FDA Orange Book · active-ingredient family
Desloratadine
Desloratadine is approved as 3 brand and 11 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:CLARINEX · NDA 021312
3
Brand (NDA)
11
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · solution, tablet, tablet, orally disintegrating
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| CLARINEXRLD×2 | ORGANON | NDA 021312 | — | Jul 14, 2005 | |
| CLARINEXRLD | ORGANON LLC | NDA 021300 | — | Sep 01, 2004 | |
| CLARINEXRLD | ORGANON | NDA 021165 | AB | Dec 21, 2001 |
Generic (ANDA) products (11)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| DESLORATADINE | TARO | ANDA 202936 | — | May 26, 2016 | |
| DESLORATADINE | TARO | ANDA 202592 | — | Jun 30, 2015 | |
| DESLORATADINE | AJENAT PHARMS | ANDA 078355 | AB | Apr 19, 2012 | |
| DESLORATADINE | NATCO PHARMA USA | ANDA 078351 | AB | Feb 10, 2012 | |
| DESLORATADINE | PERRIGO | ANDA 078361 | — | Dec 22, 2011 | |
| DESLORATADINE | DR REDDYS LABS LTD | ANDA 078365 | AB | Mar 08, 2011 | |
| DESLORATADINE | CHARTWELL RX | ANDA 078364 | — | Dec 03, 2010 | |
| DESLORATADINE | SUN PHARM INDS | ANDA 078359 | — | Nov 16, 2010 | |
| DESLORATADINE | LUPIN PHARMS | ANDA 078352 | AB | Oct 25, 2010 | |
| DESLORATADINE×2 | REDDYS | ANDA 078367 | — | Jul 12, 2010 | |
| DESLORATADINE | ORBION PHARMS | ANDA 078357 | AB | Feb 19, 2010 |
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.
Desloratadine — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
