SECUADO Drug Patent Profile

Which patents cover Secuado, and what generic alternatives are available?

Secuado is a drug marketed by Hisamitsu and is included in one NDA. There are six patents protecting this drug.

This drug has thirty-eight patent family members in nine countries.

The generic ingredient in SECUADO is asenapine. There are twelve drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the asenapine profile page.

DrugPatentWatch^® Generic Entry Outlook for Secuado

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be July 25, 2033. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for SECUADO

International Patents:	38
US Patents:	6
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	36
Patent Applications:	139
Drug Prices:	Drug price information for SECUADO
What excipients (inactive ingredients) are in SECUADO?	SECUADO excipients list
DailyMed Link:	SECUADO at DailyMed

See drug prices for SECUADO

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

Constraining patent/regulatory exclusivity:

10,022,445

NDA:

212268

Dosage:

SYSTEM;TRANSDERMAL

^*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.

Pharmacology for SECUADO

Drug Class

Atypical Antipsychotic

US Patents and Regulatory Information for SECUADO

SECUADO is protected by six US patents.

This potential generic entry date is based on patent 10,022,445.

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
Hisamitsu	SECUADO	asenapine	SYSTEM;TRANSDERMAL	212268-001	Oct 11, 2019		RX	Yes	Yes	10,583,121		Y
Hisamitsu	SECUADO	asenapine	SYSTEM;TRANSDERMAL	212268-001	Oct 11, 2019		RX	Yes	Yes	11,123,305		Y
Hisamitsu	SECUADO	asenapine	SYSTEM;TRANSDERMAL	212268-002	Oct 11, 2019		RX	Yes	No	10,583,121		Y
Hisamitsu	SECUADO	asenapine	SYSTEM;TRANSDERMAL	212268-002	Oct 11, 2019		RX	Yes	No	11,123,305		Y
Hisamitsu	SECUADO	asenapine	SYSTEM;TRANSDERMAL	212268-003	Oct 11, 2019		RX	Yes	No	9,687,474		Y

EU/EMA Drug Approvals for SECUADO

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
N.V. Organon	Sycrest	asenapine	EMEA/H/C/001177 Sycrest is indicated for the treatment of moderate to severe manic episodes associated with bipolar I disorder in adults.	Authorised	no	no	no	2010-09-01

International Patents for SECUADO

When does loss-of-exclusivity occur for SECUADO?

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

China

European Patent Office

Japan

Poland

Portugal

South Korea

Spain

Taiwan

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 SECUADO around the world.

Country	Patent Number	Title	Estimated Expiration
European Patent Office	2878300	PATCH
European Patent Office	2878298	TIMBRE ADHÉSIF ET SON PROCÉDÉ DE FABRICATION (ADHESIVE PATCH AND PRODUCTION METHOD THEREFOR)
Japan	WO2014017593	貼付剤及びその製造方法
South Korea	102013478
Taiwan	I592170

Supplementary Protection Certificates for SECUADO

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0746317	10C0056	France		PRODUCT NAME: ASENAPINE; REGISTRATION NO/DATE: EU/1/10/640/001 20100901
0746317	C300461	Netherlands		PRODUCT NAME: ASENAPINE, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, IN HET BIJZONDER HET MALEAAT; REGISTRATION NO/DATE: EU/1/10/640/001-006 20100901
0746317	SPC/GB10/046	United Kingdom		PRODUCT NAME: ASENAPINE; REGISTERED: UK EU/1/10/640/001 20100901; UK EU/1/10/640/002 20100901; UK EU/1/10/640/003 20100901; UK EU/1/10/640/004 20100901; UK EU/1/10/640/005 20100901; UK EU/1/10/640/006 20100901

Market Dynamics and Financial Trajectory for Secuado (Asenapine Transdermal System)

Introduction to Secuado

Secuado, developed by Noven Pharmaceuticals, a subsidiary of Hisamitsu Pharmaceutical Co., Inc., is the first and only transdermal patch formulation approved by the U.S. FDA for the treatment of adults with schizophrenia. This innovative delivery system marks a significant advancement in the management of schizophrenia, addressing some of the challenges associated with traditional oral or sublingual medications.

Market Need and Unmet Demand

Schizophrenia is a severe, chronic psychiatric disorder affecting over 21 million people worldwide. In the U.S., it is estimated that 1.5% to 3.0% of total national healthcare expenditures are directed towards this patient population[5].

Adherence Issues

One of the major unmet needs in schizophrenia treatment is medication adherence. Patients with schizophrenia often face challenges in adhering to their medication regimens, which can lead to poor clinical outcomes and increased healthcare costs. Secuado, as a transdermal patch, offers a more reliable mode of antipsychotic medication administration, potentially improving adherence and overall treatment efficacy[5].

