Abacavir sulfate; dolutegravir sodium; lamivudine - Generic Drug Details
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What are the generic drug sources for abacavir sulfate; dolutegravir sodium; lamivudine and what is the scope of freedom to operate?
Abacavir sulfate; dolutegravir sodium; lamivudine
is the generic ingredient in two branded drugs marketed by Viiv Hlthcare and is included in two NDAs. There are two patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.Abacavir sulfate; dolutegravir sodium; lamivudine has one hundred and fifty-six patent family members in thirty-five countries.
One supplier is listed for this compound.
Summary for abacavir sulfate; dolutegravir sodium; lamivudine
International Patents: | 156 |
US Patents: | 2 |
Tradenames: | 2 |
Applicants: | 1 |
NDAs: | 2 |
Finished Product Suppliers / Packagers: | 1 |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for abacavir sulfate; dolutegravir sodium; lamivudine |
DailyMed Link: | abacavir sulfate; dolutegravir sodium; lamivudine at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for abacavir sulfate; dolutegravir sodium; lamivudine
Generic Entry Dates for abacavir sulfate; dolutegravir sodium; lamivudine*:
Constraining patent/regulatory exclusivity:
Dosage:
TABLET;ORAL |
Generic Entry Dates for abacavir sulfate; dolutegravir sodium; lamivudine*:
Constraining patent/regulatory exclusivity:
Dosage:
TABLET, FOR SUSPENSION;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 abacavir sulfate; dolutegravir sodium; lamivudine
Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
---|---|---|---|---|---|---|
TRIUMEQ PD | Tablets for Oral Suspension | abacavir sulfate; dolutegravir sodium; lamivudine | 60 mg/5 mg/30 mg | 215413 | 1 | 2023-03-31 |
TRIUMEQ | Tablets | abacavir sulfate; dolutegravir sodium; lamivudine | 600 mg/50 mg/ 300 mg | 205551 | 5 | 2017-08-14 |
US Patents and Regulatory Information for abacavir sulfate; 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 | TRIUMEQ | abacavir sulfate; dolutegravir sodium; lamivudine | TABLET;ORAL | 205551-001 | Aug 22, 2014 | RX | Yes | Yes | 9,242,986*PED | ⤷ Try for Free | Y | ⤷ Try for Free | |||
Viiv Hlthcare | TRIUMEQ | abacavir sulfate; dolutegravir sodium; lamivudine | TABLET;ORAL | 205551-001 | Aug 22, 2014 | RX | Yes | Yes | ⤷ Try for Free | ⤷ Try for Free | ⤷ Try for Free | ||||
Viiv Hlthcare | TRIUMEQ PD | abacavir sulfate; dolutegravir sodium; lamivudine | TABLET, FOR SUSPENSION;ORAL | 215413-001 | Mar 30, 2022 | RX | Yes | Yes | ⤷ Try for Free | ⤷ Try for Free | ⤷ Try for Free | ||||
Viiv Hlthcare | TRIUMEQ PD | abacavir sulfate; dolutegravir sodium; lamivudine | TABLET, FOR SUSPENSION;ORAL | 215413-001 | Mar 30, 2022 | RX | Yes | Yes | 8,129,385*PED | ⤷ Try for Free | Y | ⤷ Try for Free | |||
Viiv Hlthcare | TRIUMEQ PD | abacavir sulfate; dolutegravir sodium; lamivudine | TABLET, FOR SUSPENSION;ORAL | 215413-001 | Mar 30, 2022 | RX | Yes | Yes | ⤷ Try for Free | ⤷ Try for Free | ⤷ Try for Free | ||||
Viiv Hlthcare | TRIUMEQ | abacavir sulfate; dolutegravir sodium; lamivudine | TABLET;ORAL | 205551-001 | Aug 22, 2014 | RX | Yes | Yes | 8,129,385*PED | ⤷ Try for Free | Y | ⤷ Try for Free | |||
>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 abacavir sulfate; dolutegravir sodium; lamivudine
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Viiv Hlthcare | TRIUMEQ | abacavir sulfate; dolutegravir sodium; lamivudine | TABLET;ORAL | 205551-001 | Aug 22, 2014 | 5,905,082*PED | ⤷ Try for Free |
Viiv Hlthcare | TRIUMEQ | abacavir sulfate; dolutegravir sodium; lamivudine | TABLET;ORAL | 205551-001 | Aug 22, 2014 | 6,294,540*PED | ⤷ Try for Free |
Viiv Hlthcare | TRIUMEQ | abacavir sulfate; dolutegravir sodium; lamivudine | TABLET;ORAL | 205551-001 | Aug 22, 2014 | 6,417,191*PED | ⤷ Try for Free |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for abacavir sulfate; dolutegravir sodium; lamivudine
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Japan | 4295353 | ⤷ Try for Free | |
European Patent Office | 3284520 | ⤷ Try for Free | |
Japan | 6130891 | ⤷ Try for Free | |
Mexico | 2008005137 | ⤷ Try for Free | |
New Zealand | 562339 | ⤷ Try for Free | |
Slovenia | 1874117 | ⤷ Try for Free | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for abacavir sulfate; dolutegravir sodium; lamivudine
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
2465580 | C02465580/01 | Switzerland | ⤷ Try for Free | PRODUCT NAME: CABOTEGRAVIR; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 67740 08.10.2021 |
2465580 | C20210013 00397 | Estonia | ⤷ Try for Free | PRODUCT NAME: KABOTEGRAVIIR;REG NO/DATE: EU/1/120/1481; 21.12.2020 |
2465580 | SPC/GB21/030 | United Kingdom | ⤷ Try for Free | PRODUCT NAME: CABOTEGRAVIR OR A PHARMACEUTICALLY ACCEPTABLE SALT OR SOLVATE THEREOF, INCLUDING CABOTEGRAVIR SODIUM.; REGISTERED: UK EU/1/20/1481 (NI) 20201221; UK PLGB 35728/0055-57 20201221 |
1874117 | C 2014 024 | Romania | ⤷ Try for Free | PRODUCT NAME: DOLUTEGRAVIR SAU O SARE SAU SOLVAT AL ACESTUIAACCEPTABILE FARMACEUTIC, INCLUSIV DOLUTEGRAVIR DESODIU; NATIONAL AUTHORISATION NUMBER: EU/1/13/892; DATE OF NATIONAL AUTHORISATION: 20140116; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/13/892; DATE OF FIRST AUTHORISATION IN EEA: 20140116 |
2465580 | C 2021 017 | Romania | ⤷ Try for Free | PRODUCT NAME: CABOTEGRAVIR; NATIONAL AUTHORISATION NUMBER: EU/1/20/1481; DATE OF NATIONAL AUTHORISATION: 20201217; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/20/1481; DATE OF FIRST AUTHORISATION IN EEA: 20201217 |
1874117 | CR 2014 00032 | Denmark | ⤷ Try for Free | PRODUCT NAME: DOLUTEGRAVIR ELLER ET FARMACEUTISK ACCEPTABELT SALT ELLER SOLVAT DERAF, HERUNDER DOLUTEGRAVIRNATRIUM; REG. NO/DATE: EU/1/13/892/001-002 20140121 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
Market Dynamics and Financial Trajectory for Abacavir Sulfate; Dolutegravir Sodium; Lamivudine
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