FDA Orange Book · active-ingredient family
Gemfibrozil
Gemfibrozil is approved as 1 brand and 20 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:LOPID · NDA 018422
1
Brand (NDA)
20
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · capsule, tablet
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| LOPIDRLD×3 | PFIZER PHARMS | NDA 018422 | AB | Nov 20, 1986 |
Generic (ANDA) products (20)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| GEMFIBROZIL | ASCENT PHARMS INC | ANDA 214603 | AB | Jan 13, 2021 | |
| GEMFIBROZIL | CADILA | ANDA 204189 | — | Aug 28, 2018 | |
| GEMFIBROZIL | CADILA PHARMS LTD | ANDA 203266 | AB | Jun 17, 2016 | |
| GEMFIBROZIL | AUROBINDO PHARMA LTD | ANDA 202726 | AB | Sep 16, 2015 | |
| GEMFIBROZIL | NORTHSTAR HLTHCARE | ANDA 079072 | AB | Sep 13, 2010 | |
| GEMFIBROZIL | HIKMA PHARMS | ANDA 078599 | — | Aug 16, 2010 | |
| GEMFIBROZIL | SUN PHARM INDS INC | ANDA 079239 | — | Dec 29, 2008 | |
| GEMFIBROZIL | IMPAX PHARMS | ANDA 078207 | AB | Jun 01, 2007 | |
| GEMFIBROZIL | EPIC PHARMA LLC | ANDA 078012 | AB | Mar 26, 2007 | |
| GEMFIBROZIL | INVAGEN PHARMS | ANDA 077836 | AB | Jul 27, 2006 | |
| GEMFIBROZIL | APOTEX | ANDA 075034 | — | Jul 20, 1998 | |
| GEMFIBROZIL | CHARTWELL RX | ANDA 074615 | — | Sep 29, 1995 | |
| GEMFIBROZIL | WATSON LABS | ANDA 074442 | — | Apr 28, 1995 | |
| GEMFIBROZIL | PHARMOBEDIENT | ANDA 074452 | — | Feb 16, 1995 | |
| GEMFIBROZIL | WATSON LABS | ANDA 074156 | — | Oct 24, 1994 | |
| GEMFIBROZIL | PUREPAC PHARM | ANDA 074360 | — | Aug 31, 1994 | |
| GEMFIBROZIL | TEVA | ANDA 074256 | — | Oct 31, 1993 | |
| GEMFIBROZIL | CHARTWELL MOLECULES | ANDA 074270 | AB | Sep 27, 1993 | |
| GEMFIBROZIL | PUREPAC PHARM | ANDA 072929 | — | Jan 29, 1993 | |
| GEMFIBROZIL | NATCO | ANDA 073466 | — | Jan 25, 1993 |
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.
Gemfibrozil — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
