Tafinlar Patent Expiration

Tafinlar is a drug owned by Novartis Pharmaceuticals Corp. It is protected by 16 US drug patents filed from 2013 to 2024 out of which none have expired yet. Based on its patents and exclusivities, its generic launch date is estimated to be Dec 29, 2038. Details of Tafinlar's patents and their expiration are given in the table below.


Drug Patent Number Drug Patent Title Drug Patent Expiry Status
These drug patents protects the active chemical substance. Only drug patent owner can launch products that use this active substance.
US8415345 Benzene sulfonamide thiazole and oxazole compounds
Jan, 2030

(5 years from now)

Active
US7994185 Benzene sulfonamide thiazole and oxazole compounds
Jan, 2030

(5 years from now)

Active
US8703781 Pharmaceutical combination of MEK inhibitor and B-RAF inhibitors
Oct, 2030

(6 years from now)

Active
These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US8835443 Pyrimidine compound and medical use thereof
Jun, 2025

(10 months from now)

Active
US8835443

(Pediatric)

Pyrimidine compound and medical use thereof
Dec, 2025

(1 year, 4 months from now)

Active
US9233956 Benzene sulfonamide thiazole and oxazole compounds
May, 2029

(4 years from now)

Active
US9233956

(Pediatric)

Benzene sulfonamide thiazole and oxazole compounds
Nov, 2029

(5 years from now)

Active
US7994185

(Pediatric)

Benzene sulfonamide thiazole and oxazole compounds
Jul, 2030

(6 years from now)

Active
US8415345

(Pediatric)

Benzene sulfonamide thiazole and oxazole compounds
Jul, 2030

(6 years from now)

Active
US8952018 Pharmaceutical combination of MEK inhibitor and B-Raf inhibitors
Oct, 2030

(6 years from now)

Active
US8703781

(Pediatric)

Pharmaceutical combination of MEK inhibitor and B-RAF inhibitors
Apr, 2031

(6 years from now)

Active
US8952018

(Pediatric)

Pharmaceutical combination of MEK inhibitor and B-Raf inhibitors
Apr, 2031

(6 years from now)

Active
US10869869 Method of adjuvant cancer treatment
Aug, 2033

(9 years from now)

Active
US10869869

(Pediatric)

Method of adjuvant cancer treatment
Mar, 2034

(9 years from now)

Active
US11504333 Pharmaceutical composition
Jun, 2038

(13 years from now)

Active
US11504333

(Pediatric)

Pharmaceutical composition
Dec, 2038

(14 years from now)

Active


FDA has granted several exclusivities to Tafinlar. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Tafinlar, regardless of the status of it's patents. These exclusivities hence play a crucial role in delaying the generic launch. Given below are details of the exclusivities granted to Tafinlar.

Exclusivity Information

Tafinlar holds 17 exclusivities out of which 11 have expired. Its last outstanding exclusivity is set to expire in 2030. Details of Tafinlar's exclusivity codes and their expiration dates are given below.


Drug Exclusivity Drug Exclusivity Expiration
New Indication(I-678) Jan 08, 2017
New Chemical Entity Exclusivity(NCE) May 29, 2018
M(M-170) Nov 20, 2018
Orphan Drug Exclusivity(ODE) May 29, 2020
Orphan Drug Exclusivity(ODE-47) May 29, 2020
New Indication(I-745) Jun 22, 2020
Orphan Drug Exclusivity(ODE-58) Jan 09, 2021
New Indication(I-778) Apr 30, 2021
New Indication(I-781) May 04, 2021
M(M-246) Oct 06, 2022
Orphan Drug Exclusivity(ODE-147) Jun 22, 2024
Orphan Drug Exclusivity(ODE-182) Apr 30, 2025
Orphan Drug Exclusivity(ODE-183) May 04, 2025
New Indication(I-894) Jun 22, 2025
Pediatric Exclusivity(PED) Dec 22, 2025
New Indication(I-908) Mar 16, 2026
Orphan Drug Exclusivity(ODE-428) Mar 16, 2030

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Several oppositions have been filed on Tafinlar's European patents. EP oppositions can significantly impact the timeline for the generic launch of drugs. If an opposition results in the revocation or amendment of a patent, it can shorten the exclusivity period of the original drug. This can lead to an earlier entry of generic versions into the market. To help you estimate the potential early arrival of Tafinlar's generic, the next section provides detailed information on ongoing and past EP oppositions related to Tafinlar patents.

