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
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 |
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 |
---|---|---|---|
Hungary | S1600060 | ⤷ Try a Trial | |
South Korea | 20170078868 | 항바이러스 치료 (ANTIBIRAL THERAPY) | ⤷ Try a Trial |
Poland | 2932970 | ⤷ Try a Trial | |
Japan | 2011236221 | HIV-INHIBITING PYRIMIDINE DERIVATIVE | ⤷ Try a Trial |
Finland | 3494972 | ⤷ Try a Trial | |
South Korea | 20080064182 | POLYCYCLIC CARBAMOYLPYRIDONE DERIVATIVE HAVING INHIBITORY ACTIVITY ON HIV INTEGRASE | ⤷ Try a Trial |
Taiwan | 200716635 | Polycyclic carbamoylpyridone derivative having HIV integrase inhibitory activity | ⤷ 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 |
---|---|---|---|---|
2932970 | 300957 | Netherlands | ⤷ Try a Trial | PRODUCT NAME: EEN COMBINATIE OMVATTENDE DOLUTEGRAVIR OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN (ZOALS DOLUTEGRAVIR NATRIUM) EN RILPIVIRINE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN (ZOALS RILPIVIRINE HYDROCHLORIDE); REGISTRATION NO/DATE: NOT AVAILABLE |
1663240 | 379 5033-2016 | Slovakia | ⤷ Try a Trial | PRODUCT NAME: RILPIVIRIN VO VSETKYCH FORMACH CHRANENYCH ZAKLADNYM PATENTOM/TENOFOVIR-ALAFENAMID VO VSETKYCH FORMACH CHRA- NENYCH ZAKLADNYM PATENTOM; REGISTRATION NO/DATE: EU/1/16/1112 20160623 |
1874117 | 300676 | Netherlands | ⤷ Try a Trial | PRODUCT NAME: DOLUTEGRAVIR OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT OF SOLVAAT DAARVAN, MET INBEGRIP VAN DOLUTEGRAVIR NATRIUM; REGISTRATION NO/DATE: EU/1/13/892 20140121 |
1663240 | 224 5022-2015 | Slovakia | ⤷ Try a Trial | PRODUCT NAME: RILPIVIRINHYDROCHLORID/TENOFOVIRDIZOPROXILFUMARAT; REGISTRATION NO/DATE: EU/1/11/737/001 - EU/1/11/737/002 20111128 |
1663240 | 1590056-6 | Sweden | ⤷ Try a Trial | PRODUCT NAME: A COMBINATION OF RILPIVIRINE, OR A PHARMACEUTICALLY ACCEPTABLE SALT OF RILPIVIRINE, INCLUDING THE HYDROCHLORIDE SALT OF RILPIVIRINE, AND TENOFOVIR DISOPROXIL, IN PARTICULAR TENOFOVIR DISOPROXIL FUMARATE; REG. NO/DATE: EU/1/11/737 20111128 |
1663240 | 93382 | Luxembourg | ⤷ Try a Trial | PRODUCT NAME: COMBINAISON DE RILPIVIRINE OU UNE FORME THERAPEUTIQUE EQUIVALENTE QUI EN DERIVE TELLE QUE PROTEGEE PAR LE BREVET DE BASE, TEL QU'UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE RILPIVIRINE, INCLUANT LE SEL CHLORHYDRATE DE RILPIVIRINE ET TENOFOVIR ALAFENAMIDE, OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI, EN PARTICULIER LE FUMARATE DE TENOFOVIR ALAFENAMIDE; AUTHORISATION NUMBER AND DATE: EU/1/16/1112 ODEFSEY - EMTRICITABINE |
1663240 | 300767 | Netherlands | ⤷ Try a Trial | DETAILS ASSIGNMENT: CHANGE OF OWNER(S), CHANGE OF OWNER(S) NAME |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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