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Last Updated: November 2, 2024

ABACAVIR SULFATE; DOLUTEGRAVIR SODIUM; LAMIVUDINE - Generic Drug Details


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What are the generic 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-five 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 ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Viiv Hlthcare TRIUMEQ PD abacavir sulfate; dolutegravir sodium; lamivudine TABLET, FOR SUSPENSION;ORAL 215413-001 Mar 30, 2022 RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Viiv Hlthcare TRIUMEQ abacavir sulfate; dolutegravir sodium; lamivudine TABLET;ORAL 205551-001 Aug 22, 2014 RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Viiv Hlthcare TRIUMEQ abacavir sulfate; dolutegravir sodium; lamivudine TABLET;ORAL 205551-001 Aug 22, 2014 RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Viiv Hlthcare TRIUMEQ PD abacavir sulfate; dolutegravir sodium; lamivudine TABLET, FOR SUSPENSION;ORAL 215413-001 Mar 30, 2022 RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Viiv Hlthcare TRIUMEQ PD abacavir sulfate; dolutegravir sodium; lamivudine TABLET, FOR SUSPENSION;ORAL 215413-001 Mar 30, 2022 RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Viiv Hlthcare TRIUMEQ abacavir sulfate; dolutegravir sodium; lamivudine TABLET;ORAL 205551-001 Aug 22, 2014 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 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 ⤷  Sign Up ⤷  Sign Up
Viiv Hlthcare TRIUMEQ abacavir sulfate; dolutegravir sodium; lamivudine TABLET;ORAL 205551-001 Aug 22, 2014 ⤷  Sign Up ⤷  Sign Up
Viiv Hlthcare TRIUMEQ abacavir sulfate; dolutegravir sodium; lamivudine TABLET;ORAL 205551-001 Aug 22, 2014 ⤷  Sign Up ⤷  Sign Up
>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
Mexico 2011006241 SINTESIS DE INHIBIDORES DE INTEGRASA DE VIH DE CARBAMOIL-PIRIDONA E INTERMEDIARIOS. (SYNTHESIS OF CARBAMOYLPYRIDONE HIV INTEGRASE INHIBITORS AND INTERMEDIATES.) ⤷  Sign Up
World Intellectual Property Organization (WIPO) 2010068253 ⤷  Sign Up
Japan 5848595 ⤷  Sign Up
Norway 340111 ⤷  Sign Up
Hungary S2100022 ⤷  Sign Up
Taiwan 200800988 Polycyclic carbamoylpyridone derivative having HIV integrase inhibitory activity ⤷  Sign Up
Poland 3045206 ⤷  Sign Up
>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 14C0041 France ⤷  Sign Up 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 202 50006-2014 Slovakia ⤷  Sign Up PRODUCT NAME: SODNA SOL DOLUTEGRAVIRU; REGISTRATION NO/DATE: EU/1/13/892/001 - EU/1/13/892/002 20140121
2465580 2021C/519 Belgium ⤷  Sign Up PRODUCT NAME: VOCABRIA-CABOTEGRAVIR; AUTHORISATION NUMBER AND DATE: EU/1/20/1481 20201221
2465580 C02465580/01 Switzerland ⤷  Sign Up PRODUCT NAME: CABOTEGRAVIR; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 67740 08.10.2021
1874117 122014000066 Germany ⤷  Sign Up PRODUCT NAME: DOLUTEGRAVIR ODER EIN PHARMAZEUTISCH VERTRAEGLICHES SALZ ODER SOLVAT DAVON, EINSCHLIESSLICH DOLUTEGRAVIRNATRIUM; REGISTRATION NO/DATE: EU/1/13/892/001-002 20140116
2465580 2190020-4 Sweden ⤷  Sign Up PRODUCT NAME: CABOTEGRAVIR OR A PHAMACEUTICALLY ACCEPTABLE SALT THEREOF; REG. NO/DATE: EU/1/20/1481 20201221
0434450 990028 Netherlands ⤷  Sign Up 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
>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.