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Serving 500+ biopharmaceutical companies globally:

Merck
Covington
Cerilliant
UBS
Argus Health
Harvard Business School
Dow
Accenture
Chubb
Fuji

Generated: July 21, 2017

DrugPatentWatch Database Preview

ISENTRESS Drug Profile

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Which patents cover Isentress, and when can generic versions of Isentress launch?

Isentress is a drug marketed by Merck Sharp Dohme and is included in three NDAs. There are five patents protecting this drug and one Paragraph IV challenge.

This drug has eighty-three patent family members in forty-one countries.

The generic ingredient in ISENTRESS is raltegravir potassium. There are five drug master file entries for this compound. Nine suppliers are listed for this compound. Additional details are available on the raltegravir potassium profile page.

Summary for Tradename: ISENTRESS

Patents:4
Applicants:1
NDAs:3
Suppliers / Packagers: see list9
Bulk Api Vendors: see list74
Clinical Trials: see list39
Patent Applications: see list5
Formulation / Manufacturing:see details
Drug Prices:see details
DailyMed Link:ISENTRESS at DailyMed

Pharmacology for Tradename: ISENTRESS

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Merck Sharp Dohme
ISENTRESS
raltegravir potassium
TABLET, CHEWABLE;ORAL203045-001Dec 21, 2011RXYesNo7,169,780► SubscribeYY ► Subscribe
Merck Sharp Dohme
ISENTRESS
raltegravir potassium
POWDER;ORAL205786-001Dec 20, 2013RXYesYes7,754,731► SubscribeYY ► Subscribe
Merck Sharp Dohme
ISENTRESS HD
raltegravir potassium
TABLET;ORAL022145-002May 26, 2017RXYesNo7,754,731► SubscribeYY ► Subscribe
Merck Sharp Dohme
ISENTRESS
raltegravir potassium
TABLET, CHEWABLE;ORAL203045-002Dec 21, 2011RXYesYes7,435,734► Subscribe ► Subscribe
Merck Sharp Dohme
ISENTRESS
raltegravir potassium
TABLET, CHEWABLE;ORAL203045-001Dec 21, 2011RXYesNo7,217,713► Subscribe ► Subscribe
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Paragraph IV activity for: ISENTRESS

Drugname Dosage Strength RLD Submissiondate
raltegravirTablets400 mgIsentress10/12/2011

Non-Orange Book Patents for Tradename: ISENTRESS

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
7,820,660N-substituted hydroxypyrimidinone carboxamide inhibitors of HIV integrase► Subscribe
8,357,798Process for preparing N-alkylated hydroxypyrimidinone compounds► 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: ISENTRESS

Country Document Number Estimated Expiration
Germany122008000016► Subscribe
Mexico2007006639► Subscribe
New Zealand533057► Subscribe
European Patent Office1819683► Subscribe
Argentina101429► 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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Supplementary Protection Certificates for Tradename: ISENTRESS

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
428Luxembourg► Subscribe91428, EXPIRES: 20230102
2008 007, C1441735Lithuania► SubscribePRODUCT NAME: RALTEGRAVIRUM; REGISTRATION NO/DATE: EU/1/07/436/001-002 20071220
C010/2008Ireland► SubscribeSPC010/2008: 20091119, EXPIRES: 20221219
67; 3-2008Slovakia► SubscribePRODUCT NAME: RALTEGRAVIR; REGISTRATION NO/DATE: Registration in Community EU/1/07/436/001-002 20071220; FORMER OWNER: ISTITUTO DI RICERCHE DI BIOLOGIA MOLECOLARE P. ANGELETTI SPA. IT
2008007,C1441735Lithuania► SubscribePRODUCT NAME: RALTEGRAVIRUM; REGISTRATION NO/DATE: EU/1/07/436/001, 2007 12 20 EU/1/07/436/002 20071220
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For more information try a trial or see the database preview and plans and pricing

Serving 500+ biopharmaceutical companies globally:

McKesson
Chinese Patent Office
Dow
Colorcon
Mallinckrodt
Accenture
McKinsey
Medtronic
Chubb
Teva

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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