FDA Orange Book · active-ingredient family
Glipizide
Glipizide is approved as 2 brand and 21 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:GLUCOTROL XL · NDA 020329
2
Brand (NDA)
21
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · tablet, tablet, extended release
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| GLUCOTROL XLRLD×3 | PFIZER | NDA 020329 | — | Aug 10, 1999 | |
| GLUCOTROLRLD×3 | PFIZER | NDA 017783 | — | May 11, 1993 |
Generic (ANDA) products (21)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| GLIPIZIDE×2 | GRAVITI PHARMS | ANDA 219159 | AB | Mar 04, 2026 | |
| GLIPIZIDE×4 | RUBICON RESEARCH | ANDA 214874 | — | Oct 03, 2023 | |
| GLIPIZIDE×3 | ZYDUS PHARMS | ANDA 203499 | AB | Jul 16, 2018 | |
| GLIPIZIDE×3 | AUROBINDO PHARMA | ANDA 206928 | AB | May 12, 2017 | |
| GLIPIZIDE×3 | UNIQUE | ANDA 204720 | AB | Dec 29, 2016 | |
| GLIPIZIDE×3 | PHARMOBEDIENT | ANDA 202298 | — | May 19, 2015 | |
| GLIPIZIDE×2 | PH HEALTH | ANDA 076159 | — | Sep 20, 2013 | |
| GLIPIZIDE×2 | SUN PHARM INDS INC | ANDA 077820 | — | Jul 11, 2006 | |
| GLIPIZIDE×3 | WATSON LABS | ANDA 076467 | AB | Mar 27, 2006 | |
| GLIPIZIDE×2 | APOTEX | ANDA 075795 | AB | Jun 13, 2001 | |
| GLIPIZIDE×2 | ACCORD HLTHCARE | ANDA 074550 | — | Sep 11, 1997 | |
| GLIPIZIDE×2 | BARR LABS INC | ANDA 074619 | — | Apr 04, 1997 | |
| GLIPIZIDE×2 | ANI PHARMS | ANDA 074387 | — | Mar 04, 1996 | |
| GLIPIZIDE×2 | ANI PHARMS | ANDA 074497 | AB | Aug 31, 1995 | |
| GLIPIZIDE×2 | CHARTWELL RX | ANDA 074542 | — | Jun 20, 1995 | |
| GLIPIZIDE×2 | PHARMOBEDIENT | ANDA 074438 | — | Jun 20, 1995 | |
| GLIPIZIDE×2 | AIPING PHARM INC | ANDA 074305 | — | Apr 07, 1995 | |
| GLIPIZIDE×2 | WATSON LABS TEVA | ANDA 074223 | AB | Feb 27, 1995 | |
| GLIPIZIDE×2 | OXFORD PHARMS | ANDA 074378 | AB | Nov 28, 1994 | |
| GLIPIZIDE×2 | WATSON LABS | ANDA 074370 | — | Nov 22, 1994 | |
| GLIPIZIDE×2 | AUROBINDO PHARMA USA | ANDA 074226 | AB | May 10, 1994 |
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.
Glipizide — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
