Question 1

Is there a generic for Sevabertinib?

Accepted Answer

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

Question 2

What is the reference-listed drug for Sevabertinib?

Accepted Answer

HYRNUO (NDA 219972, BAYER HEALTHCARE) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

Question 3

What patents protect Sevabertinib?

Accepted Answer

The Orange Book lists 1 patent against Sevabertinib products, with the earliest listed expiry in 2035. 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 Sevabertinib have FDA marketing exclusivity?

Accepted Answer

Yes. The Orange Book records 1 marketing-exclusivity period for Sevabertinib. 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 Sevabertinib are approved?

Accepted Answer

Sevabertinib is approved in the following dosage form: tablet.

Sevabertinib

Brand (NDA) products · tablet

Marketing exclusivity (1)

Listed patents (1)

Sevabertinib — frequently asked questions

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