Orange Book product · Brand (NDA)

IMCIVREE

SETMELANOTIDE ACETATE

Brand (NDA)NDA 213793RX RHYTHM

Nov 25, 2020

Approved

Brand (NDA)

Application

Not listed

TE code

Listed patents

Approval
FDA approval date of this drug product.
Nov 25, 2020
5 yr 8 mo ago
Today
Patent 9458195 expires
Listed drug substance patent expiration.
Oct 13, 2027
in 1 yr 4 mo
Exclusivity ends · ODE-336
Orphan-drug exclusivity (7 years)
Nov 25, 2027
in 1 yr 5 mo
Exclusivity ends · NPP
New patient population exclusivity (3 years)
Dec 20, 2027
in 1 yr 6 mo
Exclusivity ends · I-987
New indication exclusivity (3 years)
Mar 19, 2029
in 2 yr 9 mo
Exclusivity ends · ODE-402
Orphan-drug exclusivity (7 years)
Jun 16, 2029
in 3 yr
Exclusivity ends · ODE-508
Orphan-drug exclusivity (7 years)
Dec 20, 2031
in 5 yr 7 mo
Exclusivity ends · ODE-509
Orphan-drug exclusivity (7 years)
Dec 20, 2031
in 5 yr 7 mo
Patent 8039435 expires
Listed drug substance patent expiration.
Aug 21, 2032
in 6 yr 3 mo
Patent 11129869 expires
Listed drug product patent expiration.
Jul 04, 2034
in 8 yr 2 mo

Active ingredient

SETMELANOTIDE ACETATE

Strength

EQ 10MG BASE/ML (EQ 10MG BASE/ML)

Dosage form

SOLUTION

Route

SUBCUTANEOUS

TE code

Not listed

Application

NDA 213793

Product number

001

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
9458195	Oct 13, 2027	in 1 yr 4 mo	SubstanceProduct
8039435	Aug 21, 2032	in 6 yr 3 mo	SubstanceProduct
11129869	Jul 04, 2034	in 8 yr 2 mo	Product