Orange Book product · Brand (NDA)

SKYLA

LEVONORGESTREL

Brand (NDA)NDA 203159RX BAYER HLTHCARE

Jan 09, 2013

Approved

Brand (NDA)

Application

Not listed

TE code

Listed patents

Approval
FDA approval date of this drug product.
Jan 09, 2013
13 yr 8 mo ago
Today
Patent 11628088 expires
Listed drug product patent expiration.
Feb 07, 2027
in 8 mo
Patent 11850182 expires
Listed drug product patent expiration.
Sep 14, 2029
in 3 yr 3 mo
Patent 10561524 expires
Listed method-of-use patent (U-2948) expiration.
Sep 16, 2029
in 3 yr 4 mo

Active ingredient

LEVONORGESTREL

Strength

13.5MG

Dosage form

SYSTEM

Route

INTRAUTERINE

TE code

Not listed

Application

NDA 203159

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
11628088	Feb 07, 2027	in 8 mo	Product
11850182	Sep 14, 2029	in 3 yr 3 mo	ProductU-3819
10561524	Sep 16, 2029	in 3 yr 4 mo	U-2948