Orange Book product · Brand (NDA)

SAFYRAL

DROSPIRENONE; ETHINYL ESTRADIOL; LEVOMEFOLATE CALCIUM

Brand (NDA)NDA 022574TE ABRX BAYER HLTHCARE

Dec 16, 2010

Approved

Brand (NDA)

Application

TE code

Listed patents

Approval
FDA approval date of this drug product.
Dec 16, 2010
15 yr 9 mo ago
Today
Patent 8617597 expires
Listed drug product patent expiration.
Feb 08, 2030
in 3 yr 8 mo
Patent 11617751 expires
Listed drug product patent expiration.
Jul 17, 2030
in 4 yr 2 mo
Patent 11617751 expires
Listed drug product patent expiration.
Jul 17, 2030
in 4 yr 2 mo

Active ingredient

DROSPIRENONE; ETHINYL ESTRADIOL; LEVOMEFOLATE CALCIUM

Strength

3MG,N/A;0.03MG,N/A;0.451MG,0.451MG

Dosage form

TABLET

Route

ORAL

TE code

Application

NDA 022574

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
8617597	Feb 08, 2030	in 3 yr 8 mo	Product
11617751	Jul 17, 2030	in 4 yr 2 mo	ProductU-1
11617751	Jul 17, 2030	in 4 yr 2 mo	ProductU-3572