Upgrade to enjoy subscriber-only features like email alerts and data export. See the Plans and Pricing

Serving hundreds of leading biopharmaceutical companies globally:

Cantor Fitzgerald
Fuji
Chubb
Baxter
AstraZeneca
Citi
QuintilesIMS
Medtronic
Chinese Patent Office

Generated: July 19, 2018

DrugPatentWatch Database Preview

SUBOXONE Drug Profile

see a sample report or, see our see our flat-rate plans

« Back to Dashboard

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.

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.
Drug patent expirations by year for SUBOXONE
Generic Entry Opportunity Date for SUBOXONE
Generic Entry Date for SUBOXONE*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage::
FILM;BUCCAL, SUBLINGUAL

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

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 AB 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 AB 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 AB 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 AB 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

This preview shows a limited data set. Subscribe for full access, or try a Free Trial

see a sample report or, see our see our flat-rate plans

Paragraph IV (Patent) Challenges for SUBOXONE
Drugname Dosage Strength RLD Date
➤ Subscribe Sulingual Film 12 mg/3 mg ➤ Subscribe ➤ Sign Up
➤ Subscribe Sublingual Film 2 mg/0.5 mg and 8 mg/2 mg ➤ Subscribe ➤ Sign Up
➤ Subscribe Sublingual Film 4 mg/1 mg ➤ Subscribe ➤ Sign Up

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
8,765,167 Uniform films for rapid-dissolve dosage form incorporating anti-tacking compositions ➤ Sign Up
7,824,588 Method of making self-supporting therapeutic active-containing film ➤ Sign Up
7,897,080 Polyethylene-oxide based films and drug delivery systems made therefrom ➤ Sign Up
2,016,206,639 ➤ Sign Up
Patent No. Title Estimated Patent Expiration

This preview shows a limited data set. Subscribe for full access, or try a Free Trial

see a sample report or, see our see our flat-rate plans

For more information try a trial or see the plans and pricing

Serving hundreds of leading biopharmaceutical companies globally:

Johnson and Johnson
Medtronic
Cipla
Julphar
Colorcon
US Department of Justice
Teva
AstraZeneca
Farmers Insurance

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.