Dolutegravir sodium - Generic Drug Details
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What are the generic drug sources for dolutegravir sodium and what is the scope of freedom to operate?
Dolutegravir sodium
is the generic ingredient in four branded drugs marketed by Viiv Hlthcare and is included in four NDAs. There are five patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.Dolutegravir sodium has one hundred and fifty-five patent family members in thirty-five countries.
There are seventeen drug master file entries for dolutegravir sodium. Two suppliers are listed for this compound. There are eight tentative approvals for this compound.
Summary for dolutegravir sodium
International Patents: | 155 |
US Patents: | 5 |
Tradenames: | 4 |
Applicants: | 1 |
NDAs: | 4 |
Drug Master File Entries: | 17 |
Finished Product Suppliers / Packagers: | 2 |
Raw Ingredient (Bulk) Api Vendors: | 46 |
Clinical Trials: | 1 |
Patent Applications: | 96 |
Formulation / Manufacturing: | see details |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for dolutegravir sodium |
What excipients (inactive ingredients) are in dolutegravir sodium? | dolutegravir sodium excipients list |
DailyMed Link: | dolutegravir sodium at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for dolutegravir sodium
Generic Entry Dates for dolutegravir sodium*:
Constraining patent/regulatory exclusivity:
Dosage:
TABLET, FOR SUSPENSION;ORAL |
Generic Entry Dates for dolutegravir sodium*:
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.
Recent Clinical Trials for dolutegravir sodium
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
St Stephens Aids Trust | Phase 4 |
Generic filers with tentative approvals for DOLUTEGRAVIR SODIUM
Applicant | Application No. | Strength | Dosage Form |
⤷ Try a Trial | ⤷ Try a Trial | 50MG | TABLET;ORAL |
⤷ Try a Trial | ⤷ Try a Trial | 50MG | TABLET;ORAL |
⤷ Try a Trial | ⤷ Try a Trial | 50MG | TABLET;ORAL |
The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.
Pharmacology for dolutegravir sodium
Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
---|---|---|---|---|---|---|
TIVICAY PD | Tablets for Suspension | dolutegravir sodium | 5 mg | 213983 | 1 | 2021-07-21 |
TIVICAY | Tablets | dolutegravir sodium | 10 mg, 25 mg and 50 mg | 204790 | 4 | 2017-08-14 |
US Patents and Regulatory Information for dolutegravir sodium
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 | TIVICAY | dolutegravir sodium | TABLET;ORAL | 204790-003 | Jun 9, 2016 | DISCN | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
Viiv Hlthcare | JULUCA | dolutegravir sodium; rilpivirine hydrochloride | TABLET;ORAL | 210192-001 | Nov 21, 2017 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | Y | ⤷ Try a Trial | ||
Viiv Hlthcare | TIVICAY PD | dolutegravir sodium | TABLET, FOR SUSPENSION;ORAL | 213983-001 | Jun 12, 2020 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
Viiv Hlthcare | TIVICAY | dolutegravir sodium | TABLET;ORAL | 204790-002 | Jun 9, 2016 | DISCN | Yes | No | ⤷ 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
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Norway | 20161315 | Polysyklisk karbamoylpyridonderivat som har integrase inhibitorisk aktivitet | ⤷ Try a Trial |
Japan | 6130891 | ⤷ Try a Trial | |
Portugal | 3045206 | ⤷ Try a Trial | |
Spain | 2437268 | ⤷ Try a Trial | |
Mexico | 2007013351 | DERIVADO DE CARBAMOILPIRIDONA POLICICLICO QUE TIENE ACTIVIDAD INHIBIDORA DE LA INTEGRASA DE HIV. (POLYCYCLIC CARBAMOYLPYRIDONE DERIVATIVE HAVING HIV INTEGRASE INHIBITORY ACTIVITY.) | ⤷ Try a Trial |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for dolutegravir sodium
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
1874117 | PA2014021,C1874117 | Lithuania | ⤷ Try a Trial | PRODUCT NAME: DOLUTEGRAVIRAS ARBA JO FARMACINIU POZIURIU PRIIMTINA DRUSKA ARBA SOLVATAS, ISKAITANT DOLUTEGRAVIRO NATRIO DRUSKA; REGISTRATION NO/DATE: EU/1/13/892/001, 2014-01-16 EU/1/13/892/002 20140116 |
2465580 | C202130021 | Spain | ⤷ Try a Trial | PRODUCT NAME: CABOTEGRAVIR; NATIONAL AUTHORISATION NUMBER: EU/1/20/1481; DATE OF AUTHORISATION: 20201217; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/20/1481; DATE OF FIRST AUTHORISATION IN EEA: 20201217 |
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 | LUC00090 | Luxembourg | ⤷ Try a Trial | PRODUCT NAME: COMBINAISON COMPRENANT DU DOLUTEGRAVIR OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI (PAR EXEMPLE LE DOLUTEGRAVIR SODIQUE) ET LA RILPIVIRINE OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI (PAR EXEMPLE LE CHLORHYDRATE DE RILPIVIRINE); AUTHORISATION NUMBER AND DATE: EU/1/18/1282 20180518 |
2465580 | 122021000021 | Germany | ⤷ Try a Trial | PRODUCT NAME: CABOTEGRAVIR ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ ODER SOLVAT DAVON; REGISTRATION NO/DATE: EU/1/20/1481 20201217 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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