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 eighty patent family members in fifty-seven countries.
One supplier is listed for this compound.
Summary for DOLUTEGRAVIR SODIUM; RILPIVIRINE HYDROCHLORIDE
International Patents: | 480 |
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 | ⤷ Sign Up | ⤷ Sign Up | Y | Y | ⤷ Sign Up | ||
Viiv Hlthcare | JULUCA | dolutegravir sodium; rilpivirine hydrochloride | TABLET;ORAL | 210192-001 | Nov 21, 2017 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
Viiv Hlthcare | JULUCA | dolutegravir sodium; rilpivirine hydrochloride | TABLET;ORAL | 210192-001 | Nov 21, 2017 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | Y | ⤷ Sign Up | ||
Viiv Hlthcare | JULUCA | dolutegravir sodium; rilpivirine hydrochloride | TABLET;ORAL | 210192-001 | Nov 21, 2017 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ 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 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 | ⤷ Sign Up | ⤷ Sign Up |
Viiv Hlthcare | JULUCA | dolutegravir sodium; rilpivirine hydrochloride | TABLET;ORAL | 210192-001 | Nov 21, 2017 | ⤷ Sign Up | ⤷ Sign Up |
Viiv Hlthcare | JULUCA | dolutegravir sodium; rilpivirine hydrochloride | TABLET;ORAL | 210192-001 | Nov 21, 2017 | ⤷ Sign Up | ⤷ Sign Up |
Viiv Hlthcare | JULUCA | dolutegravir sodium; rilpivirine hydrochloride | TABLET;ORAL | 210192-001 | Nov 21, 2017 | ⤷ Sign Up | ⤷ Sign Up |
>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 |
---|---|---|---|
Lithuania | C2465580 | ⤷ Sign Up | |
Montenegro | 02182 | TERAPEUTSKA KOMBINACIJA KOJA SADRŽI DOLUTEGRAVIR, ABAKAVIR l LAMIVUDIN (THERAPEUTIC COMBINATION COMPRISING DOLUTEGRAVIR, ABACAVIR AND LAMIVUDINE) | ⤷ Sign Up |
Denmark | 3187225 | ⤷ Sign Up | |
Norway | 2017065 | ⤷ Sign Up | |
South Korea | 20130127515 | COMBINATIONS OF A PYRIMIDINE CONTAINING NNRTI WITH RT INHIBITORS | ⤷ 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 DOLUTEGRAVIR SODIUM; RILPIVIRINE HYDROCHLORIDE
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
2932970 | 1890039-9 | Sweden | ⤷ Sign Up | PRODUCT NAME: DOLUTEGRAVIR SODIUM + RILPIVIRINE HYDROCHLORIDE; REG. NO/DATE: EU/1/18/1282 20180518 |
1632232 | 300852 | Netherlands | ⤷ Sign Up | PRODUCT NAME: COMBINATIE VAN: - RILPIVIRINEHYDROCHLORIDE OF EEN THERAPEUTISCH EQUIVALENTE VORM DAARVAN ZOALS BESCHERMD DOOR HET BASISOCTROOI; - EMTRICITABINE; EN - TENOFOVIRALAFENAMIDE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN, IN HET BIJZONDER TENOFOVIRALAFENAMIDEFUMARAAT; REGISTRATION NO/DATE: EU/1/16/1112 20160623 |
1419152 | 628 | Finland | ⤷ Sign Up | |
2932970 | PA2018013,C2932970 | Lithuania | ⤷ Sign Up | PRODUCT NAME: DERINYS, APIMANTIS DOLUTEGRAVIRA ARBA FARMACINIU POZIURIU PRIIMTINA JO DRUSKA (PVZ., DOLUTEGRAVIRO NATRIO DRUSKA) IR RILPIVIRINA ARBA FARMACINIU POZIURIU PRIIMTINA JO DRUSKA (PVZ., RILPIVIRINO HIDROCHLORIDA); REGISTRATION NO/DATE: EU/1/18/1282/001-002 20180516 |
2932970 | C201830054 | Spain | ⤷ Sign Up | PRODUCT NAME: COMBINACION QUE COMPRENDE DOLUTEGRAVIR O UNA SAL FARMACEUTICAMENTE ACEPTABLE DEL MISMO (DOLUTEGRAVIR SODICO) Y RILPIVIRINA O UNA SAL FARMACEUTICAMENTE ACEPTABLE DE LA MISMA (RILPIVIRINA HIDROCLORURO); NATIONAL AUTHORISATION NUMBER: EU/1/18/1282; DATE OF AUTHORISATION: 20180516; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/18/1282; DATE OF FIRST AUTHORISATION IN EEA: 20180516 |
1632232 | 122016000111 | Germany | ⤷ Sign Up | PRODUCT NAME: KOMBINATION VON RILPIVIRINHYDROCHLORID ODER EINER THERAPEUTISCH AEQUIVALENTEN, DURCH DAS GRUNDPATENT GESCHUETZTEN FORM DAVON, EMTRICITABIN UND TENOFOVIRALAFENAMID ODER EINEM PHARMAZEUTISCH AKZEPTABLEN SALZ DAVON, INSBESONDERE TENOFOVIRALAFENAMIDFUMARAT; REGISTRATION NO/DATE: EU/1/16/1112 20160621 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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