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Generic Livalo Availability

Last updated on Sep 8, 2022.

Livalo is a brand name of pitavastatin, approved by the FDA in the following formulation(s):

LIVALO (pitavastatin calcium - tablet;oral)

  • Manufacturer: KOWA CO
    Approval date: August 3, 2009
    Strength(s): EQ 1MG BASE [RLD] [AB], EQ 2MG BASE [RLD] [AB], EQ 4MG BASE [RLD] [AB]

Has a generic version of Livalo been approved?

A generic version of Livalo has been approved by the FDA. However, this does not mean that the product will necessarily be commercially available - possibly because of drug patents and/or drug exclusivity. The following products are equivalent to Livalo and have been approved by the FDA:

pitavastatin calcium tablet;oral

  • Manufacturer: AUROBINDO PHARMA LTD
    Approval date: December 20, 2016
    Strength(s): EQ 1MG BASE [AB], EQ 2MG BASE [AB], EQ 4MG BASE [AB]
  • Manufacturer: ORIENT PHARMA CO LTD
    Approval date: February 3, 2017
    Strength(s): EQ 1MG BASE [AB], EQ 2MG BASE [AB], EQ 4MG BASE [AB]
  • Manufacturer: SAWAI USA
    Approval date: February 3, 2017
    Strength(s): EQ 1MG BASE [AB], EQ 2MG BASE [AB], EQ 4MG BASE [AB]

Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Livalo. These medications may be counterfeit and potentially unsafe. If you purchase medications online, be sure you are buying from a reputable and valid online pharmacy. Ask your health care provider for advice if you are unsure about the online purchase of any medication.

See also: Generic Drug FAQ.

Related patents

Patents are granted by the U.S. Patent and Trademark Office at any time during a drug's development and may include a wide range of claims.

  • Hyperlipemia therapeutic agent
    Patent 7,022,713
    Issued: April 4, 2006
    Inventor(s): Aoki; Taro & Yamaguchi; Junji & Sasaki; Yusuke
    Assignee(s): KOWA Co., Ltd. Nissan Chemical Industries, Ltd.

    The present invention relates to a hyperlipemia therapeutic agent comprising pitavastatins and eicosapentaenoic acid or an ester derivative thereof as effective ingredients. According to the present invention, a type IIb and type IV hyperlipemia therapeutic agent having an excellent effect of lowering the cholesterol and triglyceride in blood is provided.

    Patent expiration dates:

    • February 19, 2024
    • August 19, 2024
      Pediatric exclusivity
  • Crystalline forms of pitavastatin calcium
    Patent 8,557,993
    Issued: October 15, 2013
    Assignee(s): Nissan Chemical Industries Ltd.

    The present invention is directed to new crystalline forms of Pitavastatin hemicalcium salt, referred to hereinafter as polymorphic Forms A, B, C, D, E and F, as well as the amorphous form. Furthermore, the present invention is directed to processes for the preparation of these crystalline forms and the amorphous form and pharmaceutical compositions comprising these crystalline forms or the amorphous forms.

    Patent expiration dates:

    • February 2, 2024
      Drug product
    • August 2, 2024
      Pediatric exclusivity

Related exclusivities

Exclusivity is exclusive marketing rights granted by the FDA upon approval of a drug and can run concurrently with a patent or not. Exclusivity is a statutory provision and is granted to an NDA applicant if statutory requirements are met.

  • Exclusivity expiration dates:

    • May 16, 2022 - NEW PATIENT POPULATION
    • November 16, 2022 - PEDIATRIC EXCLUSIVITY


Term Definition
Drug Patent A drug patent is assigned by the U.S. Patent and Trademark Office and assigns exclusive legal right to the patent holder to protect the proprietary chemical formulation. The patent assigns exclusive legal right to the inventor or patent holder, and may include entities such as the drug brand name, trademark, product dosage form, ingredient formulation, or manufacturing process A patent usually expires 20 years from the date of filing, but can be variable based on many factors, including development of new formulations of the original chemical, and patent infringement litigation.
Drug Exclusivity Exclusivity is the sole marketing rights granted by the FDA to a manufacturer upon the approval of a drug and may run simultaneously with a patent. Exclusivity periods can run from 180 days to seven years depending upon the circumstance of the exclusivity grant.
RLD A Reference Listed Drug (RLD) is an approved drug product to which new generic versions are compared to show that they are bioequivalent. A drug company seeking approval to market a generic equivalent must refer to the Reference Listed Drug in its Abbreviated New Drug Application (ANDA). By designating a single reference listed drug as the standard to which all generic versions must be shown to be bioequivalent, FDA hopes to avoid possible significant variations among generic drugs and their brand name counterpart.
AB Products meeting necessary bioequivalence requirements. Multisource drug products listed under the same heading (e.g. identical active ingredients, dosage form, and routes of administration) and having the same strength (see Therapeutic Equivalence-Related Terms, Pharmaceutical Equivalents) generally will be coded AB if a study is submitted demonstrating bioequivalence. In certain instances, a number is added to the end of the AB code to make a three character code (e.g. AB1, AB2, AB7). Three-character codes are assigned only in situations when more than one reference listed drug of the same strength has been designated under the same heading. Two or more reference listed drugs are generally selected only when there are at least two potential reference drug products which are not bioequivalent to each other. If a study is submitted that demonstrates bioequivalence to a specific listed drug product, the generic product will be given the same three-character code as the reference listed drug it was compared against.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.