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Last Updated: February 28, 2024

Abacavir sulfate; dolutegravir sodium; lamivudine - Generic Drug Details


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What are the generic drug sources for abacavir sulfate; dolutegravir sodium; lamivudine and what is the scope of freedom to operate?

Abacavir sulfate; dolutegravir sodium; lamivudine is the generic ingredient in two branded drugs marketed by Viiv Hlthcare and is included in two NDAs. There are two patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Abacavir sulfate; dolutegravir sodium; lamivudine has one hundred and fifty-three patent family members in thirty-five countries.

One supplier is listed for this compound.

Summary for abacavir sulfate; dolutegravir sodium; lamivudine
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for abacavir sulfate; dolutegravir sodium; lamivudine
Generic Entry Dates for abacavir sulfate; dolutegravir sodium; lamivudine*:
Constraining patent/regulatory exclusivity:
Dosage:
TABLET;ORAL
Generic Entry Dates for abacavir sulfate; dolutegravir sodium; lamivudine*:
Constraining patent/regulatory exclusivity:
Dosage:
TABLET, FOR SUSPENSION;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 ABACAVIR SULFATE; DOLUTEGRAVIR SODIUM; LAMIVUDINE
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
TRIUMEQ PD Tablets for Oral Suspension abacavir sulfate; dolutegravir sodium; lamivudine 60 mg/5 mg/30 mg 215413 1 2023-03-31
TRIUMEQ Tablets abacavir sulfate; dolutegravir sodium; lamivudine 600 mg/50 mg/ 300 mg 205551 5 2017-08-14

US Patents and Regulatory Information for abacavir sulfate; dolutegravir sodium; lamivudine

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Viiv Hlthcare TRIUMEQ abacavir sulfate; dolutegravir sodium; lamivudine TABLET;ORAL 205551-001 Aug 22, 2014 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Viiv Hlthcare TRIUMEQ PD abacavir sulfate; dolutegravir sodium; lamivudine TABLET, FOR SUSPENSION;ORAL 215413-001 Mar 30, 2022 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Viiv Hlthcare TRIUMEQ abacavir sulfate; dolutegravir sodium; lamivudine TABLET;ORAL 205551-001 Aug 22, 2014 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Viiv Hlthcare TRIUMEQ abacavir sulfate; dolutegravir sodium; lamivudine TABLET;ORAL 205551-001 Aug 22, 2014 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Viiv Hlthcare TRIUMEQ abacavir sulfate; dolutegravir sodium; lamivudine TABLET;ORAL 205551-001 Aug 22, 2014 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 abacavir sulfate; dolutegravir sodium; lamivudine

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Viiv Hlthcare TRIUMEQ abacavir sulfate; dolutegravir sodium; lamivudine TABLET;ORAL 205551-001 Aug 22, 2014 ⤷  Try a Trial ⤷  Try a Trial
Viiv Hlthcare TRIUMEQ abacavir sulfate; dolutegravir sodium; lamivudine TABLET;ORAL 205551-001 Aug 22, 2014 ⤷  Try a Trial ⤷  Try a Trial
Viiv Hlthcare TRIUMEQ abacavir sulfate; dolutegravir sodium; lamivudine TABLET;ORAL 205551-001 Aug 22, 2014 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for abacavir sulfate; dolutegravir sodium; lamivudine

Country Patent Number Title Estimated Expiration
Slovenia 3045206 ⤷  Try a Trial
Portugal 3284520 ⤷  Try a Trial
Taiwan I378931 ⤷  Try a Trial
China 101212903 Polycyclic carbamoylpyridone derivative having HIV integrase inhibitory activity ⤷  Try a Trial
Mexico 2008005137 DERIVADO DE CARBAMOILPIRIDONA POLICICLICA QUE TIENE ACTIVIDAD INHIBIDORA EN VIH INTEGRASA. (POLYCYCLIC CARBAMOYLPYRIDONE DERIVATIVE HAVING INHIBITORY ACTIVITY ON HIV INTEGRASE.) ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for abacavir sulfate; dolutegravir sodium; lamivudine

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1874117 C20140020 00130 Estonia ⤷  Try a Trial PRODUCT NAME: DOLUTEGRAVIIR;REG NO/DATE: K(2014)305 (LOPLIK) 21.01.2014
0434450 C990028 Netherlands ⤷  Try a Trial PRODUCT NAME: ABACAVIR, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT EN/OF VAN EEN FARMACEUTISCH AANVAARDBAAR ESTER, IN HET BIJZONDER ABACAVIR SULFAAT; REGISTRATION NO/DATE: EU/1/99/112/001-002 19990708
1874117 202 50006-2014 Slovakia ⤷  Try a Trial PRODUCT NAME: SODNA SOL DOLUTEGRAVIRU; REGISTRATION NO/DATE: EU/1/13/892/001 - EU/1/13/892/002 20140121
2465580 122021000021 Germany ⤷  Try a Trial PRODUCT NAME: CABOTEGRAVIR ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ ODER SOLVAT DAVON; REGISTRATION NO/DATE: EU/1/20/1481 20201217
2465580 C02465580/01 Switzerland ⤷  Try a Trial PRODUCT NAME: CABOTEGRAVIR; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 67740 08.10.2021
>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.