FDA Orange Book · active-ingredient family
Neostigmine methylsulfate
Neostigmine methylsulfate is approved as 2 brand and 18 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:NEOSTIGMINE METHYLSULFATE · NDA 203629
2
Brand (NDA)
18
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · solution
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| NEOSTIGMINE METHYLSULFATERLD×3 | FRESENIUS KABI USA | NDA 203629 | AP | Sep 18, 2018 | |
| BLOXIVERZRLD×3 | EXELA PHARMA | NDA 204078 | — | May 31, 2013 |
Generic (ANDA) products (18)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| NEOSTIGMINE METHYLSULFATE×2 | EUGIA PHARMA | ANDA 213244 | — | Nov 02, 2023 | |
| NEOSTIGMINE METHYLSULFATE×2 | SAGENT PHARMS INC | ANDA 216542 | AP | Feb 17, 2023 | |
| NEOSTIGMINE METHYLSULFATE×2 | AVET LIFESCIENCES | ANDA 208230 | AP | Nov 25, 2022 | |
| NEOSTIGMINE METHYLSULFATE×2 | NIVAGEN PHARMS INC | ANDA 212627 | AP | Nov 03, 2022 | |
| NEOSTIGMINE METHYLSULFATE | HIKMA | ANDA 216206 | — | Jul 13, 2022 | |
| NEOSTIGMINE METHYLSULFATE | DR REDDYS | ANDA 216291 | AP | Jul 06, 2022 | |
| NEOSTIGMINE METHYLSULFATE×2 | REGCON HOLDINGS | ANDA 210652 | AP | Oct 01, 2021 | |
| NEOSTIGMINE METHYLSULFATE×2 | CAPLIN | ANDA 213074 | AP | Apr 20, 2021 | |
| NEOSTIGMINE METHYLSULFATE×2 | MEITHEAL | ANDA 212804 | AP | Apr 05, 2021 | |
| NEOSTIGMINE METHYLSULFATE×2 | GLAND | ANDA 212968 | AP | Oct 16, 2019 | |
| NEOSTIGMINE METHYLSULFATE×2 | BE PHARMS | ANDA 212512 | AP | May 13, 2019 | |
| NEOSTIGMINE METHYLSULFATE×2 | AMRING PHARMS | ANDA 210989 | AP | Aug 22, 2018 | |
| NEOSTIGMINE METHYLSULFATE×2 | DR REDDYS | ANDA 209135 | AP | Jul 10, 2018 | |
| NEOSTIGMINE METHYLSULFATE×2 | AMNEAL | ANDA 210051 | AP | Jun 15, 2018 | |
| NEOSTIGMINE METHYLSULFATE×2 | AM REGENT | ANDA 209182 | — | May 04, 2018 | |
| NEOSTIGMINE METHYLSULFATE×2 | AMPHASTAR PHARMS INC | ANDA 209933 | AP | Sep 25, 2017 | |
| NEOSTIGMINE METHYLSULFATE×2 | PH HEALTH | ANDA 208405 | AP | Apr 26, 2017 | |
| NEOSTIGMINE METHYLSULFATE×2 | HIKMA | ANDA 207042 | AP | Dec 28, 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.
Neostigmine methylsulfate — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
