission
Julphar
Dow
Queensland Health
AstraZeneca

Generated: September 24, 2018

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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 six patents protecting this drug and three Paragraph IV challenges.

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.

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 022410-001 Aug 30, 2010 AB RX Yes No ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Indivior Inc SUBOXONE buprenorphine hydrochloride; naloxone hydrochloride FILM;BUCCAL, SUBLINGUAL 022410-002 Aug 30, 2010 AB RX Yes No ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Indivior Inc SUBOXONE buprenorphine hydrochloride; naloxone hydrochloride FILM;BUCCAL, SUBLINGUAL 022410-004 Aug 10, 2012 AB RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free 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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Paragraph IV (Patent) Challenges for SUBOXONE
Drugname Dosage Strength RLD Date
➤ Subscribe Sulingual Film 12 mg/3 mg ➤ Subscribe ➤ Try a Free Trial
➤ Subscribe Sublingual Film 2 mg/0.5 mg and 8 mg/2 mg ➤ Subscribe ➤ Try a Free Trial
➤ Subscribe Sublingual Film 4 mg/1 mg ➤ Subscribe ➤ Try a Free Trial

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Serving hundreds of leading biopharmaceutical companies globally:

Covington
Accenture
Fish and Richardson
Boehringer Ingelheim
Federal Trade Commission
Julphar
Dow
Queensland Health
AstraZeneca

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