Dolutegravir sodium; lamivudine - Generic Drug Details
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What are the generic sources for dolutegravir sodium; lamivudine and what is the scope of patent protection?
Dolutegravir sodium; lamivudine
is the generic ingredient in one branded drug marketed by Viiv Hlthcare and is included in one NDA. There are three patents protecting this compound. Additional information is available in the individual branded drug profile pages.Dolutegravir sodium; lamivudine has two hundred and eighty patent family members in forty-nine countries.
One supplier is listed for this compound.
Summary for dolutegravir sodium; lamivudine
International Patents: | 280 |
US Patents: | 3 |
Tradenames: | 1 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 1 |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for dolutegravir sodium; lamivudine |
DailyMed Link: | dolutegravir sodium; lamivudine at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for dolutegravir sodium; lamivudine
Generic Entry Date for dolutegravir sodium; lamivudine*:
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.
Pharmacology for dolutegravir sodium; lamivudine
Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
---|---|---|---|---|---|---|
DOVATO | Tablets | dolutegravir sodium; lamivudine | 50 mg/300 mg | 211994 | 1 | 2019-07-30 |
US Patents and Regulatory Information for dolutegravir sodium; lamivudine
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Viiv Hlthcare | DOVATO | dolutegravir sodium; lamivudine | TABLET;ORAL | 211994-001 | Apr 8, 2019 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
Viiv Hlthcare | DOVATO | dolutegravir sodium; lamivudine | TABLET;ORAL | 211994-001 | Apr 8, 2019 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
Viiv Hlthcare | DOVATO | dolutegravir sodium; lamivudine | TABLET;ORAL | 211994-001 | Apr 8, 2019 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
>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 dolutegravir sodium; lamivudine
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Hungary | E044978 | ⤷ Try a Trial | |
Morocco | 29460 | DERIVE POLYCYCLIQUE DE LA CARBAMOYLPYRIDONE A ACTIVITE INHIBITRICE SUR L'INTEGRASE DU VIH | ⤷ Try a Trial |
Portugal | 3045206 | ⤷ Try a Trial | |
Eurasian Patent Organization | 202190473 | ПРОТИВОВИРУСНАЯ ТЕРАПИЯ | ⤷ Try a Trial |
Poland | 3127542 | ⤷ Try a Trial | |
Lithuania | 3127542 | ⤷ Try a Trial | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for dolutegravir sodium; lamivudine
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
1874117 | C201430032 | Spain | ⤷ Try a Trial | PRODUCT NAME: DOLUTEGRAVIR O UNA SAL O SOLVATO DEL MISMO FARMACEUTICAMENTE ACEPTABLE, INCLUIDA LA SAL SODICA DE DOLUTEGRAVIR.; NATIONAL AUTHORISATION NUMBER: EU/1/13/892; DATE OF AUTHORISATION: 20140116; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/13/892; DATE OF FIRST AUTHORISATION IN EEA: 20140116 |
1874117 | SPC/GB14/041 | United Kingdom | ⤷ Try a Trial | PRODUCT NAME: DOLUTEGRAVIR OR A PHARMACEUTICALLY ACCEPTABLE SALT OR SOLVATE THEREOF, INCLUDING DOLUTEGRAVIR SODIUM; REGISTERED: UK EU/1/13/892/001-006 20140121 |
2932970 | C20180031 00270 | Estonia | ⤷ Try a Trial | PRODUCT NAME: DOLUTEGRAVIIR/RILPIVIRIIN;REG NO/DATE: EU/1/18/1282 18.05.2018 |
1874117 | 300676 | Netherlands | ⤷ Try a Trial | PRODUCT NAME: DOLUTEGRAVIR OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT OF SOLVAAT DAARVAN, MET INBEGRIP VAN DOLUTEGRAVIR NATRIUM; REGISTRATION NO/DATE: EU/1/13/892 20140121 |
1874117 | 202 50006-2014 | Slovakia | ⤷ Try a Trial | PRODUCT NAME: SODNA SOL DOLUTEGRAVIRU; REGISTRATION NO/DATE: EU/1/13/892/001 - EU/1/13/892/002 20140121 |
2465580 | C02465580/01 | Switzerland | ⤷ Try a Trial | PRODUCT NAME: CABOTEGRAVIR; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 67740 08.10.2021 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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