Details for New Drug Application (NDA): 219972

NDA 219972 describes HYRNUO, which is a drug marketed by Bayer Healthcare and is included in one NDA. It is available from one supplier. There is one patent protecting this drug. Additional details are available on the HYRNUO profile page.

The generic ingredient in HYRNUO is sevabertinib. One supplier is listed for this compound. Additional details are available on the sevabertinib profile page.

Summary for 219972

Tradename:	HYRNUO
Applicant:	Bayer Healthcare
Ingredient:	sevabertinib
Patents:	1

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for 219972

Constraining patent/regulatory exclusivity:

NEW CHEMICAL ENTITY

Dosage:

TABLET;ORAL

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Suppliers and Packaging for NDA: 219972

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
HYRNUO	sevabertinib	TABLET;ORAL	219972	NDA	Bayer HealthCare Pharmaceuticals Inc.	50419-397	50419-397-01	120 TABLET, FILM COATED in 1 BOTTLE (50419-397-01)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	10MG
Approval Date:	Nov 19, 2025	TE:		RLD:	Yes
Regulatory Exclusivity Expiration:	Nov 19, 2030
Regulatory Exclusivity Use:	NEW CHEMICAL ENTITY
Patent:	10,428,063	Patent Expiration:	Oct 10, 2035	Product Flag?	Y	Substance Flag?	Y	Delist Request?

Complete Access Available with Subscription