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
US Patents: | 0 |
Tradenames: | 2 |
Applicants: | 3 |
NDAs: | 3 |
Drug Master File Entries: | 2 |
Finished Product Suppliers / Packagers: | 4 |
Raw Ingredient (Bulk) Api Vendors: | 85 |
Clinical Trials: | 4 |
Patent Applications: | 324 |
Drug Prices: | Drug price trends for CARGLUMIC ACID |
What excipients (inactive ingredients) are in CARGLUMIC ACID? | CARGLUMIC ACID excipients list |
DailyMed Link: | CARGLUMIC ACID at DailyMed |
Recent Clinical Trials for CARGLUMIC ACID
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
National Taiwan University Hospital | N/A |
King Abdullah International Medical Research Center | Phase 3 |
University Hospitals Cleveland Medical Center | Phase 2 |
Pharmacology for CARGLUMIC ACID
Drug Class | Carbamoyl Phosphate Synthetase 1 Activator |
Mechanism of Action | Carbamoyl Phosphate Synthetase 1 Activators |
Anatomical Therapeutic Chemical (ATC) Classes 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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Recordati Rare | CARBAGLU | carglumic acid | TABLET, FOR SUSPENSION;ORAL | 022562-001 | Mar 18, 2010 | AB | RX | Yes | Yes | ⤷ Subscribe | ⤷ Subscribe | ⤷ Subscribe | |||
Novitium Pharma | CARGLUMIC ACID | carglumic acid | TABLET, FOR SUSPENSION;ORAL | 213729-001 | Oct 13, 2021 | AB | RX | No | No | ⤷ Subscribe | ⤷ Subscribe | ⤷ Subscribe | |||
Navinta Llc | CARGLUMIC ACID | carglumic acid | TABLET, FOR SUSPENSION;ORAL | 213395-001 | Jun 22, 2022 | AB | RX | No | No | ⤷ Subscribe | ⤷ Subscribe | ⤷ Subscribe | |||
>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 |
CARGLUMIC ACID Market Analysis and Financial Projection Experimental
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