Generic Tafinlar Availability

Last updated on Jan 8, 2025.

Tafinlar is a brand name of dabrafenib, approved by the FDA in the following formulation(s):

TAFINLAR (dabrafenib mesylate - capsule;oral)

Manufacturer: NOVARTIS
Approval date: May 29, 2013
Strength(s): EQ 50MG BASE ^[RLD], EQ 75MG BASE ^[RLD]

TAFINLAR (dabrafenib mesylate - tablet, for suspension;oral)

Manufacturer: NOVARTIS
Approval date: March 16, 2023
Strength(s): EQ 10MG BASE ^[RLD]

Has a generic version of Tafinlar been approved?

No. There is currently no therapeutically equivalent version of Tafinlar available in the United States.

Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Tafinlar. These medications may be counterfeit and potentially unsafe. If you purchase medications online, be sure you are buying from a reputable and valid online pharmacy. Ask your health care provider for advice if you are unsure about the online purchase of any medication.

Related patents

Patents are granted by the U.S. Patent and Trademark Office at any time during a drug's development and may include a wide range of claims.

Method of adjuvant cancer treatment
Patent 10,869,869
Issued: December 22, 2020
Inventor(s): Laquerre Sylvie & Lebowitz Peter F.
Assignee(s): Novartis AG
The present invention provides a method of providing adjuvant treatment to a human patient which comprises administering to such a patient therapeutically effective doses of dabrafenib and trametinib for a time period sufficient to increase relapse-free survival (RFS).
Patent expiration dates:
- August 30, 2033
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  Patent 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
Method of adjuvant cancer treatment
Patent 10869869*PE
Issued: December 22, 2020
Inventor(s): Laquerre Sylvie & Lebowitz Peter F.
Assignee(s): Novartis AG
The present invention provides a method of providing adjuvant treatment to a human patient which comprises administering to such a patient therapeutically effective doses of dabrafenib and trametinib for a time period sufficient to increase relapse-free survival (RFS).
Patent expiration dates:
- February 28, 2034
Patent 11,504,333
Patent expiration dates:
- June 29, 2038
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  Drug product
Patent 11504333*PE
Patent expiration dates:
- December 29, 2038
Patent 7,994,185
Patent expiration dates:
- January 20, 2030
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  Patent 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
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- January 20, 2030
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  Patent 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.
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  Drug substance
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  Drug product
- January 20, 2030
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  Patent use: TREATMENT OF MELANOMA
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  Drug substance
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  Drug product
- January 20, 2030
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  Patent 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
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  Drug product
- January 20, 2030
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  Drug substance
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  Drug product
Patent 7994185*PED
Patent expiration dates:
- July 20, 2030
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  Pediatric exclusivity
Benzene sulfonamide thiazole and oxazole compounds
Patent 8,415,345
Issued: April 9, 2013
Inventor(s): Adjabeng George & Adams Jerry Leroy & Dickerson Scott Howard & Hornberger Keith & Johnson Neil W. & Kuntz Kevin & Petrov Kimberly & Ralph Jeffrey M. & Rheault Tara Renae & Schaaf Gregory & Stellwagen John & Tian Xinrong & Uehling David E. & Waterson Alex G. & Wilson Brian
Assignee(s): Glaxo SmithKline LLC
The present invention provides thiazole sulfonamide and oxazole sulfonamide compounds, compositions containing the same, as well as processes for the preparation and methods for their use as pharmaceutical agents.
Patent expiration dates:
- January 20, 2030
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  Patent 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.
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  Drug substance
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  Drug product
- January 20, 2030
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  Patent 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
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  Drug substance
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  Drug product
- January 20, 2030
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  Patent use: TREATMENT OF MELANOMA
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  Drug substance
