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DrugPatentWatch Database Preview

Lamivudine; raltegravir potassium - Generic Drug Details

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What are the generic drug sources for lamivudine; raltegravir potassium and what is the scope of lamivudine; raltegravir potassium freedom to operate?

Lamivudine; raltegravir potassium
is the generic ingredient in one branded drug marketed by Merck Sharp Dohme and is included in one NDA. There are five patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Lamivudine; raltegravir potassium has eighty-nine patent family members in forty-one countries and eighteen supplementary protection certificates in thirteen countries.

There are twenty-eight drug master file entries for lamivudine; raltegravir potassium.

Summary for lamivudine; raltegravir potassium

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Merck Sharp DohmeDUTREBISlamivudine; raltegravir potassiumTABLET;ORAL206510-001Feb 6, 2015DISCNNoNo► Subscribe► SubscribeY► Subscribe
Merck Sharp DohmeDUTREBISlamivudine; raltegravir potassiumTABLET;ORAL206510-001Feb 6, 2015DISCNNoNo► Subscribe► SubscribeY► Subscribe
Merck Sharp DohmeDUTREBISlamivudine; raltegravir potassiumTABLET;ORAL206510-001Feb 6, 2015DISCNNoNo► Subscribe► SubscribeY► Subscribe
Merck Sharp DohmeDUTREBISlamivudine; raltegravir potassiumTABLET;ORAL206510-001Feb 6, 2015DISCNNoNo► Subscribe► SubscribeY► Subscribe
Merck Sharp DohmeDUTREBISlamivudine; raltegravir potassiumTABLET;ORAL206510-001Feb 6, 2015DISCNNoNo► Subscribe► SubscribeY► Subscribe
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Non-Orange Book Patents for Generic Ingredient: lamivudine; raltegravir potassium

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 Ingredient: lamivudine; raltegravir potassium

Country Document Number Estimated Expiration
MexicoPA04003932► Subscribe
Japan2005511543► Subscribe
South Korea20070089990► Subscribe
Denmark1441735► Subscribe
Eurasian Patent Organization200400585► Subscribe
Taiwan200631944► Subscribe
Hungary230248► Subscribe
Mexico2007006639► Subscribe
Poland212914► Subscribe
Serbia52197► 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: LAMIVUDINE; RALTEGRAVIR POTASSIUM

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
30/2008Austria► SubscribePRODUCT NAME: RALTEGRAVIR ODER DESSEN PHARMAZEUTISCH ANNEHMBAREN SALZE, INSBESONDERE DAS KALIUMSALZ
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.
0080001 00016Estonia► SubscribePRODUCT NAME: ISENTRESS; REG NO/DATE: 20.12.2007 C(2007)6801
2008007Lithuania► SubscribePRODUCT NAME: RALTEGRAVIRUM; REG. NO/DATE: EU/1/07/436/001-002 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
C0022France► SubscribePRODUCT NAME: ABACAVIR SULFATE; LAMIVUDINE; REGISTRATION NO/DATE: EU/1/04/298/001 20041217
9Finland► Subscribe
2008 007, C1441735Lithuania► SubscribePRODUCT NAME: RALTEGRAVIRUM; REGISTRATION NO/DATE: EU/1/07/436/001-002 20071220
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
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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Serving leading biopharmaceutical companies globally:

Moodys
Cerilliant
QuintilesIMS
Novartis
Colorcon
Medtronic
Dow
Mallinckrodt
Harvard Business School
Chubb

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