LUMATEPERONE TOSYLATE - Generic Drug Details

What are the generic sources for lumateperone tosylate and what is the scope of patent protection?

Lumateperone tosylate is the generic ingredient in one branded drug marketed by Intra-cellular and is included in one NDA. There are twenty-three patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Lumateperone tosylate has one hundred and sixty-four patent family members in twenty countries.

One supplier is listed for this compound.

Summary for LUMATEPERONE TOSYLATE

International Patents:	164
US Patents:	23
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	34
Clinical Trials:	1
Patent Applications:	46
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for LUMATEPERONE TOSYLATE
DailyMed Link:	LUMATEPERONE TOSYLATE at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for LUMATEPERONE TOSYLATE

Constraining patent/regulatory exclusivity:

10,695,345

Dosage:

CAPSULE;ORAL

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for LUMATEPERONE TOSYLATE

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
New York State Psychiatric Institute	Phase 2
Intra-Cellular Therapies, Inc.	Phase 2

See all LUMATEPERONE TOSYLATE clinical trials

Pharmacology for LUMATEPERONE TOSYLATE

Drug Class

Atypical Antipsychotic

Anatomical Therapeutic Chemical (ATC) Classes for LUMATEPERONE TOSYLATE

N05AD	Butyrophenone derivatives
N05A	ANTIPSYCHOTICS
N05	PSYCHOLEPTICS
N	Nervous system

Paragraph IV (Patent) Challenges for LUMATEPERONE TOSYLATE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
CAPLYTA	Capsules	lumateperone tosylate	42 mg	209500	7	2023-12-20

US Patents and Regulatory Information for LUMATEPERONE TOSYLATE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Intra-cellular	CAPLYTA	lumateperone tosylate	CAPSULE;ORAL	209500-002	Apr 22, 2022		RX	Yes	No	11,690,842		Y
Intra-cellular	CAPLYTA	lumateperone tosylate	CAPSULE;ORAL	209500-002	Apr 22, 2022		RX	Yes	No	9,956,227
Intra-cellular	CAPLYTA	lumateperone tosylate	CAPSULE;ORAL	209500-002	Apr 22, 2022		RX	Yes	No	11,753,419		Y
Intra-cellular	CAPLYTA	lumateperone tosylate	CAPSULE;ORAL	209500-003	Apr 22, 2022		RX	Yes	No	11,026,951
Intra-cellular	CAPLYTA	lumateperone tosylate	CAPSULE;ORAL	209500-002	Apr 22, 2022		RX	Yes	No	9,199,995

Expired US Patents for LUMATEPERONE TOSYLATE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Intra-cellular	CAPLYTA	lumateperone tosylate	CAPSULE;ORAL	209500-001	Dec 20, 2019	7,183,282
Intra-cellular	CAPLYTA	lumateperone tosylate	CAPSULE;ORAL	209500-001	Dec 20, 2019	RE39680

International Patents for LUMATEPERONE TOSYLATE

Country	Patent Number	Title	Estimated Expiration
Poland	2262505
China	118873536	新方法
Mexico	2024010140	NUEVOS METODOS. (NOVEL METHODS.)
European Patent Office	2320731	PROCÉDÉS ET COMPOSITIONS POUR LES TROUBLES DU SOMMEIL ET D AUTRES TROUBLES (METHODS AND COMPOSITIONS FOR SLEEP DISORDERS AND OTHER DISORDERS)
South Korea	102421656

LUMATEPERONE TOSYLATE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Lumateperone Tosylate (Caplyta)

Introduction

Lumateperone tosylate, marketed as Caplyta, is a butyrophenone antipsychotic agent developed by Intra-Cellular Therapies. It has been approved for the treatment of schizophrenia in adults and is under investigation for various other psychiatric conditions, including major depressive disorder (MDD). Here, we delve into the market dynamics and financial trajectory of this promising drug.

Market Approval and Indications

Caplyta is currently approved for the treatment of schizophrenia in adults. However, its therapeutic potential extends beyond this indication. It is under development for treating schizoaffective disorders, sleep disturbances associated with neuro-psychiatric disorders, and major depressive disorders associated with bipolar I or bipolar II disorders[1].

Clinical Trials and Efficacy

Recent clinical trials have shown promising results for lumateperone as an adjunctive therapy to antidepressants in patients with MDD. Studies 501 and 502 have demonstrated statistically significant and clinically meaningful reductions in depressive symptoms, as measured by the Montgomery Asberg Depression Rating Scale (MADRS) and the Clinical Global Impression Scale for Severity of Illness (CGI-S)[2][3].

Prescription Uptake and Sales Performance

The prescription uptake of Caplyta has been robust. In the second quarter of 2024, total prescriptions increased by 36% compared to the same period in 2023. This strong prescription growth has translated into significant revenue increases. Net product sales of Caplyta for the second quarter of 2024 were $161.3 million, a 46% increase from the same period in 2023[2].

