Orange Book product · Brand (NDA)

INTRAROSA

PRASTERONE

Brand (NDA)NDA 208470RX MILLICENT

Nov 16, 2016

Approved

Brand (NDA)

Application

Not listed

TE code

Listed patents

Approval
FDA approval date of this drug product.
Nov 16, 2016
9 yr 9 mo ago
Today
Patent 8629129 expires
Listed drug product patent expiration.
Aug 07, 2028
in 2 yr 2 mo
Patent 8957054 expires
Listed method-of-use patent (U-1922) expiration.
Jan 08, 2030
in 3 yr 7 mo
Patent 8268806 expires
Listed drug product patent expiration.
Mar 19, 2031
in 4 yr 10 mo

Active ingredient

PRASTERONE

Strength

6.5MG

Dosage form

INSERT

Route

VAGINAL

TE code

Not listed

Application

NDA 208470

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
8629129	Aug 07, 2028	in 2 yr 2 mo	Product
8957054	Jan 08, 2030	in 3 yr 7 mo	U-1922
8268806	Mar 19, 2031	in 4 yr 10 mo	Product