TAFINLAR Drug Patent Profile
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Which patents cover Tafinlar, and what generic alternatives are available?
Tafinlar is a drug marketed by Novartis and is included in one NDA. There are seven patents protecting this drug.
This drug has one hundred and sixty patent family members in forty-five 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.
DrugPatentWatch® 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: | 160 |
US Patents: | 7 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 99 |
Clinical Trials: | 35 |
Patent Applications: | 3,715 |
Drug Prices: | Drug price information for TAFINLAR |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for TAFINLAR |
What excipients (inactive ingredients) are in TAFINLAR? | TAFINLAR excipients list |
DailyMed Link: | TAFINLAR at DailyMed |


DrugPatentWatch® Estimated Loss of Exclusivity (LOE) 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 |
---|---|
Eva Marie Erfurth, MD, PhD | Phase 2 |
Royal Brisbane and Women's Hospital | Phase 2 |
Eastern Health | Phase 2 |
Pharmacology for TAFINLAR
Anatomical Therapeutic Chemical (ATC) Classes for TAFINLAR
US Patents and Regulatory Information for TAFINLAR
TAFINLAR is protected by twenty-two US patents and five FDA Regulatory Exclusivities.
Based on analysis by DrugPatentWatch, the earliest date for a generic version of TAFINLAR is ⤷ Try a Trial.
This potential generic entry date is based on patent ⤷ Try a Trial.
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.
Patents protecting TAFINLAR
Method of adjuvant cancer treatment
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TAFINLAR(R) IS INDICATED, IN COMBINATION WITH TRAMETINIB, FOR THE ADJUVANT TREATMENT OF PATIENTS WITH MELANOMA WITH BRAF V600E OR V600K MUTATIONS AS DETECTED BY AN FDA-APPROVED TEST, AND INVOLVEMENT OF LYMPH NODE(S), FOLLOWING COMPLETE RESECTION
Benzene sulfonamide thiazole and oxazole compounds
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TAFINLAR IS INDICATED, IN COMBINATION WITH TRAMETINIB, FOR THE ADJUVANT TREATMENT OF PATIENTS WITH MELANOMA WITH BRAF V600E OR V600K MUTATIONS, AS DETECTED BY AN FDA-APPROVED TEST, AND INVOLVEMENT OF LYMPH NODE(S), FOLLOWING COMPLETE RESECTION
Benzene sulfonamide thiazole and oxazole compounds
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TAFINLAR IS INDICATED, IN COMBINATION WITH TRAMETINIB, FOR THE TREATMENT OF PATIENTS WITH UNRESECTABLE OR METASTATIC MELANOMA WITH BRAF V600E OR V600K MUTATIONS, AS DETECTED BY AN FDA-APPROVED TEST.
Benzene sulfonamide thiazole and oxazole compounds
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF MELANOMA
Benzene sulfonamide thiazole and oxazole compounds
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TAFINLAR IS INDICATED AS A SINGLE AGENT FOR THE TREATMENT OF PATIENTS WITH UNRESECTABLE OR METASTATIC MELANOMA WITH BRAF V600E MUTATION AS DETECTED BY AN FDA-APPROVED TEST
Benzene sulfonamide thiazole and oxazole compounds
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TAFINLAR IS INDICATED, IN COMBINATION WITH TRAMETINIB, FOR THE TREATMENT OF PATIENTS WITH UNRESECTABLE OR METASTATIC MELANOMA WITH BRAF V600E OR V600K MUTATIONS, AS DETECTED BY AN FDA-APPROVED TEST.
