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TIVICAY Drug Profile
» See Plans and Pricing
When do Tivicay patents expire, and what generic alternatives are available?
Tivicay is a drug marketed by Viiv Hlthcare and is included in two NDAs. There are two patents protecting this drug and one Paragraph IV challenge.
This drug has one hundred and thirty-three patent family members in thirty-three countries.
The generic ingredient in TIVICAY is dolutegravir sodium. There are seventeen drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the dolutegravir sodium profile page.
DrugPatentWatch® Generic Entry Outlook for Tivicay
Tivicay 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.
There are five tentative approvals for the generic drug (dolutegravir sodium), which indicates the potential for near-term generic launch.
Indicators of Generic Entry
Summary for TIVICAY
International Patents: | 133 |
US Patents: | 2 |
Applicants: | 1 |
NDAs: | 2 |
Suppliers / Packagers: | 4 |
Bulk Api Vendors: | 104 |
Clinical Trials: | 24 |
Patent Applications: | 836 |
Formulation / Manufacturing: | see details |
Drug Prices: | Drug price information for TIVICAY |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for TIVICAY |
What excipients (inactive ingredients) are in TIVICAY? | TIVICAY excipients list |
DailyMed Link: | TIVICAY at DailyMed |


DrugPatentWatch® Estimated Generic Entry Opportunity Date for TIVICAY
Generic Entry Date for TIVICAY*:
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 TIVICAY
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Chelsea and Westminster NHS Foundation Trust | Phase 1 |
Frederick National Laboratory for Cancer Research | Phase 4 |
Instituto de Investigación Hospital Universitario La Paz | Phase 2 |
Pharmacology for TIVICAY
Paragraph IV (Patent) Challenges for TIVICAY
Tradename | Dosage | Ingredient | NDA | Submissiondate |
---|---|---|---|---|
TIVICAY | TABLET;ORAL | dolutegravir sodium | 204790 | 2017-08-14 |
US Patents and Regulatory Information for TIVICAY
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Viiv Hlthcare | TIVICAY | dolutegravir sodium | TABLET;ORAL | 204790-002 | Jun 9, 2016 | RX | Yes | No | Start Trial | Start Trial | Y | Y | Start Trial | ||
Viiv Hlthcare | TIVICAY | dolutegravir sodium | TABLET;ORAL | 204790-001 | Aug 12, 2013 | RX | Yes | Yes | Start Trial | Start Trial | Y | Y | Start Trial | ||
Viiv Hlthcare | TIVICAY | dolutegravir sodium | TABLET;ORAL | 204790-003 | Jun 9, 2016 | RX | Yes | No | Start Trial | Start Trial | Y | Y | Start Trial | ||
Viiv Hlthcare | TIVICAY | dolutegravir sodium | TABLET;ORAL | 204790-001 | Aug 12, 2013 | RX | Yes | Yes | Start Trial | Start Trial | Y | Y | Start Trial | ||
Viiv Hlthcare | TIVICAY | dolutegravir sodium | TABLET;ORAL | 204790-002 | Jun 9, 2016 | RX | Yes | No | Start Trial | Start Trial | Y | Y | Start Trial | ||
Viiv Hlthcare | TIVICAY | dolutegravir sodium | TABLET;ORAL | 204790-002 | Jun 9, 2016 | RX | Yes | No | Start Trial | Start Trial | Start Trial | ||||
Viiv Hlthcare | TIVICAY | dolutegravir sodium | TABLET;ORAL | 204790-003 | Jun 9, 2016 | RX | Yes | No | Start Trial | Start Trial | Start Trial | ||||
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
International Patents for TIVICAY
Country | Patent Number | Estimated Expiration |
---|---|---|
Taiwan | I378931 | Start Trial |
Norway | 2017010 | Start Trial |
Israel | 186555 | Start Trial |
Cyprus | 1116331 | Start Trial |
Singapore | 171308 | Start Trial |
Mexico | 2011006241 | Start Trial |
World Intellectual Property Organization (WIPO) | 2006116764 | Start Trial |
>Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for TIVICAY
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
1874117 | 2014C/038 | Belgium | Start Trial | PRODUCT NAME: DOULUTEGRAVIR SODIQUE; AUTHORISATION NUMBER AND DATE: EU/1/13/892 20140121 |
2932970 | LUC00090 | Luxembourg | Start Trial | PRODUCT NAME: COMBINAISON COMPRENANT DU DOLUTEGRAVIR OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI (PAR EXEMPLE LE DOLUTEGRAVIR SODIQUE) ET LA RILPIVIRINE OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI (PAR EXEMPLE LE CHLORHYDRATE DE RILPIVIRINE); AUTHORISATION NUMBER AND DATE: EU/1/18/1282 20180518 |
1874117 | C01874117/01 | Switzerland | Start Trial | PRODUCT NAME: DOLUTEGRAVIR; REGISTRATION NO/DATE: SWISSMEDIC 63052 08.05.2014 |
1874117 | C300676 | Netherlands | Start Trial | PRODUCT NAME: DOLUTEGRAVIR OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT OF SOLVAAT DAARVAN, MET INBEGRIP VAN DOLUTEGRAVIR NATRIUM; REGISTRATION NO/DATE: EU/1/13/892 20140121 |
1874117 | 2014/032 | Ireland | Start Trial | PRODUCT NAME: DOLUTEGRAVIR OR A PHARMACEUTICALLY ACCEPTABLE SALT OR SOLVATE THEREOF, INCLUDING DOLUTEGRAVIR SODIUM; REGISTRATION NO/DATE: EU/1/13/892/001-002 20140121 |
2932970 | 42/2018 | Austria | Start Trial | PRODUCT NAME: DOLUTEGRAVIR ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON (Z.B. DOLUTEGRAVIR NATRIUM) UND RILPIVIRIN ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON (Z.B. RILPIVIRIN-HYDROCHLORID); REGISTRATION NO/DATE: EU/1/18/1282/001-002 (MITTEILUNG) 20180518 |
1874117 | 300676 | Netherlands | Start Trial | PRODUCT NAME: DOLUTEGRAVIR OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT OF SOLVAAT DAARVAN, MET INBEGRIP VAN DOLUTEGRAVIR NATRIUM; REGISTRATION NO/DATE: EU/1/13/892 20140121 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |