Orange Book product · Brand (NDA)

MILPROSA

PROGESTERONE

Brand (NDA)NDA 201110DISCN FERRING PHARMS INC

Apr 29, 2020

Approved

Brand (NDA)

Application

Not listed

TE code

Listed patents

Approval
FDA approval date of this drug product.
Apr 29, 2020
6 yr 3 mo ago
Today
Patent 10537584 expires
Listed drug product patent expiration.
Feb 03, 2029
in 2 yr 8 mo
Patent 10548904 expires
Listed method-of-use patent (U-2810) expiration.
Feb 03, 2029
in 2 yr 8 mo
Patent 8580293 expires
Listed method-of-use patent (U-2810) expiration.
Jan 21, 2030
in 3 yr 8 mo

Active ingredient

PROGESTERONE

Strength

1.78GM

Dosage form

SYSTEM

Route

VAGINAL

TE code

Not listed

Application

NDA 201110

Product number

001

Marketing status

DISCN

Reference listed drug (RLD)

Yes

Reference standard (RS)

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
10537584	Feb 03, 2029	in 2 yr 8 mo	Product
10548904	Feb 03, 2029	in 2 yr 8 mo	U-2810
8580293	Jan 21, 2030	in 3 yr 8 mo	U-2810