FDA Orange Book · active-ingredient family
Orforglipron calcium
Orforglipron calcium is approved in 1 FDA application, with therapeutic-equivalence codes, listed patents, and marketing exclusivity from the FDA Orange Book.
Reference-listed drug:FOUNDAYO · NDA 220934
1
Brand (NDA)
0
Generics (ANDA)
1
Listed patents
6
Exclusivity periods
Brand (NDA) products · tablet
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| FOUNDAYORLD×6 | ELI LILLY AND CO | NDA 220934 | — | Apr 01, 2026 |
Marketing exclusivity (6)
- NCENew chemical entity exclusivity (5 years)
Apr 01, 2031
in 4 yr 10 mo
- NCENew chemical entity exclusivity (5 years)
Apr 01, 2031
in 4 yr 10 mo
- NCENew chemical entity exclusivity (5 years)
Apr 01, 2031
in 4 yr 10 mo
- NCENew chemical entity exclusivity (5 years)
Apr 01, 2031
in 4 yr 10 mo
- NCENew chemical entity exclusivity (5 years)
Apr 01, 2031
in 4 yr 10 mo
- NCENew chemical entity exclusivity (5 years)
Apr 01, 2031
in 4 yr 10 mo
Listed patents (1)
| Patent | Expires | In | Type |
|---|---|---|---|
| RE50455 | Sep 26, 2037 | in 11 yr 5 mo | SubstanceProductU-4474 |
Orforglipron calcium — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
