Orange Book product · Brand (NDA)

TEGSEDI

INOTERSEN SODIUM

Brand (NDA)NDA 211172DISCN AKCEA THERAPS

Oct 05, 2018

Approved

Brand (NDA)

Application

Not listed

TE code

Listed patents

Approval
FDA approval date of this drug product.
Oct 05, 2018
7 yr 10 mo ago
Today
Patent 8697860 expires
Listed drug product patent expiration.
Apr 29, 2031
in 4 yr 11 mo
Patent 9061044 expires
Listed drug substance patent expiration.
Apr 29, 2031
in 4 yr 11 mo
Patent 9399774 expires
Listed method-of-use patent (U-2430) expiration.
Apr 29, 2031
in 4 yr 11 mo

Active ingredient

INOTERSEN SODIUM

Strength

EQ 284MG BASE/1.5ML (EQ 189.3MG BASE/ML)

Dosage form

SOLUTION

Route

SUBCUTANEOUS

TE code

Not listed

Application

NDA 211172

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
8697860	Apr 29, 2031	in 4 yr 11 mo	Product
9061044	Apr 29, 2031	in 4 yr 11 mo	Substance
9399774	Apr 29, 2031	in 4 yr 11 mo	U-2430