FDA Orange Book · active-ingredient family
Macimorelin acetate
Macimorelin acetate is approved in 1 FDA application, with therapeutic-equivalence codes, listed patents, and marketing exclusivity from the FDA Orange Book.
Reference-listed drug:MACRILEN · NDA 205598
1
Brand (NDA)
0
Generics (ANDA)
2
Listed patents
0
Exclusivity periods
Brand (NDA) products · for solution
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| MACRILENRLD | AETERNA ZENTARIS | NDA 205598 | — | Dec 20, 2017 |
Listed patents (2)
| Patent | Expires | In | Type |
|---|---|---|---|
| 8192719 | Oct 12, 2027 | in 1 yr 4 mo | U-2220 |
| 8192719*PED | Apr 12, 2028 | in 1 yr 10 mo |
Macimorelin acetate — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
