TAFINLAR Drug Patent Profile
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When do Tafinlar patents expire, and what generic alternatives are available?
Tafinlar is a drug marketed by Novartis and is included in two NDAs. There are eight patents protecting this drug.
This drug has one hundred and seventy-four 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 April 15, 2031. 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
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Summary for TAFINLAR
| International Patents: | 174 |
| US Patents: | 8 |
| Applicants: | 1 |
| NDAs: | 2 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 100 |
| Clinical Trials: | 35 |
| Patent Applications: | 2,143 |
| 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
*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 |
| Peter MacCallum Cancer Centre, Australia | Phase 2 |
| Austin Health | Phase 2 |
Pharmacology for TAFINLAR
US Patents and Regulatory Information for TAFINLAR
TAFINLAR is protected by eight US patents and thirteen FDA Regulatory Exclusivities.
Based on analysis by DrugPatentWatch, the earliest date for a generic version of TAFINLAR is ⤷ Sign Up.
This potential generic entry date is based on patent ⤷ Sign Up.
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: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Benzene sulfonamide thiazole and oxazole compounds
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Benzene sulfonamide thiazole and oxazole compounds
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Pharmaceutical combination of MEK inhibitor and B-RAF inhibitors
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Pyrimidine compound and medical use thereof
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Pharmaceutical combination of MEK inhibitor and B-Raf inhibitors
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Benzene sulfonamide thiazole and oxazole compounds
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
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: ⤷ Sign Up
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: ⤷ Sign Up
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: ⤷ Sign Up
TREATMENT OF PEDIATRIC PATIENTS 1 YEAR OF AGE AND OLDER WITH LOW-GRADE GLIOMA (LGG) WITH A BRAF V600E MUTATION WHO REQUIRE SYSTEMIC THERAPY
Exclusivity Expiration: ⤷ Sign Up
TREATMENT OF PEDIATRIC PATIENTS 1 YEAR OF AGE AND OLDER WITH LOW-GRADE GLIOMA WITH A BRAF V600 MUTATION WHO REQUIRE SYSTEMIC THERAPY
Exclusivity Expiration: ⤷ Sign Up
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: ⤷ Sign Up
PEDIATRIC EXCLUSIVITY
Exclusivity Expiration: ⤷ Sign Up
PEDIATRIC EXCLUSIVITY
Exclusivity Expiration: ⤷ Sign Up
PEDIATRIC EXCLUSIVITY
Exclusivity Expiration: ⤷ Sign Up
PEDIATRIC EXCLUSIVITY
Exclusivity Expiration: ⤷ Sign Up
PEDIATRIC EXCLUSIVITY
Exclusivity Expiration: ⤷ Sign Up
PEDIATRIC EXCLUSIVITY
Exclusivity Expiration: ⤷ Sign Up
NEW PRODUCT
Exclusivity Expiration: ⤷ Sign Up
| 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 | TABLET, FOR SUSPENSION;ORAL | 217514-001 | Mar 16, 2023 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| Novartis | TAFINLAR | dabrafenib mesylate | CAPSULE;ORAL | 202806-002 | May 29, 2013 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Novartis | TAFINLAR | dabrafenib mesylate | TABLET, FOR SUSPENSION;ORAL | 217514-001 | Mar 16, 2023 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Novartis | TAFINLAR | dabrafenib mesylate | CAPSULE;ORAL | 202806-002 | May 29, 2013 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Novartis | TAFINLAR | dabrafenib mesylate | CAPSULE;ORAL | 202806-002 | May 29, 2013 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Novartis | TAFINLAR | dabrafenib mesylate | CAPSULE;ORAL | 202806-002 | May 29, 2013 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Novartis | TAFINLAR | dabrafenib mesylate | CAPSULE;ORAL | 202806-001 | May 29, 2013 | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| >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
Patent: Combination
Estimated Expiration: ⤷ Sign Up
Brazil
Patent: 2012008854
Patent: combinação, kit de combinação, uso de uma combinação, composição farmacêutica, e, método para tratar câncer em um ser humano
Estimated Expiration: ⤷ Sign Up
Canada
Patent: 75803
Patent: COMBINAISON (COMBINATION)
Estimated Expiration: ⤷ Sign Up
Chile
Patent: 12000964
Patent: 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.
