FDA Orange Book · active-ingredient family
Clonidine
Clonidine is approved as 3 brand and 4 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:CATAPRES-TTS-1 · NDA 018891
3
Brand (NDA)
4
Generics (ANDA)
2
Listed patents
0
Exclusivity periods
Brand (NDA) products · suspension, extended release, system, tablet, extended release
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| CATAPRES-TTS-1RLD×3 | LAVIPHARM | NDA 018891 | AB | Oct 10, 1984 | |
| CLONIDINE | TRIS PHARMA INC | NDA 022499 | — | Dec 03, 2009 | |
| NEXICLON XR×2 | ROSEMONT | NDA 022500 | — | Dec 03, 2009 |
Generic (ANDA) products (4)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| CLONIDINE×3 | ACTAVIS LABS UT INC | ANDA 090873 | AB | May 06, 2014 | |
| CLONIDINE×3 | DR REDDYS LABS SA | ANDA 079090 | AB | Aug 20, 2010 | |
| CLONIDINE×3 | MYLAN TECHNOLOGIES | ANDA 076166 | AB | Jul 16, 2010 | |
| CLONIDINE×3 | DIFGEN PHARMS | ANDA 076157 | — | Aug 18, 2009 |
Listed patents (2)
| Patent | Expires | In | Type |
|---|---|---|---|
| 8337890 | Apr 17, 2027 | in 10 mo | Product |
| 8623409 | Sep 08, 2031 | in 5 yr 4 mo | Product |
Clonidine — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
