Mayzent is a drug owned by Novartis Pharmaceuticals Corp. It is protected by 4 US drug patents filed from 2021 to 2024 out of which none have expired yet. Mayzent's patents have been open to challenges since 27 March, 2023. Based on its patents and exclusivities, its generic launch date is estimated to be Jul 24, 2036. Details of Mayzent's patents and their expiration are given in the table below.
| Drug Patent Number | Drug Patent Title | Drug Patent Expiry | Status |
|---|---|---|---|
| These drug patents protect the active ingredient(API) of the drug. Only drug patent owner can launch products that use this active ingredient until these patents expire. | |||
| US7939519 | Immunosuppresant compounds and compositions |
Aug, 2028
(3 years from now) | Active |
| These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| US11944602 | Treatment of autoimmune disease in a patient receiving additionally a beta-blocker |
Jul, 2036
(11 years from now) | Active |
| US12071402 | Immunosuppressant formulations |
Jan, 2032
(7 years from now) | Active |
| US8492441 | Dosage regimen of an S1P receptor agonist |
Nov, 2030
(6 years from now) | Active |
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 Mayzent's patents.
Latest Legal Activities on Mayzent's Patents
Given below is the list of recent legal activities going on the following patents of Mayzent.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Application Is Considered Ready for Issue Critical | 05 Mar, 2024 | US11944602 |
| Dispatch to FDC | 05 Mar, 2024 | US11944602 |
| Issue Fee Payment Received Critical | 04 Mar, 2024 | US11944602 |
| Issue Fee Payment Verified Critical | 04 Mar, 2024 | US11944602 |
| Change in Power of Attorney (May Include Associate POA) Critical | 22 Jan, 2024 | US11944602 |
| Mail Notice of Allowance Critical | 06 Dec, 2023 | US11944602 |
| Electronic Review Critical | 06 Dec, 2023 | US11944602 |
| Email Notification Critical | 06 Dec, 2023 | US11944602 |
| Notice of Allowance Data Verification Completed Critical | 04 Dec, 2023 | US11944602 |
| Information Disclosure Statement considered Critical | 21 Nov, 2023 | US11944602 |
FDA has granted several exclusivities to Mayzent. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Mayzent, 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 Mayzent.
Exclusivity Information
Mayzent holds 2 exclusivities out of which 1 have expired. Its last outstanding exclusivity is set to expire in 2025. Details of Mayzent's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | Mar 26, 2024 |
| M(M-274) | Mar 01, 2025 |
US patents provide insights into the exclusivity only within the United States, but Mayzent 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 Mayzent's family patents as well as insights into ongoing legal events on those patents.
Mayzent's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Mayzent's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Jul 24, 2036 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Mayzent Generics:
There are no approved generic versions for Mayzent as of now.
How can I launch a generic of Mayzent before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Mayzent's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Mayzent'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 Mayzent -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 0.25 mg, 1 mg and 2 mg | 27 Mar, 2023 | 5 | 30 Nov, 2030 |
About Mayzent
Mayzent is a drug owned by Novartis Pharmaceuticals Corp. It is used for treating multiple sclerosis. Mayzent uses Siponimod as an active ingredient. Mayzent was launched by Novartis in 2019.
Approval Date:
Mayzent was approved by FDA for market use on 26 March, 2019.
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 Mayzent is 26 March, 2019, its NCE-1 date is estimated to be 27 March, 2023.
Active Ingredient:
Mayzent uses Siponimod as the active ingredient. Check out other Drugs and Companies using Siponimod ingredient
Treatment:
Mayzent is used for treating multiple sclerosis.
Dosage:
Mayzent is available in tablet form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| EQ 0.25MG BASE | TABLET | Prescription | ORAL |
| EQ 2MG BASE | TABLET | Prescription | ORAL |
| EQ 1MG BASE | TABLET | Prescription | ORAL |