FDA Orange Book · active-ingredient family
Atorvastatin calcium
Atorvastatin calcium: 2 brands, 33 generics; first approved Dec 17, 1996; generic available.
Generic availableHas discontinued products
Generic status & protection
Generic available: 33 ANDA applications approved.
Earliest patent expiry
Brands (NDA)
2
Generics (ANDA)
33
Listed patents
6
Next patent expiry
Jun 07, 2037
in 10 yr 9 mo
Brand (NDA) products
Originator applications
- CMP DEV LLCNDA 2132602023
Approved strengths under this FDA application. Strength Dosage form Route Status TE 20MG/5ML SUSPENSION ORAL Rx - - LIPITORRLDUPJOHNNDA 02070219964 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 10MG BASE TABLET ORAL Rx AB EQ 20MG BASE TABLET ORAL Rx AB EQ 40MG BASE TABLET ORAL Rx AB EQ 80MG BASE TABLET ORAL Rx AB
Generic (ANDA) products (33)
Abbreviated applications
- ATORVASTATIN CALCIUMTEVA PHARMS INCANDA 22027620254 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 10MG BASE TABLET ORAL Rx AB EQ 20MG BASE TABLET ORAL Rx AB EQ 40MG BASE TABLET ORAL Rx AB EQ 80MG BASE TABLET ORAL Rx AB - ATORVASTATIN CALCIUMMACLEODS PHARMSANDA 20848020244 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 10MG BASE TABLET ORAL Rx AB EQ 20MG BASE TABLET ORAL Rx AB EQ 40MG BASE TABLET ORAL Rx AB EQ 80MG BASE TABLET ORAL Rx AB - ATORVASTATIN CALCIUMAUROBINDO PHARMA LTDANDA 21711820244 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 10MG BASE TABLET ORAL Rx AB EQ 20MG BASE TABLET ORAL Rx AB EQ 40MG BASE TABLET ORAL Rx AB EQ 80MG BASE TABLET ORAL Rx AB - ATORVASTATIN CALCIUMSHANDONG XINHUAANDA 21188620244 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 10MG BASE TABLET ORAL Rx AB EQ 20MG BASE TABLET ORAL Rx AB EQ 40MG BASE TABLET ORAL Rx AB EQ 80MG BASE TABLET ORAL Rx AB - ATORVASTATIN CALCIUMLAURUSANDA 21451320244 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 10MG BASE TABLET ORAL Rx AB EQ 20MG BASE TABLET ORAL Rx AB EQ 40MG BASE TABLET ORAL Rx AB EQ 80MG BASE TABLET ORAL Rx AB - ATORVASTATIN CALCIUMMANKIND PHARMAANDA 21708120244 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 10MG BASE TABLET ORAL Rx AB EQ 20MG BASE TABLET ORAL Rx AB EQ 40MG BASE TABLET ORAL Rx AB EQ 80MG BASE TABLET ORAL Rx AB - ATORVASTATIN CALCIUMSTRIDES PHARMAANDA 21763420234 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 10MG BASE TABLET ORAL Discontinued - EQ 20MG BASE TABLET ORAL Discontinued - EQ 40MG BASE TABLET ORAL Discontinued - EQ 80MG BASE TABLET ORAL Discontinued - - ATORVASTATIN CALCIUMCADILA PHARMS LTDANDA 21210320234 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 10MG BASE TABLET ORAL Discontinued - EQ 20MG BASE TABLET ORAL Discontinued - EQ 40MG BASE TABLET ORAL Discontinued - EQ 80MG BASE TABLET ORAL Discontinued - - ATORVASTATIN CALCIUMHETERO LABS LTD VANDA 21434420234 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 10MG BASE TABLET ORAL Rx AB EQ 20MG BASE TABLET ORAL Rx AB EQ 40MG BASE TABLET ORAL Rx AB EQ 80MG BASE TABLET ORAL Rx AB - ATORVASTATIN CALCIUMBIOCON PHARMAANDA 21643620224 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 10MG BASE TABLET ORAL Rx AB EQ 20MG BASE TABLET ORAL Rx AB EQ 40MG BASE TABLET ORAL Rx AB EQ 80MG BASE TABLET ORAL Rx AB - ATORVASTATIN CALCIUMLEPU PHARMANDA 21684820224 