FDA Orange Book · active-ingredient family
Clarithromycin
Clarithromycin is approved as 3 brand and 23 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:BIAXIN XL · NDA 050775
3
Brand (NDA)
23
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · for suspension, tablet, tablet, extended release
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| BIAXIN XLRLD | ABBVIE | NDA 050775 | — | Mar 03, 2000 | |
| BIAXINRLD×3 | ABBVIE | NDA 050698 | — | Dec 23, 1993 | |
| BIAXINRLD×2 | ABBVIE | NDA 050662 | — | Oct 31, 1991 |
Generic (ANDA) products (23)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| CLARITHROMYCIN×2 | ALEMBIC | ANDA 210459 | AB | Jan 31, 2022 | |
| CLARITHROMYCIN×2 | JUBILANT CADISTA | ANDA 206714 | — | Apr 25, 2019 | |
| CLARITHROMYCIN | SUNSHINE | ANDA 208987 | AB | Jul 09, 2018 | |
| CLARITHROMYCIN | MPP PHARMA | ANDA 203243 | AB | Feb 29, 2016 | |
| CLARITHROMYCIN×2 | HEC PHARM | ANDA 203584 | AB | Sep 28, 2015 | |
| CLARITHROMYCIN | LUPIN | ANDA 202532 | — | Sep 15, 2015 | |
| CLARITHROMYCIN×2 | NOVITIUM PHARMA | ANDA 202710 | AB | Jun 10, 2013 | |
| CLARITHROMYCIN×2 | AUROBINDO | ANDA 065489 | AB | Jul 25, 2012 | |
| CLARITHROMYCIN×2 | SANDOZ | ANDA 065283 | — | Sep 04, 2007 | |
| CLARITHROMYCIN×2 | SUN PHARM INDS LTD | ANDA 065382 | — | Aug 30, 2007 | |
| CLARITHROMYCIN×2 | CHARTWELL | ANDA 065384 | AB | Aug 20, 2007 | |
| CLARITHROMYCIN×2 | WOCKHARDT | ANDA 065266 | — | May 31, 2006 | |
| CLARITHROMYCIN | SANDOZ | ANDA 065144 | AB | Oct 18, 2005 | |
| CLARITHROMYCIN | ANI PHARMS | ANDA 065250 | — | Aug 25, 2005 | |
| CLARITHROMYCIN | SANDOZ | ANDA 065136 | AB | Aug 25, 2005 | |
| CLARITHROMYCIN×2 | IVAX SUB TEVA PHARMS | ANDA 065137 | — | May 31, 2005 | |
| CLARITHROMYCIN×2 | TEVA | ANDA 065155 | — | May 31, 2005 | |
| CLARITHROMYCIN | DR REDDYS LABS SA | ANDA 065154 | AB | May 18, 2005 | |
| CLARITHROMYCIN×2 | PHARMOBEDIENT | ANDA 065195 | — | Mar 11, 2005 | |
| CLARITHROMYCIN | RANBAXY | ANDA 065210 | — | Jan 26, 2005 | |
| CLARITHROMYCIN×2 | SUN PHARM INDS LTD | ANDA 065174 | — | Sep 24, 2004 | |
| CLARITHROMYCIN | ACTAVIS LABS FL INC | ANDA 065145 | AB | Jun 24, 2004 | |
| CLARITHROMYCIN×2 | HIKMA | ANDA 065178 | — | May 25, 2004 |
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.
Clarithromycin — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