Benzene sulfonamide thiazole and oxazole compounds
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TAFINLAR IS INDICATED AS A SINGLE AGENT FOR THE TREATMENT OF PATIENTS WITH UNRESECTABLE OR METASTATIC MELANOMA WITH BRAF V600E MUTATION AS DETECTED BY AN FDA-APPROVED TEST
Benzene sulfonamide thiazole and oxazole compounds
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF MELANOMA
Benzene sulfonamide thiazole and oxazole compounds
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TAFINLAR IS INDICATED, IN COMBINATION WITH TRAMETINIB, FOR THE ADJUVANT TREATMENT OF PATIENTS WITH MELANOMA WITH BRAF V600E OR V600K MUTATIONS, AS DETECTED BY AN FDA-APPROVED TEST, AND INVOLVEMENT OF LYMPH NODE(S), FOLLOWING COMPLETE RESECTION
Pharmaceutical combination of MEK inhibitor and B-RAF inhibitors
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TAFINLAR IS INDICATED, IN COMBINATION WITH TRAMETINIB, FOR THE ADJUVANT TREATMENT OF PATIENTS WITH MELANOMA WITH BRAF V600E OR V600K MUTATIONS, AS DETECTED BY AN FDA-APPROVED TEST, AND INVOLVEMENT OF LYMPH NODE(S), FOLLOWING COMPLETE RESECTION
Pharmaceutical combination of MEK inhibitor and B-RAF inhibitors
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TAFINLAR IN COMBINATION WITH TRAMETINIB FOR THE TREATMENT OF PATIENTS WITH UNRESECTABLE OR METASTATIC MELANOMA
Pharmaceutical combination of MEK inhibitor and B-RAF inhibitors
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TAFINLAR IS INDICATED, IN COMBINATION WITH TRAMETINIB, FOR THE TREATMENT OF PATIENTS WITH UNRESECTABLE OR METASTATIC MELANOMA WITH BRAF V600E OR V600K MUTATIONS, AS DETECTED BY AN FDA-APPROVED TEST.
Pharmaceutical combination of MEK inhibitor and B-RAF inhibitors
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TAFINLAR IS INDICATED, IN COMBINATION WITH TRAMETINIB, FOR THE TREATMENT OF PATIENTS WITH LOCALLY ADVANCED OR METASTATIC ANAPLASTIC THYROID CANCER (ATC) WITH BRAF V600E MUTATION AND WITH NO SATISFACTORY LOCOREGIONAL TREATMENT OPTIONS
Pyrimidine compound and medical use thereof
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TAFINLAR(R) IS INDICATED, IN COMBINATION WITH TRAMETINIB, FOR THE TREATMENT OF PATIENTS WITH METASTATIC NON-SMALL CELL LUNG CANCER (NSCLC) WITH BRAF V600E MUTATION AS DETECTED BY AN FDA-APPROVED TEST.
Pyrimidine compound and medical use thereof
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TAFINLAR IS INDICATED, IN COMBINATION WITH TRAMETINIB, FOR THE TREATMENT OF PATIENTS WITH LOCALLY ADVANCED OR METASTATIC ANAPLASTIC THYROID CANCER (ATC) WITH BRAF V600E MUTATION AND WITH NO SATISFACTORY LOCOREGIONAL TREATMENT OPTIONS
Pyrimidine compound and medical use thereof
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TAFINLAR(R) IS INDICATED, IN COMBINATION WITH TRAMETINIB, FOR THE TREATMENT OF PATIENTS WITH UNRESECTABLE OR METASTATIC MELANOMA WITH BRAF V600E OR V600K MUTATIONS, AS DETECTED BY AN FDA-APPROVED TEST.
Pyrimidine compound and medical use thereof
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TAFINLAR IS INDICATED, IN COMBINATION WITH TRAMETINIB, FOR THE ADJUVANT TREATMENT OF PATIENTS WITH MELANOMA WITH BRAF V600E OR V600K MUTATIONS, AS DETECTED BY AN FDA-APPROVED TEST, AND INVOLVEMENT OF LYMPH NODE(S), FOLLOWING COMPLETE RESECTION
Pharmaceutical combination of MEK inhibitor and B-Raf inhibitors
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TAFINLAR(R) IS INDICATED, IN COMBINATION WITH TRAMETINIB, FOR THE TREATMENT OF PATIENTS WITH METASTATIC NON-SMALL CELL LUNG CANCER (NSCLC) WITH BRAF V600E MUTATION AS DETECTED BY AN FDA-APPROVED TEST.