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 10MG BASE TABLET ORAL Discontinued - EQ 20MG BASE TABLET ORAL Discontinued - EQ 40MG BASE TABLET ORAL Discontinued - EQ 80MG BASE TABLET ORAL Discontinued - - ATORVASTATIN CALCIUMAPOTEXANDA 21496920214 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 10MG BASE TABLET ORAL Rx AB EQ 20MG BASE TABLET ORAL Rx AB EQ 40MG BASE TABLET ORAL Rx AB EQ 80MG BASE TABLET ORAL Rx AB - ATORVASTATIN CALCIUMDR REDDYSANDA 21465920214 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 10MG BASE TABLET ORAL Rx AB EQ 20MG BASE TABLET ORAL Rx AB EQ 40MG BASE TABLET ORAL Rx AB EQ 80MG BASE TABLET ORAL Rx AB - ATORVASTATIN CALCIUMUMEDICAANDA 21385320204 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 10MG BASE TABLET ORAL Rx AB EQ 20MG BASE TABLET ORAL Rx AB EQ 40MG BASE TABLET ORAL Rx AB EQ 80MG BASE TABLET ORAL Rx AB - ATORVASTATIN CALCIUMPERRIGO R AND DANDA 20847820202 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 10MG BASE TABLET ORAL Discontinued - EQ 20MG BASE TABLET ORAL Discontinued - - ATORVASTATIN CALCIUMMICRO LABS LTD INDIAANDA 20594520194 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 10MG BASE TABLET ORAL Discontinued - EQ 20MG BASE TABLET ORAL Discontinued - EQ 40MG BASE TABLET ORAL Discontinued - EQ 80MG BASE TABLET ORAL Discontinued - - ATORVASTATIN CALCIUMLUPINANDA 20499120194 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 10MG BASE TABLET ORAL Discontinued - EQ 20MG BASE TABLET ORAL Discontinued - EQ 40MG BASE TABLET ORAL Discontinued - EQ 80MG BASE TABLET ORAL Discontinued - - ATORVASTATIN CALCIUMMSNANDA 21193320194 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 10MG BASE TABLET ORAL Rx AB EQ 20MG BASE TABLET ORAL Rx AB EQ 40MG BASE TABLET ORAL Rx AB EQ 80MG BASE TABLET ORAL Rx AB - ATORVASTATIN CALCIUMALKEM LABS LTDANDA 20928820184 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 10MG BASE TABLET ORAL Rx AB EQ 20MG BASE TABLET ORAL Rx AB EQ 40MG BASE TABLET ORAL Rx AB EQ 80MG BASE TABLET ORAL Rx AB - ATORVASTATIN CALCIUMZYDUS PHARMSANDA 20653620184 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 10MG BASE TABLET ORAL Rx AB EQ 20MG BASE TABLET ORAL Rx AB EQ 40MG BASE TABLET ORAL Rx AB EQ 80MG BASE TABLET ORAL Rx AB - ATORVASTATIN CALCIUMGRAVITI PHARMSANDA 20991220184 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 10MG BASE TABLET ORAL Rx AB EQ 20MG BASE TABLET ORAL Rx AB EQ 40MG BASE TABLET ORAL Rx AB EQ 80MG BASE TABLET ORAL Rx AB - ATORVASTATIN CALCIUMACCORD HLTHCAREANDA 20768720184 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 10MG BASE TABLET ORAL Rx AB EQ 20MG BASE TABLET ORAL Rx AB EQ 40MG BASE TABLET ORAL Rx AB EQ 80MG BASE TABLET ORAL Rx AB - ATORVASTATIN CALCIUMTEVA PHARMS USAANDA 20530020174 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 10MG BASE TABLET ORAL Rx AB EQ 20MG BASE TABLET ORAL Rx AB EQ 40MG BASE TABLET ORAL Rx AB EQ 80MG BASE TABLET ORAL Rx AB - ATORVASTATIN CALCIUMINVAGEN PHARMSANDA 20484620174 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 10MG BASE TABLET ORAL Discontinued - EQ 20MG BASE TABLET ORAL Discontinued - EQ 40MG BASE TABLET ORAL Discontinued - EQ 80MG BASE TABLET ORAL Discontinued - - ATORVASTATIN CALCIUMSCIEGEN PHARMSANDA 20551920164 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 