FDA Orange Book · active-ingredient family
Pitavastatin calcium
Pitavastatin calcium 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:LIVALO · NDA 022363
1
Brand (NDA)
8
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · tablet
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| LIVALORLD×3 | KOWA CO | NDA 022363 | AB | Aug 03, 2009 |
Generic (ANDA) products (8)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| PITAVASTATIN CALCIUM×3 | AMNEAL PHARMS NY | ANDA 205961 | AB | Aug 20, 2024 | |
| PITAVASTATIN CALCIUM×3 | HETERO LABS LTD V | ANDA 205977 | AB | Apr 30, 2024 | |
| PITAVASTATIN CALCIUM×3 | LUPIN | ANDA 206029 | AB | Nov 20, 2023 | |
| PITAVASTATIN CALCIUM×3 | ZYDUS PHARMS | ANDA 206047 | AB | Feb 22, 2023 | |
| PITAVASTATIN CALCIUM×3 | MYLAN | ANDA 206070 | AB | Apr 04, 2019 | |
| PITAVASTATIN CALCIUM×3 | ORIENT PHARMA CO LTD | ANDA 205932 | AB | Feb 03, 2017 | |
| PITAVASTATIN CALCIUM×3 | SAWAI USA | ANDA 205955 | AB | Feb 03, 2017 | |
| PITAVASTATIN CALCIUM×3 | AUROBINDO PHARMA | ANDA 206015 | AB | Dec 20, 2016 |
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.
Pitavastatin calcium — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
