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Serving leading biopharmaceutical companies globally:

Chinese Patent Office
UBS
Express Scripts
Healthtrust
Fuji
McKinsey
Cerilliant
Queensland Health
Harvard Business School
Deloitte

Generated: December 11, 2017

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DUTREBIS Drug Profile

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When do Dutrebis patents expire, and what generic alternatives 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 ninety patent family members in forty-one countries and eighteen supplementary protection certificates in thirteen countries.

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

Summary for DUTREBIS

Drug patent expirations by year for DUTREBIS

US Patents and Regulatory Information

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Patent Submitted Product Substance Delist Req. Exclusivity Expiration
Merck Sharp DohmeDUTREBISlamivudine; raltegravir potassiumTABLET;ORAL206510-001Feb 6, 2015DISCNNoNo► Subscribe► Subscribe► SubscribeY► Subscribe
Merck Sharp DohmeDUTREBISlamivudine; raltegravir potassiumTABLET;ORAL206510-001Feb 6, 2015DISCNNoNo► Subscribe► Subscribe► SubscribeY► Subscribe
Merck Sharp DohmeDUTREBISlamivudine; raltegravir potassiumTABLET;ORAL206510-001Feb 6, 2015DISCNNoNo► Subscribe► Subscribe► SubscribeY► Subscribe
Merck Sharp DohmeDUTREBISlamivudine; raltegravir potassiumTABLET;ORAL206510-001Feb 6, 2015DISCNNoNo► Subscribe► Subscribe► SubscribeY► Subscribe
Merck Sharp DohmeDUTREBISlamivudine; raltegravir potassiumTABLET;ORAL206510-001Feb 6, 2015DISCNNoNo► Subscribe► Subscribe► SubscribeY► 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
Eurasian Patent Organization200400585► Subscribe
Peru11482006► Subscribe
Georgia, Republic ofP20105086► Subscribe
Canada2588398► Subscribe
World Intellectual Property Organization (WIPO)2006060730► Subscribe
Argentina052034► Subscribe
China101068793► Subscribe
Iceland7213► Subscribe
Hungary230248► Subscribe
South Korea101350420► 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
2008000016Germany► SubscribePRODUCT NAME: RALTEGRAVIR, GEGEBENENFALLS IN FORM EINES PHARMAZEUTISCH ANNEHMBAREN SALZES, INSBESONDERE DES KALIUMSALZES; REGISTRATION NO/DATE: EU/1/07/436/001-002 20071220
2008 00021Denmark► Subscribe
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.
30/2008Austria► SubscribePRODUCT NAME: RALTEGRAVIR ODER DESSEN PHARMAZEUTISCH ANNEHMBAREN SALZE, INSBESONDERE DAS KALIUMSALZ
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
00340Netherlands► SubscribePRODUCT NAME: RALTEGRAVIR OF FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN, IN HET BIJZONDER HET KALIUMZOUT; 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
C0022France► SubscribePRODUCT NAME: ABACAVIR SULFATE; LAMIVUDINE; REGISTRATION NO/DATE: EU/1/04/298/001 20041217
2008 007, C1441735Lithuania► SubscribePRODUCT NAME: RALTEGRAVIRUM; REGISTRATION NO/DATE: EU/1/07/436/001-002 20071220
221021Netherlands► Subscribe20221021, EXPIRES: 20221219
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Serving leading biopharmaceutical companies globally:

Mallinckrodt
Chubb
Express Scripts
Baxter
Dow
Teva
Merck
QuintilesIMS
Daiichi Sankyo
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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