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DUTREBIS Drug Profile

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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 seventy-eight 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
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Merck Sharp Dohme
DUTREBIS
lamivudine; raltegravir potassium
TABLET;ORAL206510-001Feb 6, 2015DISCNNo7,754,731► subscribeYY ► subscribe
Merck Sharp Dohme
DUTREBIS
lamivudine; raltegravir potassium
TABLET;ORAL206510-001Feb 6, 2015DISCNNo7,820,660► subscribeY ► subscribe
Merck Sharp Dohme
DUTREBIS
lamivudine; raltegravir potassium
TABLET;ORAL206510-001Feb 6, 2015DISCNNo7,435,734► subscribe ► 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
Morocco29120► subscribe
Nicaragua200700138► subscribe
China101068793► 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
2008007,C1441735Lithuania► subscribePRODUCT NAME: RALTEGRAVIRUM; REGISTRATION NO/DATE: EU/1/07/436/001, 2007 12 20 EU/1/07/436/002 20071220
428Luxembourg► subscribe91428, EXPIRES: 20230102
00340Netherlands► subscribePRODUCT NAME: RALTEGRAVIR OF FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN, IN HET BIJZONDER HET KALIUMZOUT; REGISTRATION NO/DATE: EU/1/07/436/001-002 20071220
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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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