Dolutegravir sodium; rilpivirine hydrochloride - Generic Drug Details
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What are the generic drug sources for dolutegravir sodium; rilpivirine hydrochloride and what is the scope of patent protection?
Dolutegravir sodium; rilpivirine hydrochloride
is the generic ingredient in one branded drug marketed by Viiv Hlthcare and is included in one NDA. There are four patents protecting this compound. Additional information is available in the individual branded drug profile pages.Dolutegravir sodium; rilpivirine hydrochloride has four hundred and seventy-three patent family members in fifty-seven countries.
One supplier is listed for this compound.
Summary for dolutegravir sodium; rilpivirine hydrochloride
International Patents: | 473 |
US Patents: | 4 |
Tradenames: | 1 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 1 |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for dolutegravir sodium; rilpivirine hydrochloride |
DailyMed Link: | dolutegravir sodium; rilpivirine hydrochloride at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for dolutegravir sodium; rilpivirine hydrochloride
Generic Entry Date for dolutegravir sodium; rilpivirine hydrochloride*:
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.
Pharmacology for dolutegravir sodium; rilpivirine hydrochloride
Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
---|---|---|---|---|---|---|
JULUCA | Tablets | dolutegravir sodium; rilpivirine hydrochloride | 50 mg/25 mg | 210192 | 1 | 2019-11-19 |
US Patents and Regulatory Information for dolutegravir sodium; rilpivirine hydrochloride
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Viiv Hlthcare | JULUCA | dolutegravir sodium; rilpivirine hydrochloride | TABLET;ORAL | 210192-001 | Nov 21, 2017 | RX | Yes | Yes | ⤷ 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 | JULUCA | dolutegravir sodium; rilpivirine hydrochloride | TABLET;ORAL | 210192-001 | Nov 21, 2017 | RX | Yes | Yes | ⤷ 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 |
Expired US Patents for dolutegravir sodium; rilpivirine hydrochloride
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Viiv Hlthcare | JULUCA | dolutegravir sodium; rilpivirine hydrochloride | TABLET;ORAL | 210192-001 | Nov 21, 2017 | ⤷ Try a Trial | ⤷ Try a Trial |
Viiv Hlthcare | JULUCA | dolutegravir sodium; rilpivirine hydrochloride | TABLET;ORAL | 210192-001 | Nov 21, 2017 | ⤷ Try a Trial | ⤷ Try a Trial |
Viiv Hlthcare | JULUCA | dolutegravir sodium; rilpivirine hydrochloride | TABLET;ORAL | 210192-001 | Nov 21, 2017 | ⤷ Try a Trial | ⤷ Try a Trial |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for dolutegravir sodium; rilpivirine hydrochloride
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Ecuador | SP12012106 | TERAPIA ANTIVIRAL | ⤷ Try a Trial |
South Korea | 20160111536 | 항바이러스 치료 (ANTIBIRAL THERAPY) | ⤷ Try a Trial |
Norway | 339525 | ⤷ Try a Trial | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for dolutegravir sodium; rilpivirine hydrochloride
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 |
1419152 | C 2012 016 | Romania | ⤷ Try a Trial | PRODUCT NAME: COMBINATIE DE RILPIVIRINA SI TOATE FORMELE ECHIVALENTETERAPEUTIC ALE ACESTEIA CUM AR FI SARURILE DE ADITIE ALE RILPIVIRINEI ACCEPTABILE FARMACEUTIC, INCLUSIV SAREARILPIVIRINEI CU ACIDUL CLORHIDRIC, SI TENOFOVIR, IN PARTICULAR FUMARAT DE TENOFOVIRDISOPROXIL; NATIONAL AUTHORISATION NUMBER: EU/1/11/737/001, EU/1/11/737/002; DATE OF NATIONAL AUTHORISATION: 20111128; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/11/737/001, EU/1/11/737/002; DATE OF FIRST AUTHORISATION IN EEA: 20111128 |
3808743 | C03808743/01 | Switzerland | ⤷ Try a Trial | PRODUCT NAME: RILPIVIRIN UND EMTRICITABIN; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 62155 12.03.2013 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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