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Generic Latuda Availability

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

LATUDA (lurasidone hydrochloride - tablet;oral)

Has a generic version of Latuda been approved?

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

lurasidone hydrochloride tablet;oral

  • Manufacturer: ACCORD HLTHCARE
    Approval date: January 3, 2019
    Strength(s): 20MG [AB], 40MG [AB], 60MG [AB], 80MG [AB], 120MG [AB]
  • Manufacturer: SUN PHARM
    Approval date: January 4, 2019
    Strength(s): 20MG [AB], 40MG [AB], 60MG [AB], 80MG [AB], 120MG [AB]

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

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.

  • Pharmaceutical composition
    Patent 8,729,085
    Issued: May 20, 2014
    Assignee(s): Dainippon Sumitomo Pharma Co., Ltd.

    A preparation for oral administration comprising: a pregelatinized starch comprising N-[4-[4-(1,2-benzisothiazol-3-yl)-1-piperazinyl]-(2R,3R)-2,3-tetramethylene-butyl]-(1′R,2′S,3′R,4′S)-2,3-bicyclo[2,2,1]-heptanedicarboxyimide hydrochloride (lurasidone) represented by the formula (1) as an active ingredient; a water-soluble excipient; and a water-soluble polymeric binder, the preparation exhibiting an invariant level of elution behavior even when the content of its active ingredient is varied.

    Patent expiration dates:

    • May 26, 2026
      ✓ 
      Drug product
    • November 26, 2026
      ✓ 
      Pediatric exclusivity
  • Pharmaceutical composition
    Patent 8,883,794
    Issued: November 11, 2014
    Assignee(s): Sumitomo Dainippon Pharma Co., Ltd.

    A preparation for oral administration comprising: a pregelatinized starch comprising N-[4-[4-(1,2-benzisothiazol-3-yl)-1-piperazinyl]-(2R,3R)-2,3-tetramethylene-butyl]-(1′R,2′S,3′R,4′S)-2,3-bicyclo[2,2,1]-heptanedicarboxylmide hydrochloride (lurasidone) represented by the formula (1) as an active ingredient; a water-soluble excipient; and a water-soluble polymeric binder, the preparation exhibiting an invariant level of elution behavior even when the content of its active ingredient is varied.

    Patent expiration dates:

    • May 26, 2026
      ✓ 
      Drug product
    • November 26, 2026
      ✓ 
      Pediatric exclusivity
  • Remedy for integration dysfunction syndrome
    Patent 9,174,975
    Issued: November 3, 2015
    Assignee(s): SUMITOMO DAINIPPON PHARMA CO., LTD

    The present invention provides a novel method for treatment of schizophrenia which can improve wide-ranging symptoms of schizophrenia, especially positive symptoms and negative symptoms without being accompanied by extrapyramidal symptoms, which comprises orally administering as an active compound (1R,2S,3R,4S)—N-[(1R,2R)-2-[4-(1,2-benzoisothiazol-3-yl)-1-piperazinylmethyl]-1-cyclohexylmethyl]-2,3-bicyclo[2.2.1]heptanedicarboxyimide or a pharmaceutically acceptable salt thereof (e.g., hydrochloride) at a daily dose of 5 mg to 120 mg once a day to a patient with schizophrenia, and a therapeutic agent to be used in the method.

    Patent expiration dates:

    • February 20, 2024
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      Patent use: TREATMENT OF SCHIZOPHRENIA WITH IMPROVEMENT IN NEGATIVE SYMPTOMS AND/OR COGNITIVE DYSFUNCTION OF SCHIZOPHRENIA
    • August 20, 2024
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      Pediatric exclusivity
  • Method of treatment for mental disorders
    Patent 9,259,423
    Issued: February 16, 2016
    Assignee(s): Sumitomo Dainippon Pharma Co., Ltd.

    The invention relates to a medicament or a method for treating mental disorders, in detail, ADHD comprising lurasidone, or a combination of lurasidone and a D4 receptor agonist.

