Mayzent Patent Expiration

Mayzent is a drug owned by Novartis Pharmaceuticals Corp. It is protected by 3 US drug patents filed from 2021 to 2024 out of which none have expired yet. 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 protects the active chemical substance. Only drug patent owner can launch products that use this active substance.
US7939519 Immunosuppresant compounds and compositions
Aug, 2028

(4 years from now)

Active
These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US8492441 Dosage regimen of an S1P receptor agonist
Nov, 2030

(6 years from now)

Active
US11944602 Treatment of autoimmune disease in a patient receiving additionally a beta-blocker
Jul, 2036

(12 years from now)

Active


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

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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

Mayzent has patent protection in a total of 39 countries. It's US patent count contributes only to 12.1% of its total global patent coverage. 5 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 Mayzent.

Family Patents

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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.

Market Authorisation Date:

Mayzent was approved by FDA for market use on 26 March, 2019.

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 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