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CAPLYTA Drug Patent Profile

When do Caplyta patents expire, and when can generic versions of Caplyta launch?

Caplyta is a drug marketed by Intra-cellular and is included in one NDA. There are twenty-three patents protecting this drug and one Paragraph IV challenge.

This drug has one hundred and sixty-four patent family members in twenty countries.

The generic ingredient in CAPLYTA is lumateperone tosylate. One supplier is listed for this compound. Additional details are available on the lumateperone tosylate profile page.

DrugPatentWatch^® Generic Entry Outlook for Caplyta

Caplyta was eligible for patent challenges on December 20, 2023.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be August 30, 2039. This may change due to patent challenges or generic licensing.

There is one Paragraph IV patent challenge for this drug. This may lead to patent invalidation or a license for generic production.

Indicators of Generic Entry

Summary for CAPLYTA

International Patents:	164
US Patents:	23
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	40
Clinical Trials:	3
Patent Applications:	18
Drug Prices:	Drug price information for CAPLYTA
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for CAPLYTA
What excipients (inactive ingredients) are in CAPLYTA?	CAPLYTA excipients list
DailyMed Link:	CAPLYTA at DailyMed

See drug prices for CAPLYTA

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

Constraining patent/regulatory exclusivity:

10,695,345

NDA:

209500

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 CAPLYTA

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

Sponsor	Phase
Intra-Cellular Therapies, Inc.	Phase 4
University of Massachusetts, Worcester	Phase 4
University of New Mexico	Phase 4

See all CAPLYTA clinical trials

Pharmacology for CAPLYTA

Drug Class

Atypical Antipsychotic

Paragraph IV (Patent) Challenges for CAPLYTA

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 CAPLYTA

CAPLYTA is protected by thirty-two US patents and two FDA Regulatory Exclusivities.

This potential generic entry date is based on patent 10,695,345.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

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	209500-001	Dec 20, 2019		RX	Yes	Yes	10,464,938		Y
Intra-cellular	CAPLYTA	lumateperone tosylate	CAPSULE;ORAL	209500-003	Apr 22, 2022		RX	Yes	No	11,753,419		Y
Intra-cellular	CAPLYTA	lumateperone tosylate	CAPSULE;ORAL	209500-001	Dec 20, 2019		RX	Yes	Yes	12,122,792		Y
Intra-cellular	CAPLYTA	lumateperone tosylate	CAPSULE;ORAL	209500-001	Dec 20, 2019		RX	Yes	Yes	RE48839
Intra-cellular	CAPLYTA	lumateperone tosylate	CAPSULE;ORAL	209500-003	Apr 22, 2022		RX	Yes	No
Intra-cellular	CAPLYTA	lumateperone tosylate	CAPSULE;ORAL	209500-001	Dec 20, 2019		RX	Yes	Yes	11,806,348		Y
Intra-cellular	CAPLYTA	lumateperone tosylate	CAPSULE;ORAL	209500-001	Dec 20, 2019		RX	Yes	Yes	10,960,009

Expired US Patents for CAPLYTA

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 CAPLYTA

When does loss-of-exclusivity occur for CAPLYTA?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Australia

Brazil

Canada

China

European Patent Office

Israel

Japan

Mexico

South Korea

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering CAPLYTA around the world.

Country	Patent Number	Title	Estimated Expiration
Mexico	2024010140	NUEVOS METODOS. (NOVEL METHODS.)
Canada	2725342	GAMMA-CARBOLINES FUSIONNEES A HETEROCYCLE SUBSTITUE POUR LES TROUBLES DU SOMMEIL ET AUTRES TROUBLES (SUBSTITUTED HETEROCYCLE FUSED GAMMA-CARBOLINES FOR SLEEP DISORDERS AND OTHER DISORDERS)
South Korea	20190006606
Poland	2262505
European Patent Office	4072554
Japan	2016155849	置換ヘテロ環縮合ガンマ−カルボリンの合成 (SUBSTITUTED HETEROCYCLE FUSED GAMMA-CARBOLINE SYNTHESIS)
European Patent Office	1189904	GAMMA-CARBOLINES FUSIONNEES A HETEROCYCLE SUBSTITUE (SUBSTITUTED HETEROCYCLE FUSED GAMMA-CARBOLINES)

CAPLYTA Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for CAPLYTA

Introduction

CAPLYTA, developed by Intra-Cellular Therapies, is a significant player in the treatment of bipolar depression and other psychiatric conditions. The drug has shown robust growth and strong market dynamics, making it a focal point for both medical professionals and investors.

Strong Prescription Uptake

CAPLYTA has consistently demonstrated strong prescription uptake. In the second quarter of 2024, total prescriptions increased by 36% compared to the same period in 2023, and by 10% compared to the first quarter of 2024[1]. Similarly, in the third quarter of 2024, CAPLYTA total prescriptions increased by 38% compared to the same period in 2023, and by 9% compared to the second quarter of 2024[5].

Financial Performance

Quarterly Sales

• In the first quarter of 2024, CAPLYTA net product sales reached $144.8 million, marking a 53% year-over-year increase[2][3].
• In the second quarter of 2024, CAPLYTA net product sales were $161.3 million, a 46% increase from the same period in 2023[1].
• For the third quarter of 2024, net product sales of CAPLYTA were $175.2 million, representing a 39% increase over the same period in 2023[5].

Annual Sales Guidance

The full-year 2024 net product sales guidance for CAPLYTA has been adjusted multiple times to reflect the drug's strong performance. Initially set at $645 to $675 million, it was later raised to $665 to $685 million[5].

