Orange Book product · Brand (NDA)

VYLEESI (AUTOINJECTOR)

BREMELANOTIDE ACETATE

Brand (NDA)NDA 210557RX COSETTE

Jun 21, 2019

Approved

Brand (NDA)

Application

Not listed

TE code

Listed patents

Approval
FDA approval date of this drug product.
Jun 21, 2019
7 yr 1 mo ago
Today
Patent 10286034 expires
Listed method-of-use patent (U-2568) expiration.
Nov 05, 2033
in 7 yr 6 mo
Patent 9352013 expires
Listed method-of-use patent (U-2568) expiration.
Nov 05, 2033
in 7 yr 6 mo
Patent 9700592 expires
Listed method-of-use patent (U-2568) expiration.
Nov 05, 2033
in 7 yr 6 mo
Patent 11590209 expires
Listed method-of-use patent (U-3539) expiration.
Apr 29, 2041
in 15 yr 1 mo

Active ingredient

BREMELANOTIDE ACETATE

Strength

EQ 1.75MG BASE/0.3ML (EQ 1.75MG BASE/0.3 ML)

Dosage form

SOLUTION

Route

SUBCUTANEOUS

TE code

Not listed

Application

NDA 210557

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
10286034	Nov 05, 2033	in 7 yr 6 mo	U-2568
9352013	Nov 05, 2033	in 7 yr 6 mo	U-2568
9700592	Nov 05, 2033	in 7 yr 6 mo	U-2568
11590209	Apr 29, 2041	in 15 yr 1 mo	U-3539