Question 1

Is there a generic for Capmatinib hydrochloride?

Accepted Answer

The FDA Orange Book does not currently list an approved generic (ANDA) for Capmatinib hydrochloride. It is available as 1 brand (NDA) application.

Question 2

What is the reference-listed drug for Capmatinib hydrochloride?

Accepted Answer

TABRECTA (NDA 213591, NOVARTIS PHARM) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

Question 3

What patents protect Capmatinib hydrochloride?

Accepted Answer

The Orange Book lists 7 patents against Capmatinib hydrochloride products, with the earliest listed expiry in 2027. 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.

Question 4

Does Capmatinib hydrochloride have FDA marketing exclusivity?

Accepted Answer

Yes. The Orange Book records 2 marketing-exclusivity periods for Capmatinib hydrochloride. Exclusivity is granted by FDA at approval (for example new-chemical-entity, orphan-drug, or pediatric exclusivity) and runs independently of any listed patents.

Question 5

What dosage forms of Capmatinib hydrochloride are approved?

Accepted Answer

Capmatinib hydrochloride is approved in the following dosage form: tablet.

Patent	Expires	In	Type
12084449	Nov 19, 2027	in 1 yr 5 mo	U-2813
8461330	Nov 19, 2027	in 1 yr 5 mo	SubstanceProduct
8901123	May 20, 2029	in 3 yr	U-2813
8420645	Jun 05, 2031	in 5 yr	SubstanceProduct
7767675	Nov 19, 2032	in 6 yr 6 mo	SubstanceProduct
10596178	Jul 22, 2035	in 9 yr 3 mo	Product
12208101	Jul 22, 2035	in 9 yr 3 mo	Product

Capmatinib hydrochloride

Brand (NDA) products · tablet

Marketing exclusivity (2)

Listed patents (7)

Capmatinib hydrochloride — frequently asked questions

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