FDA Orange Book · active-ingredient family
Entacapone
Entacapone is approved as 1 brand and 8 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:COMTAN · NDA 020796
1
Brand (NDA)
8
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · tablet
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| COMTANRLD | ORION PHARMA | NDA 020796 | AB | Oct 19, 1999 |
Generic (ANDA) products (8)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| ENTACAPONE | ALEMBIC | ANDA 212601 | AB | Jan 04, 2022 | |
| ENTACAPONE | SUNSHINE | ANDA 206669 | AB | Oct 03, 2018 | |
| ENTACAPONE | AJANTA PHARMA LTD | ANDA 205792 | AB | Aug 31, 2017 | |
| ENTACAPONE | MACLEODS PHARMS LTD | ANDA 207210 | AB | Jun 05, 2017 | |
| ENTACAPONE | AUROBINDO PHARMA LTD | ANDA 203437 | AB | Jun 19, 2015 | |
| ENTACAPONE | PHARMOBEDIENT | ANDA 202394 | — | May 13, 2013 | |
| ENTACAPONE | WOCKHARDT BIO AG | ANDA 078941 | AB | Aug 16, 2012 | |
| ENTACAPONE | SUN PHARM | ANDA 090690 | AB | Jul 16, 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.
Entacapone — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
