Question 1

Is there a generic for Tepotinib hydrochloride?

Accepted Answer

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

Question 2

What is the reference-listed drug for Tepotinib hydrochloride?

Accepted Answer

TEPMETKO (NDA 214096, EMD SERONO INC) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

Question 3

What patents protect Tepotinib hydrochloride?

Accepted Answer

The Orange Book lists 8 patents against Tepotinib hydrochloride products, with the earliest listed expiry in 2028. 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 Tepotinib hydrochloride have FDA marketing exclusivity?

Accepted Answer

Yes. The Orange Book records 2 marketing-exclusivity periods for Tepotinib 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 Tepotinib hydrochloride are approved?

Accepted Answer

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

Patent	Expires	In	Type
9284300	Apr 29, 2028	in 1 yr 11 mo	Product
8921357	May 30, 2028	in 2 yr	SubstanceProduct
8658643	Jul 04, 2028	in 2 yr 1 mo	U-3077
9403799	Jul 04, 2028	in 2 yr 1 mo	U-3077
9062029	Jul 04, 2028	in 2 yr 1 mo	Product
8927540	Jul 21, 2028	in 2 yr 1 mo	U-3078
8329692	Oct 30, 2029	in 3 yr 5 mo	SubstanceProduct
8580781	Mar 19, 2030	in 3 yr 10 mo	SubstanceProduct

Tepotinib hydrochloride

Brand (NDA) products · tablet

Marketing exclusivity (2)

Listed patents (8)

Tepotinib hydrochloride — frequently asked questions

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