FDA Orange Book · active-ingredient family
Repaglinide
Repaglinide is approved as 1 brand and 8 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:PRANDIN · NDA 020741
1
Brand (NDA)
8
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · tablet
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| PRANDINRLD×3 | GEMINI LABS LLC | NDA 020741 | — | Dec 22, 1997 |
Generic (ANDA) products (8)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| REPAGLINIDE×3 | MACLEODS PHARMS LTD | ANDA 207209 | AB | Mar 22, 2023 | |
| REPAGLINIDE×3 | KENTON | ANDA 091517 | — | Apr 24, 2015 | |
| REPAGLINIDE×3 | ACTAVIS TOTOWA | ANDA 090008 | — | Jan 22, 2014 | |
| REPAGLINIDE×3 | AUROBINDO PHARMA LTD | ANDA 203820 | AB | Jan 22, 2014 | |
| REPAGLINIDE×3 | CHARTWELL RX | ANDA 078555 | AB | Nov 22, 2013 | |
| REPAGLINIDE×3 | QUAGEN | ANDA 090252 | — | Aug 23, 2013 | |
| REPAGLINIDE×3 | PADAGIS US | ANDA 201189 | — | Jul 17, 2013 | |
| REPAGLINIDE×2 | SUN PHARM INDS INC | ANDA 077571 | — | Jul 11, 2013 |
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.
Repaglinide — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
