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SUBOXONE Drug Profile

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Which patents cover Suboxone, and what substitute generic drugs are available?

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

This drug has one hundred and twenty-seven 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:3
Applicants:1
NDAs:2
Suppliers / Packagers: see list6
Clinical Trials: see list47
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 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, 2010RXYesNo8,475,832► SubscribeY ► Subscribe
Indivior Inc
SUBOXONE
buprenorphine hydrochloride; naloxone hydrochloride
FILM;BUCCAL, SUBLINGUAL022410-002Aug 30, 2010RXYesNo8,475,832► SubscribeY ► Subscribe
Indivior Inc
SUBOXONE
buprenorphine hydrochloride; naloxone hydrochloride
FILM;BUCCAL, SUBLINGUAL022410-003Aug 10, 2012RXYesNo8,475,832► SubscribeY ► Subscribe
Indivior Inc
SUBOXONE
buprenorphine hydrochloride; naloxone hydrochloride
FILM;BUCCAL, SUBLINGUAL022410-004Aug 10, 2012RXYesYes8,017,150► SubscribeY ► Subscribe
Indivior Inc
SUBOXONE
buprenorphine hydrochloride; naloxone hydrochloride
FILM;BUCCAL, SUBLINGUAL022410-002Aug 30, 2010RXYesNo8,603,514► SubscribeY ► Subscribe
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Paragraph IV activity 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
9,108,340Process for manufacturing a resulting multi-layer pharmaceutical film► Subscribe
8,765,167Uniform films for rapid-dissolve dosage form incorporating anti-tacking compositions► Subscribe
2,016,206,639► Subscribe
8,663,687Film compositions for delivery of actives► Subscribe
8,900,497Process for making a film having a substantially uniform distribution of components► 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
Australia2007300197► Subscribe
Canada2621263► Subscribe
Australia2012261557► Subscribe
Japan5819827► Subscribe
Japan2006516634► 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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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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