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 in its drug Rydapt on Apr 28, 2017. 4 different companies have introduced drugs containing Midostaurin.


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.

Given below is the list recent legal activities going on the following patents of Midostaurin.

Activity Date Patent Number
Patent litigations
Court Processing Terminated 03 Apr, 2024 US7973031
Maintenance Fee Reminder Mailed 04 Mar, 2024 US8222244
Payment of Maintenance Fee, 12th Year, Large Entity 21 Dec, 2022 US7973031
Patent Term Extension Certificate 27 Apr, 2022 US7973031
Withdrawal of Application for PTE 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

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
Mumbai Lupin Limited
Pune Lupin Bioresearch Center
Vasco Da Gama Lupin Limited
Aurangabad Lupin Ltd.
Dabhasa LUPIN MANUFACTURING SOLUTIONS LIMITED
Pithampur Lupin Limited
Navi Mumbai LUPIN LIMITED
Mandideep Lupin Limited (Unit II)
Mandideep Lupin Limited
Nagpur Lupin Limited
Tarapur, Thane Lupin Limited
Pirangut Lupin Limited
Anakapalli District Lupin Manufacturing Solutions Limited
Pithampur Lupin Limited (Unit 1)
United States
Coral Springs Lupin Research Inc
Baltimore Lupin Pharmaceuticals Inc.





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