DrugPatentWatch Database Preview
TIVICAY Drug Profile
Which patents cover Tivicay, and when can generic versions of Tivicay launch?
Tivicay 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 seven patent family members in thirty-one 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.
Summary for TIVICAY
| International Patents: | 107 |
| US Patents: | 2 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 4 |
| Bulk Api Vendors: | 63 |
| Clinical Trials: | 21 |
| Patent Applications: | 62 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for TIVICAY |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for TIVICAY |
| DailyMed Link: | TIVICAY at DailyMed |
Generic Entry Opportunity Date for TIVICAY
*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.
Pharmacology for TIVICAY
Synonyms for TIVICAY
| 1051375-19-9 |
| 1Q1V9V5WYQ |
| AK174049 |
| AKOS025396662 |
| B5856 |
| CHEBI:76007 |
| CHEMBL1213165 |
| CS-3496 |
| D10113 |
| Dolutegravir (sodium) |
| DOLUTEGRAVIR SODIUM |
| Dolutegravir sodium (JAN/USAN) |
| Dolutegravir sodium [USAN] |
| EX-A1694 |
| FT-0697030 |
| GSK 1349572A |
| GSK-1349572A |
| GSK1349572 sodiuM salt |
| GSK1349572A |
| HY-13238A |
| KS-00000T34 |
| MolPort-039-136-625 |
| s4642 |
| Sodium (4R,12aS)-9-((2,4-difluorobenzyl)carbamoyl)-4-methyl-6,8-dioxo-3,4,6,8,12,12a-hexahydro-2H-pyrido[1',2':4,5]pyrazino[2,1-b][1,3]oxazin-7-olate |
| Sodium (4R,12aS)-9-((2,4-difluorobenzyl)carbamoyl)-4-methyl-6,8-dioxo-3,4,6,8,12,12a-hexahydro-2H-pyrido[1',2':4,5]pyrazino[2,1-b][1,3]oxazin-7-olate;Sodium (4R,12aS)-9-((2,4-difluorobenzyl)carbamoyl)-4-methyl-6,8-dioxo-3,4,6 |
| sodium (4R,12aS)-9-[(2,4-difluorobenzyl)carbamoyl]-4-methyl-6,8-dioxo-3,4,6,8,12,12a-hexahydro-2H-pyrido[1',2':4,5]pyrazino[2,1-b][1,3]oxazin-7-olate |
| Tivicay (TN) |
| UNII-1Q1V9V5WYQ |
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 | ➤ Sign Up | ➤ Sign Up | Y | Y | ➤ Sign Up | ||
| Viiv Hlthcare | TIVICAY | dolutegravir sodium | TABLET;ORAL | 204790-003 | Jun 9, 2016 | RX | Yes | No | ➤ Sign Up | ➤ Sign Up | ➤ Sign Up | ||||
| Viiv Hlthcare | TIVICAY | dolutegravir sodium | TABLET;ORAL | 204790-002 | Jun 9, 2016 | RX | Yes | No | ➤ Sign Up | ➤ Sign Up | ➤ Sign Up | ||||
| Viiv Hlthcare | TIVICAY | dolutegravir sodium | TABLET;ORAL | 204790-001 | Aug 12, 2013 | RX | Yes | Yes | ➤ Sign Up | ➤ Sign Up | ➤ Sign Up | ||||
| Viiv Hlthcare | TIVICAY | dolutegravir sodium | TABLET;ORAL | 204790-003 | Jun 9, 2016 | RX | Yes | No | ➤ Sign Up | ➤ Sign Up | ➤ Sign Up | ||||
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
Paragraph IV (Patent) Challenges for TIVICAY
| Drugname | Dosage | Strength | RLD | Date |
|---|---|---|---|---|
| ➤ Subscribe | Tablets | 10 mg, 25 mg and 50 mg | ➤ Subscribe | ➤ Sign Up |
International Patents for TIVICAY
| Country | Document Number | Estimated Expiration |
|---|---|---|
| Portugal | 2465580 | ➤ Sign Up |
| Russian Federation | 2527451 | ➤ Sign Up |
| Japan | 5848595 | ➤ Sign Up |
| Japan | 5131689 | ➤ Sign Up |
| Brazil | PI0617842 | ➤ Sign Up |
| Country | Document Number | Estimated Expiration |
Supplementary Protection Certificates for TIVICAY
| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|
| 2 50006-2014 | Slovakia | ➤ Sign Up | PRODUCT NAME: SODNA SOL DOLUTEGRAVIRU; REGISTRATION NO/DATE: EU/1/13/892/001 - EU/1/13/892/002 20140121 |
| 0140020 00130 | Estonia | ➤ Sign Up | PRODUCT NAME: DOLUTEGRAVIIR;REG NO/DATE: K(2014)305 (LOPLIK) 21.01.2014 |
| 90036-9 | Sweden | ➤ Sign Up | PRODUCT NAME: DOLUTEGRAVIR ELLER ETT FARMACEUTISKT ACCEPTABELT SALT ELLER SOLVAT DAERAV, INKLUSIVE DOLUTEGRAVIRNATRIUM; REG. NO/DATE: EU/1/13/892 20140116 |
| 0676 | Netherlands | ➤ Sign Up | PRODUCT NAME: DOLUTEGRAVIR OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT OF SOLVAAT DAARVAN, MET INBEGRIP VAN DOLUTEGRAVIR NATRIUM; REGISTRATION NO/DATE: EU/1/13/892 20140121 |
| 2014000066 | Germany | ➤ Sign Up | PRODUCT NAME: DOLUTEGRAVIR ODER EIN PHARMAZEUTISCH VERTRAEGLICHES SALZ ODER SOLVAT DAVON, EINSCHLIESSLICH DOLUTEGRAVIRNATRIUM; REGISTRATION NO/DATE: EU/1/13/892/001-002 20140116 |
| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
