Orange Book product · Brand (NDA)

ATORVALIQ

ATORVASTATIN CALCIUM

Brand (NDA)NDA 213260RX CMP DEV LLC

Feb 01, 2023

Approved

Brand (NDA)

Application

Not listed

TE code

Listed patents

Approval
FDA approval date of this drug product.
Feb 01, 2023
3 yr 5 mo ago
Today
Patent 11369567 expires
Listed drug product patent expiration.
Jun 07, 2037
in 11 yr 2 mo
Patent 11654106 expires
Listed drug product patent expiration.
Jun 07, 2037
in 11 yr 2 mo
Patent 11654106 expires
Listed drug product patent expiration.
Jun 07, 2037
in 11 yr 2 mo
Patent 11925704 expires
Listed drug product patent expiration.
Jun 07, 2037
in 11 yr 2 mo
Patent 12168069 expires
Listed drug product patent expiration.
Jun 07, 2037
in 11 yr 2 mo
Patent 12370136 expires
Listed drug product patent expiration.
Jun 07, 2037
in 11 yr 2 mo
Patent 12599553 expires
Listed drug product patent expiration.
Jun 07, 2037
in 11 yr 2 mo

Active ingredient

ATORVASTATIN CALCIUM

Strength

20MG/5ML

Dosage form

SUSPENSION

Route

ORAL

TE code

Not listed

Application

NDA 213260

Product number

001

Marketing status

Reference listed drug (RLD)

Yes

Reference standard (RS)

Yes

Active-ingredient family

This is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
Patent	Expires	In	Type
11369567	Jun 07, 2037	in 11 yr 2 mo	Product
11654106	Jun 07, 2037	in 11 yr 2 mo	ProductU-3612
11654106	Jun 07, 2037	in 11 yr 2 mo	ProductU-3613
11925704	Jun 07, 2037	in 11 yr 2 mo	ProductU-3853
12168069	Jun 07, 2037	in 11 yr 2 mo	Product
12370136	Jun 07, 2037	in 11 yr 2 mo	Product
12599553	Jun 07, 2037	in 11 yr 2 mo	Product