Detailed Analysis of the Scope and Claims of United States Patent 10,695,345
Introduction to Lumateperone and Caplyta
Lumateperone, marketed under the brand name Caplyta, is a novel second-generation antipsychotic used primarily to manage both positive and negative symptoms in patients with schizophrenia. It is developed and owned by Intra-Cellular Therapies, Inc.[1][2][3].
Overview of Patent 10,695,345
Patent Title and Number
The patent in question is titled "Pharmaceutical capsule compositions comprising lumateperone mono-tosylate" and bears the number US10,695,345. It was issued on June 30, 2020[2][4].
Inventors and Assignees
The inventors listed for this patent include Li Peng and Davis Robert, with Intra-Cellular Therapies, Inc. as the assignee[2][4].
Scope of the Patent
Pharmaceutical Compositions
This patent covers pharmaceutical compositions that include lumateperone, either in its free form or as a pharmaceutically acceptable salt, such as the mono-tosylate salt. These compositions can be formulated into various dosage forms, including capsules[2][4].
Methods of Manufacture
The patent also describes processes for the manufacture of these pharmaceutical compositions. This includes the preparation of lumateperone and its salts, as well as the formulation of these active ingredients into capsules[4].
Methods of Use
The patent outlines methods of use for these compositions in the treatment or prophylaxis of various diseases. Specifically, it mentions the treatment of schizophrenia and other central nervous system disorders[2][4].
Claims of the Patent
Active Ingredient
The primary claim revolves around the use of lumateperone, a specific chemical compound with the structure 4-((6bR,10aS)-3-methyl-2,3,6b,9,10,10a-hexahydro-1H-pyrido[3′,4′:4,5]pyrrolo[1,2,3-de]quinoxalin-8(7H)-yl)-1-(4-fluorophenyl)-1-butanone, and its pharmaceutically acceptable salts, such as the mono-tosylate salt[2][4].
Dosage Forms
The patent claims cover various dosage forms, particularly capsules, which can contain lumateperone in its free form or as a salt. These capsules can be designed to release the active ingredient in a controlled manner[4].
Combination Therapies
The patent also includes claims for compositions that combine lumateperone with one or more additional therapeutic agents. This allows for the treatment of a broader range of conditions and potentially enhances therapeutic efficacy[2].
Patent Expiration Dates
The patent is set to expire on August 30, 2039. This date is significant because it marks the end of the exclusive rights granted to Intra-Cellular Therapies, Inc. to manufacture and market Caplyta without generic competition[2][3].
Patent Landscape and Generic Availability
Current Patents and Exclusivities
Caplyta is protected by a series of patents, with the majority expiring between 2029 and 2040. The presence of these patents and associated exclusivities delays the entry of generic versions of the drug into the market. As of the current date, there is no therapeutically equivalent generic version of Caplyta available in the United States[2][3].
Generic Launch Date
The estimated generic launch date for Caplyta is December 10, 2040, based on the expiration of the relevant patents and exclusivities[3].
Impact on Treatment and Market
Therapeutic Significance
Lumateperone's unique mechanism of action and its ability to manage both positive and negative symptoms of schizophrenia make it a valuable treatment option. The patent protection ensures that Intra-Cellular Therapies, Inc. can continue to invest in research and development without immediate generic competition[1].
Market Dominance
The exclusive rights granted by the patent allow Intra-Cellular Therapies, Inc. to maintain market dominance for Caplyta until the patents expire. This period of exclusivity is crucial for the company to recoup its investment in the drug's development and to generate revenue[2][3].
Conclusion
The United States Patent 10,695,345 is a critical component of the intellectual property portfolio for Caplyta, protecting the pharmaceutical compositions, methods of manufacture, and methods of use for lumateperone. The patent's scope and claims ensure that Intra-Cellular Therapies, Inc. retains exclusive rights to this valuable antipsychotic medication until its expiration in 2039.
Key Takeaways
- Patent Number and Title: US10,695,345 - "Pharmaceutical capsule compositions comprising lumateperone mono-tosylate"
- Inventors and Assignees: Li Peng, Davis Robert; Intra-Cellular Therapies, Inc.
- Scope: Covers pharmaceutical compositions, methods of manufacture, and methods of use for lumateperone.
- Expiration Date: August 30, 2039
- Generic Availability: Estimated generic launch date is December 10, 2040
- Therapeutic Significance: Valuable treatment option for schizophrenia
- Market Impact: Ensures market dominance for Intra-Cellular Therapies, Inc. until patent expiration
FAQs
What is the primary active ingredient in Caplyta?
The primary active ingredient in Caplyta is lumateperone, a second-generation antipsychotic[1].
What is the patent number for the pharmaceutical compositions of Caplyta?
The patent number is US10,695,345[2].
When does the patent for Caplyta expire?
The patent is set to expire on August 30, 2039[2][3].
Is there a generic version of Caplyta available?
No, there is currently no therapeutically equivalent generic version of Caplyta available in the United States[2].
What is the estimated generic launch date for Caplyta?
The estimated generic launch date is December 10, 2040[3].
Cited Sources
- DrugBank: Lumateperone: Uses, Interactions, Mechanism of Action.
- Drugs.com: Generic Caplyta Availability.
- Pharsight: Caplyta patent expiration.
- Google Patents: Pharmaceutical capsule compositions comprising lumateperone mono-tosylate.