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  Drug product
- January 20, 2030
  ✓
  Patent 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
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  Drug substance
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  Drug product
- January 20, 2030
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  Drug substance
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  Drug product
Benzene sulfonamide thiazole and oxazole compounds
Patent 8415345*PED
Issued: April 9, 2013
Inventor(s): Adjabeng George & Adams Jerry Leroy & Dickerson Scott Howard & Hornberger Keith & Johnson Neil W. & Kuntz Kevin & Petrov Kimberly & Ralph Jeffrey M. & Rheault Tara Renae & Schaaf Gregory & Stellwagen John & Tian Xinrong & Uehling David E. & Waterson Alex G. & Wilson Brian
Assignee(s): Glaxo SmithKline LLC
The present invention provides thiazole sulfonamide and oxazole sulfonamide compounds, compositions containing the same, as well as processes for the preparation and methods for their use as pharmaceutical agents.
Patent expiration dates:
- July 20, 2030
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  Pediatric exclusivity
Pharmaceutical combination of MEK inhibitor and B-RAF inhibitors
Patent 8,703,781
Issued: April 22, 2014
Inventor(s): Dumble Melissa & Kumar Rakesh & Laquerre Sylvie & Lebowitz Peter
Assignee(s): GlaxoSmithKline LLC
A novel combination comprising the MEK inhibitor N-{3-[3-cyclopropyl-5-(2-fluoro-4-iodo-phenylamino)6,8-dimethyl;-2,4,7-trioxo-3,4,6,7-tetrahydro-2H-pyrido[4,3-d]pyrimidin-1-yl]phenyl}acetamide, or a pharmaceutically acceptable salt or solvate thereof, with a B-Raf inhibitor, particularly N-{3-[5-(2-Amino-4-pyrimidinyl)-2-(1,1-dimethylethyl)-1,3-thiazol-4-yl]-2-fluorophen-}-2,6-difluorobenzenesulfonamide or a pharmaceutically acceptable salt thereof, pharmaceutical compositions comprising the same and methods of using such combinations and compositions in the treatment of conditions in which the inhibition of MEK and/or B-Raf is beneficial, eg. cancer.
Patent expiration dates:
- October 15, 2030
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  Patent 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
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  Drug substance
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- October 15, 2030
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  Patent use: TAFINLAR IN COMBINATION WITH TRAMETINIB FOR THE TREATMENT OF PATIENTS WITH UNRESECTABLE OR METASTATIC MELANOMA
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  Drug substance
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  Drug product
- October 15, 2030
  ✓
  Patent 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.
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  Drug substance
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  Drug product
- October 15, 2030
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  Patent 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
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  Drug substance
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  Drug product
- October 15, 2030
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  Patent use: TAFINLAR IS INDICATED, IN COMBINATION WITH TRAMETINIB, FOR THE TREATMENT OF PEDIATRIC PATIENTS 1 YEAR OF AGE AND OLDER WITH LOW-GRADE GLIOMA (LGG) WITH A BRAF V600E MUTATION WHO REQUIRE SYSTEMIC THERAPY
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  Drug product
Pharmaceutical combination of MEK inhibitor and B-RAF inhibitors
Patent 8703781*PED
Issued: April 22, 2014
Inventor(s): Dumble Melissa & Kumar Rakesh & Laquerre Sylvie & Lebowitz Peter
Assignee(s): GlaxoSmithKline LLC
A novel combination comprising the MEK inhibitor N-{3-[3-cyclopropyl-5-(2-fluoro-4-iodo-phenylamino)6,8-dimethyl;-2,4,7-trioxo-3,4,6,7-tetrahydro-2H-pyrido[4,3-d]pyrimidin-1-yl]phenyl}acetamide, or a pharmaceutically acceptable salt or solvate thereof, with a B-Raf inhibitor, particularly N-{3-[5-(2-Amino-4-pyrimidinyl)-2-(1,1-dimethylethyl)-1,3-thiazol-4-yl]-2-fluorophen-}-2,6-difluorobenzenesulfonamide or a pharmaceutically acceptable salt thereof, pharmaceutical compositions comprising the same and methods of using such combinations and compositions in the treatment of conditions in which the inhibition of MEK and/or B-Raf is beneficial, eg. cancer.
Patent expiration dates:
- April 15, 2031
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  Pediatric exclusivity
Pyrimidine compound and medical use thereof
Patent 8,835,443
Issued: September 16, 2014
Inventor(s): Kawasaki Hisashi & Abe Hiroyuki & Hayakawa Kazuhide & Iida Tetsuya & Kikuchi Shinichi & Yamaguchi Takayuki & Nanayama Toyomichi & Kurachi Hironori & Tamaru Masahiro & Hori Yoshikazu & Takahashi Mitsuru & Yoshida Takayuki & Sakai Toshiyuki
Assignee(s): Japan Tobacco Inc.
The present invention relates to a pyrimidine compound or a pharmaceutically acceptable salt thereof represented by the following formula [I]
