FDA Orange Book · active-ingredient family
Glycopyrrolate; neostigmine methylsulfate
Glycopyrrolate; neostigmine methylsulfate is approved in 1 FDA application, with therapeutic-equivalence codes, listed patents, and marketing exclusivity from the FDA Orange Book.
Reference-listed drug:PREVDUO · NDA 216903
1
Brand (NDA)
0
Generics (ANDA)
5
Listed patents
0
Exclusivity periods
Brand (NDA) products · solution
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| PREVDUORLD | AZURITY | NDA 216903 | — | Feb 23, 2023 |
Listed patents (5)
| Patent | Expires | In | Type |
|---|---|---|---|
| 11110054 | Oct 25, 2038 | in 12 yr 6 mo | Product |
| 11938217 | Oct 25, 2038 | in 12 yr 6 mo | Product |
| 10456354 | Oct 25, 2038 | in 12 yr 6 mo | Product |
| 12151020 | Oct 25, 2038 | in 12 yr 6 mo | Product |
| 12383491 | Oct 25, 2038 | in 12 yr 6 mo | Product |
Glycopyrrolate; neostigmine methylsulfate — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
