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Serving hundreds of leading biopharmaceutical companies globally:

Johnson and Johnson
Healthtrust
Dow
Covington
McKesson
Mallinckrodt
Daiichi Sankyo
Boehringer Ingelheim
Julphar

Generated: July 23, 2018

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.

There are twenty-nine drug master file entries for lamivudine; raltegravir potassium.
Summary for lamivudine; raltegravir potassium
International Patents:89
US Patents:5
Tradenames:1
Applicants:1
NDAs:1
Drug Master File Entries: 29
Clinical Trials: 1
DailyMed Link:lamivudine; raltegravir potassium at DailyMed

US Patents and Regulatory Information 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 Dohme DUTREBIS lamivudine; raltegravir potassium TABLET;ORAL 206510-001 Feb 6, 2015 DISCN No No ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Merck Sharp Dohme DUTREBIS lamivudine; raltegravir potassium TABLET;ORAL 206510-001 Feb 6, 2015 DISCN No No ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Merck Sharp Dohme DUTREBIS lamivudine; raltegravir potassium TABLET;ORAL 206510-001 Feb 6, 2015 DISCN No No ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Merck Sharp Dohme DUTREBIS lamivudine; raltegravir potassium TABLET;ORAL 206510-001 Feb 6, 2015 DISCN No No ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

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Non-Orange Book US Patents for 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
8,357,798 Process for preparing N-alkylated hydroxypyrimidinone compounds ➤ Sign Up
Patent No. Title Estimated Patent Expiration

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Supplementary Protection Certificates for lamivudine; raltegravir potassium

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2008 007, C1441735 Lithuania ➤ Sign Up PRODUCT NAME: RALTEGRAVIRUM; REGISTRATION NO/DATE: EU/1/07/436/001-002 20071220
30/2008 Austria ➤ Sign Up PRODUCT NAME: RALTEGRAVIR ODER DESSEN PHARMAZEUTISCH ANNEHMBAREN SALZE, INSBESONDERE DAS KALIUMSALZ
2008007,C1441735 Lithuania ➤ Sign Up PRODUCT NAME: RALTEGRAVIRUM; REGISTRATION NO/DATE: EU/1/07/436/001, 2007 12 20 EU/1/07/436/002 20071220
2008007 Lithuania ➤ Sign Up PRODUCT NAME: RALTEGRAVIRUM; REG. NO/DATE: EU/1/07/436/001-002 20071220
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Fish and Richardson
Baxter
Queensland Health
Accenture
Mallinckrodt
Julphar
Teva
Farmers Insurance
UBS

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.