Generic Lipitor Availability

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

LIPITOR (atorvastatin calcium - tablet;oral)

  • Manufacturer: PFIZER
    Approval date: December 17, 1996
    Strength(s): EQ 10MG BASE [AB], EQ 20MG BASE [AB], EQ 40MG BASE [AB]
  • Manufacturer: PFIZER
    Approval date: April 7, 2000
    Strength(s): EQ 80MG BASE [RLD] [AB]

Has a generic version of Lipitor been approved?

A generic version of Lipitor 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 Lipitor and have been approved by the FDA:

atorvastatin calcium tablet;oral

  • Manufacturer: APOTEX INC
    Approval date: May 29, 2012
    Strength(s): EQ 10MG BASE [AB], EQ 20MG BASE [AB], EQ 40MG BASE [AB], EQ 80MG BASE [AB]
  • Manufacturer: DR REDDYS LABS LTD
    Approval date: July 17, 2012
    Strength(s): EQ 10MG BASE [AB], EQ 20MG BASE [AB], EQ 40MG BASE [AB], EQ 80MG BASE [AB]
  • Manufacturer: KUDCO IRELAND
    Approval date: April 5, 2013
    Strength(s): EQ 10MG BASE [AB], EQ 20MG BASE [AB], EQ 40MG BASE [AB], EQ 80MG BASE [AB]
  • Manufacturer: MYLAN PHARMS INC
    Approval date: May 29, 2012
    Strength(s): EQ 10MG BASE [AB], EQ 20MG BASE [AB], EQ 40MG BASE [AB], EQ 80MG BASE [AB]
  • Manufacturer: RANBAXY LABS LTD
    Approval date: November 30, 2011
    Strength(s): EQ 10MG BASE [AB], EQ 20MG BASE [AB], EQ 40MG BASE [AB], EQ 80MG BASE [AB]
  • Manufacturer: SANDOZ INC
    Approval date: May 29, 2012
    Strength(s): EQ 10MG BASE [AB], EQ 20MG BASE [AB], EQ 40MG BASE [AB], EQ 80MG BASE [AB]

Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Lipitor. 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: About generic drugs.

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.

  • Stable oral CI-981 formulation and process of preparing same
    Patent 5,686,104
    Issued: November 11, 1997
    Inventor(s): Mills; Nancy & Muhammad; Nouman A. & Weiss; Jay & Nesbitt; Russell U.
    Assignee(s): Warner-Lambert Company
    An oral pharmaceutical composition is provided for treating hypercholestereolemia or hyperlipidemia containing an advantageous formulation for stabilizing the HMG-CoA coenzyme A inhibitor, CI-981 Hemi-Calcium, of formula (IA) ##STR1## with effective amounts of calcium carbonate. A method for preparing a CI-981 stabilizing composition is described.
    Patent expiration dates:
    • November 11, 2014
      ✓ 
      Patent use: METHOD OF INHIBITING CHOLESTEROL BIOSYNTHESIS AND TREATING HYPERCHOLESTEROLEMIA AND METHOD FOR TREATING HYPERLIPIDEMIA
      ✓ 
      Drug product
    • May 11, 2015
      ✓ 
      Pediatric exclusivity
  • Crystalline [R- (R*,R*)]-2-(4-Dfluorophenyl)-.beta.,.delta.-dihydroxy-5-(1-methylethyl)- 3-phenyl-4-[(phenylamino)carbonyl]-1H-pyrrole-1-heptanoic acid hemi calcium salt (atorvastatin)
    Patent 5,969,156
    Issued: October 19, 1999
    Inventor(s): Briggs; Christopher A. & Jennings; Rex A. & Wade; Robert & Harasawa; Kikuko & Ichikawa; Shigeru & Minohara; Kazuo & Nakagawa; Shinsuke
    Assignee(s): Warner-Lambert Company
    Crystalline forms of atorvastatin and hydrates thereof are useful hypolipidemic and hypocholesterolemic agents.
    Patent expiration dates:
    • July 8, 2016
      ✓ 
      Drug substance
    • January 8, 2017
      ✓ 
      Pediatric exclusivity
  • Stable oral CI-981 formulation and process for preparing same
    Patent 6,126,971
    Issued: October 3, 2000
    Inventor(s): Mills; Nancy & Muhammad; Nouman A. & Weiss; Jay & Nesbitt; Russell U.
    Assignee(s): Warner-Lambert Company
    An oral pharmaceutical composition is provided for treating hypercholestereolemia or hyperlipidemia containing an advantageous formulation for stabilizing the HMG-CoA coenzyme A inhibitor, CI-981 Hemi-Calcium, of formula (IA) ##STR1## with effective amounts of calcium carbonate. A method for preparing a CI-981 stabilizing composition is described.
    Patent expiration dates:
    • July 19, 2013
      ✓ 
      Pediatric exclusivity

Glossary

TermDefinition
Drug PatentA 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 ExclusivityExclusivity 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.
RLDA 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.
ABProducts meeting necessary bioequivalence requirements. Multisource drug products listed under the same heading (i.e., identical active ingredients(s), dosage form, and route(s) 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 (i.e., AB1, AB2, AB3, etc.). 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.
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