CARGLUMIC ACID Drug Patent Profile
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Which patents cover Carglumic Acid, and when can generic versions of Carglumic Acid launch?
Carglumic Acid is a drug marketed by Navinta Llc and Novitium Pharma and is included in two NDAs.
The generic ingredient in CARGLUMIC ACID 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 Carglumic Acid
A generic version of CARGLUMIC ACID was approved as carglumic acid by NOVITIUM PHARMA on October 13th, 2021.
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Summary for CARGLUMIC ACID
| US Patents: | 0 |
| Applicants: | 2 |
| NDAs: | 2 |
| Finished Product Suppliers / Packagers: | 3 |
| Raw Ingredient (Bulk) Api Vendors: | 85 |
| Clinical Trials: | 4 |
| Patent Applications: | 219 |
| Drug Prices: | Drug price information for CARGLUMIC ACID |
| 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 |
| Children's Hospital of Philadelphia | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Navinta Llc | CARGLUMIC ACID | carglumic acid | TABLET, FOR SUSPENSION;ORAL | 213395-001 | Jun 22, 2022 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Novitium Pharma | CARGLUMIC ACID | carglumic acid | TABLET, FOR SUSPENSION;ORAL | 213729-001 | Oct 13, 2021 | AB | RX | No | 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 |
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 |
