Details for New Drug Application (NDA): 219301
✉ Email this page to a colleague
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. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the sebetralstat profile page.
The generic ingredient in EKTERLY is sebetralstat. There is one drug master file entry for this compound. 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
Generic Entry Date for 219301*:
Constraining patent/regulatory exclusivity:
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) |
| EKTERLY | sebetralstat | TABLET;ORAL | 219301 | NDA | KalVista Pharmaceuticals Ltd | 82928-300 | 82928-300-05 | 2 BLISTER PACK in 1 CARTON (82928-300-05) / 2 TABLET in 1 BLISTER PACK (82928-300-02) |
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 | ||||||||
| Regulatory Exclusivity Expiration: | Jul 3, 2032 | ||||||||
| Regulatory Exclusivity Use: | TREATMENT OF ACUTE ATTACKS OF HEREDITARY ANGIOEDEMA (HAE) IN ADULT AND PEDIATRIC PATIENTS AGED12 YEARS AND OLDER | ||||||||
| Patent: | 10,364,238 | Patent Expiration: | Nov 26, 2035 | Product Flag? | Y | Substance Flag? | Y | Delist Request? | |
Complete Access Available with Subscription
