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Serving leading biopharmaceutical companies globally:

Dow
Teva
Merck
Johnson and Johnson
Fuji
Julphar
Cerilliant
McKesson
Queensland Health
Chinese Patent Office

Generated: February 25, 2018

DrugPatentWatch Database Preview

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 five patents protecting this drug and three Paragraph IV challenges.

This drug has one hundred and thirty-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-three suppliers are listed for this compound. Additional details are available on the buprenorphine hydrochloride; naloxone hydrochloride profile page.
Summary for SUBOXONE
International Patents:135
US Patents:5
Applicants:1
NDAs:2
Suppliers / Packagers: 5
Clinical Trials: 60
Formulation / Manufacturing:see details
Drug Prices:see details
DailyMed Link:SUBOXONE at DailyMed
Drug patent expirations by year for SUBOXONE
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 022410-001 Aug 30, 2010 RX Yes No ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Indivior Inc SUBOXONE buprenorphine hydrochloride; naloxone hydrochloride FILM;BUCCAL, SUBLINGUAL 022410-004 Aug 10, 2012 RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Indivior Inc SUBOXONE buprenorphine hydrochloride; naloxone hydrochloride FILM;BUCCAL, SUBLINGUAL 022410-003 Aug 10, 2012 RX Yes No ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Indivior Inc SUBOXONE buprenorphine hydrochloride; naloxone hydrochloride FILM;BUCCAL, SUBLINGUAL 022410-001 Aug 30, 2010 RX Yes No ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Indivior Inc SUBOXONE buprenorphine hydrochloride; naloxone hydrochloride FILM;BUCCAL, SUBLINGUAL 022410-002 Aug 30, 2010 RX Yes No ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Indivior Inc SUBOXONE buprenorphine hydrochloride; naloxone hydrochloride FILM;BUCCAL, SUBLINGUAL 022410-004 Aug 10, 2012 RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Indivior Inc SUBOXONE buprenorphine hydrochloride; naloxone hydrochloride FILM;BUCCAL, SUBLINGUAL 022410-003 Aug 10, 2012 RX Yes No ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Indivior Inc SUBOXONE buprenorphine hydrochloride; naloxone hydrochloride FILM;BUCCAL, SUBLINGUAL 022410-004 Aug 10, 2012 RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Indivior Inc SUBOXONE buprenorphine hydrochloride; naloxone hydrochloride FILM;BUCCAL, SUBLINGUAL 022410-004 Aug 10, 2012 RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Indivior Inc SUBOXONE buprenorphine hydrochloride; naloxone hydrochloride FILM;BUCCAL, SUBLINGUAL 022410-002 Aug 30, 2010 RX Yes No ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
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 Submissiondate
➤ Subscribe Sulingual Film 12 mg/3 mg ➤ Subscribe 3/26/2014
➤ Subscribe Sublingual Film 2 mg/0.5 mg and 8 mg/2 mg ➤ Subscribe 10/15/2012
➤ Subscribe Sublingual Film 4 mg/1 mg ➤ Subscribe 5/14/2013

Non-Orange Book US Patents for SUBOXONE

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
8,900,498 Process for manufacturing a resulting multi-layer pharmaceutical film ➤ Sign Up
2,016,206,639 ➤ Sign Up
7,666,337 Polyethylene oxide-based films and drug delivery systems made therefrom ➤ Sign Up
8,652,378 Uniform films for rapid dissolve dosage form incorporating taste-masking compositions ➤ Sign Up
8,900,497 Process for making a film having a substantially uniform distribution of components ➤ Sign Up
7,824,588 Method of making self-supporting therapeutic active-containing film ➤ Sign Up
7,910,031 Process for forming an ingestible thin film with non-self-aggregating uniform heterogeneity ➤ Sign Up
8,663,687 Film compositions for delivery of actives ➤ Sign Up
7,910,641 PH modulated films for delivery of actives ➤ Sign Up
7,897,080 Polyethylene-oxide based films and drug delivery systems made therefrom ➤ Sign Up
Patent No. Title Estimated Patent Expiration

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International Patents for SUBOXONE

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Serving hundreds of leading biopharmaceutical companies globally:

Fuji
Chubb
Queensland Health
Farmers Insurance
US Department of Justice
McKesson
Teva
Deloitte
Healthtrust

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 verifification 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.

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