FDA Orange Book · active-ingredient family
Glycopyrrolate; indacaterol maleate
Glycopyrrolate; indacaterol maleate is approved in 1 FDA application, with therapeutic-equivalence codes, listed patents, and marketing exclusivity from the FDA Orange Book.
Reference-listed drug:UTIBRON NEOHALER · NDA 207930
1
Brand (NDA)
0
Generics (ANDA)
2
Listed patents
0
Exclusivity periods
Brand (NDA) products · powder
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| UTIBRON NEOHALERRLD | NOVARTIS | NDA 207930 | — | Oct 29, 2015 |
Listed patents (2)
| Patent | Expires | In | Type |
|---|---|---|---|
| 8479730 | Oct 11, 2028 | in 2 yr 4 mo | Product |
| 8182838 | Oct 20, 2028 | in 2 yr 4 mo | Product |
Glycopyrrolate; indacaterol maleate — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
