Rydapt Patent Expiration

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. 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 active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US8222244 Staurosporine derivatives as inhibitors of FLT3 receptor tyrosine kinase activity
Oct, 2022

(1 year, 8 months ago)

Expired
US7973031 Staurosporine derivatives as inhibitors of FLT3 receptor tyrosine kinase activity
Oct, 2028

(4 years from now)

Active
US8575146 Pharmaceutical uses of staurosporine derivatives
Dec, 2030

(6 years from now)

Active


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 has 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 or infringement 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
Patent litigations
US8575146 January, 2011 Decision 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-140) Apr 28, 2024
Orphan Drug Exclusivity(ODE-141) Apr 28, 2024
Orphan Drug Exclusivity(ODE) Apr 28, 2024

Stay ahead of others in designing the generic launch strategy of these 5 blockbuster drugs expiring in next 5 years.

Get the exclusive patent insights now. Don't be the last to know.

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

Rydapt has patent protection in a total of 27 countries. It's US patent count contributes only to 16.4% of its total global patent coverage. 4 countries have all of their patents expired or invalidated which has opened up potential generic launch opportunities in these countries. Click below to unlock the full patent family tree for Rydapt.

Family Patents

Coming Soon

Patent Strength Analyzer

Let us know if you're excited!

🤩🥱

Thank you for your response 🥳



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 Generics:

Midostaurin is the generic name for the brand Rydapt. 2 different companies have already filed for the generic of Rydapt, with Lupin 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.

Market Authorisation Date:

Rydapt was approved by FDA for market use on 28 April, 2017.

NCE-1 date:

NCE-1 date is also known as the four year date as it is four years after the original drug approval. 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