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Last Updated: March 29, 2024

Dolutegravir sodium; rilpivirine hydrochloride - Generic Drug Details


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What are the generic 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 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
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

International Patents for dolutegravir sodium; rilpivirine hydrochloride

Country Patent Number Title Estimated Expiration
Norway 2016025 ⤷  Try a Trial
Australia 2017268621 ANTIVIRAL THERAPY ⤷  Try a Trial
Cyprus 1116509 ⤷  Try a Trial
Philippines 12007502373 Polycyclic carbamoylpyridone derivative having inhibitory activity on HIV integrase ⤷  Try a Trial
Brazil 122015023612 compostos derivados de pirimidina, seu uso, composição farmacêutica e produto ⤷  Try a Trial
Costa Rica 9032 FUMARATO DE 4-((4-((4-(2-CIANOETENIL)-2,6-DIMETILFENIL)AMINO-2- PIRIMIDINIL)AMINO)BENZONITRILO ⤷  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
1419152 C01419152/02 Switzerland ⤷  Try a Trial PRODUCT NAME: RILPIVIRIN UND TENOFOVIR; REGISTRATION NO/DATE: SWISSMEDIC 62155 12.03.2013
1874117 14C0041 France ⤷  Try a Trial PRODUCT NAME: DOLUTEGRAVIR ET SES SELS OU SOLVATES PHARMACEUTIQUEMENT ACCEPTABLES,NOTAMMENT LE DOLUTEGRAVIR SODIQUE.; REGISTRATION NO/DATE: EU/1/13/892/001-002 20140121
1874117 C300676 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
3808743 C03808743/01 Switzerland ⤷  Try a Trial PRODUCT NAME: RILPIVIRIN UND EMTRICITABIN; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 62155 12.03.2013
1419152 2012C/020 Belgium ⤷  Try a Trial PRODUCT NAME: RILPIVIRINE; AUTHORISATION NUMBER AND DATE: EU/1/11/736/001 20111130
2465580 LUC00210 Luxembourg ⤷  Try a Trial PRODUCT NAME: CABOTEGRAVIR; AUTHORISATION NUMBER AND DATE: EU/1/20/1481 20201221
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.