FDA Orange Book · active-ingredient family
Cevimeline hydrochloride
Cevimeline hydrochloride is approved as 1 brand and 9 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:EVOXAC · NDA 020989
1
Brand (NDA)
9
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · capsule
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| EVOXACRLD | COSETTE | NDA 020989 | AB | Jan 11, 2000 |
Generic (ANDA) products (9)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| CEVIMELINE HYDROCHLORIDE | ZYDUS LIFESCIENCES | ANDA 220267 | AB | Mar 11, 2026 | |
| CEVIMELINE HYDROCHLORIDE | MACLEODS PHARMS LTD | ANDA 206808 | AB | Sep 20, 2024 | |
| CEVIMELINE HYDROCHLORIDE | BIONPHARMA | ANDA 218290 | AB | Nov 08, 2023 | |
| CEVIMELINE HYDROCHLORIDE | AUROBINDO PHARMA | ANDA 215056 | AB | Apr 18, 2023 | |
| CEVIMELINE HYDROCHLORIDE | RUBICON RESEARCH | ANDA 216682 | AB | Apr 06, 2023 | |
| CEVIMELINE HYDROCHLORIDE | NOVEL LABS INC | ANDA 204746 | AB | Dec 30, 2016 | |
| CEVIMELINE HYDROCHLORIDE | RISING | ANDA 203775 | AB | Jun 04, 2014 | |
| CEVIMELINE HYDROCHLORIDE | HIKMA | ANDA 091591 | AB | Jul 08, 2013 | |
| CEVIMELINE HYDROCHLORIDE | APOTEX INC | ANDA 091260 | — | Aug 25, 2011 |
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.
Cevimeline hydrochloride — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