Benzene sulfonamide thiazole and oxazole compounds
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TAFINLAR IS INDICATED, IN COMBINATION WITH TRAMETINIB, FOR THE TREATMENT OF PATIENTS WITH UNRESECTABLE OR METASTATIC MELANOMA WITH BRAF V600E OR V600K MUTATIONS, AS DETECTED BY AN FDA-APPROVED TEST.
Benzene sulfonamide thiazole and oxazole compounds
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TAFINLAR IS INDICATED, IN COMBINATION WITH TRAMETINIB, FOR THE ADJUVANT TREATMENT OF PATIENTS WITH MELANOMA WITH BRAF V600E OR V600K MUTATIONS, AS DETECTED BY AN FDA-APPROVED TEST, AND INVOLVEMENT OF LYMPH NODE(S), FOLLOWING COMPLETE RESECTION
Benzene sulfonamide thiazole and oxazole compounds
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TAFINLAR IS INDICATED AS A SINGLE AGENT FOR THE TREATMENT OF PATIENTS WITH UNRESECTABLE OR METASTATIC MELANOMA WITH BRAF V600E MUTATION AS DETECTED BY AN FDA-APPROVED TEST
Benzene sulfonamide thiazole and oxazole compounds
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF PATIENTS WITH UNRESECTABLE OR METASTATIC MELANOMA WITH BRAF V600E MUTATIONS AFTER CONFIRMING THE PRESENCE OF BRAF V600E MUTATION
FDA Regulatory Exclusivity protecting TAFINLAR
TRAMETINIB IS INDICATED, IN COMBINATION WITH DABRAFENIB, FOR THE ADJUVANT TREATMENT OF PATIENTS WITH MELANOMA WITH BRAF V600E OR V600K MUTATIONS, AS DETECTED BY AN FDA-APPROVED TEST, AND INVOLVEMENT OF LYMPH NODE(S), FOLLOWING COMPLETE RESECTION
Exclusivity Expiration: ⤷ Try a Trial
TRAMETINIB AND DABRAFENIB IN COMBINATION, FOR THE TREATMENT OF PATIENTS WITH LOCALLY ADVANCED OR METASTATIC ANAPLASTIC THYROID CANCER (ATC) WITH BRAF V600E MUTATION AND WITH NO SATISFACTORY LOCOREGIONAL TREATMENT OPTIONS
Exclusivity Expiration: ⤷ Try a Trial
DABRAFENIB IN COMBINATION WITH TRAMETINIB, FOR THE TX. OF PTS WITH METASTATIC NON-SMALL CELL LUNG CANCERWITH BRAF V600E MUTATION AS DETECTED BY AN FDA-APPROVED TEST
Exclusivity Expiration: ⤷ Try a Trial
ADDITION OF STUDY BRF117277, A NON-RANDOMIZED, OPEN-LABEL, MULTI-CENTER, MULTI-COHORT TRIAL OF DABRAFENIB PLUS TRAMETINIB IN SUBJECTS WITH BRAF MUTATION-POSITIVE MELANOMA THAT HAS METASTASIZED TO THE BRAIN
Exclusivity Expiration: ⤷ Try a Trial
DABRAFENIB IS INDICATED IN COMBINATION WITH TRAMETINIB, FOR THE TREATMENT OF ADULT AND PEDIATRIC PATIENTS 6 YEARS OF AGE AND OLDER WITH UNRESECTABLE OR METASTATIC SOLID TUMORS WITH BRAF V600E MUTATION WHO HAVE PROGRESSED FOLLOWING PRIOR TREATMENT AND HAVE NO SATISFACTORY ALTERNATIVE TREATMENT OPTIONS
Exclusivity Expiration: ⤷ Try a Trial
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 | 202806-002 | May 29, 2013 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | Y | ⤷ Try a Trial | ||
Novartis | TAFINLAR | dabrafenib mesylate | CAPSULE;ORAL | 202806-002 | May 29, 2013 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Novartis | TAFINLAR | dabrafenib mesylate | CAPSULE;ORAL | 202806-002 | May 29, 2013 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Novartis | TAFINLAR | dabrafenib mesylate | CAPSULE;ORAL | 202806-002 | May 29, 2013 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | Y | ⤷ Try a Trial | ||
Novartis | TAFINLAR | dabrafenib mesylate | CAPSULE;ORAL | 202806-001 | May 29, 2013 | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Novartis | TAFINLAR | dabrafenib mesylate | CAPSULE;ORAL | 202806-001 | May 29, 2013 | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a 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
When does loss-of-exclusivity occur for TAFINLAR?
Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:
Australia
Patent: 10306653
Estimated Expiration: ⤷ Try a Trial
Brazil
Patent: 2012008854
Estimated Expiration: ⤷ Try a Trial
Canada
Patent: 75803
Estimated Expiration: ⤷ Try a Trial
Chile
Patent: 12000964
Estimated Expiration: ⤷ Try a Trial
China
Patent: 2655753
Estimated Expiration: ⤷ Try a Trial
Colombia
Patent: 31498
Estimated Expiration: ⤷ Try a Trial
Costa Rica
Patent: 120155
Estimated Expiration: ⤷ Try a Trial
Croatia
Patent: 0191617
Estimated Expiration: ⤷ Try a Trial
Patent: 0221304
Estimated Expiration: ⤷ Try a Trial
Denmark
Patent: 88033
Estimated Expiration: ⤷ Try a Trial
Patent: 60498
Estimated Expiration: ⤷ Try a Trial
Dominican Republic
Patent: 012000091
Estimated Expiration: ⤷ Try a Trial
Eurasian Patent Organization
Patent: 0589
Estimated Expiration: ⤷ Try a Trial
Patent: 1290149
Estimated Expiration: ⤷ Try a Trial
European Patent Office
Patent: 88033
Estimated Expiration: ⤷ Try a Trial
Patent: 60498
Estimated Expiration: ⤷ Try a Trial
Patent: 59217
Estimated Expiration: ⤷ Try a Trial
Hungary
Patent: 46139
Estimated Expiration: ⤷ Try a Trial
Patent: 60206
Estimated Expiration: ⤷ Try a Trial
Israel
Patent: 9073
Estimated Expiration: ⤷ Try a Trial
Japan
Patent: 18929
Estimated Expiration: ⤷ Try a Trial
Patent: 13508294
Estimated Expiration: ⤷ Try a Trial
Lithuania
Patent: 88033
Estimated Expiration: ⤷ Try a Trial
Patent: 60498
Estimated Expiration: ⤷ Try a Trial
Malaysia
Patent: 4759
Estimated Expiration: ⤷ Try a Trial
Mexico
Patent: 12004413
Estimated Expiration: ⤷ Try a Trial
Montenegro
Patent: 497
Estimated Expiration: ⤷ Try a Trial
Morocco
Patent: 746
Estimated Expiration: ⤷ Try a Trial
New Zealand
Patent: 8913
Estimated Expiration: ⤷ Try a Trial
Peru
Patent: 121093
Estimated Expiration: ⤷ Try a Trial
Poland
Patent: 88033
Estimated Expiration: ⤷ Try a Trial
Patent: 60498
Estimated Expiration: ⤷ Try a Trial
Portugal
Patent: 88033
Estimated Expiration: ⤷ Try a Trial
Patent: 60498
Estimated Expiration: ⤷ Try a Trial
Serbia
Patent: 181
Estimated Expiration: ⤷ Try a Trial
Patent: 702
Estimated Expiration: ⤷ Try a Trial
Slovenia
Patent: 88033
Estimated Expiration: ⤷ Try a Trial
South Africa
Patent: 1202612
Estimated Expiration: ⤷ Try a Trial
South Korea
Patent: 1729116
Estimated Expiration: ⤷ Try a Trial
Patent: 120104547
Estimated Expiration: ⤷ Try a Trial
Spain
Patent: 45479
Estimated Expiration: ⤷ Try a Trial
Patent: 30157
Estimated Expiration: ⤷ Try a Trial
Ukraine
Patent: 5064
Estimated Expiration: ⤷ Try a Trial
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.
