Orange Book product · Brand (NDA)

NATAZIA

DIENOGEST; ESTRADIOL VALERATE

Brand (NDA)NDA 022252RX BAYER HLTHCARE

May 06, 2010

Approved

Brand (NDA)

Application

Not listed

TE code

Listed patents

Approval
FDA approval date of this drug product.
May 06, 2010
16 yr 4 mo ago
Patent 8071577 expires
Listed drug product patent expiration.
May 13, 2026
1 mo ago
Today
Patent 8153616 expires
Listed method-of-use patent (U-1240) expiration.
Jan 30, 2028
in 1 yr 8 mo

Active ingredient

DIENOGEST; ESTRADIOL VALERATE

Strength

N/A,2MG,3MG,N/A,N/A;3MG,2MG,2MG,1MG,N/A

Dosage form

TABLET

Route

ORAL

TE code

Not listed

Application

NDA 022252

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
8071577	May 13, 2026	1 mo ago	ProductU-1
8153616	Jan 30, 2028	in 1 yr 8 mo	U-1240