FDA Orange Book · active-ingredient family
Levoleucovorin calcium
Levoleucovorin calcium is approved as 2 brand and 12 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:LEVOLEUCOVORIN CALCIUM · NDA 208723
2
Brand (NDA)
12
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · powder, solution
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| LEVOLEUCOVORIN CALCIUMRLD | ACTAVIS LLC | NDA 208723 | — | Sep 29, 2016 | |
| FUSILEVRLD×3 | ACROTECH BIOPHARMA | NDA 020140 | — | Mar 07, 2008 |
Generic (ANDA) products (12)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| LEVOLEUCOVORIN CALCIUM×2 | HAINAN POLY PHARM | ANDA 217314 | AP | May 22, 2023 | |
| LEVOLEUCOVORIN CALCIUM | PRAXGEN | ANDA 213797 | — | Nov 02, 2021 | |
| LEVOLEUCOVORIN CALCIUM | MEITHEAL | ANDA 211003 | — | Aug 22, 2019 | |
| LEVOLEUCOVORIN CALCIUM×2 | MEITHEAL | ANDA 211002 | AP | Aug 16, 2019 | |
| LEVOLEUCOVORIN CALCIUM×2 | GLAND | ANDA 210892 | AP | Sep 14, 2018 | |
| LEVOLEUCOVORIN CALCIUM×2 | INGENUS PHARMS LLC | ANDA 210623 | — | May 03, 2018 | |
| LEVOLEUCOVORIN CALCIUM | AMNEAL | ANDA 207548 | — | Sep 08, 2017 | |
| LEVOLEUCOVORIN CALCIUM | ACTAVIS LLC | ANDA 206516 | — | Feb 13, 2017 | |
| LEVOLEUCOVORIN CALCIUM | AMNEAL | ANDA 207547 | — | Feb 13, 2017 | |
| LEVOLEUCOVORIN CALCIUM | HIKMA | ANDA 206263 | — | Jun 16, 2016 | |
| LEVOLEUCOVORIN CALCIUM×2 | PHARMOBEDIENT | ANDA 203576 | — | Oct 20, 2015 | |
| LEVOLEUCOVORIN CALCIUM×2 | SANDOZ | ANDA 203563 | AP | Mar 09, 2015 |
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.
Levoleucovorin calcium — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
