FDA Orange Book · active-ingredient family
Ezetimibe; simvastatin
Ezetimibe; simvastatin is approved as 1 brand and 9 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:VYTORIN · NDA 021687
1
Brand (NDA)
9
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · tablet
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| VYTORINRLD×4 | ORGANON | NDA 021687 | AB | Jul 23, 2004 |
Generic (ANDA) products (9)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| EZETIMIBE AND SIMVASTATIN×4 | TORRENT | ANDA 209461 | — | Jan 27, 2025 | |
| EZETIMIBE AND SIMVASTATIN×4 | SCIEGEN PHARMS | ANDA 211663 | — | Dec 10, 2024 | |
| EZETIMIBE AND SIMVASTATIN×4 | AUROBINDO PHARMA USA | ANDA 200082 | AB | Dec 17, 2020 | |
| EZETIMIBE AND SIMVASTATIN×4 | GLENMARK PHARMS LTD | ANDA 208699 | AB | Jun 27, 2019 | |
| EZETIMIBE AND SIMVASTATIN×4 | ALKEM LABS LTD | ANDA 209222 | AB | Dec 22, 2017 | |
| EZETIMIBE AND SIMVASTATIN×4 | AMNEAL PHARMS CO | ANDA 208831 | — | Nov 21, 2017 | |
| EZETIMIBE AND SIMVASTATIN×4 | ANI PHARMS | ANDA 201890 | — | Apr 26, 2017 | |
| EZETIMIBE AND SIMVASTATIN×4 | DR REDDYS LABS SA | ANDA 200909 | AB | Apr 26, 2017 | |
| EZETIMIBE AND SIMVASTATIN×4 | WATSON LABS INC | ANDA 202968 | — | Apr 26, 2017 |
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.
Ezetimibe; simvastatin — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