Market Access and Expansion

Sales Force Expansion

To leverage the growing opportunity with primary care physicians, Intra-Cellular Therapies has expanded its sales force. In the third quarter of 2024, the company added approximately 150 sales representatives, with plans for a second expansion in 2025 in anticipation of potential approval for the adjunctive treatment of major depressive disorder (MDD)[1][5].

Market Coverage

CAPLYTA enjoys extensive market access, covering approximately 90% of commercially insured lives and greater than 99% of Medicare Part D and Medicaid lives. The LytaLink patient and prescriber support program has also been effective in supporting patient access to CAPLYTA[4].

Clinical Pipeline and Developments

Adjunctive Treatment for MDD

Intra-Cellular Therapies has announced positive Phase 3 results from Study 501 and Study 502 evaluating lumateperone (the active ingredient in CAPLYTA) as an adjunctive therapy to antidepressants in patients with MDD. A supplemental new drug application (sNDA) submission for this indication is anticipated in the fourth quarter of 2024[1][5].

Other Clinical Programs

The company is advancing several other clinical programs, including studies for generalized anxiety disorder (GAD), psychosis associated with Alzheimer’s disease, and agitation associated with Alzheimer’s disease. Additionally, there are ongoing programs for lumateperone in pediatric patients and a long-acting injectable (LAI) formulation[5].

Financial Health and Outlook

Revenue and Expenses

• Total revenues for the third quarter of 2024 were $175.4 million, compared to $126.2 million for the same period in 2023[5].
• Selling, general and administrative (SG&A) expenses for the third quarter of 2024 were $132.1 million, compared to $105.2 million for the same period in 2023. Research and development (R&D) expenses were $66.8 million, up from $41.6 million in the same period of 2023[5].

Cash Position

Intra-Cellular Therapies maintains a strong cash position, with $1.0 billion in cash, cash equivalents, investment securities, and restricted cash as of September 30, 2024. This includes proceeds from a public offering in April 2024 that raised approximately $575 million[2][5].

Regulatory and Market Access Updates

Medicare Part D Exception

CAPLYTA qualified for the Specified Small Manufacturer Exception pertaining to the Part D redesign of the Inflation Reduction Act, which enhances its market access[1].

Industry Expert Insights

"We continued to deliver strong growth for CAPLYTA in the first quarter," said Dr. Sharon Mates, Chairman and CEO of Intra-Cellular Therapies. "To fully leverage the growing opportunity with primary care physicians in our current CAPLYTA indications, we plan to increase the size of our sales force during the third quarter of this year to expand our reach and frequency in primary care offices."[2]

Key Statistics

• Q1 2024 Sales: $144.8 million, a 53% increase from Q1 2023[2][3].
• Q2 2024 Sales: $161.3 million, a 46% increase from Q2 2023[1].
• Q3 2024 Sales: $175.2 million, a 39% increase from Q3 2023[5].
• 2023 Total Prescriptions: 85% growth over 2022[4].
• 2024 Sales Guidance: $665 to $685 million[5].

Future Outlook

Given the strong prescription uptake, expanding sales force, and positive clinical results, CAPLYTA is poised for continued growth. The potential approval for adjunctive treatment of MDD and the advancement of other clinical programs further solidify its position in the market.

"CAPLYTA has shown strong efficacy, safety, and convenient dosing, with growing adoption among prescribers," highlighting the drug's market potential and the company's strategic initiatives[3].

Key Takeaways

• CAPLYTA has demonstrated robust prescription growth and significant revenue increases.
• The drug's market access is extensive, covering a large portion of commercially insured and Medicare/Medicaid lives.
• Intra-Cellular Therapies is expanding its sales force to leverage growing opportunities.
• Positive clinical results and upcoming regulatory submissions are expected to further boost CAPLYTA's market presence.
• The company maintains a strong financial position, supporting its ongoing and future initiatives.

FAQs

What is CAPLYTA used for?

CAPLYTA is used for the treatment of bipolar depression in adults. It is also being evaluated for other indications, including major depressive disorder (MDD) as an adjunctive therapy to antidepressants.

How has CAPLYTA performed in terms of sales in 2024?

In the first quarter of 2024, CAPLYTA net product sales were $144.8 million, a 53% increase from the same period in 2023. In the second quarter, sales were $161.3 million, a 46% increase, and in the third quarter, sales reached $175.2 million, a 39% increase over the same period in 2023[1][2][5].

What are the key clinical developments for CAPLYTA?

Positive Phase 3 results have been announced for the use of lumateperone as an adjunctive therapy to antidepressants in patients with MDD. A supplemental new drug application (sNDA) submission for this indication is anticipated in the fourth quarter of 2024[1][5].

How is Intra-Cellular Therapies expanding its market reach for CAPLYTA?

The company is expanding its sales force by approximately 150 sales representatives in the third quarter of 2024 and plans a second expansion in 2025 in anticipation of potential approval for the adjunctive treatment of MDD[1][5].

What is the current financial outlook for Intra-Cellular Therapies?

The full-year 2024 net product sales guidance for CAPLYTA has been raised to $665 to $685 million. The company also narrowed its SG&A expense guidance to $490 to $510 million and R&D expense guidance to $220 to $230 million[5].

Sources

1. Intra-Cellular Therapies Reports Second Quarter 2024 Financial Results - Biospace
2. Intra-Cellular Therapies Reports First Quarter 2024 Financial Results - Intra-Cellular Therapies
3. Earnings call: Intra-Cellular reports robust growth in CAPLYTA sales - Investing.com
4. Intra-Cellular Therapies Reports Fourth Quarter And Full-Year 2023 Financial Results - Intra-Cellular Therapies
5. Intra-Cellular Therapies Reports Third Quarter 2024 Financial Results - GlobeNewswire