Patent expiration dates:
- June 10, 2025
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  Patent 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.
- June 10, 2025
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  Patent 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
- June 10, 2025
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  Patent 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.
- June 10, 2025
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  Patent 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
- June 10, 2025
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  Patent use: TAFINLAR IS INDICATED, IN COMBINATION WITH TRAMETINIB, FOR THE TREATMENT OF PEDIATRIC PATIENTS 1 YEAR OF AGE AND OLDER WITH LOW-GRADE GLIOMA (LGG) WITH A BRAF V600E MUTATION WHO REQUIRE SYSTEMIC THERAPY
Pyrimidine compound and medical use thereof
Patent 8835443*PED
Issued: September 16, 2014
Inventor(s): Kawasaki Hisashi & Abe Hiroyuki & Hayakawa Kazuhide & Iida Tetsuya & Kikuchi Shinichi & Yamaguchi Takayuki & Nanayama Toyomichi & Kurachi Hironori & Tamaru Masahiro & Hori Yoshikazu & Takahashi Mitsuru & Yoshida Takayuki & Sakai Toshiyuki
Assignee(s): Japan Tobacco Inc.
The present invention relates to a pyrimidine compound or a pharmaceutically acceptable salt thereof represented by the following formula [I]
Patent expiration dates:
- December 10, 2025
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  Pediatric exclusivity
Pharmaceutical combination of MEK inhibitor and B-Raf inhibitors
Patent 8,952,018
Issued: February 10, 2015
Inventor(s): Dumble Melissa & Kumar Rakesh & Laquerre Sylvie & Lebowitz Peter
Assignee(s): GlaxosmithKline LLC
A novel combination comprising the MEK inhibitor N-{3-[3-cyclopropyl-5-(2-fluoro-4-iodo-phenylamino)6,8-dimethyl; -2,4,7-trioxo-3,4,6,7-tetrahydro-2H-pyrido[4,3-d]pyrimidin-1-yl]phenyl}acetamide, or a pharmaceutically acceptable salt or solvate thereof, with a B-Raf inhibitor, particularly N-{3-[5-(2-Amino-4-pyrimidinyl)-2-(1,1-dimethylethyl)-1,3-thiazol-4-yl]-2-fluorophenyl}-2,6-difluorobenzenesulfonamide or a pharmaceutically acceptable salt thereof, pharmaceutical compositions comprising the same and methods of using such combinations and compositions in the treatment of conditions in which the inhibition of MEK and/or B-Raf is beneficial, eg. cancer.
Patent expiration dates:
- October 15, 2030
  ✓
  Patent 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.
Pharmaceutical combination of MEK inhibitor and B-Raf inhibitors
Patent 8952018*PED
Issued: February 10, 2015
Inventor(s): Dumble Melissa & Kumar Rakesh & Laquerre Sylvie & Lebowitz Peter
Assignee(s): GlaxosmithKline LLC
A novel combination comprising the MEK inhibitor N-{3-[3-cyclopropyl-5-(2-fluoro-4-iodo-phenylamino)6,8-dimethyl; -2,4,7-trioxo-3,4,6,7-tetrahydro-2H-pyrido[4,3-d]pyrimidin-1-yl]phenyl}acetamide, or a pharmaceutically acceptable salt or solvate thereof, with a B-Raf inhibitor, particularly N-{3-[5-(2-Amino-4-pyrimidinyl)-2-(1,1-dimethylethyl)-1,3-thiazol-4-yl]-2-fluorophenyl}-2,6-difluorobenzenesulfonamide or a pharmaceutically acceptable salt thereof, pharmaceutical compositions comprising the same and methods of using such combinations and compositions in the treatment of conditions in which the inhibition of MEK and/or B-Raf is beneficial, eg. cancer.
Patent expiration dates:
- April 15, 2031
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  Pediatric exclusivity
Benzene sulfonamide thiazole and oxazole compounds
Patent 9,233,956
Issued: January 12, 2016
Inventor(s): Rheault Tara Renae
Assignee(s): Novartis AG
The present invention provides thiazole sulfonamide and oxazole sulfonamide compounds, compositions containing the same, as well as processes for the preparation and methods for their use as pharmaceutical agents.
Patent expiration dates:
- May 4, 2029
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  Patent 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.
- May 4, 2029
  ✓
  Patent 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
- May 4, 2029
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  Patent 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
- May 4, 2029
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  Patent use: TREATMENT OF PATIENTS WITH UNRESECTABLE OR METASTATIC MELANOMA WITH BRAF V600E MUTATIONS AFTER CONFIRMING THE PRESENCE OF BRAF V600E MUTATION
Benzene sulfonamide thiazole and oxazole compounds
Patent 9233956*PED
Issued: January 12, 2016
Inventor(s): Rheault Tara Renae
Assignee(s): Novartis AG
The present invention provides thiazole sulfonamide and oxazole sulfonamide compounds, compositions containing the same, as well as processes for the preparation and methods for their use as pharmaceutical agents.
Patent expiration dates:
- November 4, 2029
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  Pediatric exclusivity

Related exclusivities

Exclusivity is exclusive marketing rights granted by the FDA upon approval of a drug and can run concurrently with a patent or not. Exclusivity is a statutory provision and is granted to an NDA applicant if statutory requirements are met.

Exclusivity expiration dates:
- June 22, 2024 - DABRAFENIB IN COMBINATION WITH TRAMETINIB, FOR THE TX. OF PTS WITH METASTATIC NON-SMALL CELL LUNG CANCER WITH BRAF V600E MUTATION AS DETECTED BY AN FDA-APPROVED TEST
- December 22, 2024 - PEDIATRIC EXCLUSIVITY
- April 30, 2025 - 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
- May 4, 2025 - 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
- June 22, 2025 - 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
- October 30, 2025 - PEDIATRIC EXCLUSIVITY
- November 4, 2025 - PEDIATRIC EXCLUSIVITY
- December 22, 2025 - PEDIATRIC EXCLUSIVITY
- March 16, 2026 - TREATMENT OF PEDIATRIC PATIENTS 1 YEAR OF AGE AND OLDER WITH LOW-GRADE GLIOMA WITH A BRAF V600 MUTATION WHO REQUIRE SYSTEMIC THERAPY
- March 16, 2026 - NEW PRODUCT
- September 16, 2026 - PEDIATRIC EXCLUSIVITY
- March 16, 2030 - TREATMENT OF PEDIATRIC PATIENTS 1 YEAR OF AGE AND OLDER WITH LOW-GRADE GLIOMA (LGG) WITH A BRAF V600E MUTATION WHO REQUIRE SYSTEMIC THERAPY
- September 16, 2030 - PEDIATRIC EXCLUSIVITY

More about Tafinlar (dabrafenib)

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Glossary

Term	Definition
Drug Patent	A drug patent is assigned by the U.S. Patent and Trademark Office and assigns exclusive legal right to the patent holder to protect the proprietary chemical formulation. The patent assigns exclusive legal right to the inventor or patent holder, and may include entities such as the drug brand name, trademark, product dosage form, ingredient formulation, or manufacturing process A patent usually expires 20 years from the date of filing, but can be variable based on many factors, including development of new formulations of the original chemical, and patent infringement litigation.
Drug Exclusivity	Exclusivity is the sole marketing rights granted by the FDA to a manufacturer upon the approval of a drug and may run simultaneously with a patent. Exclusivity periods can run from 180 days to seven years depending upon the circumstance of the exclusivity grant.
RLD	A Reference Listed Drug (RLD) is an approved drug product to which new generic versions are compared to show that they are bioequivalent. A drug company seeking approval to market a generic equivalent must refer to the Reference Listed Drug in its Abbreviated New Drug Application (ANDA). By designating a single reference listed drug as the standard to which all generic versions must be shown to be bioequivalent, FDA hopes to avoid possible significant variations among generic drugs and their brand name counterpart.

Further information

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Drug Status

Availability Prescription only Rx

Pregnancy & Lactation Risk data available

CSA Schedule* Not a controlled drug N/A

Approval History Drug history at FDA

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Pill GS LHF 75 mg is Tafinlar 75 mg — Tafinlar 75 mg (GS LHF 75 mg)