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Last Updated: February 28, 2020

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MAYZENT Drug Profile

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When do Mayzent patents expire, and when can generic versions of Mayzent launch?

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

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Summary for MAYZENT
International Patents:132
US Patents:2
Suppliers / Packagers: 1
Bulk Api Vendors: 7
Patent Applications: 4
Drug Prices: Drug price information for MAYZENT
DailyMed Link:MAYZENT at DailyMed
Drug patent expirations by year for MAYZENT
Drug Prices for MAYZENT

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Generic Entry Opportunity Date for MAYZENT
Generic Entry Date for MAYZENT*:
Constraining patent/regulatory exclusivity:

*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.

Synonyms for MAYZENT
1-(4-{1-[(E)-4-Cyclohexyl-3-trifluoromethyl-benzyloxyimino]-ethyl}-2-ethyl-benzyl)-azetidine-3-carboxylic acid
compound 32 [PMID: 24900670]
Siponimod (BAF312)

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
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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Serving leading biopharmaceutical companies globally:

Johnson and Johnson

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.