Financial Performance

Quarterly Financial Highlights

• In the first quarter of 2024, total revenues were $144.9 million, with net product sales of Caplyta reaching $144.8 million, a 53% increase from the same period in 2023[3].
• For the second quarter of 2024, total revenues were $161.4 million, with net product sales of Caplyta at $161.3 million, representing a 46% increase year-over-year[2].

Annual Sales Guidance

The financial outlook for Caplyta is optimistic. The 2024 net product sales guidance has been raised to $650 to $680 million, reflecting the drug's growing market presence and acceptance[2][3].

Operating Expenses and Net Loss

Despite the strong revenue growth, Intra-Cellular Therapies has reported net losses. For the second quarter of 2024, the net loss was $16.2 million, an improvement from the $42.8 million net loss in the same period in 2023. The increase in selling, general, and administrative (SG&A) expenses and research and development (R&D) expenses has been driven by sales force expansion and ongoing clinical trials[2].

Cost of Product Sales and R&D Expenses

The cost of product sales has increased, reflecting higher production volumes. For the second quarter of 2024, the cost of product sales was $11.4 million, up from $7.2 million in the same period in 2023. R&D expenses also increased to $56.2 million, primarily due to the ongoing development of lumateperone for additional indications[2].

Safety Profile and Adverse Events

While lumateperone has shown significant therapeutic benefits, its safety profile is also under scrutiny. Post-marketing safety data have identified common adverse events such as somnolence, sedation, and dry mouth. The median time to onset of these adverse events is approximately 13 days, with most events occurring within the first month of treatment[4].

Competitive Strategy and Market Positioning

Intra-Cellular Therapies is leveraging the positive clinical trial results and strong prescription uptake to position Caplyta as a key player in the psychiatric treatment market. The company's strategy includes expanding its sales force, particularly in the primary care segment, to further increase market penetration[2].

Regulatory Considerations and Likelihood of Approval

The likelihood of approval for lumateperone in new indications is a critical factor in its market dynamics. GlobalData's proprietary machine learning models provide insights into the drug's likelihood of approval and phase transition success rates, helping stakeholders make informed decisions[1].

Future Outlook and Pipeline Development

Intra-Cellular Therapies is focused on advancing its pipeline, including the submission of a supplemental New Drug Application (sNDA) for lumateperone as an adjunctive therapy to antidepressants in patients with MDD, anticipated in the second half of 2024. Positive outcomes from these regulatory submissions could further bolster the drug's market position and financial performance[2][3].

Key Takeaways

• Strong Prescription Uptake: Caplyta has seen significant increases in prescriptions, driving revenue growth.
• Expanding Indications: Positive clinical trial results for MDD and other psychiatric conditions are set to expand the drug's market.
• Financial Performance: Net product sales have increased substantially, with a raised 2024 sales guidance.
• Operating Expenses: Increased SG&A and R&D expenses reflect the company's investment in sales force expansion and clinical trials.
• Safety Profile: Common adverse events include somnolence, sedation, and dry mouth, with most occurring within the first month of treatment.

FAQs

What is lumateperone tosylate (Caplyta) used for?

Lumateperone tosylate, marketed as Caplyta, is approved for the treatment of schizophrenia in adults and is under development for other psychiatric conditions, including major depressive disorder (MDD) and bipolar disorders.

What are the recent financial highlights for Caplyta?

In the second quarter of 2024, Caplyta's net product sales were $161.3 million, a 46% increase from the same period in 2023. The 2024 net product sales guidance has been raised to $650 to $680 million.

What are the common adverse events associated with lumateperone?

Common adverse events include somnolence, sedation, and dry mouth, with most events occurring within the first month of treatment.

What is the current status of lumateperone in clinical trials for MDD?

Lumateperone has shown positive results in Phase 3 trials as an adjunctive therapy to antidepressants in patients with MDD. A supplemental New Drug Application (sNDA) is anticipated in the second half of 2024.

How does the safety profile of lumateperone impact its market dynamics?

The safety profile, while indicating common adverse events, does not seem to deter the strong prescription uptake and revenue growth. Continuous pharmacovigilance and post-marketing surveillance are crucial to maintaining a favorable safety profile.

Sources

1. GlobalData: "Lumateperone Tosylate in Major Depressive Disorder - Market Analysis and Trend Insights" - July 2024.
2. BioSpace: "Intra-Cellular Therapies Reports Second Quarter 2024 Financial Results" - August 2024.
3. BioSpace: "Intra-Cellular Therapies Reports First Quarter 2024 Financial Results" - May 2024.
4. Frontiers in Pharmacology: "Post-marketing safety concerns with lumateperone" - May 2024.
5. Intra-Cellular Therapies: "Intra-Cellular Therapies Reports First Quarter 2023 Financial Results" - May 2023.