FDA Orange Book · active-ingredient family
Levodopa
Levodopa is approved in 4 FDA applications, with therapeutic-equivalence codes, listed patents, and marketing exclusivity from the FDA Orange Book.
Reference-listed drug:INBRIJA · NDA 209184
4
Brand (NDA)
0
Generics (ANDA)
6
Listed patents
0
Exclusivity periods
Brand (NDA) products · capsule, powder, tablet
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| INBRIJARLD | MERZ | NDA 209184 | — | Dec 21, 2018 | |
| BENDOPA×3 | VALEANT PHARM INTL | NDA 016948 | — | Approved Prior to Jan 1, 1982 | |
| DOPAR×5 | SHIRE | NDA 016913 | — | Approved Prior to Jan 1, 1982 | |
| LARODOPA×6 | ROCHE | NDA 016912 | — | Approved Prior to Jan 1, 1982 |
Listed patents (6)
| Patent | Expires | In | Type |
|---|---|---|---|
| RE43711 | Feb 03, 2029 | in 2 yr 8 mo | U-2484 |
| 8685442 | Nov 16, 2032 | in 6 yr 6 mo | Product |
| 8945612 | Nov 16, 2032 | in 6 yr 6 mo | Product |
| 8545878 | Nov 16, 2032 | in 6 yr 6 mo | Product |
| 9393210 | Nov 16, 2032 | in 6 yr 6 mo | Product |
| 12458615 | Oct 21, 2033 | in 7 yr 5 mo | U-2484 |
Levodopa — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
