Rydapt is a drug owned by Novartis Pharmaceuticals Corp. It is protected by 3 US drug patents filed in 2017. Out of these, 2 drug patents are active and 1 has expired. Rydapt's patents have been open to challenges since 28 April, 2021. Based on its patents and exclusivities, its generic launch date is estimated to be Dec 02, 2030. Details of Rydapt's patents and their expiration are given in the table below.
| Drug Patent Number | Drug Patent Title | Drug Patent Expiry | Status |
|---|---|---|---|
| These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| US8575146 | Pharmaceutical uses of staurosporine derivatives |
Dec, 2030
(6 years from now) | Active |
| US7973031 | Staurosporine derivatives as inhibitors of FLT3 receptor tyrosine kinase activity |
Oct, 2028
(3 years from now) | Active |
| US8222244 | Staurosporine derivatives as inhibitors of FLT3 receptor tyrosine kinase activity |
Oct, 2022
(2 years ago) |
Expired
|
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 Rydapt's patents.
Latest Legal Activities on Rydapt's Patents
Given below is the list of recent legal activities going on the following patents of Rydapt.
| 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 |
While patent expiration is one way of estimating the generic date of a drug, if a patent gets invalidated somehow, the generic of the drug may arrive early. Being aware of all relevant patents can help in avoiding legal pitfalls. Given below are details of the litigation history of Rydapt and ongoing litigations to help you estimate the early arrival of Rydapt generic.
Rydapt's Litigations
Rydapt been subject to various legal proceedings, including patent litigations. The earliest legal proceeding was initiated on Jan 31, 2011, against patent number US8575146. The petitioner , challenged the validity of this patent, with Steven Coutre as the respondent. Click below to track the latest information on how companies are challenging Rydapt's patents.
| Patent | Proceeding Filing Date | Status | Respondent | Petitioner |
|---|---|---|---|---|
 | ||||
| US8575146 | January, 2011 |
Decision
(22 Mar, 2013) | Steven Coutre | |
FDA has granted some exclusivities to Rydapt. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Rydapt, regardless of the status of it's patents. These exclusivities hence play a crucial role in delaying the generic launch. Given below are details of the exclusivities granted to Rydapt.
Exclusivity Information
Rydapt holds 4 exclusivities. All of its exclusivities have expired in 2024. Details of Rydapt's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | Apr 28, 2022 |
| Orphan Drug Exclusivity(ODE) | Apr 28, 2024 |
| Orphan Drug Exclusivity(ODE-140) | Apr 28, 2024 |
| Orphan Drug Exclusivity(ODE-141) | Apr 28, 2024 |
US patents provide insights into the exclusivity only within the United States, but Rydapt is protected by patents in multiple countries. Understanding the full scope of patent protection is crucial in strategizing market entry. By looking at the broader patent landscape, you can identify markets with weaker patent protection which could be ideal generic entry points. The following section offers details on Rydapt's family patents as well as insights into ongoing legal events on those patents.
Rydapt's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Rydapt's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Dec 02, 2030 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Rydapt Generic API suppliers:
Midostaurin is the generic name for the brand Rydapt. 3 different companies have already filed for the generic of Rydapt, with Dr Reddys having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Rydapt's generic
How can I launch a generic of Rydapt before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Rydapt's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Rydapt's sponsor is invalid, unenforceable, or will not be infringed by your generic product.
Given below are the details of the already filed Para IV certificates on Rydapt -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 25 mg | 28 Apr, 2021 | 4 | 02 Dec, 2030 |
About Rydapt
Rydapt is a drug owned by Novartis Pharmaceuticals Corp. It 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. Rydapt uses Midostaurin as an active ingredient. Rydapt was launched by Novartis in 2017.
Approval Date:
Rydapt was approved by FDA for market use on 28 April, 2017.
NCE-1 date:
NCE-1 date also known as the four year date occurs four years after the original drug approval and marks the first opportunity for a generic manufacturer to file an ANDA with a Paragraph IV certification. This is the earliest point when generic competition might begin, provided the challenge is successful. Since the approval date for Rydapt is 28 April, 2017, its NCE-1 date is estimated to be 28 April, 2021.
Active Ingredient:
Rydapt uses Midostaurin as the active ingredient. Check out other Drugs and Companies using Midostaurin ingredient
Treatment:
Rydapt 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.
Dosage:
Rydapt is available in capsule form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 25MG | CAPSULE | Prescription | ORAL |