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Last Updated: March 24, 2023

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 freedom to operate?

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-one patent family members in forty-four countries.

One supplier is listed for this compound.

Summary for doravirine; lamivudine; tenofovir disoproxil fumarate
International Patents:91
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
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
Prism Health North TexasPhase 3
Merck Sharp & Dohme LLCPhase 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 See Plans and Pricing See Plans and Pricing See Plans and Pricing
Msd Merck Co DELSTRIGO doravirine; lamivudine; tenofovir disoproxil fumarate TABLET;ORAL 210807-001 Aug 30, 2018 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Msd Merck Co DELSTRIGO doravirine; lamivudine; tenofovir disoproxil fumarate TABLET;ORAL 210807-001 Aug 30, 2018 RX Yes Yes See Plans and Pricing See Plans and Pricing Y Y See Plans and Pricing
Msd Merck Co DELSTRIGO doravirine; lamivudine; tenofovir disoproxil fumarate TABLET;ORAL 210807-001 Aug 30, 2018 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Msd Merck Co DELSTRIGO doravirine; lamivudine; tenofovir disoproxil fumarate TABLET;ORAL 210807-001 Aug 30, 2018 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Msd Merck Co DELSTRIGO doravirine; lamivudine; tenofovir disoproxil fumarate TABLET;ORAL 210807-001 Aug 30, 2018 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

International Patents for doravirine; lamivudine; tenofovir disoproxil fumarate

Country Patent Number Title Estimated Expiration
Serbia 54017 NE-NUKLEOZIDNI INHIBITORI REVERZNE TRANSKRIPTAZE (NON-NUCLEOSIDE REVERSE TRANSCRIPTASE INHIBITORS) See Plans and Pricing
Lithuania C2924034 See Plans and Pricing
Hong Kong 1209121 包含非核苷逆轉錄酶抑制劑的藥物組合物 (PHARMACEUTICAL COMPOSITION COMPRISING A NON-NUCLEOSIDE REVERSE TRANSCRIPTASE INHIBITOR) See Plans and Pricing
Argentina 080859 DERIVADOS 1,2,4 TRIAZOLO-PIRIDINICOS INHIBIDORES NO NUCLEOSIDICOS DE LA TRANSCRIPTASA INVERSA, UTILES PARA TRATAR INFECCIONES POR VIH Y COMPOSICIONES FARMACEUTICAS QUE LOS CONTIENEN. See Plans and Pricing
Colombia 6630126 Inhibidores no nucleosídicos de la transcriptasa inversa See Plans and Pricing
China 102971308 Non-nucleoside reverse transcriptase inhibitors See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for doravirine; lamivudine; tenofovir disoproxil fumarate

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2924034 300981 Netherlands See Plans and Pricing PRODUCT NAME: DORAVIRINE, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT IN COMBINATIE MET LAMIVUDINE, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, IN COMBINATIE MET TENOFOVIR OF EEN ESTER DAARVAN, IN HET BIJZONDER EEN DISOPROXIL ESTER, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, IN HET BIJZONDER EEN FUMARAAT ZOUT; REGISTRATION NO/DATE: EU/1/18/1333/001-002 20181126
2552902 C02552902/01 Switzerland See Plans and Pricing PRODUCT NAME: DORAVIRIN; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 67065 17.12.2019
2924034 CR 2019 00024 Denmark See Plans and Pricing PRODUCT NAME: DORAVIRINE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF IN COMBINATION WITH LAMIVUDINE AND IN COMBINATION WITH TENOFOVIR DISOPROXIL FUMARATE; REG. NO/DATE: EU/1/18/1333 20181126
2552902 PA2019506 Lithuania See Plans and Pricing PRODUCT NAME: DORAVIRINAS ARBA JO FARMACINIU POZIURIU PRIIMTINA DRUSKA; REGISTRATION NO/DATE: EU/1/18/1332 20181122
2924034 CA 2019 00024 Denmark See Plans and Pricing PRODUCT NAME: DORAVIRINE, LAMIVUDINE AND DISOPROXIL; REG. NO/DATE: EU/1/18/1333 20181126
2552902 C201930026 Spain See Plans and Pricing 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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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