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MAYZENT Drug Profile
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» See Plans and PricingWhen do Mayzent patents expire, and what generic alternatives are available?
Mayzent is a drug marketed by Novartis and is included in one NDA. There are two patents protecting this drug.
This drug has one hundred and thirty-two patent family members in thirty-seven countries.
The generic ingredient in MAYZENT is siponimod fumaric acid. One supplier is listed for this compound. Additional details are available on the siponimod fumaric acid profile page.
US ANDA Litigation and Generic Entry Outlook for Mayzent
Mayzent will be eligible for patent challenges on March 26, 2023. This date may extended up to six months if a pediatric exclusivity extension is applied to the drug's patents.
By analyzing the patents and regulatory protections it appears that the earliest date
for generic entry will be May 19, 2024. This may change due to patent challenges or generic licensing.
Indicators of Generic Entry
Summary for MAYZENT
| International Patents: | 132 |
| US Patents: | 2 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 6 |
| Patent Applications: | 4 |
| Drug Prices: | Drug price information for MAYZENT |
| DailyMed Link: | MAYZENT at DailyMed |
Generic Entry Opportunity Date for MAYZENT
Generic Entry Date for MAYZENT*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
TABLET;ORAL |
*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.
US Patents and Regulatory Information for MAYZENT
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Novartis | MAYZENT | siponimod fumaric acid | TABLET;ORAL | 209884-001 | Mar 26, 2019 | RX | Yes | No | Start Trial | Start Trial | Start Trial | ||||
| Novartis | MAYZENT | siponimod fumaric acid | TABLET;ORAL | 209884-002 | Mar 26, 2019 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
| Novartis | MAYZENT | siponimod fumaric acid | TABLET;ORAL | 209884-001 | Mar 26, 2019 | RX | Yes | No | Start Trial | Start Trial | Y | Y | Start Trial | ||
| Novartis | MAYZENT | siponimod fumaric acid | TABLET;ORAL | 209884-001 | Mar 26, 2019 | RX | Yes | No | Start Trial | Start Trial | Start Trial | ||||
| Novartis | MAYZENT | siponimod fumaric acid | TABLET;ORAL | 209884-002 | Mar 26, 2019 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
| Novartis | MAYZENT | siponimod fumaric acid | TABLET;ORAL | 209884-002 | Mar 26, 2019 | RX | Yes | Yes | Start Trial | Start Trial | Y | Y | Start Trial | ||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
International Patents for MAYZENT
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Hungary | E026400 | Start Trial |
| Argentina | 044403 | Start Trial |
| China | 1787817 | Start Trial |
| Cyprus | 1118299 | Start Trial |
| Peru | 20050158 | Start Trial |
| Mexico | PA05012459 | Start Trial |
| Japan | 4575920 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
