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 protect the active ingredient(API) of the drug. Only drug patent owner can launch products that use this active ingredient until these patents expire. | |||
| US8703781 | Pharmaceutical combination of MEK inhibitor and B-RAF inhibitors |
Oct, 2030
(5 years from now) | Active |
| US8415345 | Benzene sulfonamide thiazole and oxazole compounds |
Jan, 2030
(4 years from now) | Active |
| US7994185 | Benzene sulfonamide thiazole and oxazole compounds |
Jan, 2030
(4 years from now) | Active |
| These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
|
US11504333 (Pediatric) | Pharmaceutical composition |
Dec, 2038
(13 years from now) | Active |
| US11504333 | Pharmaceutical composition |
Jun, 2038
(13 years from now) | Active |
|
US10869869 (Pediatric) | Method of adjuvant cancer treatment |
Feb, 2034
(8 years from now) | Active |
| US10869869 | Method of adjuvant cancer treatment |
Aug, 2033
(8 years from now) | Active |
|
US8952018 (Pediatric) | Pharmaceutical combination of MEK inhibitor and B-Raf inhibitors |
Apr, 2031
(5 years from now) | Active |
|
US8703781 (Pediatric) | Pharmaceutical combination of MEK inhibitor and B-RAF inhibitors |
Apr, 2031
(5 years from now) | Active |
| US8952018 | Pharmaceutical combination of MEK inhibitor and B-Raf inhibitors |
Oct, 2030
(5 years from now) | Active |
|
US7994185 (Pediatric) | Benzene sulfonamide thiazole and oxazole compounds |
Jul, 2030
(5 years from now) | Active |
|
US8415345 (Pediatric) | Benzene sulfonamide thiazole and oxazole compounds |
Jul, 2030
(5 years from now) | Active |
|
US9233956 (Pediatric) | Benzene sulfonamide thiazole and oxazole compounds |
Nov, 2029
(4 years from now) | Active |
| US9233956 | Benzene sulfonamide thiazole and oxazole compounds |
May, 2029
(3 years from now) | Active |
|
US8835443 (Pediatric) | Pyrimidine compound and medical use thereof |
Dec, 2025
(6 months from now) | Active |
| US8835443 | Pyrimidine compound and medical use thereof |
Jun, 2025
(9 days from now) | Active |
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 Tafinlar's patents.
Latest Legal Activities on Tafinlar's Patents
Given below is the list of recent legal activities going on the following patents of Tafinlar.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| 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 Critical | 22 Nov, 2022 | US11504333 |
| Recordation of Patent Grant Mailed Critical | 22 Nov, 2022 | US11504333 |
| Email Notification Critical | 03 Nov, 2022 | US11504333 |
| Issue Notification Mailed Critical | 02 Nov, 2022 | US11504333 |
| Application Is Considered Ready for Issue Critical | 21 Oct, 2022 | US11504333 |
| Dispatch to FDC | 21 Oct, 2022 | US11504333 |
| Issue Fee Payment Received Critical | 18 Oct, 2022 | US11504333 |
| Issue Fee Payment Verified Critical | 18 Oct, 2022 | US11504333 |
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 18 exclusivities out of which 13 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) | Sep 16, 2026 |
| New Indication(I-908) | Mar 16, 2026 |
| New Product(NP) | Mar 16, 2026 |
| Orphan Drug Exclusivity(ODE-428) | Mar 16, 2030 |
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 |
|---|---|---|---|
 | |||
| 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
Explore Our Curated Drug Screens
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 2023.
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.
Approval Date:
Tafinlar was approved by FDA for market use on 16 March, 2023.
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 - capsule form for oral use, tablet, for suspension form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| EQ 10MG BASE | TABLET, FOR SUSPENSION | Prescription | ORAL |
| EQ 50MG BASE | CAPSULE | Prescription | ORAL |
| EQ 75MG BASE | CAPSULE | Prescription | ORAL |