FDA Orange Book · active-ingredient family
Carbidopa; entacapone; levodopa
Carbidopa; entacapone; levodopa is approved as 1 brand and 7 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:STALEVO 100 · NDA 021485
1
Brand (NDA)
7
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · tablet
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| STALEVO 100RLD×6 | ORION PHARMA | NDA 021485 | AB | Jun 11, 2003 |
Generic (ANDA) products (7)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| CARBIDOPA, LEVODOPA AND ENTACAPONE×6 | ALEMBIC | ANDA 218535 | AB | Feb 05, 2026 | |
| CARBIDOPA, LEVODOPA AND ENTACAPONE×6 | MACLEODS PHARMS LTD | ANDA 214495 | AB | Apr 15, 2025 | |
| CARBIDOPA, LEVODOPA AND ENTACAPONE×6 | RISING | ANDA 213212 | AB | Jan 25, 2022 | |
| CARBIDOPA, LEVODOPA AND ENTACAPONE×6 | PHARMOBEDIENT | ANDA 203424 | — | Aug 13, 2020 | |
| CARBIDOPA, LEVODOPA AND ENTACAPONE | WOCKHARDT LTD | ANDA 090786 | — | Nov 20, 2012 | |
| CARBIDOPA, LEVODOPA AND ENTACAPONE×5 | WOCKHARDT LTD | ANDA 090833 | — | Nov 20, 2012 | |
| CARBIDOPA, LEVODOPA AND ENTACAPONE×2 | SUN PHARM | ANDA 079085 | — | May 10, 2012 |
Listed patents
No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Carbidopa; entacapone; levodopa — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
