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. Four suppliers are listed for this compound. Additional details are available on the carglumic acid profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Carbaglu
A generic version of CARBAGLU was approved as carglumic acid by NOVITIUM PHARMA on October 13th, 2021.
Summary for CARBAGLU
| US Patents: | 0 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 85 |
| Clinical Trials: | 6 |
| Patent Applications: | 219 |
| What excipients (inactive ingredients) are in CARBAGLU? | CARBAGLU excipients list |
| DailyMed Link: | CARBAGLU at DailyMed |
Recent Clinical Trials for CARBAGLU
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| National Taiwan University Hospital | N/A |
| King Abdullah International Medical Research Center | Phase 3 |
| Boston Children's Hospital | Phase 2 |
Pharmacology for CARBAGLU
| Drug Class | Carbamoyl Phosphate Synthetase 1 Activator |
| Mechanism of Action | Carbamoyl Phosphate Synthetase 1 Activators |
Anatomical Therapeutic Chemical (ATC) Classes for CARBAGLU
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: ⤷ 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 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 |
