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Last Updated: July 5, 2020

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TRIUMEQ Drug Profile


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Which patents cover Triumeq, and when can generic versions of Triumeq launch?

Triumeq is a drug marketed by Viiv Hlthcare and is included in one NDA. There are two patents protecting this drug and one Paragraph IV challenge.

This drug has one hundred and thirty patent family members in thirty-three countries.

The generic ingredient in TRIUMEQ is abacavir sulfate; dolutegravir sodium; lamivudine. There are twelve drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the abacavir sulfate; dolutegravir sodium; lamivudine profile page.

US ANDA Litigation and Generic Entry Outlook for Triumeq

Triumeq was eligible for patent challenges on August 12, 2017.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be December 8, 2029. This may change due to patent challenges or generic licensing.

There have been sixteen patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

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Drug patent expirations by year for TRIUMEQ
Drug Prices for TRIUMEQ

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Generic Entry Opportunity Date for TRIUMEQ
Generic Entry Date for TRIUMEQ*:
Constraining patent/regulatory exclusivity:
NDA:
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.

Recent Clinical Trials for TRIUMEQ

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
University of NairobiPhase 4
Ospedale Amedeo di SavoiaPhase 3
Azienda Ospedaliera San PaoloPhase 3

See all TRIUMEQ clinical trials

Paragraph IV (Patent) Challenges for TRIUMEQ
Tradename Dosage Ingredient NDA Submissiondate
TRIUMEQ TABLET;ORAL abacavir sulfate; dolutegravir sodium; lamivudine 205551 2017-08-14

US Patents and Regulatory Information for TRIUMEQ

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   Start Trial   Start Trial Y Y   Start Trial
Viiv Hlthcare TRIUMEQ abacavir sulfate; dolutegravir sodium; lamivudine TABLET;ORAL 205551-001 Aug 22, 2014 RX Yes Yes   Start Trial   Start Trial Y Y   Start 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 TRIUMEQ

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

Supplementary Protection Certificates for TRIUMEQ

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0817637 CA 2005 00028 Denmark   Start Trial
1874117 30/2014 Austria   Start Trial PRODUCT NAME: DOLUTEGRAVIR ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ ODER SOLVAT DAVON, EINSCHLIESSLICH DELUTEGRAVIR-NATRIUM; REGISTRATION NO/DATE: EU/1/13/892/001-002 (MITTEILUNG) 20140121
1874117 202 50006-2014 Slovakia   Start Trial PRODUCT NAME: SODNA SOL DOLUTEGRAVIRU; REGISTRATION NO/DATE: EU/1/13/892/001 - EU/1/13/892/002 20140121
1874117 517 Finland   Start Trial
1874117 14C0041 France   Start 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 SPC/GB14/041 United Kingdom   Start Trial PRODUCT NAME: DOLUTEGRAVIR OR A PHARMACEUTICALLY ACCEPTABLE SALT OR SOLVATE THEREOF, INCLUDING DOLUTEGRAVIR SODIUM; REGISTERED: UK EU/1/13/892/001-006 20140121
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

Mallinckrodt
Harvard Business School
Moodys
Merck
Express Scripts
Johnson and Johnson

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.