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-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
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 PD | abacavir sulfate; dolutegravir sodium; lamivudine | TABLET, FOR SUSPENSION;ORAL | 215413-001 | Mar 30, 2022 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Viiv Hlthcare | TRIUMEQ PD | abacavir sulfate; dolutegravir sodium; lamivudine | TABLET, FOR SUSPENSION;ORAL | 215413-001 | Mar 30, 2022 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Viiv Hlthcare | TRIUMEQ | abacavir sulfate; dolutegravir sodium; lamivudine | TABLET;ORAL | 205551-001 | Aug 22, 2014 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
>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 | ⤷ Sign Up | ⤷ Sign Up |
Viiv Hlthcare | TRIUMEQ | abacavir sulfate; dolutegravir sodium; lamivudine | TABLET;ORAL | 205551-001 | Aug 22, 2014 | ⤷ Sign Up | ⤷ Sign Up |
Viiv Hlthcare | TRIUMEQ | abacavir sulfate; dolutegravir sodium; lamivudine | TABLET;ORAL | 205551-001 | Aug 22, 2014 | ⤷ Sign Up | ⤷ Sign Up |
>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 |
---|---|---|---|
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) | ⤷ Sign Up |
Portugal | 3372281 | ⤷ Sign Up | |
Japan | 2012131791 | SYNTHESIS OF CARBAMOYLPYRIDONE HIV INTEGRASE INHIBITORS AND THEIR INTERMEDIATES | ⤷ Sign Up |
>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 |
---|---|---|---|---|
0817637 | 23/2005 | Austria | ⤷ Sign Up | 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 | CR 2014 00032 | Denmark | ⤷ Sign Up | PRODUCT NAME: DOLUTEGRAVIR ELLER ET FARMACEUTISK ACCEPTABELT SALT ELLER SOLVAT DERAF, HERUNDER DOLUTEGRAVIRNATRIUM; REG. NO/DATE: EU/1/13/892/001-002 20140121 |
1874117 | 30/2014 | Austria | ⤷ Sign Up | PRODUCT NAME: DOLUTEGRAVIR ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ ODER SOLVAT DAVON, EINSCHLIESSLICH DOLUTEGRAVIR-NATRIUM; REGISTRATION NO/DATE: EU/1/13/892/001-002 (MITTEILUNG) 20140121 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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