abacavir sulfate; dolutegravir sodium; lamivudine - Profile
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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-seven patent family members in thirty-five countries.
Summary for abacavir sulfate; dolutegravir sodium; lamivudine
| International Patents: | 157 |
| US Patents: | 2 |
| Tradenames: | 2 |
| Applicants: | 1 |
| NDAs: | 2 |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for abacavir sulfate; dolutegravir sodium; lamivudine |
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.
Paragraph IV (Patent) Challenges 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 | 9,242,986*PED | ⤷ Start Trial | Y | ⤷ Start Trial | |||
| 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 | ⤷ Start Trial | Y | ⤷ Start Trial | |||
| Viiv Hlthcare | TRIUMEQ PD | abacavir sulfate; dolutegravir sodium; lamivudine | TABLET, FOR SUSPENSION;ORAL | 215413-001 | Mar 30, 2022 | RX | Yes | Yes | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | ||||
| Viiv Hlthcare | TRIUMEQ PD | abacavir sulfate; dolutegravir sodium; lamivudine | TABLET, FOR SUSPENSION;ORAL | 215413-001 | Mar 30, 2022 | RX | Yes | Yes | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start 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 abacavir sulfate; dolutegravir sodium; lamivudine
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Austria | E516026 | ⤷ Start Trial | |
| Australia | 2006239177 | Polycyclic carbamoylpyridone derivative having HIV integrase inhibitory activity | ⤷ Start Trial |
| Australia | 2006307101 | Polycyclic carbamoylpyridone derivative having inhibitory activity on HIV integrase | ⤷ Start Trial |
| Brazil | PI0610030 | composto, processo para a preparação de um composto, método de tratamento de uma infecção por hiv em um humano, uso de um composto, e, composição farmacêutica | ⤷ Start 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 | 132021000000098 | Italy | ⤷ Start Trial | PRODUCT NAME: CABOTEGRAVIR(VOCABRIA); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/20/1481, 20201221 |
| 1874117 | C201430032 | Spain | ⤷ Start 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 |
| 2465580 | 2021C/519 | Belgium | ⤷ Start Trial | PRODUCT NAME: VOCABRIA-CABOTEGRAVIR; AUTHORISATION NUMBER AND DATE: EU/1/20/1481 20201221 |
| 1874117 | 202 50006-2014 | Slovakia | ⤷ Start Trial | PRODUCT NAME: SODNA SOL DOLUTEGRAVIRU; REGISTRATION NO/DATE: EU/1/13/892/001 - EU/1/13/892/002 20140121 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
Investment Analysis on the Pharmaceutical Trio: Abacavir Sulfate, Dolutegravir Sodium, and Lamivudine
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