Is there a generic for Dabrafenib mesylate?

The FDA Orange Book does not currently list an approved generic (ANDA) for Dabrafenib mesylate. It is available as 2 brand (NDA) applications.

What is the reference-listed drug for Dabrafenib mesylate?

TAFINLAR (NDA 217514, NOVARTIS) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What patents protect Dabrafenib mesylate?

The Orange Book lists 14 patents against Dabrafenib mesylate products, with the earliest listed expiry in 2029. Listed patents cover the drug substance, drug product, or approved methods of use, and a generic launching before they expire must file a Paragraph IV certification.

Does Dabrafenib mesylate have FDA marketing exclusivity?

Yes. The Orange Book records 12 marketing-exclusivity periods for Dabrafenib mesylate. Exclusivity is granted by FDA at approval (for example new-chemical-entity, orphan-drug, or pediatric exclusivity) and runs independently of any listed patents.

What dosage forms of Dabrafenib mesylate are approved?

Dabrafenib mesylate is approved in the following dosage forms: capsule, tablet, for suspension.

FDA Orange Book · active-ingredient family

Dabrafenib mesylate

Dabrafenib mesylate: 2 brands, 0 generics; first approved May 29, 2013; on patent until May 04, 2029.

On patent12 exclusivity periods

Generic status & protection

Protected until May 04, 2029 (earliest listed patent expiry).

Earliest patent expiry May 04, 2029Latest exclusivity ends Sep 16, 2030

Brands (NDA)

Generics (ANDA)

Listed patents

Next patent expiry

May 04, 2029

in 2 yr 10 mo

Originator applications

Brand (NDA) products

TAFINLARRLDRS

NOVARTISNDA 2175142023

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 10MG BASE	TABLET, FOR SUSPENSION	ORAL	Rx	—

TAFINLARRLD

NOVARTISNDA 20280620132 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 50MG BASE	CAPSULE	ORAL	Rx	—
EQ 75MG BASE	CAPSULE	ORAL	Rx	—

Protection horizon

Patent & exclusivity timeline

Patent expiryExclusivity endToday

Hatch-Waxman

Marketing exclusivity

Marketing exclusivity (12)

I-908New indication exclusivity (3 years)
Mar 16, 2026
4 mo ago
ODE-428Orphan-drug exclusivity (7 years)
Mar 16, 2030
in 3 yr 9 mo
PEDPediatric exclusivity (adds 6 months)
Sep 16, 2030
in 4 yr 3 mo
PEDPediatric exclusivity (adds 6 months)
Sep 16, 2026
in 2 mo
I-908New indication exclusivity (3 years)
Mar 16, 2026
4 mo ago
ODE-428Orphan-drug exclusivity (7 years)
Mar 16, 2030
in 3 yr 9 mo
PEDPediatric exclusivity (adds 6 months)
Sep 16, 2030
in 4 yr 3 mo
PEDPediatric exclusivity (adds 6 months)
Sep 16, 2026
in 2 mo
NPNew product exclusivity (3 years)
Mar 16, 2026
4 mo ago
ODE-428Orphan-drug exclusivity (7 years)
Mar 16, 2030
in 3 yr 9 mo
PEDPediatric exclusivity (adds 6 months)
Sep 16, 2030
in 4 yr 3 mo
PEDPediatric exclusivity (adds 6 months)
Sep 16, 2026
in 2 mo

Orange Book patent file

Listed patents

Listed patents (14)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
Patent	Expires	In	Type
9233956	May 04, 2029	in 2 yr 10 mo	U-2032
9233956*PED	Nov 04, 2029	in 3 yr 4 mo
7994185	Jan 20, 2030	in 3 yr 7 mo	SubstanceProductU-2296
8415345	Jan 20, 2030	in 3 yr 7 mo	SubstanceProductU-2032
7994185*PED	Jul 20, 2030	in 4 yr 1 mo
8415345*PED	Jul 20, 2030	in 4 yr 1 mo
8703781	Oct 15, 2030	in 4 yr 4 mo	SubstanceProductU-2296
8952018	Oct 15, 2030	in 4 yr 4 mo	U-2027
8952018*PED	Apr 15, 2031	in 4 yr 10 mo
8703781*PED	Apr 15, 2031	in 4 yr 10 mo
10869869	Aug 30, 2033	in 7 yr 3 mo	U-3185
10869869*PED	Feb 28, 2034	in 7 yr 9 mo
11504333	Jun 29, 2038	in 12 yr 2 mo	Product
11504333*PED	Dec 29, 2038	in 12 yr 8 mo

FDA approval span

Approval history

First approval

May 29, 2013

13 yr 4 mo ago

Most recent approval

Mar 16, 2023

3 yr 4 mo ago

Approvals span 2013–2023 across 2 FDA applications.

Brand (NDA) 2100%

Generic (ANDA) 00%

Dabrafenib mesylate — frequently asked questions

Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.

Built directly from the FDA Orange Book data file (products, patents, and exclusivity). TE codes, RLD/RS flags, patent expirations, and exclusivity dates match the official FDA record. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.

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