small molecule

TAFINLAR

DABRAFENIB MESYLATE

Loss of exclusivityDecember 2038latest FDA-listed patent expiry

CompanyNovartis →See this company's full patent-cliff portfolio

Drug detail

Brand name	TAFINLAR
Active ingredient	DABRAFENIB MESYLATE
Strength	EQ 10MG BASE
Dosage form	TABLET, FOR SUSPENSION
Route	ORAL
Modality	Small molecule
FDA approval	March 2023
Marketing status	RX

Listed patents

Patent	Expires	Type
11504333*PED	December 2038	—
11504333	June 2038	product
8703781*PED	April 2031	—
8703781	October 2030	substance, product
8415345*PED	July 2030	—
7994185*PED	July 2030	—
7994185	January 2030	substance, product
8415345	January 2030	substance, product

Regulatory exclusivity

Code	Expires
PED	September 2030
ODE-428	March 2030
PED	September 2026
NP	March 2026

Source: FDA Orange Book, layered on the CliffBio company graph. Cliff dates are the latest FDA-listed patent expiry; estimates are projections, not legal advice.

Drug detail

Listed patents

Regulatory exclusivity

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