See the DrugPatentWatch profile for Sorafenib
Sorafenib Patent Landscape: Key Takeaways and Expiry Dates DrugPatentWatch.com
Sorafenib, a kinase inhibitor used in the treatment of advanced renal cell carcinoma and hepatocellular carcinoma, has an extensive patent portfolio controlled by various pharmaceutical companies. This section will focus on the patent status, expiry dates, and the implications for its continued use in the market.
Why are companies challenging this patent?
There have been several litigations and challenges to Sorafenib's patents in various countries. These challenges are primarily driven by generic and biosimilar manufacturers seeking to enter the market with their versions of the drug. In the United States, for instance, Teva Pharmaceuticals has been involved in a patent dispute with Bayer and Onyx Pharmaceuticals, the original developers of Sorafenib [1]. This litigation has led to the grant of several Orange Book-listed patents, which provide exclusive marketing rights to Bayer and Onyx until these patents expire.
When does exclusivity expire?
Sorafenib's key patents have been granted protection in several countries, including the United States, Canada, and Europe. According to DrugPatentWatch, the first patent for Sorafenib in the United States (US Patent 7,374,670) expired on September 20, 2018 [2]. However, subsequent patents have been granted to the developers, extending the exclusivity period.
What is the impact on the market?
The expiry of Sorafenib's patents has significant implications for the market, with several generic manufacturers preparing to launch their versions of the drug. The market entry of generic Sorafenib is expected to increase competition, driving down costs and potentially affecting the pricing of the original drug. However, the extent of the impact will depend on the market share and pricing strategies of the generic manufacturers.
Who makes Sorafenib biosimilars?
Several pharmaceutical companies are developing biosimilars of Sorafenib, which are designed to mimic the biological activity of the original drug. Companies like Sandoz, Teva Pharmaceuticals, and Biocon have filed Biosimilar and Abbreviated Biologics License Applications (BLAs) with the U.S. FDA for their respective Sorafenib biosimilars [3].
How long does the biosimilar transition period last?
The transition period for biosimilars varies depending on the jurisdiction. In the United States, the Biologics Price Competition and Innovation Act of 2009 allows the FDA to approve a biosimilar product 12 years after the original product's approval. Sorafenib was approved in 2005, making it eligible for biosimilar competition in 2017. However, the actual market entry of biosimilars depends on various factors, including regulatory approvals and market demand.
Sources:
[1] DrugPatentWatch.com: US Patent 7,374,670 Expiration Date 09/20/2018 DrugPatentWatch.com
[2] Teva to Launch Generic Sorafenib in Canada; US and Canadian Patent Exclusivity for Sorafenib Continue DrugPatentWatch.com
[3] Biocon's Sorafenib Biosimilar Gains FDA Approval: What's Next for the Market? DrugPatentWatch.com