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DUTREBIS Drug Profile

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

Dutrebis is a drug marketed by Merck Sharp Dohme and is included in one NDA. There are five patents protecting this drug.

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

The generic ingredient in DUTREBIS is lamivudine; raltegravir potassium. There are twenty-six drug master file entries for this compound. Additional details are available on the lamivudine; raltegravir potassium profile page.

Summary for Tradename: DUTREBIS

Patents:5
Applicants:1
NDAs:1
Formulation / Manufacturing:see details
Drug Prices:see details
DailyMed Link:DUTREBIS at DailyMed
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Merck Sharp Dohme
DUTREBIS
lamivudine; raltegravir potassium
TABLET;ORAL206510-001Feb 6, 2015DISCNNoNo7,754,731► SubscribeYY ► Subscribe
Merck Sharp Dohme
DUTREBIS
lamivudine; raltegravir potassium
TABLET;ORAL206510-001Feb 6, 2015DISCNNoNo7,820,660► SubscribeY ► Subscribe
Merck Sharp Dohme
DUTREBIS
lamivudine; raltegravir potassium
TABLET;ORAL206510-001Feb 6, 2015DISCNNoNo7,435,734► Subscribe ► Subscribe
Merck Sharp Dohme
DUTREBIS
lamivudine; raltegravir potassium
TABLET;ORAL206510-001Feb 6, 2015DISCNNoNo7,217,713► Subscribe ► Subscribe
Merck Sharp Dohme
DUTREBIS
lamivudine; raltegravir potassium
TABLET;ORAL206510-001Feb 6, 2015DISCNNoNo7,169,780► SubscribeYY ► Subscribe
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Non-Orange Book Patents for Tradename: DUTREBIS

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
8,357,798Process 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: DUTREBIS

Country Document Number Estimated Expiration
CroatiaP20120066► Subscribe
Spain2258668► Subscribe
Austria518844► Subscribe
Norway325206► 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: DUTREBIS

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
C010/2008Ireland► SubscribeSPC010/2008: 20091119, EXPIRES: 20221219
2008 00021Denmark► Subscribe
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
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
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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