Midostaurin Patent Expiration
Midostaurin is used for treating aggressive systemic mastocytosis, systemic mastocytosis with associated hematological neoplasm, mast cell leukemia, and newly diagnosed acute myeloid leukemia with FLT3 mutation-positive. It was first introduced by Novartis Pharmaceuticals Corp
Midostaurin Patents
Given below is the list of patents protecting Midostaurin, 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 |
|---|---|---|---|---|
| Rydapt | US8575146 | Pharmaceutical uses of staurosporine derivatives | Dec 02, 2030 | Novartis |
| Rydapt | US7973031 | Staurosporine derivatives as inhibitors of FLT3 receptor tyrosine kinase activity | Oct 09, 2028 | Novartis |
| Rydapt | US8222244 | Staurosporine derivatives as inhibitors of FLT3 receptor tyrosine kinase activity |
Oct 29, 2022
(Expired) | Novartis |
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 Midostaurin's patents.
Latest Legal Activities on Midostaurin's Patents
Given below is the list recent legal activities going on the following patents of Midostaurin.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Court Processing Terminated | 03 Apr, 2024 | US7973031 |
| Maintenance Fee Reminder Mailed Critical | 04 Mar, 2024 | US8222244 |
| Payment of Maintenance Fee, 12th Year, Large Entity | 21 Dec, 2022 | US7973031 |
| Patent Term Extension Certificate Critical | 27 Apr, 2022 | US7973031 |
| Withdrawal of Application for PTE Critical | 10 Mar, 2022 | US8222244 |
| Notice of Final Determination -Eligible | 10 Mar, 2022 | US7973031 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 21 Apr, 2021 | US8575146 |
| 37 CFR 1.750 Request for reconsideration | 15 Apr, 2021 | US7973031 |
| Notice of Final Determination -Election Required | 18 Mar, 2021 | US7973031 |
| Notice of Final Determination -Election Required | 18 Mar, 2021 | US8222244 |
Midostaurin's Family Patents
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Midostaurin Generic API Manufacturers
Several generic applications have been filed for Midostaurin. The first generic version for Midostaurin was by Teva Pharmaceuticals Development Inc and was approved on Apr 29, 2024. And the latest generic version is by Dr Reddys Laboratories Ltd and was approved on Jun 28, 2024.
Given below is the list of companies who have filed for Midostaurin generic, along with the locations of their manufacturing plants worldwide.
1. DR REDDYS
Dr Reddys Laboratories Ltd has filed for 1 generic for Midostaurin. Given below are the details of the strengths of this generic introduced by Dr Reddys.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 25MG | capsule | Prescription | ORAL | AB | Jun 28, 2024 |
2. LUPIN
Lupin Inc has filed for 1 generic for Midostaurin. Given below are the details of the strengths of this generic introduced by Lupin.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 25MG | capsule | Prescription | ORAL | AB | May 10, 2024 |
Manufacturing Plant Locations New
Lupin's manufacturing plants are situated in 2 countries - India, United States. Given below are the details of these plant locations as well as the firm names of Lupin as present at those locations.
| Country | City | Firm Name | ||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| India |
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| United States |
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3. TEVA PHARMS
Teva Pharmaceuticals Development Inc has filed for 1 generic for Midostaurin. Given below are the details of the strengths of this generic introduced by Teva Pharms.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 25MG | capsule | Discontinued | ORAL | N/A | Apr 29, 2024 |