Application 219301

Type: NDA
Sponsor: KALVISTA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	EKTERLY	SEBETRALSTAT	TABLET;ORAL	300MG	Yes	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N219301-001	EKTERLY	SEBETRALSTAT	300MG	TABLET / ORAL		RLD, RS	2025-07-03

Orange Book patents#

Current patent rows page 1 of 1 · 8 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N219301-001	10364238	2035-11-26		Drug substance, Drug product	2025-07-29
N219301-001	10611758	2035-11-26	U-4223		2025-07-29
N219301-001	11001578	2035-11-26		Drug substance, Drug product	2025-07-29
N219301-001	11084809	2035-11-26	U-4223	Drug substance, Drug product	2025-07-29
N219301-001	11198691	2035-11-26	U-4223		2025-07-29
N219301-001	11739068	2037-06-23	U-4223		2025-07-29
N219301-001	11230537	2037-12-25		Drug substance, Drug product	2025-07-29
N219301-001	11234939	2039-01-26	U-4223	Drug product	2025-07-29

Orange Book exclusivity#

Current exclusivity rows page 1 of 1 · 2 matching rows.

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N219301-001	NCE	2030-07-03
N219301-001	ODE-534	2032-07-03

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N219301-001	EKTERLY	300MG	TABLET / ORAL	RLD, RS	2025-07-03	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N219301-001	EKTERLY	300MG	TABLET / ORAL	RLD, RS	2025-07-03	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N219301-001	EKTERLY	300MG	TABLET / ORAL	RLD, RS	2025-07-03	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N219301-001	EKTERLY	300MG	TABLET / ORAL	RLD, RS	2025-07-03	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N219301-001	EKTERLY	300MG	TABLET / ORAL	RLD, RS	2025-07-03	`6a471c1ec25d…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N219301-001	EKTERLY	300MG	TABLET / ORAL	RLD, RS	2025-07-03	`a50c72e98297…`

Observed Orange Book patent history#

Patent history page 1 of 2 · 48 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-09-14 22:38:34	2026-08	N219301-001	10364238	2035-11-26		Drug substance, Drug product	2025-07-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N219301-001	10611758	2035-11-26	U-4223		2025-07-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N219301-001	11001578	2035-11-26		Drug substance, Drug product	2025-07-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N219301-001	11084809	2035-11-26	U-4223	Drug substance, Drug product	2025-07-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N219301-001	11198691	2035-11-26	U-4223		2025-07-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N219301-001	11739068	2037-06-23	U-4223		2025-07-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N219301-001	11230537	2037-12-25		Drug substance, Drug product	2025-07-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N219301-001	11234939	2039-01-26	U-4223	Drug product	2025-07-29	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N219301-001	10364238	2035-11-26		Drug substance, Drug product	2025-07-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N219301-001	10611758	2035-11-26	U-4223		2025-07-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N219301-001	11001578	2035-11-26		Drug substance, Drug product	2025-07-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N219301-001	11084809	2035-11-26	U-4223	Drug substance, Drug product	2025-07-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N219301-001	11198691	2035-11-26	U-4223		2025-07-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N219301-001	11739068	2037-06-23	U-4223		2025-07-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N219301-001	11230537	2037-12-25		Drug substance, Drug product	2025-07-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N219301-001	11234939	2039-01-26	U-4223	Drug product	2025-07-29	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N219301-001	10364238	2035-11-26		Drug substance, Drug product	2025-07-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N219301-001	10611758	2035-11-26	U-4223		2025-07-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N219301-001	11001578	2035-11-26		Drug substance, Drug product	2025-07-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N219301-001	11084809	2035-11-26	U-4223	Drug substance, Drug product	2025-07-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N219301-001	11198691	2035-11-26	U-4223		2025-07-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N219301-001	11739068	2037-06-23	U-4223		2025-07-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N219301-001	11230537	2037-12-25		Drug substance, Drug product	2025-07-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N219301-001	11234939	2039-01-26	U-4223	Drug product	2025-07-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N219301-001	10364238	2035-11-26		Drug substance, Drug product	2025-07-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N219301-001	10611758	2035-11-26	U-4223		2025-07-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N219301-001	11001578	2035-11-26		Drug substance, Drug product	2025-07-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N219301-001	11084809	2035-11-26	U-4223	Drug substance, Drug product	2025-07-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N219301-001	11198691	2035-11-26	U-4223		2025-07-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N219301-001	11739068	2037-06-23	U-4223		2025-07-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N219301-001	11230537	2037-12-25		Drug substance, Drug product	2025-07-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N219301-001	11234939	2039-01-26	U-4223	Drug product	2025-07-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N219301-001	10364238	2035-11-26		Drug substance, Drug product	2025-07-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N219301-001	10611758	2035-11-26	U-4223		2025-07-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N219301-001	11001578	2035-11-26		Drug substance, Drug product	2025-07-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N219301-001	11084809	2035-11-26	U-4223	Drug substance, Drug product	2025-07-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N219301-001	11198691	2035-11-26	U-4223		2025-07-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N219301-001	11739068	2037-06-23	U-4223		2025-07-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N219301-001	11230537	2037-12-25		Drug substance, Drug product	2025-07-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N219301-001	11234939	2039-01-26	U-4223	Drug product	2025-07-29	`6a471c1ec25d…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2026-09-14 22:38:34	2026-08	N219301-001	NCE	2030-07-03	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N219301-001	ODE-534	2032-07-03	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N219301-001	NCE	2030-07-03	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N219301-001	ODE-534	2032-07-03	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N219301-001	NCE	2030-07-03	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N219301-001	NCE	2030-07-03	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N219301-001	NCE	2030-07-03	`6a471c1ec25d…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N219301-001	NCE	2030-07-03	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N219301-001	ODE-534	2032-07-03	`a50c72e98297…`

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
EKTERLY	SEBETRALSTAT	KalVista Pharmaceuticals Ltd	1d145e2f-8e7e-2e90-e063-6294a90a4449	2026-04-01	Adverse reactions	Exact identifier application applno (NDA): 219301 application number: NDA219301

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Documents#

Document, Submission type, Date table
Document	Submission type	Date
83059	ORIG	2025-08-07
82746	ORIG	2025-07-08
82745	ORIG	2025-07-08