Generic Latuda Availability
Last updated on Mar 13, 2025.
Latuda is a brand name of lurasidone, approved by the FDA in the following formulation(s):
LATUDA (lurasidone hydrochloride - tablet;oral)
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Manufacturer: SUNOVION PHARMS INC
Approval date: October 28, 2010
Strength(s): 40MG [RLD] [AB], 80MG [RLD] [AB] -
Manufacturer: SUNOVION PHARMS INC
Approval date: December 7, 2011
Strength(s): 20MG [RLD] [AB] -
Manufacturer: SUNOVION PHARMS INC
Approval date: April 26, 2012
Strength(s): 120MG [RLD] [AB] -
Manufacturer: SUNOVION PHARMS INC
Approval date: July 12, 2013
Strength(s): 60MG [RLD] [AB]
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
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Manufacturer: ACCORD HLTHCARE
Approval date: January 3, 2019
Strength(s): 20MG [AB], 40MG [AB], 60MG [AB], 80MG [AB], 120MG [AB] -
Manufacturer: ADAPTIS
Approval date: December 28, 2020
Strength(s): 20MG [AB], 40MG [AB], 60MG [AB], 80MG [AB], 120MG [AB] -
Manufacturer: ALEMBIC
Approval date: May 13, 2021
Strength(s): 20MG [AB], 40MG [AB], 60MG [AB], 80MG [AB], 120MG [AB] -
Manufacturer: ALKEM LABS LTD
Approval date: December 13, 2022
Strength(s): 20MG [AB], 40MG [AB], 60MG [AB], 80MG [AB], 120MG [AB] -
Manufacturer: AMNEAL PHARMS CO
Approval date: January 3, 2019
Strength(s): 20MG [AB], 40MG [AB], 60MG [AB], 80MG [AB], 120MG [AB] -
Manufacturer: ANNORA PHARMA
Approval date: August 21, 2024
Strength(s): 20MG [AB], 40MG [AB], 60MG [AB], 80MG [AB], 120MG [AB] -
Manufacturer: AUROBINDO PHARMA LTD
Approval date: March 10, 2023
Strength(s): 20MG [AB], 40MG [AB], 60MG [AB], 80MG [AB], 120MG [AB] -
Manufacturer: DR REDDYS
Approval date: August 24, 2021
Strength(s): 20MG [AB], 40MG [AB], 60MG [AB], 80MG [AB] -
Manufacturer: HERITAGE PHARMA AVET
Approval date: September 4, 2019
Strength(s): 20MG [AB], 40MG [AB], 60MG [AB], 80MG [AB] -
Manufacturer: HERITAGE PHARMA AVET
Approval date: February 28, 2023
Strength(s): 120MG [AB] -
Manufacturer: INVAGEN PHARMS
Approval date: January 3, 2019
Strength(s): 20MG [AB], 40MG [AB], 60MG [AB], 80MG [AB], 120MG [AB] -
Manufacturer: JUBILANT GENERICS
Approval date: December 6, 2024
Strength(s): 20MG [AB], 40MG [AB], 60MG [AB], 80MG [AB], 120MG [AB] -
Manufacturer: LUPIN LTD
Approval date: January 3, 2019
Strength(s): 20MG [AB], 40MG [AB], 60MG [AB], 80MG [AB], 120MG [AB] -
Manufacturer: MACLEODS PHARMS LTD
Approval date: June 9, 2023
Strength(s): 20MG [AB], 40MG [AB], 60MG [AB], 80MG [AB], 120MG [AB] -
Manufacturer: MSN
Approval date: September 9, 2022
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] -
Manufacturer: TORRENT
Approval date: January 3, 2019
Strength(s): 20MG [AB], 40MG [AB], 80MG [AB], 120MG [AB] -
Manufacturer: TORRENT
Approval date: January 13, 2025
Strength(s): 60MG [AB] -
Manufacturer: ZYDUS PHARMS
Approval date: March 19, 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 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.
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Pharmaceutical composition
Patent 8,729,085
Issued: May 20, 2014
Inventor(s): Fujihara Kazuyuki
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✓
- May 26, 2026
-
Pharmaceutical composition
Patent 8729085*PED
Issued: May 20, 2014
Inventor(s): Fujihara Kazuyuki
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:
- November 26, 2026✓
- November 26, 2026
-
Pharmaceutical composition
Patent 8,883,794
Issued: November 11, 2014
Inventor(s): Fujihara Kazuyuki
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✓
- May 26, 2026
-
Pharmaceutical composition
Patent 8883794*PED
Issued: November 11, 2014
Inventor(s): Fujihara Kazuyuki
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:
- November 26, 2026✓
- November 26, 2026
-
Method of treatment for mental disorders
Patent 9,259,423
Issued: February 16, 2016
Inventor(s): Ikeda Kazuhito & Ishiyama Takeo
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 Dreceptor agonist.
Patent expiration dates:
- May 23, 2031✓
- May 23, 2031
-
Method of treatment for mental disorders
Patent 9259423*PED
Issued: February 16, 2016
Inventor(s): Ikeda Kazuhito & Ishiyama Takeo
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 Dreceptor agonist.
Patent expiration dates:
- November 23, 2031✓
- November 23, 2031
-
Pharmaceutical composition
Patent 9,555,027
Issued: January 31, 2017
Inventor(s): Fujihara Kazuyuki
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✓✓
- May 26, 2026
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Method of treatment for mental disorders
Patent 9,827,242
Issued: November 28, 2017
Inventor(s): Ikeda Kazuhito & Ishiyama Takeo
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 Dreceptor agonist.
Patent expiration dates:
- May 23, 2031✓
- May 23, 2031✓
- May 23, 2031
-
Pharmaceutical composition
Patent 9,907,794
Issued: March 6, 2018
Inventor(s): Fujihara Kazuyuki
Assignee(s): SUMITOMO DAINIPPON PHARMA CO., LTDA 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✓
- May 26, 2026
-
Pharmaceutical composition
Patent 9907794*PED
Issued: March 6, 2018
Inventor(s): Fujihara Kazuyuki
Assignee(s): SUMITOMO DAINIPPON PHARMA CO., LTDA 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:
- November 26, 2026✓
- November 26, 2026
-
Process for producing imide compound
Patent RE45573
Issued: June 23, 2015
Inventor(s): Kakiya Yuzo & Oda Mayumi
Assignee(s): Sumitomo Dainippon Pharma Co., Ltd.The present invention provides an excellent industrial process for producing an imide compound hydrochloride.
Patent expiration dates:
- June 23, 2025✓
- June 23, 2025
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Process for producing imide compound
Patent RE45573*PED
Issued: June 23, 2015
Inventor(s): Kakiya Yuzo & Oda Mayumi
Assignee(s): Sumitomo Dainippon Pharma Co., Ltd.The present invention provides an excellent industrial process for producing an imide compound hydrochloride.
Patent expiration dates:
- December 23, 2025✓
- December 23, 2025
More about Latuda (lurasidone)
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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 (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.