Details for New Drug Application (NDA): 219301

NDA 219301 describes EKTERLY, which is a drug marketed by Kalvista and is included in one NDA. It is available from one supplier. There are eight patents protecting this drug. Additional details are available on the EKTERLY profile page.

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

Summary for 219301

Tradename:	EKTERLY
Applicant:	Kalvista
Ingredient:	sebetralstat
Patents:	8

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for 219301

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.

Pharmacology for NDA: 219301

Mechanism of Action

Kallikrein Inhibitors

Suppliers and Packaging for NDA: 219301

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
EKTERLY	sebetralstat	TABLET;ORAL	219301	NDA	KalVista Pharmaceuticals Ltd	82928-300	82928-300-04	4 BLISTER PACK in 1 CARTON (82928-300-04) / 1 TABLET in 1 BLISTER PACK (82928-300-01)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	300MG
Approval Date:	Jul 3, 2025	TE:		RLD:	Yes
Regulatory Exclusivity Expiration:	Jul 3, 2030
Regulatory Exclusivity Use:	NEW CHEMICAL ENTITY
Patent:	10,364,238	Patent Expiration:	Nov 26, 2035	Product Flag?	Y	Substance Flag?	Y	Delist Request?
Patent:	10,611,758	Patent Expiration:	Nov 26, 2035	Product Flag?		Substance Flag?		Delist Request?
Patented Use:	TREATMENT OF ACUTE ATTACKS OF HEREDITARY ANGIOEDEMA (HAE) IN ADULTS AND PEDIATRIC PATIENTS 12 YEARS OF AGE AND OLDER

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