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Last Updated: September 26, 2022

CARBAGLU Drug Patent Profile


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When do Carbaglu patents expire, and what generic alternatives are available?

Carbaglu is a drug marketed by Recordati Rare and is included in one NDA.

The generic ingredient in CARBAGLU is carglumic acid. There are two drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the carglumic acid profile page.

Summary for CARBAGLU
US Patents:0
Applicants:1
NDAs:1
Finished Product Suppliers / Packagers: 1
Raw Ingredient (Bulk) Api Vendors: 75
Clinical Trials: 6
Patent Applications: 289
What excipients (inactive ingredients) are in CARBAGLU?CARBAGLU excipients list
DailyMed Link:CARBAGLU at DailyMed
Drug patent expirations by year for CARBAGLU
Recent Clinical Trials for CARBAGLU

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SponsorPhase
National Taiwan University HospitalN/A
King Abdullah International Medical Research CenterPhase 3
Mendel TuchmanPhase 2

See all CARBAGLU clinical trials

US Patents and Regulatory Information for CARBAGLU

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

FDA Regulatory Exclusivity protecting CARBAGLU

IN PEDIATRIC AND ADULT PATIENTS AS ADJUNCTIVE THERAPY TO STANDARD OF CARE FOR THE TREATMENT OF ACUTE HYPERAMMONEMIA DUE TO PROPIONIC ACIDEMIA (PA) OR METHYLMALONIC ACIDEMIA (MMA)
Exclusivity Expiration: See Plans and Pricing

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Recordati Rare CARBAGLU carglumic acid TABLET, FOR SUSPENSION;ORAL 022562-001 Mar 18, 2010 AB RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
>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 CARBAGLU

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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