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TRIUMEQ Drug Profile
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» See Plans and PricingWhich 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
Summary for TRIUMEQ
| International Patents: | 130 |
| US Patents: | 2 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 1 |
| Clinical Trials: | 16 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for TRIUMEQ |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for TRIUMEQ |
| DailyMed Link: | TRIUMEQ at DailyMed |
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
| Sponsor | Phase |
|---|---|
| University of Nairobi | Phase 4 |
| Ospedale Amedeo di Savoia | Phase 3 |
| Azienda Ospedaliera San Paolo | Phase 3 |
Pharmacology for TRIUMEQ
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 |
International Patents for TRIUMEQ
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Poland | 336888 | Start Trial |
| Czech Republic | 9302612 | Start Trial |
| Israel | 225207 | Start Trial |
| Canada | 2289654 | Start Trial |
| World Intellectual Property Organization (WIPO) | 9852949 | Start Trial |
| Eurasian Patent Organization | 000626 | Start Trial |
| >Country | >Patent Number | >Estimated 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 |
