Question 1

Is there a generic for Aprocitentan?

Accepted Answer

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

Question 2

What is the reference-listed drug for Aprocitentan?

Accepted Answer

TRYVIO (NDA 217686, IDORSIA) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

Question 3

What patents protect Aprocitentan?

Accepted Answer

The Orange Book lists 6 patents against Aprocitentan products, with the earliest listed expiry in 2029. 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 Aprocitentan have FDA marketing exclusivity?

Accepted Answer

Yes. The Orange Book records 1 marketing-exclusivity period for Aprocitentan. 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 Aprocitentan are approved?

Accepted Answer

Aprocitentan is approved in the following dosage form: tablet.

Patent	Expires	In	Type
8324232	Sep 21, 2029	in 3 yr 4 mo	SubstanceProductU-3878
11174247	Nov 06, 2037	in 11 yr 7 mo	U-3879
12297189	Feb 26, 2038	in 11 yr 10 mo	Product
10919881	Feb 26, 2038	in 11 yr 10 mo	SubstanceProduct
11787782	Mar 02, 2038	in 11 yr 10 mo	U-3877
11680058	Jul 26, 2038	in 12 yr 3 mo	U-3878

Aprocitentan

Brand (NDA) products · tablet

Marketing exclusivity (1)

Listed patents (6)

Aprocitentan — frequently asked questions

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