Generic competition · all medicines · read 12 November 2026

Is there a generic of Dabrafenib Mesylate, and who makes it?

Dabrafenib Mesylate appears in 2 dosage-form groups in the FDA Orange Book as of 12 November 2026, with no generic maker listed as marketed. 2 groups have a brand listed as marketed and no generic listed as marketed. The data does not state why, and it does not state that one is coming. This is the Orange Book's listing, not a forecast.

Compiled and checked by Vincent Wesley Couey (ORCID 0009-0005-6869-308X) from the Orange Book data files, downloaded 12 November 2026.

Not medical advice. This page reports what the FDA's Orange Book lists, not what a pharmacy has in stock, what anything costs, or whether a generic is right for you. Ask your pharmacist or prescriber about your own medicine.

Dabrafenib Mesylate2 dosage-form groups in the Orange Book

0generic makers listed

Dabrafenib Mesylate appears in 2 dosage-form groups in the FDA Orange Book as of 12 November 2026, with no generic maker listed as marketed.
2 groups have a brand listed as marketed and no generic listed as marketed. The data does not state why, and it does not state that one is coming.
Patents and exclusivities are shown as listed by the application holder; the Orange Book does not rule on them, and a listed patent is not a statement that a generic is blocked. This says nothing about price, supply or quality.

Capsule, Oral

Brand listed, no generic listed as marketed

Brand listed as marketed: Tafinlar. No generic is listed as marketed.

generic makers listed as marketed, by first approvallisted patent expiryexclusivity end

Patents and exclusivities still listed

16 March 2030Exclusivity ODE-428 Tafinlar
16 September 2030Exclusivity PED Tafinlar
4 May 2029Patent 9233956
4 November 2029Patent 9233956*PED
20 January 2030Patent 7994185 drug substance
20 January 2030Patent 8415345 drug substance
20 July 2030Patent 7994185*PED
20 July 2030Patent 8415345*PED
15 October 2030Patent 8703781 drug substance
15 October 2030Patent 8952018

4 more patents are listed.

Tablet, For Suspension, Oral

Brand listed, no generic listed as marketed

Brand listed as marketed: Tafinlar. No generic is listed as marketed.

generic makers listed as marketed, by first approvallisted patent expiryexclusivity end

Patents and exclusivities still listed

16 March 2030Exclusivity ODE-428 Tafinlar
16 September 2030Exclusivity PED Tafinlar
20 January 2030Patent 8415345 drug substance
20 January 2030Patent 7994185 drug substance
20 July 2030Patent 8415345*PED
20 July 2030Patent 7994185*PED
15 October 2030Patent 8703781 drug substance
15 April 2031Patent 8703781*PED
29 June 2038Patent 11504333 drug product
29 December 2038Patent 11504333*PED

US Food and Drug Administration, Orange Book data files, downloaded 12 November 2026. A listed patent is not a ruling that a generic is blocked, and no figure here says anything about price, supply or quality. Check the Orange Book.

Where can you go from this result?

Open it in the check to search another medicine, or see every brand with no generic listed. The FDA explains generic approval in how generic drugs are approved and the FDA generic drug facts, and the Orange Book itself is the FDA Orange Book. To check what is available now, ask your pharmacist, and see the FDA drug shortages page.