FDA Orange Book · active-ingredient family
Levocarnitine
Levocarnitine is approved as 3 brand and 10 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:CARNITOR · NDA 020182
3
Brand (NDA)
10
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · injectable, solution, tablet
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| CARNITORRLD | LEADIANT BIOSCI INC | NDA 020182 | AP | Dec 16, 1992 | |
| CARNITORRLD×2 | LEADIANT BIOSCI INC | NDA 019257 | AA | Apr 10, 1986 | |
| CARNITORRLD×2 | LEADIANT BIOSCI INC | NDA 018948 | AB | Dec 27, 1985 |
Generic (ANDA) products (10)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| LEVOCARNITINE | DEVA HOLDING AS | ANDA 217430 | AP | Jun 30, 2025 | |
| LEVOCARNITINE | NOVITIUM PHARMA | ANDA 216384 | AB | Dec 09, 2022 | |
| LEVOCARNITINE | SCIEGEN PHARMS | ANDA 212533 | AA | Nov 10, 2021 | |
| LEVOCARNITINE×2 | NOVITIUM PHARMA | ANDA 211676 | AA | Aug 14, 2019 | |
| LEVOCARNITINE | HIKMA | ANDA 077399 | — | Oct 25, 2007 | |
| LEVOCARNITINE | RISING | ANDA 076858 | AB | Sep 20, 2004 | |
| LEVOCARNITINE | RISING | ANDA 076851 | AA | Aug 10, 2004 | |
| LEVOCARNITINE | AM REGENT | ANDA 075861 | AP | Jun 22, 2001 | |
| LEVOCARNITINE | HIKMA | ANDA 075567 | AP | Mar 29, 2001 | |
| LEVOCARNITINE | TEVA PHARMS USA | ANDA 075881 | — | Mar 29, 2001 |
Listed patents
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.
Levocarnitine — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
