Orange Book product · Brand (NDA)

KYNAMRO

MIPOMERSEN SODIUM

Brand (NDA)NDA 203568DISCN KASTLE THERAPS LLC

Jan 29, 2013

Approved

Brand (NDA)

Application

Not listed

TE code

Listed patents

Approval
FDA approval date of this drug product.
Jan 29, 2013
13 yr 7 mo ago
Today
Patent 7511131 expires
Listed drug substance patent expiration.
Jan 29, 2027
in 7 mo

Active ingredient

MIPOMERSEN SODIUM

Strength

200MG/ML (200MG/ML)

Dosage form

SOLUTION

Route

SUBCUTANEOUS

TE code

Not listed

Application

NDA 203568

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
7511131	Jan 29, 2027	in 7 mo	Substance