FDA Orange Book · active-ingredient family
Plerixafor
Plerixafor is approved as 1 brand and 9 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:MOZOBIL · NDA 022311
1
Brand (NDA)
9
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · solution
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| MOZOBILRLD | GENZYME | NDA 022311 | AP | Dec 15, 2008 |
Generic (ANDA) products (9)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| PLERIXAFOR | HETERO LABS LTD VI | ANDA 217560 | AP | Jun 16, 2025 | |
| PLERIXAFOR | GLAND | ANDA 206644 | AP | May 03, 2024 | |
| PLERIXAFOR | ZYDUS PHARMS | ANDA 208980 | — | Jul 26, 2023 | |
| PLERIXAFOR | AMNEAL | ANDA 215334 | AP | Jul 24, 2023 | |
| PLERIXAFOR | DR REDDYS | ANDA 205182 | AP | Jul 24, 2023 | |
| PLERIXAFOR | EUGIA PHARMA | ANDA 213672 | AP | Jul 24, 2023 | |
| PLERIXAFOR | MEITHEAL | ANDA 215698 | AP | Jul 24, 2023 | |
| PLERIXAFOR | MSN | ANDA 211901 | AP | Jul 24, 2023 | |
| PLERIXAFOR | TEVA PHARMS USA INC | ANDA 205197 | — | Jul 24, 2023 |
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.
Plerixafor — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
