FDA Orange Book · active-ingredient family
Nateglinide
Nateglinide 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:STARLIX · NDA 021204
1
Brand (NDA)
8
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · tablet
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| STARLIXRLD×2 | NOVARTIS | NDA 021204 | — | Dec 22, 2000 |
Generic (ANDA) products (8)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| NATEGLINIDE×2 | CADILA PHARMS LTD | ANDA 206432 | AB | Apr 19, 2019 | |
| NATEGLINIDE×2 | RISING | ANDA 205544 | AB | Jun 18, 2018 | |
| NATEGLINIDE×2 | ZYDUS PHARMS | ANDA 205248 | AB | Jul 06, 2016 | |
| NATEGLINIDE×2 | ALVOGEN | ANDA 205055 | — | Dec 11, 2015 | |
| NATEGLINIDE×2 | WATSON LABS | ANDA 077462 | AB | Mar 30, 2011 | |
| NATEGLINIDE×2 | DR REDDYS LABS LTD | ANDA 077461 | AB | Sep 09, 2009 | |
| NATEGLINIDE×2 | STRIDES PHARMA INTL | ANDA 077463 | AB | Sep 09, 2009 | |
| NATEGLINIDE×2 | TEVA PHARMS | ANDA 077467 | — | Sep 09, 2009 |
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.
Nateglinide — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
