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Last Updated: March 28, 2024

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-one patent family members in fifty-seven countries.

One supplier is listed for this compound.

Summary for dolutegravir sodium; rilpivirine hydrochloride
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.

Paragraph IV (Patent) Challenges 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
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
>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

International Patents for dolutegravir sodium; rilpivirine hydrochloride

Country Patent Number Title Estimated Expiration
Singapore 155885 FURAMATE OF 4-((4-((4-(2-CYANOETHENYL)-2,6-DIMETHYLPHENYL)AMINO)-2- PYRIMIDINYL)AMINO)BENZONITRILE ⤷  Try a Trial
South Korea 101830715 ⤷  Try a Trial
European Patent Office 1789139 HYDROCHLORIDE DE 4-((4-((4-(2-CYANOÉTHÉNYL)-2,6-DIMÉTHYLPHÉNYL AMINO -2-PYRIMIDINYL AMINO BENZONITRILE (FUMARATE OF 4-((4-((4-(2-CYANOETHENYL)-2,6-DIMETHYLPHENYL AMINO -2-PYRIMIDINYL AMINO BENZONITRILE) ⤷  Try a Trial
Cyprus 1115151 ⤷  Try a Trial
China 1541215 抑制HIV的嘧啶衍生物 (HIV inhibiting pyrimidines derivatives) ⤷  Try a Trial
Japan WO2007049675 HIVインテグラーゼ阻害活性を有する多環性カルバモイルピリドン誘導体 ⤷  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
1663240 1690061-5 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 ALAFENAMIDE, OR A PHARMCEUTICALLY ACCEPTABLE SALT THEREOF INCLUDING TENOFOVIR ALAFENAMIDE FUMARATE.; REG. NO/DATE: EU/1/16/1112 20160623
1663240 CA 2015 00055 Denmark ⤷  Try a Trial PRODUCT NAME: KOMBINATION AF RILPIVIRIN ELLER EN TERAPEUTISK AEKVIVALENT FORM DERAF, SOM ER BESKYTTET AF GRUNDPATENTET, SASOM ET FARMECEUTISK ACCEPTABELT SALT AF RILPIVIRIN, HERUNDER HYDROCHLORIDSALTET AF RILPIVIRIN, TENOFOVIR, NAVNLIG TENOFOVIRDISOPROXILFUMARAT; REG. NO/DATE: EU/1/11/737/001-002 20111128
1663240 2015/053 Ireland ⤷  Try a Trial PRODUCT NAME: A COMBINATION OF RILPIVIRINE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, INCLUDING THE HYDROCHLORIDE SALT, TENOFOVIR, IN PARTICULAR TENOFOVIR DISOPROXIL FUMARATE, AND EMTRICITABINE; REGISTRATION NO/DATE: EU/1/11/737/001-002 20111128
1419152 122012000038 Germany ⤷  Try a Trial PRODUCT NAME: KOMBINATION AUS RILPIVIRIN ODER EINER STEREOCHEMISCH ISOMEREN FORM ODER EINEM PHARMAZEUTISCH UNBEDENKLICHEN ADDITIONSSALZ DESSELBEN, EINSCHLIESSLICH DES CHLORWASSERSTOFFSAEURESALZES VON RILPIVIRIN, UND TENOFOVIR, INSBESONDERE TENOFOVIRDISOPROXILFUMARAT.; REGISTRATION NO/DATE: EU/1/11/737/001 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 58/2015 Austria ⤷  Try a Trial PRODUCT NAME: KOMBINATION VON RILPIVIRIN ODER EINEM PHARMAZEUTISCH ANNEHMBAREN SALZ VON RILPIVIRIN, EINSCHLIESSLICH DES HYDROCHLORIDSALZES VON RILPIVIRIN, UND EMTRICITABIN; REGISTRATION NO/DATE: EU/1/11/737/001-002 20111128
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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