Orange Book product · Brand (NDA)

NEXAVAR

SORAFENIB TOSYLATE

Brand (NDA)NDA 021923TE ABRX BAYER HLTHCARE

Dec 20, 2005

Approved

Brand (NDA)

Application

TE code

Listed patents

Approval
FDA approval date of this drug product.
Dec 20, 2005
20 yr 10 mo ago
Today
Patent 8877933 expires
Listed drug substance patent expiration.
Dec 24, 2027
in 1 yr 6 mo
Patent 9737488 expires
Listed drug product patent expiration.
Sep 10, 2028
in 2 yr 3 mo
Patent 9737488 expires
Listed drug product patent expiration.
Sep 10, 2028
in 2 yr 3 mo
Patent 9737488 expires
Listed drug product patent expiration.
Sep 10, 2028
in 2 yr 3 mo

Active ingredient

SORAFENIB TOSYLATE

Strength

EQ 200MG BASE

Dosage form

TABLET

Route

ORAL

TE code

Application

NDA 021923

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
8877933	Dec 24, 2027	in 1 yr 6 mo	SubstanceProductU-1624
9737488	Sep 10, 2028	in 2 yr 3 mo	ProductU-2107
9737488	Sep 10, 2028	in 2 yr 3 mo	ProductU-1480
9737488	Sep 10, 2028	in 2 yr 3 mo	ProductU-1696