10MG BASE TABLET ORAL Rx AB EQ 20MG BASE TABLET ORAL Rx AB EQ 40MG BASE TABLET ORAL Rx AB EQ 80MG BASE TABLET ORAL Rx AB - ATORVASTATIN CALCIUMLANNETT CO INCANDA 09162420134 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 10MG BASE TABLET ORAL Rx AB EQ 20MG BASE TABLET ORAL Rx AB EQ 40MG BASE TABLET ORAL Rx AB EQ 80MG BASE TABLET ORAL Rx AB - ATORVASTATIN CALCIUMDR REDDYS LABS LTDANDA 09165020123 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 10MG BASE TABLET ORAL Rx AB EQ 20MG BASE TABLET ORAL Rx AB EQ 40MG BASE TABLET ORAL Rx AB - ATORVASTATIN CALCIUMDR REDDYS LABS LTDANDA 2023572012
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 80MG BASE TABLET ORAL Rx AB - ATORVASTATIN CALCIUMAPOTEX INCANDA 09054820124 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 10MG BASE TABLET ORAL Rx AB EQ 20MG BASE TABLET ORAL Rx AB EQ 40MG BASE TABLET ORAL Rx AB EQ 80MG BASE TABLET ORAL Rx AB - ATORVASTATIN CALCIUMCHARTWELL RXANDA 07757520124 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 10MG BASE TABLET ORAL Rx AB EQ 20MG BASE TABLET ORAL Rx AB EQ 40MG BASE TABLET ORAL Rx AB EQ 80MG BASE TABLET ORAL Rx AB - ATORVASTATIN CALCIUMMYLAN PHARMS INCANDA 09122620124 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 10MG BASE TABLET ORAL Rx AB EQ 20MG BASE TABLET ORAL Rx AB EQ 40MG BASE TABLET ORAL Rx AB EQ 80MG BASE TABLET ORAL Rx AB - ATORVASTATIN CALCIUMTEVA PHARMSANDA 07877320124 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 10MG BASE TABLET ORAL Discontinued - EQ 20MG BASE TABLET ORAL Discontinued - EQ 40MG BASE TABLET ORAL Discontinued - EQ 80MG BASE TABLET ORAL Discontinued - - ATORVASTATIN CALCIUMSUN PHARM INDS LTDANDA 07647720114 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 10MG BASE TABLET ORAL Discontinued - EQ 20MG BASE TABLET ORAL Discontinued - EQ 40MG BASE TABLET ORAL Discontinued - EQ 80MG BASE TABLET ORAL Discontinued -
Patent & exclusivity timeline
Protection horizon
Patent expiryExclusivity endToday
Listed patents
Orange Book patent file
| Patent | Expires | In | Type |
|---|---|---|---|
| 11654106 | in 10 yr 9 mo | ProductU-3612 | |
| 11925704 | in 10 yr 9 mo | ProductU-3853 | |
| 12370136 | in 10 yr 9 mo | Product | |
| 12599553 | in 10 yr 9 mo | Product | |
| 12168069 | in 10 yr 9 mo | Product | |
| 11369567 | in 10 yr 9 mo | Product |
Approval history
FDA approval span
First approval
30 yr 3 mo ago
Most recent approval
11 mo ago
Approvals span 1996–2025 across 35 FDA applications.
Brand (NDA) 26%
Generic (ANDA) 3394%
Atorvastatin calcium: frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
Built directly from the FDA Orange Book data file (products, patents, and exclusivity). TE codes, RLD/RS flags, patent expirations, and exclusivity dates match the official FDA record. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Related FDA reference tools
- FDA Purple BookLicensed biologics, biosimilars, interchangeables, BLA records, and exclusivity dates.
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- 510(k) Predicate DatabaseSearch FDA 510(k) clearances and map predicate-device lineage.
- FDA 483 DatabaseFDA Form 483 observations and inspection records by firm, date, and citation.
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