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Serving leading biopharmaceutical companies globally:

Teva
Queensland Health
Johnson and Johnson
Express Scripts
Cipla
QuintilesIMS
Novartis
Chinese Patent Office
Moodys
Covington

Generated: October 18, 2017

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 ninety 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 Generic Name: lamivudine; raltegravir potassium

US Patents:5
Tradenames:1
Applicants:1
NDAs:1
Drug Master File Entries: see list28
Clinical Trials: see list1,333
Drug Prices:see low prices
DailyMed Link:lamivudine; raltegravir potassium at DailyMed
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
DUTREBIS
lamivudine; raltegravir potassium
TABLET;ORAL206510-001Feb 6, 2015DISCNNoNo► Subscribe► SubscribeY► Subscribe
Merck Sharp Dohme
DUTREBIS
lamivudine; raltegravir potassium
TABLET;ORAL206510-001Feb 6, 2015DISCNNoNo► Subscribe► SubscribeY► Subscribe
Merck Sharp Dohme
DUTREBIS
lamivudine; raltegravir potassium
TABLET;ORAL206510-001Feb 6, 2015DISCNNoNo► Subscribe► SubscribeY► Subscribe
Merck Sharp Dohme
DUTREBIS
lamivudine; raltegravir potassium
TABLET;ORAL206510-001Feb 6, 2015DISCNNoNo► Subscribe► SubscribeY ► Subscribe
Merck Sharp Dohme
DUTREBIS
lamivudine; raltegravir potassium
TABLET;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
South Africa200402796► Subscribe
Cyprus1112859► Subscribe
Peru11482006► Subscribe
China102229605► Subscribe
Norway20073404► Subscribe
World Intellectual Property Organization (WIPO)2006060712► Subscribe
Nicaragua200700138► Subscribe
Luxembourg91428► Subscribe
TunisiaSN07215► Subscribe
Poland212914► 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
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.
C010/2008Ireland► SubscribeSPC010/2008: 20091119, EXPIRES: 20221219
00340Netherlands► SubscribePRODUCT NAME: RALTEGRAVIR OF FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN, IN HET BIJZONDER HET KALIUMZOUT; REGISTRATION NO/DATE: EU/1/07/436/001-002 20071220
2008000016Germany► SubscribePRODUCT NAME: RALTEGRAVIR, GEGEBENENFALLS IN FORM EINES PHARMAZEUTISCH ANNEHMBAREN SALZES, INSBESONDERE DES KALIUMSALZES; REGISTRATION NO/DATE: EU/1/07/436/001-002 20071220
428Luxembourg► Subscribe91428, EXPIRES: 20230102
/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
2008 007, C1441735Lithuania► SubscribePRODUCT NAME: RALTEGRAVIRUM; REGISTRATION NO/DATE: EU/1/07/436/001-002 20071220
2008007,C1441735Lithuania► SubscribePRODUCT NAME: RALTEGRAVIRUM; REGISTRATION NO/DATE: EU/1/07/436/001, 2007 12 20 EU/1/07/436/002 20071220
1441735/01Switzerland► SubscribeFORMER OWNER: ISTITUTO DI RICERCHE DI BIOLOGIA MOLECOLARE P. ANGELETTI S.P.A., IT
0080001 00016Estonia► SubscribePRODUCT NAME: ISENTRESS; REG NO/DATE: 20.12.2007 C(2007)6801
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For more information try a trial or see the database preview and plans and pricing

Serving leading biopharmaceutical companies globally:

Citi
McKesson
Mallinckrodt
Dow
Argus Health
QuintilesIMS
Merck
Healthtrust
Novartis
Federal Trade Commission

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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