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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?

No. There is currently no therapeutically equivalent version of Latuda available in the United States.

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: 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.

  • Imide derivatives, and their production and use
    Patent 5,532,372
    Issued: July 2, 1996
    Inventor(s): Saji; Ikutaro & Muto; Masayuki & Tanno; Norihiko & Yoshigi; Mayumi
    Assignee(s): Sumitomo Pharmaceuticals Company, Ltd.
    An imide compound of the formula: ##STR1## wherein Z is a group of the formula: ##STR2## in which the substituents are defined herein, and n is an integer of 0 to 1; D is a group of the formula: EQU --(CH.sub.2).sub.p --A--(CH.sub.2).sub.q -- in which A is a non-aromatic hydrocarbon ring optionally bridged with a lower alkylene group or an oxygen atom, said non-aromatic hydrocarbon ring and said lower alkylene group being each optionally substituted with at least one lower alkyl, and p and q are each an integer of 0, 1 or 2; and Ar is an aromatic group, a heterocyclic aromatic group, a benzoyl group, a phenoxy group or a phenylthio group and G is >N--, >CH-- or >COH-- or Ar is a biphenylmethylidene group and G is >C.dbd., all of the above groups being each optionally substituted with at least one of lower alkyl, lower alkoxy and halogen; and its acid addition salts, useful as an antipsycotic agent.
    Patent expiration dates:
    • July 2, 2018
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      Drug substance
  • 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
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      Drug product
  • 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
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      Drug product
  • 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:
    • June 25, 2026
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      Patent use: TREATMENT OF SCHIZOPHRENIA WITH IMPROVEMENT IN NEGATIVE SYMPTOMS AND/OR COGNITIVE DYSFUNCTION OF SCHIZOPHRENIA
  • 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
  • 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

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:
    • October 28, 2015 - NEW CHEMICAL ENTITY
    • June 28, 2016 - TREATMENT OF PATIENTS WITH DEPRESSIVE EPISODES ASSOCIATED WITH BIPOLAR I DISORDER (BIPOLAR DEPRESSION) AS MONOTHERAPY AND AS ADJUNCTIVE THERAPY WITH LITHIUM OR VALPROATE

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.
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