Regorafenib Patent Expiration
Regorafenib is Used for treating gastrointestinal stromal tumors (GIST) in patients, including those who have previously been treated with imatinib and those with resistance to a KIT tyrosine kinase inhibitor. It was first introduced by Bayer Healthcare Pharmaceuticals Inc
Regorafenib Patents
Given below is the list of patents protecting Regorafenib, along with the drug name that holds that patent and the company name owning that drug.
| Drug Used in | Drug Patent Number | Drug Patent Title | Drug Patent Expiry | Drug Owner |
|---|---|---|---|---|
| Stivarga | US9957232 | 4-[4-({[4-chloro-3-(trifluoromethyl)phenyl]carbamoyl}amino)-3-fluorophenoxy]-N-methylpyridine-2-carboxamide monohydrate | Jul 09, 2032 | Bayer Hlthcare |
| Stivarga | US9458107 | Process for the preparation of 4-{4-[({[4 chloro-3-(trifluoromethyl)-phenyl]amino}carbonyl)amino]-3-fluorphenoxy-N-ethylpyridie-carboxamide, its salts and monohydrate | Apr 08, 2031 | Bayer Hlthcare |
| Stivarga | US8637553 | Fluoro substituted omega-carboxyaryl diphenyl urea for the treatment and prevention of diseases and conditions | Feb 16, 2031 | Bayer Hlthcare |
| Stivarga | US8680124 | Treatment of cancers with acquired resistance to kit inhibitors | Jun 02, 2030 | Bayer Hlthcare |
| Stivarga | US7351834 | ω-Carboxyaryl substituted diphenyl ureas as raf kinase inhibitors |
Jan 12, 2020
(Expired) | Bayer Hlthcare |
A patent's expiry date may change depending upon legal activities going on that patent. Critical
activities like
abandoning of a patent, term extension of a patent or amendment of its claims can increase or
decrease the life of a
patent hence affecting its expiry date and in turn affecting the generic launch date of that
drug. Tracking these
ongoing activities on a patent application helps to keep an eye on the latest developments in
the patent process of
the drug which can give an idea of how early a drug's generic could be available. The next
section provides a list
of recent legal activities on Regorafenib's patents.
Latest Legal Activities on Regorafenib's Patents
Given below is the list recent legal activities going on the following patents of Regorafenib.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 8th Year, Large Entity | 22 Oct, 2025 | US9957232 |
| Payment of Maintenance Fee, 12th Year, Large Entity | 16 Jul, 2025 | US8637553(Litigated) |
| Payment of Maintenance Fee, 8th Year, Large Entity | 20 Mar, 2024 | US9458107(Litigated) |
| Payment of Maintenance Fee, 4th Year, Large Entity | 20 Oct, 2021 | US9957232 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 14 Jul, 2021 | US8637553(Litigated) |
| Payment of Maintenance Fee, 4th Year, Large Entity | 19 Mar, 2020 | US9458107(Litigated) |
| Patent Issue Date Used in PTA Calculation Critical
| 01 May, 2018 | US9957232 |
| Recordation of Patent Grant Mailed Critical
| 01 May, 2018 | US9957232 |
| Email Notification Critical
| 12 Apr, 2018 | US9957232 |
| Issue Notification Mailed Critical
| 11 Apr, 2018 | US9957232 |
Regorafenib's Family Patents
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Clinical Trials
Recent Clinical Trials on Regorafenib:
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.
