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Serving 500+ biopharmaceutical companies globally:

Cantor Fitzgerald
Daiichi Sankyo
Merck
Cipla
Accenture
Johnson and Johnson
Farmers Insurance
Citi
Medtronic
Chubb

Generated: September 25, 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-five 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. Ten 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 list10
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, 2011RXYesNo► Subscribe► SubscribeY► Subscribe
Merck Sharp Dohme
ISENTRESS
raltegravir potassium
POWDER;ORAL205786-001Dec 20, 2013RXYesYes► Subscribe► SubscribeY► Subscribe
Merck Sharp Dohme
ISENTRESS HD
raltegravir potassium
TABLET;ORAL022145-002May 26, 2017RXYesNo► Subscribe► SubscribeY► Subscribe
Merck Sharp Dohme
ISENTRESS
raltegravir potassium
TABLET, CHEWABLE;ORAL203045-002Dec 21, 2011RXYesYes► Subscribe► SubscribeY► Subscribe
Merck Sharp Dohme
ISENTRESS
raltegravir potassium
TABLET, CHEWABLE;ORAL203045-001Dec 21, 2011RXYesNo► Subscribe► SubscribeY► Subscribe
Merck Sharp Dohme
ISENTRESS
raltegravir potassium
TABLET;ORAL022145-001Oct 12, 2007RXYesYes► Subscribe► SubscribeY► Subscribe
Merck Sharp Dohme
ISENTRESS HD
raltegravir potassium
TABLET;ORAL022145-002May 26, 2017RXYesNo► Subscribe► SubscribeY► Subscribe
Merck Sharp Dohme
ISENTRESS
raltegravir potassium
TABLET, CHEWABLE;ORAL203045-002Dec 21, 2011RXYesYes► Subscribe► SubscribeY► Subscribe
Merck Sharp Dohme
ISENTRESS
raltegravir potassium
POWDER;ORAL205786-001Dec 20, 2013RXYesYes► Subscribe► Subscribe► Subscribe
Merck Sharp Dohme
ISENTRESS
raltegravir potassium
POWDER;ORAL205786-001Dec 20, 2013RXYesYes► Subscribe► SubscribeY► Subscribe
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Paragraph IV (Patent) Challenges 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
Morocco29120► Subscribe
CroatiaP20120066► Subscribe
Taiwan200631944► Subscribe
Norway338784► Subscribe
Spain2370136► Subscribe
Japan2008521933► Subscribe
Hong Kong1085665► Subscribe
South Africa200402796► Subscribe
Ukraine77454► Subscribe
MexicoPA04003932► 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
C0026France► SubscribePRODUCT NAME: RALTEGRAVIR OU L(UN DE SES SELS PHARMACEUTIQUEMENT ACCCEPTABLES EN PARTICULIER UN SEL DE POTASSIUM; REGISTRATION NO/DATE IN FRANCE: EU/1/07/436/001 DU 20071220; REGISTRATION NO/DATE AT EEC: EU/1/07/436/001 DU 20071220
2008007Lithuania► SubscribePRODUCT NAME: RALTEGRAVIRUM; REG. NO/DATE: EU/1/07/436/001-002 20071220
2008 007, C1441735Lithuania► SubscribePRODUCT NAME: RALTEGRAVIRUM; REGISTRATION NO/DATE: EU/1/07/436/001-002 20071220
1441735/01Switzerland► SubscribeFORMER OWNER: ISTITUTO DI RICERCHE DI BIOLOGIA MOLECOLARE P. ANGELETTI S.P.A., IT
/2008Austria► SubscribePRODUCT NAME: RALTEGRAVIR ODER DESSEN PHARMAZEUTISCH ANNEHMBAREN SALZE, INSBESONDERE DAS KALIUMSALZ; REGISTRATION NO/DATE: EU/1/07/436/001- EU/1/07/436/002 20071220
00340Netherlands► SubscribePRODUCT NAME: RALTEGRAVIR OF FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN, IN HET BIJZONDER HET KALIUMZOUT; REGISTRATION NO/DATE: EU/1/07/436/001-002 20071220
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
30/2008Austria► SubscribePRODUCT NAME: RALTEGRAVIR ODER DESSEN PHARMAZEUTISCH ANNEHMBAREN SALZE, INSBESONDERE DAS KALIUMSALZ
428Luxembourg► Subscribe91428, EXPIRES: 20230102
C/GB08/020United Kingdom► SubscribeSUPPLEMENTARY PROTECTION CERTIFICATE NO SPC/GB08/020 GRANTED TO ISTITUTO DI RICERCHE DI BIOLOGIA MOLECOLARE P. IN RESPECT OF THE PRODUCT RALTEGRAVIR OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, ESPECIALLY THE POTASSIUM SALT, THE GRANT OF WHICH WAS ADVERTISED IN JOURNAL NO 6346 DATED 05 JANUARY 2011 HAS HAD ITS MAXIMUM PERIOD OF DURATION CORRECTED, SUBJECT TO THE PAYMENT OF THE PRESCRIBED FEES IT WILL EXPIRE ON 01 JANUARY 2023.
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For more information try a trial or see the database preview and plans and pricing

Serving 500+ biopharmaceutical companies globally:

Chubb
Julphar
Farmers Insurance
Daiichi Sankyo
US Department of Justice
UBS
Cantor Fitzgerald
Mallinckrodt
Moodys
Chinese Patent Office

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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