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Mallinckrodt
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Generated: September 23, 2017

DrugPatentWatch Database Preview

SUBOXONE Drug Profile

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What is the patent landscape for Suboxone, and when can generic versions of Suboxone launch?

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

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

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

Summary for Tradename: SUBOXONE

Patents:4
Applicants:1
NDAs:2
Suppliers / Packagers: see list5
Clinical Trials: see list58
Formulation / Manufacturing:see details
Drug Prices:see details
DailyMed Link:SUBOXONE at DailyMed

Pharmacology for Tradename: 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, SUBLINGUAL022410-001Aug 30, 2010RXYesNo► Subscribe► SubscribeY ► Subscribe
Indivior Inc
SUBOXONE
buprenorphine hydrochloride; naloxone hydrochloride
TABLET;SUBLINGUAL020733-002Oct 8, 2002DISCNYesNo► Subscribe► Subscribe► Subscribe
Indivior Inc
SUBOXONE
buprenorphine hydrochloride; naloxone hydrochloride
FILM;BUCCAL, SUBLINGUAL022410-003Aug 10, 2012RXYesNo► Subscribe► SubscribeY ► Subscribe
Indivior Inc
SUBOXONE
buprenorphine hydrochloride; naloxone hydrochloride
FILM;BUCCAL, SUBLINGUAL022410-001Aug 30, 2010RXYesNo► Subscribe► SubscribeY ► Subscribe
Indivior Inc
SUBOXONE
buprenorphine hydrochloride; naloxone hydrochloride
FILM;BUCCAL, SUBLINGUAL022410-002Aug 30, 2010RXYesNo► Subscribe► SubscribeY ► Subscribe
Indivior Inc
SUBOXONE
buprenorphine hydrochloride; naloxone hydrochloride
FILM;BUCCAL, SUBLINGUAL022410-003Aug 10, 2012RXYesNo► Subscribe► SubscribeY ► Subscribe
Indivior Inc
SUBOXONE
buprenorphine hydrochloride; naloxone hydrochloride
FILM;BUCCAL, SUBLINGUAL022410-004Aug 10, 2012RXYesYes► Subscribe► SubscribeY ► Subscribe
Indivior Inc
SUBOXONE
buprenorphine hydrochloride; naloxone hydrochloride
FILM;BUCCAL, SUBLINGUAL022410-004Aug 10, 2012RXYesYes► Subscribe► SubscribeY ► Subscribe
Indivior Inc
SUBOXONE
buprenorphine hydrochloride; naloxone hydrochloride
FILM;BUCCAL, SUBLINGUAL022410-001Aug 30, 2010RXYesNo► Subscribe► SubscribeY ► Subscribe
Indivior Inc
SUBOXONE
buprenorphine hydrochloride; naloxone hydrochloride
FILM;BUCCAL, SUBLINGUAL022410-001Aug 30, 2010RXYesNo► Subscribe► SubscribeY ► Subscribe
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Paragraph IV (Patent) Challenges for SUBOXONE

Drugname Dosage Strength RLD Submissiondate
buprenorphine hydrochloride and naloxone hydrochlorideSulingual Film12 mg/3 mgSuboxone3/26/2014
buprenorphine hydrochloride and naloxone hydrochlorideSublingual Film2 mg/0.5 mg and 8 mg/2 mgSuboxone10/15/2012
buprenorphine hydrochloride and naloxone hydrochlorideSublingual Film4 mg/1 mgSuboxone5/14/2013

Non-Orange Book Patents for Tradename: 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
8,685,437Thin film with non-self-aggregating uniform heterogeneity and drug delivery systems made therefrom► Subscribe
8,765,167Uniform films for rapid-dissolve dosage form incorporating anti-tacking compositions► Subscribe
9,108,340Process for manufacturing a resulting multi-layer pharmaceutical film► Subscribe
2,016,206,639► Subscribe
7,824,588Method of making self-supporting therapeutic active-containing film► Subscribe
7,666,337Polyethylene oxide-based films and drug delivery systems made therefrom► Subscribe
8,900,497Process for making a film having a substantially uniform distribution of components► Subscribe
7,425,292Thin film with non-self-aggregating uniform heterogeneity and drug delivery systems made therefrom► Subscribe
8,906,277Process for manufacturing a resulting pharmaceutical film► Subscribe
8,663,687Film compositions for delivery of actives► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.

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International Patent Family for Tradename: SUBOXONE

Country Document Number Estimated Expiration
Canada2473967► Subscribe
Japan5819827► Subscribe
Japan2005528328► Subscribe
European Patent Office1799453► Subscribe
Japan4879458► Subscribe
Japan5165888► Subscribe
Japan2011140507► Subscribe
BrazilPI0410956► Subscribe
Japan5538905► Subscribe
Austria536869► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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Serving 500+ biopharmaceutical companies globally:

Dow
Argus Health
Covington
Federal Trade Commission
Baxter
Healthtrust
Chinese Patent Office
UBS
Mallinckrodt
Accenture

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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