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
Sponsor | Phase |
---|---|
Centre de Recherches et d'Etude sur la Pathologie Tropicale et le Sida | N/A |
Prism Health North Texas | Phase 3 |
Merck Sharp & Dohme LLC | Phase 3 |
See all doravirine; lamivudine; tenofovir disoproxil fumarate clinical trials
Pharmacology 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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