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Last Updated: October 28, 2021

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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 patent protection?

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-five patent family members in forty-three countries.

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

Summary for lamivudine; raltegravir potassium
International Patents:95
US Patents:5
Tradenames:1
Applicants:1
NDAs:1
Drug Master File Entries: 29
Clinical Trials: 1
DailyMed Link:lamivudine; raltegravir potassium at DailyMed
Recent Clinical Trials for lamivudine; raltegravir potassium

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
St. James's Hospital, IrelandPhase 4

See all lamivudine; raltegravir potassium clinical trials

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 ⤷  Free Forever Trial ⤷  Free Forever Trial Y ⤷  Free Forever Trial
Merck Sharp Dohme DUTREBIS lamivudine; raltegravir potassium TABLET;ORAL 206510-001 Feb 6, 2015 DISCN No No ⤷  Free Forever Trial ⤷  Free Forever Trial Y ⤷  Free Forever Trial
Merck Sharp Dohme DUTREBIS lamivudine; raltegravir potassium TABLET;ORAL 206510-001 Feb 6, 2015 DISCN No No ⤷  Free Forever Trial ⤷  Free Forever Trial Y ⤷  Free Forever Trial
Merck Sharp Dohme DUTREBIS lamivudine; raltegravir potassium TABLET;ORAL 206510-001 Feb 6, 2015 DISCN No No ⤷  Free Forever Trial ⤷  Free Forever Trial Y ⤷  Free Forever Trial
Merck Sharp Dohme DUTREBIS lamivudine; raltegravir potassium TABLET;ORAL 206510-001 Feb 6, 2015 DISCN No No ⤷  Free Forever Trial ⤷  Free Forever Trial Y ⤷  Free Forever Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Supplementary Protection Certificates for lamivudine; raltegravir potassium

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1441735 PA2008 007, C1441735 Lithuania ⤷  Free Forever Trial PRODUCT NAME: RALTEGRAVIRUM; REGISTRATION NO/DATE: EU/1/07/436/001-002 20071220
1441735 122008000016 Germany ⤷  Free Forever Trial PRODUCT NAME: RALTEGRAVIR, GEGEBENENFALLS IN FORM EINES PHARMAZEUTISCH ANNEHMBAREN SALZES, INSBESONDERE DES KALIUMSALZES; REGISTRATION NO/DATE: EU/1/07/436/001-002 20071220
1441735 SZ 30/2008 Austria ⤷  Free Forever Trial PRODUCT NAME: RALTEGRAVIR ODER DESSEN PHARMAZEUTISCH ANNEHMBAREN SALZE, INSBESONDERE DAS KALIUMSALZ
1441735 C20080001 Estonia ⤷  Free Forever Trial PRODUCT NAME: ISENTRESS; AUTHORISATION NO.: EMA/106827/2018; AUTHORISATION DATE: 20180222
0382526 96C0035 Belgium ⤷  Free Forever Trial PRODUCT NAME: LAMIVUDINE; NAT. REGISTRATION NO/DATE: EU/1/96/015/001 19960808; FIRST REGISTRATION: CH 53 662 013 19960228
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
Colorcon
Harvard Business School
Express Scripts
Dow
McKinsey

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