Viewing data from:

EKTERLY

NDA

SEBETRALSTAT | N219301 | KALVISTA PHARMACEUTICALS LTD

1 strength8 unique patents2 unique exclusivities

Patent Timeline

8 unique patents, 2 exclusivities by expiration date

Active (8)TodayExclusivity

2026

2027

2028

2029

2030

2031

2032

2033

2034

2035

2036

2037

2038

2039

Today

Nov. 26, 2035

Nov. 26, 2035

Nov. 26, 2035

Nov. 26, 2035

Nov. 26, 2035

Dec. 25, 2037

Jan. 26, 2039

Jun. 23, 2037

NCE

Jul. 3, 2030

ODE-534

Jul. 3, 2032

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Jul 8, 2025	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 300MG

RLD

8 patents2 exclusivities▴

TABLET;ORAL | Approved: Jul 3, 2025

Patents (8)

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
10364238	Nov 26, 2035	—	Yes	Yes	—	—
10611758	Nov 26, 2035	—	—	—		—
11001578	Nov 26, 2035	—	Yes	Yes	—	—
11084809	Nov 26, 2035	—	Yes	Yes		—
11198691	Nov 26, 2035	—	—	—		—
11230537	Dec 25, 2037	—	Yes	Yes	—	—
11234939	Jan 26, 2039	—	—	Yes		—
11739068	Jun 23, 2037	—	—	—		—

Exclusivities (2)

Code	Date	Status
NCE	Jul 3, 2030	Active
ODE-534	Jul 3, 2032	Active

Change History (1)

Recent changes detected for this application.

ADDED7/1/2026

KalVista added orphan drug exclusivity to Ekterly (sebetralstat) for NDA 219301, effective through the orphan designation period tied to ODE-534.

New: New record