FDA Orange Book · active-ingredient family
Bicalutamide
Bicalutamide is approved as 1 brand and 13 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:CASODEX · NDA 020498
1
Brand (NDA)
13
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · tablet
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| CASODEXRLD | ANI PHARMS | NDA 020498 | AB | Oct 04, 1995 |
Generic (ANDA) products (13)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| BICALUTAMIDE | CHARTWELL RX | ANDA 091011 | AB | Jun 10, 2015 | |
| BICALUTAMIDE | APOTEX | ANDA 200274 | — | May 21, 2015 | |
| BICALUTAMIDE | ROXANE | ANDA 078285 | — | Mar 24, 2011 | |
| BICALUTAMIDE | FRESENIUS KABI USA | ANDA 079045 | — | May 13, 2010 | |
| BICALUTAMIDE | WATSON LABS TEVA | ANDA 078634 | AB | Aug 28, 2009 | |
| BICALUTAMIDE | ACCORD HLTHCARE | ANDA 078917 | AB | Jul 06, 2009 | |
| BICALUTAMIDE | ADAPTIS | ANDA 079089 | AB | Jul 06, 2009 | |
| BICALUTAMIDE | KUDCO IRELAND | ANDA 077995 | — | Jul 06, 2009 | |
| BICALUTAMIDE | RISING | ANDA 079185 | — | Jul 06, 2009 | |
| BICALUTAMIDE | SANDOZ | ANDA 078575 | AB | Jul 06, 2009 | |
| BICALUTAMIDE | SUN PHARM | ANDA 079110 | AB | Jul 06, 2009 | |
| BICALUTAMIDE | SYNTHON PHARMS | ANDA 077973 | — | Jul 06, 2009 | |
| BICALUTAMIDE | TEVA | ANDA 076932 | — | Jul 06, 2009 |
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.
Bicalutamide — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
