Generic Lexapro Availability

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

LEXAPRO (escitalopram oxalate - solution;oral)

  • Manufacturer: FOREST LABS
    Approval date: November 27, 2002
    Strength(s): EQ 5MG BASE/5ML [RLD] [AA]

LEXAPRO (escitalopram oxalate - tablet;oral)

  • Manufacturer: FOREST LABS
    Approval date: August 14, 2002
    Strength(s): EQ 5MG BASE [AB], EQ 10MG BASE [AB], EQ 20MG BASE [RLD] [AB]

Has a generic version of Lexapro been approved?

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

escitalopram oxalate solution;oral

  • Manufacturer: AMNEAL PHARMS
    Approval date: March 14, 2012
    Strength(s): EQ 5MG BASE/5ML [AA]
  • Manufacturer: AUROBINDO PHARMA LTD
    Approval date: April 2, 2012
    Strength(s): EQ 5MG BASE/5ML [AA]
  • Manufacturer: HETERO LABS LTD III
    Approval date: June 12, 2012
    Strength(s): EQ 5MG BASE/5ML [AA]
  • Manufacturer: SILARX PHARMS INC
    Approval date: June 12, 2013
    Strength(s): EQ 5MG BASE/5ML [AA]
  • Manufacturer: TARO
    Approval date: May 3, 2012
    Strength(s): EQ 5MG BASE/5ML [AA]

escitalopram oxalate tablet;oral

  • Manufacturer: ACCORD HLTHCARE
    Approval date: September 11, 2012
    Strength(s): EQ 5MG BASE [AB], EQ 10MG BASE [AB], EQ 20MG BASE [AB]
  • Manufacturer: APOTEX INC
    Approval date: September 11, 2012
    Strength(s): EQ 5MG BASE [AB], EQ 10MG BASE [AB], EQ 20MG BASE [AB]
  • Manufacturer: AUROBINDO PHARMA LTD
    Approval date: September 11, 2012
    Strength(s): EQ 5MG BASE [AB], EQ 10MG BASE [AB], EQ 20MG BASE [AB]
  • Manufacturer: HIKMA PHARMS
    Approval date: September 11, 2012
    Strength(s): EQ 5MG BASE [AB], EQ 10MG BASE [AB], EQ 20MG BASE [AB]
  • Manufacturer: INVAGEN PHARMS
    Approval date: September 11, 2012
    Strength(s): EQ 5MG BASE [AB], EQ 10MG BASE [AB], EQ 20MG BASE [AB]
  • Manufacturer: JUBILANT ORGANOSYS
    Approval date: September 12, 2012
    Strength(s): EQ 5MG BASE [AB], EQ 10MG BASE [AB], EQ 20MG BASE [AB]
  • Manufacturer: LUPIN LTD
    Approval date: September 11, 2012
    Strength(s): EQ 5MG BASE [AB], EQ 10MG BASE [AB], EQ 20MG BASE [AB]
  • Manufacturer: MACLEODS PHARMS LTD
    Approval date: September 11, 2012
    Strength(s): EQ 5MG BASE [AB], EQ 10MG BASE [AB], EQ 20MG BASE [AB]
  • Manufacturer: STI PHARMA LLC
    Approval date: September 12, 2012
    Strength(s): EQ 5MG BASE [AB], EQ 10MG BASE [AB], EQ 20MG BASE [AB]
  • Manufacturer: TEVA PHARMS USA
    Approval date: March 14, 2012
    Strength(s): EQ 5MG BASE [AB], EQ 10MG BASE [AB], EQ 20MG BASE [AB]
  • Manufacturer: TORRENT PHARMS LTD
    Approval date: September 11, 2012
    Strength(s): EQ 5MG BASE [AB], EQ 10MG BASE [AB], EQ 20MG BASE [AB]
  • Manufacturer: ZYDUS PHARMS USA INC
    Approval date: September 11, 2012
    Strength(s): EQ 5MG BASE [AB], EQ 10MG BASE [AB], EQ 20MG BASE [AB]

Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Lexapro. 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.

  • Crystalline composition containing escitalopram
    Patent 6,916,941
    Issued: July 12, 2005
    Inventor(s): Christensen; Troels Volsgaard & Liljegren; Ken & Elema; Michiel Onne & Andresen; Lene & Mahashabde; Shashank & Assenza; Sebastian P.
    Assignee(s): H. Lundbeck A/S
    Crystalline particles of escitalopram oxalate with a particle size of at least 40 μm is disclosed. Method for the manufacture of said crystalline particles and pharmaceutical compositions comprising said crystalline particles are also disclosed.
    Patent expiration dates:
    • August 12, 2022
      ✓ 
      Drug substance
      ✓ 
      Drug product
    • February 12, 2023
      ✓ 
      Pediatric exclusivity
  • Crystalline composition containing escitalopram
    Patent 7,420,069
    Issued: September 2, 2008
    Inventor(s): Christensen; Troels Volsgaard & Liljegren; Ken & Elema; Michiel Onne & Andresen; Lene & Mahashabde; Shashank & Assenza; Sebastian P.
    Assignee(s): H. Lundbeck A/S
    Crystalline particles of escitalopram oxalate with a particle size of at least 40 μm is disclosed. Method for the manufacture of said crystalline particles and pharmaceutical compositions comprising said crystalline particles are also disclosed.
    Patent expiration dates:
    • August 12, 2022
      ✓ 
      Drug product
    • February 12, 2023
      ✓ 
      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.
AAProducts in conventional dosage forms not presenting bioequivalence problems. Products coded as AA contain active ingredients and dosage forms that are not regarded as presenting either actual or potential bioequivalence problems or drug quality or standards issues. However, all oral dosage forms must, nonetheless, meet an appropriate in vitro bioequivalence standard that is acceptable to the Agency in order to be approved.
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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