FDA Orange Book · active-ingredient family
Atorvastatin calcium
Atorvastatin calcium is approved as 2 brand and 33 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:ATORVALIQ · NDA 213260
2
Brand (NDA)
33
Generics (ANDA)
6
Listed patents
0
Exclusivity periods
Brand (NDA) products · suspension, tablet
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| ATORVALIQRLD | CMP DEV LLC | NDA 213260 | — | Feb 01, 2023 | |
| LIPITORRLD×4 | UPJOHN | NDA 020702 | AB | Dec 17, 1996 |
Generic (ANDA) products (33)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| ATORVASTATIN CALCIUM×4 | TEVA PHARMS INC | ANDA 220276 | AB | Nov 13, 2025 | |
| ATORVASTATIN CALCIUM×4 | MACLEODS PHARMS LTD | ANDA 208480 | AB | Jun 03, 2024 | |
| ATORVASTATIN CALCIUM×4 | AUROBINDO PHARMA LTD | ANDA 217118 | AB | Feb 13, 2024 | |
| ATORVASTATIN CALCIUM×4 | SHANDONG XINHUA | ANDA 211886 | AB | Jan 25, 2024 | |
| ATORVASTATIN CALCIUM×4 | LAURUS | ANDA 214513 | AB | Jan 22, 2024 | |
| ATORVASTATIN CALCIUM×4 | MANKIND PHARMA | ANDA 217081 | AB | Jan 05, 2024 | |
| ATORVASTATIN CALCIUM×4 | STRIDES PHARMA | ANDA 217634 | — | Dec 21, 2023 | |
| ATORVASTATIN CALCIUM×4 | CADILA PHARMS LTD | ANDA 212103 | — | Oct 16, 2023 | |
| ATORVASTATIN CALCIUM×4 | HETERO LABS LTD V | ANDA 214344 | AB | Sep 12, 2023 | |
| ATORVASTATIN CALCIUM×4 | BIOCON PHARMA | ANDA 216436 | AB | Nov 23, 2022 | |
| ATORVASTATIN CALCIUM×4 | LEPU PHARM | ANDA 216848 | — | Nov 03, 2022 | |
| ATORVASTATIN CALCIUM×4 | APOTEX | ANDA 214969 | AB | Sep 02, 2021 | |
| ATORVASTATIN CALCIUM×4 | DR REDDYS | ANDA 214659 | AB | Jul 14, 2021 | |
| ATORVASTATIN CALCIUM×4 | UMEDICA | ANDA 213853 | BX | Aug 19, 2020 | |
| ATORVASTATIN CALCIUM×2 | PERRIGO R AND D | ANDA 208478 | — | Jun 23, 2020 | |
| ATORVASTATIN CALCIUM×4 | MICRO LABS LTD INDIA | ANDA 205945 | AB | Nov 07, 2019 | |
| ATORVASTATIN CALCIUM×4 | LUPIN | ANDA 204991 | — | Mar 06, 2019 | |
| ATORVASTATIN CALCIUM×4 | MSN | ANDA 211933 | AB | Feb 08, 2019 | |
| ATORVASTATIN CALCIUM×4 | ALKEM LABS LTD | ANDA 209288 | AB | Dec 21, 2018 | |
| ATORVASTATIN CALCIUM×4 | ZYDUS PHARMS | ANDA 206536 | AB | Nov 20, 2018 | |
| ATORVASTATIN CALCIUM×4 | GRAVITI PHARMS | ANDA 209912 | AB | Jun 18, 2018 | |
| ATORVASTATIN CALCIUM×4 | ACCORD HLTHCARE | ANDA 207687 | AB | Mar 30, 2018 | |
| ATORVASTATIN CALCIUM×4 | TEVA PHARMS USA | ANDA 205300 | AB | Mar 27, 2017 | |
| ATORVASTATIN CALCIUM×4 | INVAGEN PHARMS | ANDA 204846 | — | Jan 09, 2017 | |
| ATORVASTATIN CALCIUM×4 | SCIEGEN PHARMS | ANDA 205519 | AB | May 19, 2016 | |
| ATORVASTATIN CALCIUM×4 | LANNETT CO INC | ANDA 091624 | AB | Apr 05, 2013 | |
| ATORVASTATIN CALCIUM×3 | DR REDDYS LABS LTD | ANDA 091650 | AB | Jul 17, 2012 | |
| ATORVASTATIN CALCIUM | DR REDDYS LABS LTD | ANDA 202357 | AB | Jul 17, 2012 | |
| ATORVASTATIN CALCIUM×4 | APOTEX INC | ANDA 090548 | AB | May 29, 2012 | |
| ATORVASTATIN CALCIUM×4 | CHARTWELL RX | ANDA 077575 | AB | May 29, 2012 | |
| ATORVASTATIN CALCIUM×4 | MYLAN PHARMS INC | ANDA 091226 | AB | May 29, 2012 | |
| ATORVASTATIN CALCIUM×4 | TEVA PHARMS | ANDA 078773 | — | May 29, 2012 | |
| ATORVASTATIN CALCIUM×4 | SUN PHARM INDS LTD | ANDA 076477 | — | Nov 30, 2011 |
Listed patents (6)
| Patent | Expires | In | Type |
|---|---|---|---|
| 11654106 | Jun 07, 2037 | in 11 yr 2 mo | ProductU-3612 |
| 11925704 | Jun 07, 2037 | in 11 yr 2 mo | ProductU-3853 |
| 12370136 | Jun 07, 2037 | in 11 yr 2 mo | Product |
| 12599553 | Jun 07, 2037 | in 11 yr 2 mo | Product |
| 12168069 | Jun 07, 2037 | in 11 yr 2 mo | Product |
| 11369567 | Jun 07, 2037 | in 11 yr 2 mo | Product |
Atorvastatin calcium — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
