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Last Updated: November 21, 2024

DORAVIRINE; LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATE - Generic Drug Details


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What are the generic drug sources for doravirine; lamivudine; tenofovir disoproxil fumarate and what is the scope of patent protection?

Doravirine; lamivudine; tenofovir disoproxil fumarate is the generic ingredient in one branded drug marketed by Msd Merck Co and is included in one NDA. There are three patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Doravirine; lamivudine; tenofovir disoproxil fumarate has ninety-seven patent family members in forty-five countries.

One supplier is listed for this compound.

Summary for DORAVIRINE; LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATE
International Patents:97
US Patents:3
Tradenames:1
Applicants:1
NDAs:1
Finished Product Suppliers / Packagers: 1
Clinical Trials: 13
DailyMed Link:DORAVIRINE; LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATE at DailyMed
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for DORAVIRINE; LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATE
Generic Entry Date for DORAVIRINE; LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATE*:
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 DORAVIRINE; LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATE

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

SponsorPhase
Centre de Recherches et d'Etude sur la Pathologie Tropicale et le SidaN/A
Merck Sharp & Dohme LLCPhase 3
Prism Health North TexasPhase 3

See all DORAVIRINE; LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATE clinical trials

Paragraph IV (Patent) Challenges for DORAVIRINE; LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATE
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
DELSTRIGO Tablets doravirine; lamivudine; tenofovir disoproxil fumarate 100 mg/300 mg/ 300 mg 210807 1 2022-08-30

US Patents and Regulatory Information for DORAVIRINE; LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Msd Merck Co DELSTRIGO doravirine; lamivudine; tenofovir disoproxil fumarate TABLET;ORAL 210807-001 Aug 30, 2018 RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Msd Merck Co DELSTRIGO doravirine; lamivudine; tenofovir disoproxil fumarate TABLET;ORAL 210807-001 Aug 30, 2018 RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Msd Merck Co DELSTRIGO doravirine; lamivudine; tenofovir disoproxil fumarate TABLET;ORAL 210807-001 Aug 30, 2018 RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y Y ⤷  Sign Up
Msd Merck Co DELSTRIGO doravirine; lamivudine; tenofovir disoproxil fumarate TABLET;ORAL 210807-001 Aug 30, 2018 RX Yes Yes ⤷  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

Supplementary Protection Certificates for DORAVIRINE; LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATE

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2924034 CA 2019 00024 Denmark ⤷  Sign Up PRODUCT NAME: DORAVIRINE, LAMIVUDINE AND DISOPROXIL; REG. NO/DATE: EU/1/18/1333 20181126
2924034 LUC00114 Luxembourg ⤷  Sign Up PRODUCT NAME: DORAVIRINE OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELLE-CI EN COMBINAISON AVEC LA LAMIVUDINE OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELLE-CI EN COMBINAISON AVEC DU TENOFOVIR OU UN DE SES ESTERS, EN PARTICULIER UN ESTER DE DISOPROXIL OU UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES, EN PARTICULIER UN SEL DE FUMARATE; AUTHORISATION NUMBER AND DATE: EU/1/18/1333 20181126
2552902 2019C/004 Belgium ⤷  Sign Up PRODUCT NAME: DORAVIRINE,DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT; AUTHORISATION NUMBER AND DATE: EU/1/18/1333/001-002 20181126
2924034 PA2019507 Lithuania ⤷  Sign Up PRODUCT NAME: DORAVIRINAS ARBA JO DRUSKA, LAMIVUDINAS ARBA JO DRUSKA, TENOFOVIRAS ARBA JO ESTERIS, YPAC DIZOPROKSILO ESTERIS ARBA JO DRUSKA, YPAC FUMARATO DRUSKA; REGISTRATION NO/DATE: EU/1/18/1333 20181122
2552902 PA2019506 Lithuania ⤷  Sign Up PRODUCT NAME: DORAVIRINAS ARBA JO FARMACINIU POZIURIU PRIIMTINA DRUSKA; REGISTRATION NO/DATE: EU/1/18/1332 20181122
2552902 C201930026 Spain ⤷  Sign Up PRODUCT NAME: DORAVIRINA O UNA SAL FARMACEUTICAMENTE ACEPTABLE DE LA MISMA; NATIONAL AUTHORISATION NUMBER: EU/1/18/1333; DATE OF AUTHORISATION: 20181122; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/18/1333; DATE OF FIRST AUTHORISATION IN EEA: 20181122
2924034 1990024-0 Sweden ⤷  Sign Up PRODUCT NAME: DORAVIRINE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF IN COMBINATION WITH LAMIVUDINE AND TENOFOVIR DISOPROXIL FUMARATE; REG. NO/DATE: EU/1/18/1333 20181126
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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