Sorafenib Tosylate Patent Expiration

Sorafenib Tosylate is Used for treating advanced renal cell carcinoma, carcinoma of the thyroid, and unresectable hepatocellular carcinoma. It was first introduced by Bayer Healthcare Pharmaceuticals Inc in its drug Nexavar on Dec 20, 2005. 7 different companies have introduced drugs containing Sorafenib Tosylate.


Sorafenib Tosylate Patents

Given below is the list of patents protecting Sorafenib Tosylate, along with the drug name that holds that patent and the company name owning that drug.

Filter patents by

NEW
Drug Used in Drug Patent Number Drug Patent Title Drug Patent Expiry Drug Owner
Nexavar US9737488 Pharmaceutical composition for the treatment of cancer Sep 10, 2028 Bayer Hlthcare
Nexavar US8877933 Thermodynamically stable form of a tosylate salt Dec 24, 2027 Bayer Hlthcare
Nexavar US8618141 Aryl ureas with angiogenesis inhibiting activity Feb 11, 2023

(Expired)

Bayer Hlthcare
Nexavar US7235576 Omega-carboxyaryl substituted diphenyl ureas as raf kinase inhibitors Jan 12, 2020

(Expired)

Bayer Hlthcare
Nexavar US7351834 ω-Carboxyaryl substituted diphenyl ureas as raf kinase inhibitors Jan 12, 2020

(Expired)

Bayer Hlthcare
Nexavar US7897623 ω-carboxyl aryl substituted diphenyl ureas as p38 kinase inhibitors Jan 12, 2020

(Expired)

Bayer Hlthcare
Nexavar US8124630 ω-carboxyaryl substituted diphenyl ureas as raf kinase inhibitors Jan 12, 2020

(Expired)

Bayer Hlthcare
Nexavar US8841330 Omega-carboxyaryl substituted diphenyl ureas as raf kinase inhibitors Jan 12, 2020

(Expired)

Bayer Hlthcare



Sorafenib Tosylate's Family Patents

Family Patents

Explore Our Curated Drug Screens

Drugs Generating Over $1 Billion in Annual Revenue
Explore the top-performing drugs that dominate the pharmaceutical industry
View List
NCE-1 Patent Expiry in the Next 1 Year
Identify opportunities as new chemical entity (NCE-1) patents approach expiry
View List
Recently Granted Patents in EP
Find the opportunity to file Oppositions
View List



Clinical Trials

Recent Clinical Trials on Sorafenib Tosylate:

Sometimes companies keep conducting clinical trials even after the drug's approval to discover new formulations, methods of use, or new treatment indications, so they could file for additional patents or receive regulatory exclusivity extensions, such as pediatric exclusivity, potentially delaying generic competition. Based on these recent clinical trials, generic companies need to consider the potential for new intellectual property or regulatory hurdles. These strategic moves by the drug owner might delay generic substitution or lead to additional sales of the brand drug, even after patent expiry.

Title Lead Sponsor Collaborators Status Phases
Clinical Trials
Sorafenib in Treating Patients With Angiosarcoma That is Locally Advanced, Metastatic, or Unable to Be Removed by Surgery Centre Oscar Lambret NA COMPLETED
(Sep 1, 2026)
PHASE2
Sunitinib Malate or Sorafenib Tosylate in Treating Patients With Kidney Cancer That Was Removed By Surgery National Cancer Institute (NCI) NA COMPLETED
(May 1, 2026)
PHASE3
Sorafenib Tosylate in Treating Patients With Desmoid Tumors or Aggressive Fibromatosis National Cancer Institute (NCI) NA COMPLETED
(May 1, 2026)
PHASE3


Sorafenib Tosylate Generic API Manufacturers

Several generic applications have been filed for Sorafenib Tosylate. The first generic version for Sorafenib Tosylate was by Mylan Pharmaceuticals Inc and was approved on Sep 10, 2020. And the latest generic version is by Apotex Inc and was approved on Jan 27, 2025.

Given below is the list of companies who have filed for Sorafenib Tosylate generic, along with the locations of their manufacturing plants worldwide.


Sorafenib Tosylate News

Mandatory Licensing: A Tool for Reconciling Patent Rights with Essential Needs

05 Dec, 2025

See More