FDA Orange Book · active-ingredient family
Sunitinib malate
Sunitinib malate 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:SUTENT · NDA 021938
1
Brand (NDA)
8
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · capsule
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| SUTENTRLD×4 | CPPI CV | NDA 021938 | AB | Jan 26, 2006 |
Generic (ANDA) products (8)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| SUNITINIB MALATE×4 | MSN | ANDA 214824 | AB | Feb 14, 2025 | |
| SUNITINIB MALATE×4 | EUGIA PHARMA | ANDA 218615 | AB | Mar 14, 2024 | |
| SUNITINIB MALATE×4 | NATCO PHARMA | ANDA 218024 | AB | Oct 24, 2023 | |
| SUNITINIB MALATE×4 | FOSUN WANBANG | ANDA 218012 | AB | Aug 21, 2023 | |
| SUNITINIB MALATE×4 | DR REDDYS | ANDA 215843 | AB | Apr 11, 2022 | |
| SUNITINIB MALATE×4 | MYLAN | ANDA 201275 | AB | Dec 06, 2021 | |
| SUNITINIB MALATE×4 | TEVA PHARMS USA | ANDA 213803 | AB | Nov 30, 2021 | |
| SUNITINIB MALATE×4 | SUN PHARM | ANDA 213914 | AB | Aug 16, 2021 |
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.
Sunitinib malate — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