Estimated Expiration: ⤷ Sign Up
China
Patent: 2655753
Patent: Combination
Estimated Expiration: ⤷ Sign Up
Colombia
Patent: 31498
Patent: COMBINACIÓN QUE COMPRENDE UN INHIBIDORDE MEK Y UN INHIBIDOR DE B- RAF úTIL EN EL TRATAMIENTO DE TRASTORNOS HIPERPROLIFERATIVOS
Estimated Expiration: ⤷ Sign Up
Costa Rica
Patent: 120155
Patent: COMBINACION
Estimated Expiration: ⤷ Sign Up
Croatia
Patent: 0191617
Estimated Expiration: ⤷ Sign Up
Patent: 0221304
Estimated Expiration: ⤷ Sign Up
Cyprus
Patent: 22013
Estimated Expiration: ⤷ Sign Up
Denmark
Patent: 88033
Estimated Expiration: ⤷ Sign Up
Patent: 60498
Estimated Expiration: ⤷ Sign Up
Dominican Republic
Patent: 012000091
Patent: COMBINACIONES UTILES PARA EL TRATAMIENTO DE CANCER EN UN MAMIFERO
Estimated Expiration: ⤷ Sign Up
Eurasian Patent Organization
Patent: 0589
Patent: ПРОТИВОРАКОВАЯ КОМБИНАЦИЯ (ANTICANCER COMBINATION)
Estimated Expiration: ⤷ Sign Up
Patent: 1290149
Patent: КОМБИНАЦИЯ
Estimated Expiration: ⤷ Sign Up
European Patent Office
Patent: 88033
Patent: Combination comprenant un inhibiteur de MEK et un inhibiteur de B-raf (Combination comprising an MEK inhibitor and a B-raf inhibitor)
Estimated Expiration: ⤷ Sign Up
Patent: 60498
Patent: COMBINATION COMPRENANT UN INHIBITEUR DE MEK ET UN INHIBITEUR DE B-RAF (COMBINATION COMPRISING AN MEK INHIBITOR AND A B-RAF INHIBITOR)
Estimated Expiration: ⤷ Sign Up
Patent: 59217
Patent: COMBINATION COMPRENANT UN INHIBITEUR DE MEK ET UN INHIBITEUR DE B-RAF (COMBINATION COMPRISING AN MEK INHIBITOR AND A B-RAF INHIBITOR)
Estimated Expiration: ⤷ Sign Up
Hungary
Patent: 46139
Estimated Expiration: ⤷ Sign Up
Patent: 60206
Estimated Expiration: ⤷ Sign Up
Israel
Patent: 9073
Patent: צירוף תרופתי לטיפול בסרטן (Pharmaceutical combination for treatment of cancer)
Estimated Expiration: ⤷ Sign Up
Japan
Patent: 18929
Estimated Expiration: ⤷ Sign Up
Patent: 13508294
Estimated Expiration: ⤷ Sign Up
Lithuania
Patent: 88033
Estimated Expiration: ⤷ Sign Up
Patent: 60498
Estimated Expiration: ⤷ Sign Up
Malaysia
Patent: 4759
Patent: PHARMACEUTICAL COMBINATION OF MEK INIDBITOR AND B-RAF INHIBITORS
Estimated Expiration: ⤷ Sign Up
Mexico
Patent: 12004413
Patent: COMBINACION. (COMBINATION.)
