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TAFINLAR Drug Profile
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See Plans and PricingWhen do Tafinlar patents expire, and what generic alternatives are available?
Tafinlar is a drug marketed by Novartis and is included in one NDA. There are six patents protecting this drug.
This drug has one hundred and sixteen patent family members in forty-three countries.
The generic ingredient in TAFINLAR is dabrafenib mesylate. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the dabrafenib mesylate profile page.
US ANDA Litigation and Generic Entry Outlook for Tafinlar
Tafinlar was eligible for patent challenges on May 29, 2017.
By analyzing the patents and regulatory protections it appears that the earliest date
for generic entry will be October 15, 2030. This may change due to patent challenges or generic licensing.
There has been one patent litigation case 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 TAFINLAR
| International Patents: | 116 |
| US Patents: | 6 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 76 |
| Clinical Trials: | 23 |
| Patent Applications: | 81 |
| Drug Prices: | Drug price information for TAFINLAR |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for TAFINLAR |
| DailyMed Link: | TAFINLAR at DailyMed |
Generic Entry Opportunity Date for TAFINLAR
Generic Entry Date for TAFINLAR*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
CAPSULE;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 TAFINLAR
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| National Cancer Institute (NCI) | Phase 2 |
| Pediatric Brain Tumor Consortium | Phase 1/Phase 2 |
| Novartis Pharmaceuticals | Phase 4 |
Recent Litigation for TAFINLAR
Identify potential future generic entrants
District Court Litigation
| Case Name | Date |
|---|---|
| Plexxikon Inc. v. Novartis Pharmaceuticals Corporation | 2017-08-03 |
Pharmacology for TAFINLAR
Synonyms for TAFINLAR
| (GSK2118436) pound notDabrafenib |
| 1195765-45-7 |
| 4CA-0431 |
| AB0087834 |
| AB01565833_02 |
| ABP001006 |
| AC-25889 |
| AKOS024463285 |
| AKOS032950004 |
| AOB87722 |
| API01001 |
| AS-19634 |
| AX8262770 |
| BC297817 |
| BCP09341 |
| BDBM50428286 |
| Benzenesulfonamide, N-[3-[5-(2-amino-4-pyrimidinyl)-2-(1,1-dimethylethyl)-4-thiazolyl]-2-fluorophenyl]-2,6-difluoro- |
| BFSMGDJOXZAERB-UHFFFAOYSA-N |
| BRD-K09951645-066-01-2 |
| C23H20F3N5O2S2 |
| CHEBI:75045 |
| CHEMBL2028663 |
| CS-0692 |
| D10064 |
| Dabrafenib |
| Dabrafenib (Free Base) |
| Dabrafenib (GSK2118436) |
| Dabrafenib (USAN) |
| Dabrafenib [USAN:INN] |
| Dabrafenib Mesylate (GSK-2118436) |
| DABRAFENIB, KB-57246 |
| DB08912 |
| DTXSID20152499 |
| EX-A1320 |
| FD5028 |
| GSK 2118436 |
| GSK 2118436A |
| GSK-2118436A |
| GSK2118436A |
| GTPL6494 |
| HMS3656D12 |
| HY-14660 |
| J-004153 |
| KB-01625 |
| KB-57246 |
| KS-000005OR |
| MLS006011052 |
| MolPort-028-720-422 |
| N-(3-(5-(2-aminopyrimidin-4-yl)-2-(tert-butyl)thiazol-4-yl)-2-fluorophenyl)-2,6-difluorobenzenesulfonamide |
| N-(3-(5-(2-aminopyrimidin-4-yl)-2-tert-butylthiazol-4-yl)-2-fluorophenyl)-2,6-difluorobenzenesulfonamide |
| N-[3-[5-(2-Amino-4-pyrimidinyl)-2-(tert-butyl)-4-thiazolyl]-2-fluorophenyl]-2,6-difluorobenzenesulfo |
| N-[3-[5-(2-Amino-4-pyrimidinyl)-2-(tert-butyl)-4-thiazolyl]-2-fluorophenyl]-2,6-difluorobenzenesulfonamide |
| N-[3-[5-(2-aminopyrimidin-4-yl)-2-tert-butyl-1,3-thiazol-4-yl]-2-fluorophenyl]-2,6-difluorobenzenesulfonamide |
| N-{3-(5-(2-aminopyrimidin-4-yl)-2-(1,1-dimethylethyl)thiazol-4-yl)-2-fluorophenyl}-2,6- difluorobenzenesulfonamide |
| N-{3-[5-(2-amino-4-pyrimidinyl)-2-(1,1-dimethylethyl)-1,3-thiazol-4-yl]-2-fluorophenyl}-2,6-difluorobenzenesulfonamide |
| N-{3-[5-(2-aminopyrimidin-4-yl)-2-tert-butyl-1,3-thiazol-4-yl]-2-fluorophenyl}-2,6-difluorobenzenesulfonamide |
| N-{3-[5-(2-aminopyrimidin-4-yl)-2-tert-butylthiazol-4-yl]-2-fluorophenyl}-2,6-difluorobenzenesulfonamide |
| NCGC00346716-01 |
| NCGC00346716-14 |
| P06 |
| QCR-129 |
| QGP4HA4G1B |
| S2807 |
| SB13355 |
| SCHEMBL806377 |
| SMR004702844 |
| SW219503-1 |
| Tube719 |
| UNII-QGP4HA4G1B |
| W-5688 |
| Y1871 |
| ZINC68153186 |
US Patents and Regulatory Information for TAFINLAR
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Novartis | TAFINLAR | dabrafenib mesylate | CAPSULE;ORAL | 202806-001 | May 29, 2013 | RX | Yes | No | Start Trial | Start Trial | Start Trial | ||||
| Novartis | TAFINLAR | dabrafenib mesylate | CAPSULE;ORAL | 202806-002 | May 29, 2013 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
| Novartis | TAFINLAR | dabrafenib mesylate | CAPSULE;ORAL | 202806-002 | May 29, 2013 | RX | Yes | Yes | 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 TAFINLAR
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Spain | 2297723 | Start Trial |
| Israel | 179671 | Start Trial |
| China | 102655753 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for TAFINLAR
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1761528 | C300701 | Netherlands | Start Trial | PRODUCT NAME: TRAMETINIB, DESGEWENST IN DE VORM VAN EEN FRAMACEUTISCH AANVAARDBAAR ZOUT, HYDRAAT OF SOLVAAT DAARVAN; REGISTRATION NO/DATE: EU/1/14/931/01-06 20140702 |
| 1761528 | PA2014039,C1761528 | Lithuania | Start Trial | PRODUCT NAME: TRAMETINIBAS; REGISTRATION NO/DATE: EU/1/14/931/01-06 20140630 |
| 1761528 | 132014902315090 | Italy | Start Trial | PRODUCT NAME: TRAMETINIB, OPZIONALMENTE NELLA FORMA DI UN SUO SALE, IDRATO O SOLVATO FARMACEUTICAMENTE ACCETTABILE(MEKINIST); AUTHORISATION NUMBER(S) AND DATE(S): EU/I/14/931/001-006, 20140702 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