Tafinlar's oppositions filed in EPO

Tafinlar has faced multiple oppositions in the European Patent Office. The earliest opposition was filed on Dec 21, 2016, by Stada Arzneimittel Ag. This opposition was filed on patent number EP09743378A. Click below to reveal the latest opposition data.


Application Filing Date Opposition Party Legal Status
Patent litigations
EP19174594A May, 2023 Brand Murray Fuller LLP Granted and Under Opposition
EP19174594A May, 2023 STADA Arzneimittel AG Granted and Under Opposition
EP13835019A Jun, 2022 Generics [UK] Limited Granted and Under Opposition
EP13835019A Jun, 2022 Teva Pharmaceutical Industries Ltd Granted and Under Opposition
EP13835019A Jun, 2022 STADA Arzneimittel AG Granted and Under Opposition
EP10824148A Mar, 2020 Teva Pharmaceutical Industries Ltd Opposition rejected
EP10824148A Mar, 2020 Generics (UK) Ltd Opposition rejected
EP09743378A Dec, 2016 STADA Arzneimittel AG Opposition rejected


US patents provide insights into the exclusivity only within the United States, but Tafinlar is protected by patents in multiple countries. Understanding the full scope of patent protection is crucial in strategizing market entry. By looking at the broader patent landscape, you can identify markets with weaker patent protection which could be ideal generic entry points. The following section offers details on Tafinlar's family patents as well as insights into ongoing legal events on those patents.

Tafinlar's family patents

Tafinlar has patent protection in a total of 45 countries. It's US patent count contributes only to 18.4% of its total global patent coverage. 5 countries have all of their patents expired or invalidated which has opened up potential generic launch opportunities in these countries. Click below to unlock the full patent family tree for Tafinlar.

Family Patents

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Generic Launch

Generic Release Date:

Tafinlar's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Dec 29, 2038 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)

Tafinlar Generics:

There are no approved generic versions for Tafinlar as of now.





About Tafinlar

Tafinlar is a drug owned by Novartis Pharmaceuticals Corp. It is used for treating metastatic melanoma and anaplastic thyroid cancer with specific genetic mutations. Tafinlar uses Dabrafenib Mesylate as an active ingredient. Tafinlar was launched by Novartis in 2013.

Can you believe Tafinlar received compensation for the extended wait time during the regulatory approval process?

A supplementary protection certificate (SPC) is a type of intellectual property right granted in the European Union. It provides an extension of the term of protection for a medicinal product that has been authorized for sale in the EU, beyond the 20-year term provided by the basic patent. The aim of SPCs is to compensate for the time taken to get regulatory approval for a new drug, and to provide an incentive for companies to invest in research and development in the field of medicinal products.

Market Authorisation Date:

Tafinlar was approved by FDA for market use on 29 May, 2013.

NCE-1 date:

NCE-1 date is also known as the four year date as it is four years after the original drug approval. Since the approval date for Tafinlar is 29 May, 2013, its NCE-1 date is estimated to be 22 December, 2024

Active Ingredient:

Tafinlar uses Dabrafenib Mesylate as the active ingredient. Check out other Drugs and Companies using Dabrafenib Mesylate ingredient

Treatment:

Tafinlar is used for treating metastatic melanoma and anaplastic thyroid cancer with specific genetic mutations.

Dosage:

Tafinlar is available in the following dosage forms - tablet, for suspension form for oral use, capsule form for oral use. Given below is detailed information on Dosage -

Strength Dosage Form Availability Application Pathway
EQ 75MG BASE CAPSULE Prescription ORAL
EQ 50MG BASE CAPSULE Prescription ORAL
EQ 10MG BASE TABLET, FOR SUSPENSION Prescription ORAL