Question 1

Is there a generic for Carglumic acid?

Accepted Answer

Yes. The FDA Orange Book lists 2 approved generic (ANDA) applications for Carglumic acid, referencing the brand CARBAGLU. Generics rated with an "A" therapeutic-equivalence code are considered substitutable for the brand.

Question 2

What is the reference-listed drug for Carglumic acid?

Accepted Answer

CARBAGLU (NDA 022562, RECORDATI RARE) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

Question 3

Does Carglumic acid have FDA marketing exclusivity?

Accepted Answer

Yes. The Orange Book records 1 marketing-exclusivity period for Carglumic acid. Exclusivity is granted by FDA at approval (for example new-chemical-entity, orphan-drug, or pediatric exclusivity) and runs independently of any listed patents.

Question 4

What dosage forms of Carglumic acid are approved?

Accepted Answer

Carglumic acid is approved in the following dosage form: tablet, for suspension.

Product	Applicant	Application	TE	Approved
CARGLUMIC ACID	NAVINTA LLC	ANDA 213395	AB	Jun 22, 2022
CARGLUMIC ACID	NOVITIUM PHARMA	ANDA 213729	AB	Oct 13, 2021

Carglumic acid

Brand (NDA) products · tablet, for suspension

Generic (ANDA) products (2)

Marketing exclusivity (1)

Listed patents

Carglumic acid — frequently asked questions

Your Next Submission Could Take 6+ Fewer Weeks and Cost $250K Less.