FDA Orange Book · active-ingredient family
Clonazepam
Clonazepam is approved as 2 brand and 17 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:KLONOPIN RAPIDLY DISINTEGRATING · NDA 020813
2
Brand (NDA)
17
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · tablet, tablet, orally disintegrating
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| KLONOPIN RAPIDLY DISINTEGRATINGRLD×5 | ROCHE | NDA 020813 | — | Dec 23, 1997 | |
| KLONOPINRLD×5 | CHEPLAPHARM | NDA 017533 | AB | Approved Prior to Jan 1, 1982 |
Generic (ANDA) products (17)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| CLONAZEPAM×5 | RUBICON RESEARCH | ANDA 216988 | AB | May 21, 2026 | |
| CLONAZEPAM×5 | ALEMBIC | ANDA 211033 | AB | Jun 28, 2019 | |
| CLONAZEPAM×5 | SUN PHARM INDS INC | ANDA 078654 | — | Aug 27, 2014 | |
| CLONAZEPAM×3 | PRINSTON INC | ANDA 077856 | AB | Jun 28, 2006 | |
| CLONAZEPAM×5 | BARR | ANDA 077194 | AB | Aug 10, 2005 | |
| CLONAZEPAM×5 | PH HEALTH | ANDA 077171 | AB | Aug 03, 2005 | |
| CLONAZEPAM×3 | ACCORD HLTHCARE | ANDA 077147 | AB | May 02, 2005 | |
| CLONAZEPAM×3 | SUN PHARM INDS INC | ANDA 075423 | — | Apr 27, 2001 | |
| CLONAZEPAM×3 | RUBICON RESEARCH | ANDA 075468 | AB | Oct 06, 2000 | |
| CLONAZEPAM×3 | AUROBINDO PHARMA USA | ANDA 075150 | AB | Oct 05, 1998 | |
| CLONAZEPAM×3 | TEVA | ANDA 074920 | — | Aug 04, 1998 | |
| CLONAZEPAM×3 | WATSON LABS | ANDA 074964 | — | Dec 30, 1997 | |
| CLONAZEPAM×3 | QUAGEN | ANDA 074940 | — | Oct 30, 1997 | |
| CLONAZEPAM×3 | CHARTWELL RX | ANDA 074925 | AB | Sep 30, 1997 | |
| CLONAZEPAM×3 | SANDOZ | ANDA 074979 | AB | Aug 29, 1997 | |
| CLONAZEPAM×3 | ACTAVIS ELIZABETH | ANDA 074869 | AB | Oct 31, 1996 | |
| CLONAZEPAM×3 | TEVA | ANDA 074569 | AB | Sep 10, 1996 |
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.
Clonazepam — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
