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Last Updated: March 28, 2024

CARGLUMIC ACID - Generic Drug Details


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What are the generic sources for carglumic acid and what is the scope of freedom to operate?

Carglumic acid is the generic ingredient in two branded drugs marketed by Recordati Rare, Navinta Llc, and Novitium Pharma, and is included in three NDAs. Additional information is available in the individual branded drug profile pages.

There are two drug master file entries for carglumic acid. Four suppliers are listed for this compound.

Summary for CARGLUMIC ACID
Drug Prices for CARGLUMIC ACID

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Recent Clinical Trials for CARGLUMIC ACID

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SponsorPhase
National Taiwan University HospitalN/A
King Abdullah International Medical Research CenterPhase 3
Boston Children's HospitalPhase 2

See all CARGLUMIC ACID clinical trials

Pharmacology for CARGLUMIC ACID

US Patents and Regulatory Information for CARGLUMIC ACID

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Novitium Pharma CARGLUMIC ACID carglumic acid TABLET, FOR SUSPENSION;ORAL 213729-001 Oct 13, 2021 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Navinta Llc CARGLUMIC ACID carglumic acid TABLET, FOR SUSPENSION;ORAL 213395-001 Jun 22, 2022 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Recordati Rare CARBAGLU carglumic acid TABLET, FOR SUSPENSION;ORAL 022562-001 Mar 18, 2010 AB RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

EU/EMA Drug Approvals for CARGLUMIC ACID

Company Drugname Inn Product Number / Indication Status Generic Biosimilar Orphan Marketing Authorisation Marketing Refusal
Eurocept International BV Ucedane carglumic acid EMEA/H/C/004019
Ucedane is indicated in treatment of:hyperammonaemia due to N-acetylglutamate synthase primary deficiency;Hyperammonaemia due to isovaleric acidaemia;Hyperammonaemia due to methymalonic acidaemia;Hyperammonaemia due to propionic acidaemia.
Authorised yes no no 2017-06-23
Recordati Rare Diseases Carbaglu carglumic acid EMEA/H/C/000461
Carbaglu is indicated in treatment of:hyperammonaemia due to N-acetylglutamate-synthase primary deficiency;hyperammonaemia due to isovaleric acidaemia;hyperammonaemia due to methymalonic acidaemia;hyperammonaemia due to propionic acidaemia.
Authorised no no no 2003-01-24
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

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