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Last Updated: November 22, 2024

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 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 two 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.

Summary for LAMIVUDINE; RALTEGRAVIR POTASSIUM
International Patents:95
US Patents:2
Tradenames:1
Applicants:1
NDAs:1
Clinical Trials: 1
DailyMed Link:LAMIVUDINE; RALTEGRAVIR POTASSIUM at DailyMed
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for LAMIVUDINE; RALTEGRAVIR POTASSIUM
Generic Entry Date for LAMIVUDINE; RALTEGRAVIR POTASSIUM*:
Constraining patent/regulatory exclusivity:
Dosage:
TABLET;ORAL

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

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 ⤷  Sign Up ⤷  Sign Up ⤷  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

Expired US Patents for LAMIVUDINE; RALTEGRAVIR POTASSIUM

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Merck Sharp Dohme DUTREBIS lamivudine; raltegravir potassium TABLET;ORAL 206510-001 Feb 6, 2015 ⤷  Sign Up ⤷  Sign Up
Merck Sharp Dohme DUTREBIS lamivudine; raltegravir potassium TABLET;ORAL 206510-001 Feb 6, 2015 ⤷  Sign Up ⤷  Sign Up
Merck Sharp Dohme DUTREBIS lamivudine; raltegravir potassium TABLET;ORAL 206510-001 Feb 6, 2015 ⤷  Sign Up ⤷  Sign Up
Merck Sharp Dohme DUTREBIS lamivudine; raltegravir potassium TABLET;ORAL 206510-001 Feb 6, 2015 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

EU/EMA Drug Approvals for LAMIVUDINE; RALTEGRAVIR POTASSIUM

Company Drugname Inn Product Number / Indication Status Generic Biosimilar Orphan Marketing Authorisation Marketing Refusal
Merck Sharp Dohme Limited Dutrebis lamivudine, raltegravir potassium EMEA/H/C/003823
Dutrebis is indicated in combination with other anti‑retroviral medicinal products for the treatment of human immunodeficiency virus (HIV‑1) infection in adults, adolescents, and children from the age of 6 years and weighing at least 30 kg without present or past evidence of viral resistance to antiviral agents of the InSTI (Integrase Strand Transfer Inhibitor) and NRTI (Nucleoside Reverse Transcriptase Inhibitor) classes (see sections 4.2, 4.4 and 5.1).
Withdrawn no no no 2015-03-26
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

International Patents for LAMIVUDINE; RALTEGRAVIR POTASSIUM

Country Patent Number Title Estimated Expiration
European Patent Office 1819700 SEL DE POTASSIUM D'UN INHIBITEUR DE L'INTEGRASE DU VIH (POTASSIUM SALT OF AN HIV INTEGRASE INHIBITOR) ⤷  Sign Up
Georgia, Republic of P20105086 POTASSIUM SALT OF AN HIV INTEGRASE INHIBITOR ⤷  Sign Up
Costa Rica 9146 SAL POTASICA DE UN INHIBIDOR DE LA INTEGRASA DE VIH ⤷  Sign Up
Peru 20061148 SAL POTASICA DE N-(4-FLUOROBENCIL)-5-HIDROXI-1-METIL-2-(1-METIL-1-{[(5-METIL-1,3,4-OXADIAZOL-2-IL)CARBONIL]AMINO}ETIL)-6-OXO-1,6-DIHIDROPIRIMIDIN-4-CARBOXAMIDA ⤷  Sign Up
Montenegro 00427 N-SUPSTITUISANI HIDROKSIPIRAMIDINON KARBOKSAMIDNI INHIBITORI HIV INTEGRAZE (N-SUBSTITUTED HYDROXYPYRIMIDINONE CARBOXAMIDE INHIBITORS OF HIV INTEGRASE) ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for LAMIVUDINE; RALTEGRAVIR POTASSIUM

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1441735 SPC/GB08/020 United Kingdom ⤷  Sign Up PRODUCT NAME: RALTEGRAVIR OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, ESPECIALLY THE POTASSIUM SALT; REGISTERED: UK EU/1/07/436/001 20080102
3494972 2024C/522 Belgium ⤷  Sign Up PRODUCT NAME: DOLUTEGRAVIR OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT ERVAN, MET INBEGRIP VAN DOLUTEGRAVIRNATRIUM, EN LAMIVUDINE; AUTHORISATION NUMBER AND DATE: EU/1/19/1370 20190703
3494972 LUC00346 Luxembourg ⤷  Sign Up PRODUCT NAME: DOLUTEGRAVIR OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE, Y COMPRIS LE DOLUTEGRAVIR SODIQUE, ET LAMIVUDINE; AUTHORISATION NUMBER AND DATE: EU/1/19/1370 20190703
3494972 301277 Netherlands ⤷  Sign Up PRODUCT NAME: DOLUTEGRAVIR OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT, WAARONDER DOLUTEGRAVIRNATRIUM, EN LAMIVUDINE; REGISTRATION NO/DATE: EU/1/19/1370 20190703
0817637 05C0022 France ⤷  Sign Up PRODUCT NAME: ABACAVIR SULFATE; LAMIVUDINE; REGISTRATION NO/DATE: EU/1/04/298/001 20041217
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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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 verification 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.