See the table below for additional patents covering TAFINLAR around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Spain | 2397825 | ⤷ Try a Trial | |
Japan | 2011519940 | ⤷ Try a Trial | |
Canada | 2775803 | COMBINAISON (COMBINATION) | ⤷ Try a Trial |
Ukraine | 105064 | КОМБИНАЦИЯ, СОДЕРЖАЩАЯ ИНГИБИТОР МЭК И ИНГИБИТОР В-Raf;КОМБІНАЦІЯ, ЩО МІСТИТЬ ІНГІБІТОР МЕК ТА ІНГІБІТОР В-Raf (COMBINATION COMPRISING THE MEK INHIBITOR AND B-Raf INHIBITOR) | ⤷ Try a Trial |
Chile | 2012000964 | Combinacion de n-{3-[3-ciclopropil-5-(2-fluoro-4-yodo-fenilamino)-6,8-dimetil-2,4,7-trioxo-3,4,6,7-tetrahidro-2h-pirido-[4,3d]-pirimidin-1-il]fenil}-acetamida y n-{3-[5-(2-amino-4-pirimidinil)-2-(1,1-dimetil-etil)-1,3-tiazol-4-il]-2-fluoro-fenil}-2,6-difluoro-bencen-sulfonamida; kit; composicion; uso para tratar cancer. | ⤷ Try a Trial |
World Intellectual Property Organization (WIPO) | 2005121142 | ⤷ Try a Trial | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for TAFINLAR
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
1761528 | 68/2014 | Austria | ⤷ Try a Trial | PRODUCT NAME: TRAMETINIB, GEGEBENENFALLS IN FORM EINES PHARMAZEUTISCH VERTRAEGLICHEN SALZES, HYDRATS ODER SOLVATS DAVON; REGISTRATION NO/DATE: EU/1/14/931 (MITTEILUNG) 20140702 |
1761528 | C20140036 00120 | Estonia | ⤷ Try a Trial | CHANGE OF OWNER'S ADDRESS |
1761528 | CA 2014 00055 | Denmark | ⤷ Try a Trial | PRODUCT NAME: TRAMETINIB, EVENTUELT I FORM AF ET FARMACEUTISK ACCEPTABELT SALT, HYDRAT ELLER SOLVAT DERAF, HERUNDER TRAMETINIBDIMETHYLSULFOXID; REG. NO/DATE: EU/1/14/931/01-06 20140630 |
1761528 | SPC/GB14/081 | United Kingdom | ⤷ Try a Trial | PRODUCT NAME: TRAMETINIB, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACEPTABLE SALT, HYDRATE OR SOLVATE THEREOF.; REGISTERED: UK EU/1/14/931(01-06) 20140702 |
1761528 | 122014000102 | Germany | ⤷ Try a Trial | PRODUCT NAME: TRAMETINIB, GEGEBENFALLS IN FORM EINES PHARMAZEUTISCH VERTRAEGLICHEN SALZES, HYDRATS ODER SOLVATS DAVON; REGISTRATION NO/DATE: EU/1/14/931/01-06 20140630 |
1761528 | PA2014039,C1761528 | Lithuania | ⤷ Try a Trial | PRODUCT NAME: TRAMETINIBAS; REGISTRATION NO/DATE: EU/1/14/931/01-06 20140630 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |