Dabrafenib Mesylate Patent Expiration

Dabrafenib Mesylate is used for treating metastatic melanoma and anaplastic thyroid cancer with specific genetic mutations. It was first introduced by Novartis Pharmaceuticals Corp in its drug Tafinlar on May 29, 2013.


Dabrafenib Mesylate Patents

Given below is the list of patents protecting Dabrafenib Mesylate, along with the drug name that holds that patent and the company name owning that drug.

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Drug Used in Drug Patent Number Drug Patent Title Drug Patent Expiry Drug Owner
Tafinlar US11504333

(Pediatric)

Pharmaceutical composition Dec 29, 2038 Novartis
Tafinlar US11504333 Pharmaceutical composition Jun 29, 2038 Novartis
Tafinlar US10869869

(Pediatric)

Method of adjuvant cancer treatment Feb 28, 2034 Novartis
Tafinlar US10869869 Method of adjuvant cancer treatment Aug 30, 2033 Novartis
Tafinlar US8703781

(Pediatric)

Pharmaceutical combination of MEK inhibitor and B-RAF inhibitors Apr 15, 2031 Novartis
Tafinlar US8952018

(Pediatric)

Pharmaceutical combination of MEK inhibitor and B-Raf inhibitors Apr 15, 2031 Novartis
Tafinlar US8703781 Pharmaceutical combination of MEK inhibitor and B-RAF inhibitors Oct 15, 2030 Novartis
Tafinlar US8952018 Pharmaceutical combination of MEK inhibitor and B-Raf inhibitors Oct 15, 2030 Novartis
Tafinlar US7994185

(Pediatric)

Benzene sulfonamide thiazole and oxazole compounds Jul 20, 2030 Novartis
Tafinlar US8415345

(Pediatric)

Benzene sulfonamide thiazole and oxazole compounds Jul 20, 2030 Novartis
Tafinlar US7994185 Benzene sulfonamide thiazole and oxazole compounds Jan 20, 2030 Novartis
Tafinlar US8415345 Benzene sulfonamide thiazole and oxazole compounds Jan 20, 2030 Novartis
Tafinlar US9233956

(Pediatric)

Benzene sulfonamide thiazole and oxazole compounds Nov 04, 2029 Novartis
Tafinlar US9233956 Benzene sulfonamide thiazole and oxazole compounds May 04, 2029 Novartis
Tafinlar US8835443

(Pediatric)

Pyrimidine compound and medical use thereof Dec 10, 2025

(Expired)

Novartis
Tafinlar US8835443 Pyrimidine compound and medical use thereof Jun 10, 2025

(Expired)

Novartis



A patent's expiry date may change depending upon legal activities going on that patent. Critical activities like abandoning of a patent, term extension of a patent or amendment of its claims can increase or decrease the life of a patent hence affecting its expiry date and in turn affecting the generic launch date of that drug. Tracking these ongoing activities on a patent application helps to keep an eye on the latest developments in the patent process of the drug which can give an idea of how early a drug's generic could be available. The next section provides a list of recent legal activities on Dabrafenib Mesylate's patents.

Given below is the list recent legal activities going on the following patents of Dabrafenib Mesylate.

Activity Date Patent Number
Patent litigations
Payment of Maintenance Fee, 12th Year, Large Entity 25 Sep, 2024 US8415345
Payment of Maintenance Fee, 8th Year, Large Entity 28 Jun, 2023 US9233956
Payment of Maintenance Fee, 12th Year, Large Entity 25 Jan, 2023 US7994185
Patent Issue Date Used in PTA Calculation 22 Nov, 2022 US11504333
Recordation of Patent Grant Mailed 22 Nov, 2022 US11504333
Email Notification 03 Nov, 2022 US11504333
Issue Notification Mailed 02 Nov, 2022 US11504333
Application Is Considered Ready for Issue 21 Oct, 2022 US11504333
Dispatch to FDC 21 Oct, 2022 US11504333
Issue Fee Payment Received 18 Oct, 2022 US11504333


Dabrafenib Mesylate's Family Patents

Family Patents

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Clinical Trials

Recent Clinical Trials on Dabrafenib Mesylate:

Sometimes companies keep conducting clinical trials even after the drug's approval to discover new formulations, methods of use, or new treatment indications, so they could file for additional patents or receive regulatory exclusivity extensions, such as pediatric exclusivity, potentially delaying generic competition. Based on these recent clinical trials, generic companies need to consider the potential for new intellectual property or regulatory hurdles. These strategic moves by the drug owner might delay generic substitution or lead to additional sales of the brand drug, even after patent expiry.

Title Lead Sponsor Collaborators Status Phases
Clinical Trials
Testing the Addition of the Anti-cancer Drug, Tazemetostat, to (Dabrafenib and Trametinib) for Metastatic Melanoma That Has Progressed on the Usual Treatment National Cancer Institute (NCI) NA ACTIVE NOT RECRUITING
(Aug 1, 2026)
PHASE1, PHASE2
Dabrafenib and Trametinib Followed by Ipilimumab and Nivolumab or Ipilimumab and Nivolumab Followed by Dabrafenib and Trametinib in Treating Patients With Stage III-IV BRAFV600 Melanoma National Cancer Institute (NCI) NA ACTIVE NOT RECRUITING
(Jul 1, 2026)
PHASE3
Dabrafenib Combined With Trametinib After Radiation Therapy in Treating Patients With Newly-Diagnosed High-Grade Glioma National Cancer Institute (NCI) NA ACTIVE NOT RECRUITING
(Jul 1, 2026)
PHASE2
Testing Dabrafenib and Trametinib With or Without Hydroxychloroquine in Stage IIIC or IV BRAF V600E/K Melanoma ECOG-ACRIN Cancer Research Group NA TERMINATED
(Jul 1, 2026)
PHASE2
Dabrafenib and Trametinib for BRAF V600 Mutant Low-Grade Gliomas University of California, San Francisco NA RECRUITING
(Jul 1, 2026)
PHASE2
Testing Trametinib and Dabrafenib as a Potential Targeted Treatment in Cancers With BRAF Genetic Changes (MATCH-Subprotocol H) National Cancer Institute (NCI) NA ACTIVE NOT RECRUITING
(Jun 1, 2026)
PHASE2


Dabrafenib Mesylate Generic API Manufacturers

Given below is the list of companies who have filed for Dabrafenib Mesylate generic, along with the locations of their manufacturing plants worldwide.