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Serving leading biopharmaceutical companies globally:

Merck
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Healthtrust
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Teva
Cantor Fitzgerald
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Generated: December 13, 2017

DrugPatentWatch Database Preview

Details for Patent: 8,158,156

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Which drugs does patent 8,158,156 protect, and when does it expire?


Patent 8,158,156 protects EMBEDA and is included in one NDA. There have been three Paragraph IV challenges on Embeda.

This patent has thirty-two patent family members in twenty-one countries.

Summary for Patent: 8,158,156

Title:Abuse-deterrent multi-layer pharmaceutical composition comprising an opioid antagonist and an opioid agonist
Abstract: Provided herein is a pharmaceutical composition comprising an antagonist, an agonist, a seal coat, and a sequestering polymer, wherein the antagonist, agonist, seal coat and at least one sequestering polymer are all components of a single unit, and wherein the seal coat forms a layer physically separating the antagonist from the agonist from one another. Methods for manufacturing such a pharmaceutical composition are also provided.
Inventor(s): Matthews; Frank (Edison, NJ), Boehm; Garth (Westfield, NJ), Tang; Lijuan (Flemington, NJ), Liang; Alfred (Edison, NJ)
Assignee: Alpharma Pharmaceuticals, LLC (Bridgewater, NJ)
Application Number:11/820,499
Patent Claim Types:
see list of patent claims
Use; Composition; Formulation;

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Patent Submitted Product Substance Delist Req. Patented / Exclusive Use
Alpharma PharmsEMBEDAmorphine sulfate; naltrexone hydrochlorideCAPSULE, EXTENDED RELEASE;ORAL022321-001Aug 13, 2009RXYesNo► Subscribe► Subscribe► SubscribeMANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG TERM OPIOD TREATEMENT BY ORALLY ADMINISTERING AN INTACT COMPOSITION AS CLAIMED.
Alpharma PharmsEMBEDAmorphine sulfate; naltrexone hydrochlorideCAPSULE, EXTENDED RELEASE;ORAL022321-002Aug 13, 2009RXYesNo► Subscribe► Subscribe► SubscribeMANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG TERM OPIOD TREATEMENT BY ORALLY ADMINISTERING AN INTACT COMPOSITION AS CLAIMED.
Alpharma PharmsEMBEDAmorphine sulfate; naltrexone hydrochlorideCAPSULE, EXTENDED RELEASE;ORAL022321-003Aug 13, 2009RXYesNo► Subscribe► Subscribe► SubscribeMANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG TERM OPIOD TREATEMENT BY ORALLY ADMINISTERING AN INTACT COMPOSITION AS CLAIMED.
Alpharma PharmsEMBEDAmorphine sulfate; naltrexone hydrochlorideCAPSULE, EXTENDED RELEASE;ORAL022321-004Aug 13, 2009RXYesYes► Subscribe► Subscribe► SubscribeMANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG TERM OPIOD TREATEMENT BY ORALLY ADMINISTERING AN INTACT COMPOSITION AS CLAIMED.
Alpharma PharmsEMBEDAmorphine sulfate; naltrexone hydrochlorideCAPSULE, EXTENDED RELEASE;ORAL022321-005Aug 13, 2009RXYesNo► Subscribe► Subscribe► SubscribeMANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG TERM OPIOD TREATEMENT BY ORALLY ADMINISTERING AN INTACT COMPOSITION AS CLAIMED.
Alpharma PharmsEMBEDAmorphine sulfate; naltrexone hydrochlorideCAPSULE, EXTENDED RELEASE;ORAL022321-006Aug 13, 2009RXYesNo► Subscribe► Subscribe► SubscribeMANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG TERM OPIOD TREATEMENT BY ORALLY ADMINISTERING AN INTACT COMPOSITION AS CLAIMED.
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Non-Orange Book Patents for Patent: 8,158,156

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
7,682,633Pharmaceutical composition► Subscribe
8,877,247Abuse-deterrent multi-layer pharmaceutical composition comprising an opioid antagonist and an opioid agonist► Subscribe
8,846,104Pharmaceutical compositions for the deterrence and/or prevention of abuse► Subscribe
7,682,634Pharmaceutical compositions► 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 Patent: 8,158,156

Country Document Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Slovenia2719378► Subscribe
Slovenia2526932► Subscribe
Slovenia2484346► Subscribe
Slovenia2034975► Subscribe
Russian Federation2445077► Subscribe
Portugal2719378► Subscribe
Russian Federation2009101082► Subscribe
Portugal2526932► Subscribe
Portugal2034975► Subscribe
Portugal2484346► 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 leading biopharmaceutical companies globally:

Deloitte
Cerilliant
QuintilesIMS
McKinsey
Cantor Fitzgerald
Merck
Argus Health
Mallinckrodt
AstraZeneca
McKesson

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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