Question 1

Is there a generic for Sebetralstat?

Accepted Answer

The FDA Orange Book does not currently list an approved generic (ANDA) for Sebetralstat. It is available as 1 brand (NDA) application.

Question 2

What is the reference-listed drug for Sebetralstat?

Accepted Answer

EKTERLY (NDA 219301, KALVISTA) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

Question 3

What patents protect Sebetralstat?

Accepted Answer

The Orange Book lists 8 patents against Sebetralstat products, with the earliest listed expiry in 2035. Listed patents cover the drug substance, drug product, or approved methods of use, and a generic launching before they expire must file a Paragraph IV certification.

Question 4

Does Sebetralstat have FDA marketing exclusivity?

Accepted Answer

Yes. The Orange Book records 2 marketing-exclusivity periods for Sebetralstat. Exclusivity is granted by FDA at approval (for example new-chemical-entity, orphan-drug, or pediatric exclusivity) and runs independently of any listed patents.

Question 5

What dosage forms of Sebetralstat are approved?

Accepted Answer

Sebetralstat is approved in the following dosage form: tablet.

Patent	Expires	In	Type
11198691	Nov 26, 2035	in 9 yr 7 mo	U-4223
11084809	Nov 26, 2035	in 9 yr 7 mo	SubstanceProductU-4223
10611758	Nov 26, 2035	in 9 yr 7 mo	U-4223
10364238	Nov 26, 2035	in 9 yr 7 mo	SubstanceProduct
11001578	Nov 26, 2035	in 9 yr 7 mo	SubstanceProduct
11739068	Jun 23, 2037	in 11 yr 2 mo	U-4223
11230537	Dec 25, 2037	in 11 yr 8 mo	SubstanceProduct
11234939	Jan 26, 2039	in 12 yr 9 mo	ProductU-4223

Sebetralstat

Brand (NDA) products · tablet

Marketing exclusivity (2)

Listed patents (8)

Sebetralstat — frequently asked questions

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