Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Last Updated: December 14, 2019

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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 twenty-eight 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. Two suppliers are 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 12th, 2017.

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

There have been fifteen patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Historic data indicate that 48% of cases that proceed to trial are decided in favor of the generic patent challenger.

Drug patent expirations by year for TRIUMEQ
Drug Prices for TRIUMEQ

See drug prices for TRIUMEQ

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
Catholic University of the Sacred HeartPhase 3
Azienda Ospedaliera Universitaria SenesePhase 3
Ospedale Amedeo di SavoiaPhase 3

See all TRIUMEQ clinical trials

Recent Litigation for TRIUMEQ

Identify potential future generic entrants

District Court Litigation
Case NameDate
ViiV Healthcare Company v. Gilead Sciences, Inc.2018-02-07
ViiV Healthcare Company v. Sandoz Inc.2017-12-11
ViiV Healthcare Company v. Cipla Limited2017-12-04

See all TRIUMEQ litigation

PTAB Litigation
PetitionerDate
Teva Pharmaceuticals USA, Inc.2015-01-08
Apotex Corp.2014-06-02

See all TRIUMEQ litigation

Synonyms for TRIUMEQ
1319715-09-7
Abacavir / dolutegravir / lamivudine
Abacavir and dolutegravir and lamivudine
Abacavir mixture with dolutegravir and lamivudine
Abacavir sulfate mixture with dolutegravir and lamivudine
Abacavir, dolutegravir and lamivudine
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 23/2005 Austria   Start Trial PRODUCT NAME: KOMBINATION, UMFASSEND ABACAVIR BZW. EIN PHYSIOLOGISCH AKZEPTABLES SALZ, ESTER, SALZ DES ESTERS ODER SOLVAT DAVON UND LAMIVUDIN BZW. EIN PHYSIOLOGISCH AKZEPTABLES SALZ, ESTER, SALZ DES; REGISTRATION NO/DATE: EU/1/04/298/001, EU/1/04/298/002 20041217
1874117 CR 2014 00032 Denmark   Start Trial PRODUCT NAME: DOLUTEGRAVIR ELLER ET FARMACEUTISK ACCEPTABELT SALT ELLER SOLVAT DERAF, HERUNDER DOLUTEGRAVIRNATRIUM; REG. NO/DATE: EU/1/13/892/001-002 20140121
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 C20140020 00130 Estonia   Start Trial PRODUCT NAME: DOLUTEGRAVIIR;REG NO/DATE: K(2014)305 (LOPLIK) 21.01.2014
1874117 PA2014021,C1874117 Lithuania   Start Trial PRODUCT NAME: DOLUTEGRAVIRAS ARBA JO FARMACINIU POZIURIU PRIIMTINA DRUSKA ARBA SOLVATAS, ISKAITANT DOLUTEGRAVIRO NATRIO DRUSKA; REGISTRATION NO/DATE: EU/1/13/892/001, 2014-01-16 EU/1/13/892/002 20140116
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Moodys
Medtronic
Harvard Business School
Johnson and Johnson
McKesson
Express Scripts

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 verifification 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.