Estimated Expiration: ⤷ Sign Up
Montenegro
Patent: 497
Patent: KOMBINACIJA KOJA SADRŽI INHIBITOR MEK I INHIBITOR B-RAF (COMBINATION COMPRISING AN MEK INHIBITOR AND A B-RAF INHIBITOR)
Estimated Expiration: ⤷ Sign Up
Morocco
Patent: 746
Patent: التركيبة
Estimated Expiration: ⤷ Sign Up
New Zealand
Patent: 8913
Patent: Combination of an MEK inhibitor and a B-Raf inhibitor for the treatment of cancer
Estimated Expiration: ⤷ Sign Up
Peru
Patent: 121093
Patent: COMBINACION FARMACEUTICA QUE COMPRENDE UN INHIBIDOR DE MEK Y UN INHIBIDOR DE B-RAF
Estimated Expiration: ⤷ Sign Up
Poland
Patent: 88033
Estimated Expiration: ⤷ Sign Up
Patent: 60498
Estimated Expiration: ⤷ Sign Up
Portugal
Patent: 88033
Estimated Expiration: ⤷ Sign Up
Patent: 60498
Estimated Expiration: ⤷ Sign Up
Serbia
Patent: 181
Patent: KOMBINACIJA KOJA SADRŽI INHIBITOR MEK I INHIBITOR B-RAF (COMBINATION COMPRISING AN MEK INHIBITOR AND A B-RAF INHIBITOR)
Estimated Expiration: ⤷ Sign Up
Patent: 702
Patent: KOMBINACIJA KOJA SADRŽI INHIBITOR MEK I INHIBITOR B-RAF (COMBINATION COMPRISING AN MEK INHIBITOR AND A B-RAF INHIBITOR)
Estimated Expiration: ⤷ Sign Up
Slovenia
Patent: 88033
Estimated Expiration: ⤷ Sign Up
South Africa
Patent: 1202612
Patent: COMBINATION
Estimated Expiration: ⤷ Sign Up
South Korea
Patent: 1729116
Estimated Expiration: ⤷ Sign Up
Patent: 120104547
Patent: COMBINATION
Estimated Expiration: ⤷ Sign Up
Spain
Patent: 45479
Estimated Expiration: ⤷ Sign Up
Patent: 30157
Estimated Expiration: ⤷ Sign Up
Ukraine
Patent: 5064
Patent: 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)
Estimated Expiration: ⤷ Sign Up
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 |
|---|---|---|---|
| Australia | 2016244279 | METHOD OF ADJUVANT CANCER TREATMENT | ⤷ Sign Up |
| South Africa | 201202612 | COMBINATION | ⤷ Sign Up |
| World Intellectual Property Organization (WIPO) | 2014039375 | ⤷ Sign Up | |
| Taiwan | I432430 | ⤷ Sign Up | |
| New Zealand | 552090 | 5-Amino-2,4,7-trioxo-3,4,7,8-tetrahydro-2H-pyrido[2,3-d]pyrimidine derivatives and related compounds for the treatment of cancer | ⤷ Sign Up |
| Japan | 2019529343 | 新規な医薬組成物 | ⤷ Sign Up |
| Poland | 1761528 | ⤷ Sign Up | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for TAFINLAR
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1761528 | PA2014039 | Lithuania | ⤷ Sign Up | PRODUCT NAME: TRAMETINIBUM; REGISTRATION NO/DATE: EU/1/14/931/01-06 20140630 |
| 1761528 | 122014000102 | Germany | ⤷ Sign Up | 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 | SPC/GB14/081 | United Kingdom | ⤷ Sign Up | 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 | 205 5032-2014 | Slovakia | ⤷ Sign Up | PRODUCT NAME: TRAMETINIB, PRIPADNE VO FORME JEHO FARMACEUTICKY PRIJATELNEJ SOLI, HYDRATU ALEBO SOLVATU; REGISTRATION NO/DATE: EU/1/14/931 20140702 |
| 1761528 | C20140036 00120 | Estonia | ⤷ Sign Up | CHANGE OF OWNER'S ADDRESS |
| 1761528 | 1490063-3 | Sweden | ⤷ Sign Up | PRODUCT NAME: TRAMETINIB, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, HYDRATE OR SOLVATE THEREOF; REG. NO/DATE: EU/1/14/931 20140702 |
| 1761528 | C300701 | Netherlands | ⤷ Sign Up | 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 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
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