FDA Orange Book · active-ingredient family
Carglumic acid
Carglumic acid: 1 brand, 2 generics; first approved Mar 18, 2010; generic available.
Generic available1 exclusivity period
Generic status & protection
Generic available: 2 ANDA applications approved.
Latest exclusivity ends
Brands (NDA)
1
Generics (ANDA)
2
Listed patents
0
Presentations
3
Brand (NDA) products
Originator applications
- RECORDATI RARENDA 0225622010
Approved strengths under this FDA application. Strength Dosage form Route Status TE 200MG TABLET, FOR SUSPENSION ORAL Rx AB
Generic (ANDA) products (2)
Abbreviated applications
- CARGLUMIC ACIDNAVINTA LLCANDA 2133952022
Approved strengths under this FDA application. Strength Dosage form Route Status TE 200MG TABLET, FOR SUSPENSION ORAL Rx AB - CARGLUMIC ACIDNOVITIUM PHARMAANDA 2137292021
Approved strengths under this FDA application. Strength Dosage form Route Status TE 200MG TABLET, FOR SUSPENSION ORAL Rx AB
Patent & exclusivity timeline
Protection horizon
Patent expiryExclusivity endToday
Marketing exclusivity
Hatch-Waxman
- ODE-345Orphan-drug exclusivity (7 years)
in 1 yr 5 mo
Listed patents
Orange Book patent file
No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Approval history
FDA approval span
First approval
16 yr 8 mo ago
Most recent approval
4 yr 3 mo ago
Approvals span 2010–2022 across 3 FDA applications.
Brand (NDA) 133%
Generic (ANDA) 267%
Carglumic acid: frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
Built directly from the FDA Orange Book data file (products, patents, and exclusivity). TE codes, RLD/RS flags, patent expirations, and exclusivity dates match the official FDA record. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Related FDA reference tools
- FDA Purple BookLicensed biologics, biosimilars, interchangeables, BLA records, and exclusivity dates.
- FDA BiosimilarsFDA-approved biosimilars and interchangeable biosimilars, by reference product.
- 510(k) Predicate DatabaseSearch FDA 510(k) clearances and map predicate-device lineage.
- FDA 483 DatabaseFDA Form 483 observations and inspection records by firm, date, and citation.