    Patent expiration dates:

    • May 23, 2031
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      Patent use: TREATMENT OF SCHIZOPHRENIA OR BIPOLAR DEPRESSION WITH IMPROVEMENT IN ATTENTION FUNCTION IN SCHIZOPHRENIA AND/OR BIPOLAR DISORDER
    • November 23, 2031
      ✓ 
      Pediatric exclusivity
  • Pharmaceutical composition
    Patent 9,555,027
    Issued: January 31, 2017
    Assignee(s): SUMITOMO DAINIPPON PHARMA CO., LTD.

    A preparation for oral administration comprising: a pregelatinized starch comprising N-[4-[4-(1,2-benzisothiazol-3-yl)-1-piperazinyl]-(2R,3R)-2,3-tetramethylene-butyl]-(1′R,2′S,3′R,4′S)-2,3-bicyclo[2,2,1]-heptanedicarboxyimide hydrochloride (lurasidone) represented by the formula (1) as an active ingredient; a water-soluble excipient; and a water-soluble polymeric binder, the preparation exhibiting an invariant level of elution behavior even when the content of its active ingredient is varied.

    Patent expiration dates:

    • May 26, 2026
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      Patent use: TREATMENT OF SCHIZOPHRENIA
      ✓ 
      Drug product
  • Patent 9,815,827

    Patent expiration dates:

    • February 20, 2024
      ✓ 
      Patent use: TREATMENT OF MAJOR DEPRESSIVE EPISODES ASSOCIATED WITH BIPOLAR I DISORDER
    • February 20, 2024
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      Patent use: TREATMENT OF SCHIZOPHRENIA
  • Method of treatment for mental disorders
    Patent 9,827,242
    Issued: November 28, 2017
    Assignee(s): SUMITOMO DAINIPPON PHARMA CO., LTD.

    The invention relates to a medicament or a method for treating mental disorders, in detail, ADHD comprising lurasidone, or a combination of lurasidone and a D4 receptor agonist.

    Patent expiration dates:

    • May 23, 2031
      ✓ 
      Patent use: TREATMENT OF SCHIZOPHRENIA WITH IMPROVEMENT IN ATTENTION FUNCTION IN SCHIZOPHRENIA
    • May 23, 2031
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      Patent use: TREATMENT OF BIPOLAR DEPRESSION WITH IMPROVEMENT IN ATTENTION FUNCTION IN BIPOLAR DISORDER
  • Pharmaceutical composition
    Patent 9,907,794
    Issued: March 6, 2018
    Assignee(s): SUMITOMO DAINIPPON PHARMA CO., LTD

    A preparation for oral administration comprising: a pregelatinized starch comprising N-[4-[4-(1,2-benzisothiazol-3-yl)-1-piperazinyl]-(2R,3R)-2,3-tetramethylene-butyl]-(1′R,2′S,3′R,4′S)-2,3-bicyclo[2,2,1]-heptanedicarboxyimide hydrochloride (lurasidone) represented by the formula (1) as an active ingredient; a water-soluble excipient; and a water-soluble polymeric binder, the preparation exhibiting an invariant level of elution behavior even when the content of its active ingredient is varied.

    Patent expiration dates:

    • May 26, 2026
      ✓ 
      Drug product
  • Process for producing imide compound
    Patent RE45573
    Issued: June 23, 2015
    Assignee(s): Sumitomo Dainippon Pharma Co., Ltd.

    The present invention provides an excellent industrial process for producing an imide compound hydrochloride. The process for producing an imide compound hydrochloride of the formula (2): or an enantiomer thereof, which comprises treating a compound of the formula (1): or an enantiomer thereof with an aqueous hydrochloric acid solution in a hydrophilic solvent, followed by crystallizing the resultant.

    Patent expiration dates:

    • June 23, 2025
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      Drug substance
    • December 23, 2025
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      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:

    • January 27, 2020 - NEW PATIENT POPULATION
    • January 27, 2020 - REVISIONS TO THE PEDIATRIC USE SECTION OF THE LABELING REFLECTING LACK OF EFFICACY FOR IRRITABILITY ASSOCIATED WITH AUTISTIC DISORDER IN PEDIATRIC PATIENTS AGES 6-17
    • July 27, 2020 - PEDIATRIC EXCLUSIVITY
    • March 5, 2021 - NEW PATIENT POPULATION

Further information

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

Glossary

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 (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.