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 Jun 07, 2037

Brands (NDA)

2

Generics (ANDA)

33

Listed patents

6

Next patent expiry

Jun 07, 2037

in 11 yr 1 mo

Originator applications

Brand (NDA) products

CMP DEV LLCNDA 2132602023

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
20MG/5ML	SUSPENSION	ORAL	Rx	—

UPJOHNNDA 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

Abbreviated applications

Generic (ANDA) products (33)

ATORVASTATIN CALCIUM

TEVA 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 CALCIUM

MACLEODS PHARMS LTDANDA 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 CALCIUM

AUROBINDO 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 CALCIUM

SHANDONG 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 CALCIUM

LAURUSANDA 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 CALCIUM

MANKIND 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 CALCIUM

STRIDES 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 CALCIUM

CADILA 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 CALCIUM

HETERO 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 CALCIUM

BIOCON 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 CALCIUM

LEPU 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 CALCIUM

APOTEXANDA 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 CALCIUM

DR 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 CALCIUM

UMEDICAANDA 21385320204 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 10MG BASE	TABLET	ORAL	Rx	BX
EQ 20MG BASE	TABLET	ORAL	Rx	BX
EQ 40MG BASE	TABLET	ORAL	Rx	BX
EQ 80MG BASE	TABLET	ORAL	Rx	BX

ATORVASTATIN CALCIUM

PERRIGO 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 CALCIUM

MICRO LABS LTD INDIAANDA 20594520194 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 CALCIUM

LUPINANDA 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 CALCIUM

MSNANDA 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 CALCIUM

ALKEM 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 CALCIUM

ZYDUS 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 CALCIUM

GRAVITI 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 CALCIUM

ACCORD 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 CALCIUM

TEVA 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 CALCIUM

INVAGEN 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 CALCIUM

SCIEGEN 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 CALCIUM

LANNETT 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 CALCIUM

DR 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 CALCIUM

DR REDDYS LABS LTDANDA 2023572012

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 80MG BASE	TABLET	ORAL	Rx	AB

ATORVASTATIN CALCIUM

APOTEX 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 CALCIUM

CHARTWELL 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 CALCIUM

MYLAN 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 CALCIUM

TEVA 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 CALCIUM

SUN 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	—

Protection horizon

Patent & exclusivity timeline

Patent expiryExclusivity endToday

Orange Book patent file

Listed patents

Listed patents (6)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
Patent	Expires	In	Type
11654106	Jun 07, 2037	in 11 yr 1 mo	ProductU-3612
11925704	Jun 07, 2037	in 11 yr 1 mo	ProductU-3853
12370136	Jun 07, 2037	in 11 yr 1 mo	Product
12599553	Jun 07, 2037	in 11 yr 1 mo	Product
12168069	Jun 07, 2037	in 11 yr 1 mo	Product
11369567	Jun 07, 2037	in 11 yr 1 mo	Product

FDA approval span

Approval history

First approval

Dec 17, 1996

30 yr ago

Most recent approval

Nov 13, 2025

8 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.

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