Assyro AI

FDA Orange Book · active-ingredient family

Sorafenib tosylate

Sorafenib tosylate is approved as 1 brand and 6 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:NEXAVAR · NDA 021923

1

Brand (NDA)

6

Generics (ANDA)

2

Listed patents

0

Exclusivity periods

Brand (NDA) products · tablet

ProductApplicantApplicationTEApproved
NEXAVARRLDBAYER HLTHCARENDA 021923ABDec 20, 2005

Generic (ANDA) products (6)

ProductApplicantApplicationTEApproved
SORAFENIB TOSYLATEAPOTEXANDA 212228—Jan 27, 2025
SORAFENIB TOSYLATETORRENTANDA 217095ABApr 12, 2023
SORAFENIB TOSYLATEYABAO PHARMANDA 209050ABNov 09, 2022
SORAFENIB TOSYLATEDR REDDYSANDA 216073ABJun 07, 2022
SORAFENIB TOSYLATETEVA PHARMS USA INCANDA 209567ABNov 12, 2020
SORAFENIB TOSYLATEMYLANANDA 207012ABSep 10, 2020

Listed patents (2)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
8877933Dec 24, 2027in 1 yr 6 mo
SubstanceProductU-1624
9737488Sep 10, 2028in 2 yr 3 mo
ProductU-2107

Sorafenib tosylate — frequently asked questions

Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.

Agent CTA Background

Your Next Submission Could Take 6+ Fewer Weeks and Cost $250K Less.

Book a Demo