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Last Updated: November 22, 2024

Arimoclomol citrate - Generic Drug Details


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What are the generic sources for arimoclomol citrate and what is the scope of patent protection?

Arimoclomol citrate is the generic ingredient in one branded drug marketed by Zevra Denmark and is included in one NDA. Additional information is available in the individual branded drug profile pages.

One supplier is listed for this compound.

Summary for arimoclomol citrate
US Patents:0
Tradenames:1
Applicants:1
NDAs:1
Finished Product Suppliers / Packagers: 1
Clinical Trials: 2
Patent Applications: 20
What excipients (inactive ingredients) are in arimoclomol citrate?arimoclomol citrate excipients list
DailyMed Link:arimoclomol citrate at DailyMed
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for arimoclomol citrate
Generic Entry Date for arimoclomol citrate*:
Constraining patent/regulatory exclusivity:
NEW CHEMICAL ENTITY
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.

Recent Clinical Trials for arimoclomol citrate

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
OrphazymePhase 3

See all arimoclomol citrate clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for arimoclomol citrate

US Patents and Regulatory Information for arimoclomol citrate

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 214927-004 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
Zevra Denmark MIPLYFFA arimoclomol citrate CAPSULE;ORAL 214927-003 Sep 20, 2024 RX Yes No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Zevra Denmark MIPLYFFA arimoclomol citrate CAPSULE;ORAL 214927-001 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.