Question 1

Is there a generic for Zongertinib?

Accepted Answer

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

Question 2

What is the reference-listed drug for Zongertinib?

Accepted Answer

HERNEXEOS (NDA 219042, BOEHRINGER INGELHEIM) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

Question 3

What patents protect Zongertinib?

Accepted Answer

The Orange Book lists 2 patents against Zongertinib products, with the earliest listed expiry in 2026. 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 Zongertinib have FDA marketing exclusivity?

Accepted Answer

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

Accepted Answer

Zongertinib is approved in the following dosage form: tablet.

Patent	Expires	In	Type
12171739	Nov 15, 2026	in 5 mo	SubstanceProduct
11608343	Jul 21, 2041	in 15 yr 4 mo	SubstanceProductU-4245

Zongertinib

Brand (NDA) products · tablet

Marketing exclusivity (1)

Listed patents (2)

Zongertinib — frequently asked questions

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