Question 1

Is there a generic for Relacorilant?

Accepted Answer

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

Question 2

What is the reference-listed drug for Relacorilant?

Accepted Answer

LIFYORLI (COPACKAGED) (NDA 220641, CORCEPT THERAP) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

Question 3

What patents protect Relacorilant?

Accepted Answer

The Orange Book lists 10 patents against Relacorilant products, with the earliest listed expiry in 2033. 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 Relacorilant have FDA marketing exclusivity?

Accepted Answer

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

Accepted Answer

Relacorilant is approved in the following dosage form: capsule.

Patent	Expires	In	Type
10456392	May 24, 2033	in 7 yr	U-4457
9273047	May 24, 2033	in 7 yr	U-4457
11576907	May 24, 2033	in 7 yr	SubstanceProductU-4458
8859774	May 24, 2033	in 7 yr	SubstanceProduct
11925626	Dec 18, 2039	in 13 yr 8 mo	Product
12514849	Dec 18, 2039	in 13 yr 8 mo	Product
11464764	Apr 14, 2040	in 14 yr	Product
11285145	May 26, 2041	in 15 yr 2 mo	U-4458
12589094	May 26, 2041	in 15 yr 2 mo	U-4457
12152028	Dec 22, 2041	in 15 yr 9 mo	ProductU-4457

Relacorilant

Brand (NDA) products · capsule

Marketing exclusivity (1)

Listed patents (10)

Relacorilant — frequently asked questions

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