By tracking patent expirations, patent litigation, generic and biosimilar development, you can anticipate these market-shaping forces and stay one step ahead.
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TIVICAY PD Drug Profile
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When do Tivicay Pd patents expire, and when can generic versions of Tivicay Pd launch?
Tivicay Pd is a drug marketed by Viiv Hlthcare and is included in one NDA. There are two patents protecting this drug.
This drug has one hundred and thirty-three patent family members in thirty-three countries.
The generic ingredient in TIVICAY PD 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 Pd
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 PD
| International Patents: | 133 |
| US Patents: | 2 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Clinical Trials: | 25 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for TIVICAY PD |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for TIVICAY PD |
| What excipients (inactive ingredients) are in TIVICAY PD? | TIVICAY PD excipients list |
| DailyMed Link: | TIVICAY PD at DailyMed |
DrugPatentWatch® Estimated Generic Entry Opportunity Date for TIVICAY PD
Generic Entry Date for TIVICAY PD*:
Constraining patent/regulatory exclusivity:
NDA:
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.
Recent Clinical Trials for TIVICAY PD
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Chelsea and Westminster NHS Foundation Trust | Phase 3 |
| Chelsea and Westminster NHS Foundation Trust | Phase 1 |
| Frederick National Laboratory for Cancer Research | Phase 4 |
Pharmacology for TIVICAY PD
ATC Classes for TIVICAY PD
US Patents and Regulatory Information for TIVICAY PD
| 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 PD | dolutegravir sodium | TABLET, FOR SUSPENSION;ORAL | 213983-001 | Jun 12, 2020 | RX | Yes | Yes | Get Started Free | Get Started Free | Y | Y | Get Started Free | ||
| Viiv Hlthcare | TIVICAY PD | dolutegravir sodium | TABLET, FOR SUSPENSION;ORAL | 213983-001 | Jun 12, 2020 | RX | Yes | Yes | Get Started Free | Get Started Free | Y | Y | Get Started Free | ||
| >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 PD
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| South Africa | 200803423 | Get Started Free |
| Brazil | PI0610030 | Get Started Free |
| South Korea | 20080064182 | Get Started Free |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for TIVICAY PD
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1874117 | 14C0041 | France | Get Started Free | 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 | C 2014 024 | Romania | Get Started Free | PRODUCT NAME: DOLUTEGRAVIR SAU O SARE SAU SOLVAT AL ACESTUIAACCEPTABILE FARMACEUTIC, INCLUSIV DOLUTEGRAVIR DESODIU; NATIONAL AUTHORISATION NUMBER: EU/1/13/892; DATE OF NATIONAL AUTHORISATION: 20140116; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/13/892; DATE OF FIRST AUTHORISATION IN EEA: 20140116 |
| 1874117 | 300676 | Netherlands | Get Started Free | 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 |
