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Last Updated: November 22, 2024

MIPLYFFA Drug Patent Profile


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Which patents cover Miplyffa, and when can generic versions of Miplyffa launch?

Miplyffa is a drug marketed by Zevra Denmark and is included in one NDA.

The generic ingredient in MIPLYFFA is arimoclomol citrate. One supplier is listed for this compound. Additional details are available on the arimoclomol citrate profile page.

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Summary for MIPLYFFA
US Patents:0
Applicants:1
NDAs:1
Finished Product Suppliers / Packagers: 1
Patent Applications: 222
What excipients (inactive ingredients) are in MIPLYFFA?MIPLYFFA excipients list
DailyMed Link:MIPLYFFA at DailyMed
Drug patent expirations by year for MIPLYFFA
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for MIPLYFFA
Generic Entry Date for MIPLYFFA*:
Constraining patent/regulatory exclusivity:
NEW CHEMICAL ENTITY
NDA:
Dosage:
CAPSULE;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 MIPLYFFA

MIPLYFFA is protected by zero US patents and one FDA Regulatory Exclusivity.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of MIPLYFFA is ⤷  Sign Up.

This potential generic entry date is based on NEW CHEMICAL ENTITY.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

FDA Regulatory Exclusivity protecting MIPLYFFA

NEW CHEMICAL ENTITY
Exclusivity Expiration: ⤷  Sign Up

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Zevra Denmark MIPLYFFA arimoclomol citrate CAPSULE;ORAL 214927-001 Sep 20, 2024 RX Yes No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Zevra Denmark MIPLYFFA arimoclomol citrate CAPSULE;ORAL 214927-004 Sep 20, 2024 RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Zevra Denmark MIPLYFFA arimoclomol citrate CAPSULE;ORAL 214927-002 Sep 20, 2024 RX Yes No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
>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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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 verification 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.