Orange Book product · Brand (NDA)

ACTHAR GEL (AUTOINJECTOR)

CORTICOTROPIN

Brand (NDA)NDA 008372RX MALLINCKRODT IRELAND

Feb 29, 2024

Approved

Brand (NDA)

Application

Not listed

TE code

Listed patents

Approval
FDA approval date of this drug product.
Feb 29, 2024
2 yr 4 mo ago
Today
Patent 11752199 expires
Listed method-of-use patent (U-3686) expiration.
Jul 18, 2041
in 15 yr 4 mo
Patent 11752199 expires
Listed method-of-use patent (U-3687) expiration.
Jul 18, 2041
in 15 yr 4 mo
Patent 11752199 expires
Listed method-of-use patent (U-3688) expiration.
Jul 18, 2041
in 15 yr 4 mo

Active ingredient

CORTICOTROPIN

Strength

80 UNITS/ML

Dosage form

INJECTABLE

Route

INJECTION

TE code

Not listed

Application

NDA 008372

Product number

004

Marketing status

Reference listed drug (RLD)

Yes

Reference standard (RS)

Yes

Active-ingredient family

This is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
Patent	Expires	In	Type
11752199	Jul 18, 2041	in 15 yr 4 mo	U-3686
11752199	Jul 18, 2041	in 15 yr 4 mo	U-3687
11752199	Jul 18, 2041	in 15 yr 4 mo	U-3688