ABACAVIR SULFATE; DOLUTEGRAVIR SODIUM; LAMIVUDINE - Generic Drug Details
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What are the generic 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-five patent family members in thirty-five countries.
One supplier is listed for this compound.
Summary for ABACAVIR SULFATE; DOLUTEGRAVIR SODIUM; LAMIVUDINE
International Patents: | 155 |
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
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 | ⤷ Try a Trial | ⤷ Try a Trial |
Viiv Hlthcare | TRIUMEQ | abacavir sulfate; dolutegravir sodium; lamivudine | TABLET;ORAL | 205551-001 | Aug 22, 2014 | ⤷ Try a Trial | ⤷ Try a Trial |
Viiv Hlthcare | TRIUMEQ | abacavir sulfate; dolutegravir sodium; lamivudine | TABLET;ORAL | 205551-001 | Aug 22, 2014 | ⤷ Try a Trial | ⤷ Try a Trial |
>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 |
---|---|---|---|
European Patent Office | 2527007 | Dérivé de carbamoylpyridone polycyclique doté d'une activité inhibitrice de l'intégrase du VIH (Polycyclic carbamoylpyridone derivative having HIV integrase inhibitory activity) | ⤷ Try a Trial |
Australia | 2009325128 | Synthesis of carbamoylpyridone HIV integrase inhibitors and intermediates | ⤷ Try a Trial |
Japan | 6130891 | ⤷ Try a Trial | |
Spain | 2892304 | ⤷ Try a Trial | |
Canada | 2626956 | DERIVE DE CARBAMOYLPYRIDONE POLYCYCLIQUE AYANT UNE ACTIVITE D'INHIBITION SUR L'INTEGRASE DU VIH (POLYCYCLIC CARBAMOYLPYRIDONE DERIVATIVE HAVING INHIBITORY ACTIVITY ON HIV INTEGRASE) | ⤷ Try a Trial |
South Korea | 101847887 | ⤷ Try a Trial | |
>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 | SPC/GB21/030 | United Kingdom | ⤷ Try a Trial | 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 |
0817637 | 23/2005 | Austria | ⤷ Try a Trial | PRODUCT NAME: KOMBINATION, UMFASSEND ABACAVIR BZW. EIN PHYSIOLOGISCH AKZEPTABLES SALZ, ESTER, SALZ DES ESTERS ODER SOLVAT DAVON UND LAMIVUDIN BZW. EIN PHYSIOLOGISCH AKZEPTABLES SALZ, ESTER, SALZ DES; REGISTRATION NO/DATE: EU/1/04/298/001, EU/1/04/298/002 20041217 |
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 | 122014000066 | Germany | ⤷ Try a Trial | PRODUCT NAME: DOLUTEGRAVIR ODER EIN PHARMAZEUTISCH VERTRAEGLICHES SALZ ODER SOLVAT DAVON, EINSCHLIESSLICH DOLUTEGRAVIRNATRIUM; REGISTRATION NO/DATE: EU/1/13/892/001-002 20140116 |
2465580 | C 2021 017 | Romania | ⤷ Try a Trial | 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 | C 2014 024 | Romania | ⤷ Try a Trial | 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 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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