Clinical Efficacy and Safety

Efficacy

Secuado's efficacy was demonstrated in a Phase 3, double-blind, placebo-controlled study involving 616 adult patients with schizophrenia. The study showed statistically significant improvements in the Positive and Negative Syndrome Scale (PANSS) and the Clinical Global Impression-Severity (CGI-S) scores compared to placebo at week six[1][4][5].

Safety Profile

The safety profile of Secuado is consistent with what is known for sublingual asenapine. Common adverse reactions include extrapyramidal disorder, application site reactions, and weight gain. The drug also carries a Boxed Warning for increased mortality in elderly patients with dementia-related psychosis and is contraindicated in patients with severe hepatic impairment[1][4][5].

Market Size and Growth Potential

Current Market

The approval of Secuado expands the market for atypical antipsychotics, which is a significant segment within the broader psychiatric drug market. Given the chronic nature of schizophrenia and the need for continuous treatment, the market for antipsychotic medications is substantial and growing.

Financial Trajectory

• Pricing: Secuado is priced around $1,475 for a supply of 30 films, depending on the pharmacy and location. This pricing is competitive within the atypical antipsychotic market, although it is currently available only as a brand-name drug[2].
• Market Potential: The introduction of Secuado into the market addresses an unmet need for a more reliable and convenient antipsychotic treatment option. This can lead to increased market share and revenue for Noven Pharmaceuticals. The chronic nature of schizophrenia ensures a steady demand for effective treatments, contributing to a stable financial trajectory.
• Cost Implications: While the initial cost of Secuado may seem high, the long-term benefits of improved adherence and potentially better clinical outcomes could reduce overall healthcare costs associated with schizophrenia management[5].

Competitive Landscape

Unique Selling Point

Secuado's transdermal delivery system is its unique selling point, offering a convenient and potentially more adherent treatment option compared to traditional oral or sublingual formulations. This differentiation can help it stand out in a crowded market dominated by other atypical antipsychotics[1][4].

Comparative Effectiveness

While the comparative effectiveness of Secuado relative to other antipsychotic drugs has not been extensively studied, its demonstrated safety, efficacy, and tolerability profile support its position as a valuable addition to current treatment options[5].

Patient Assistance and Access Programs

Pricing and Discounts

To make Secuado more accessible, various discount programs and patient assistance initiatives are available. For example, the Drugs.com Discount Card can save patients up to 80% on the cost of Secuado and other prescription medications[2].

Regulatory Environment

FDA Approval

The FDA approval of Secuado in 2019 marked a significant regulatory milestone. The approval process was supported by robust clinical data from Phase 3 trials, ensuring that the drug meets stringent safety and efficacy standards[1][4].

Future Outlook

Market Expansion

As more patients and healthcare providers become aware of the benefits of transdermal asenapine, the market for Secuado is expected to expand. This could lead to increased revenue and a stronger market presence for Noven Pharmaceuticals.

Research and Development

Continued research and development in the field of psychiatric medications, including potential new indications for Secuado, could further enhance its market position and financial trajectory.

Key Takeaways

• Innovative Delivery: Secuado is the first transdermal patch for schizophrenia, offering improved adherence and convenience.
• Clinical Efficacy: Demonstrated significant improvements in PANSS and CGI-S scores in clinical trials.
• Safety Profile: Consistent with sublingual asenapine, with common adverse reactions including extrapyramidal disorder and application site reactions.
• Market Potential: Addresses an unmet need in schizophrenia treatment, with potential for significant market share and revenue.
• Pricing and Access: Available with discount programs to improve patient access.

FAQs

What is Secuado used for?

Secuado is used for the treatment of adults with schizophrenia. It is the first and only transdermal patch formulation approved for this condition[1][4].

How does Secuado work?

Secuado works by delivering asenapine, an atypical antipsychotic, through a transdermal patch. This delivery system helps maintain steady plasma concentrations of the drug over 24 hours[5].

What are the common side effects of Secuado?

Common side effects include extrapyramidal disorder, application site reactions, and weight gain. It also carries a Boxed Warning for increased mortality in elderly patients with dementia-related psychosis[1][4].

How much does Secuado cost?

The cost for Secuado is around $1,475 for a supply of 30 films, depending on the pharmacy and location. Discount programs are available to reduce the cost[2].

Is Secuado available as a generic?

No, Secuado is currently available only as a brand-name drug. A generic version is not yet available[2].

What are the benefits of using Secuado over other antipsychotics?

Secuado offers improved adherence due to its transdermal delivery system, which can lead to better clinical outcomes and reduced healthcare costs associated with schizophrenia management[5].

Sources

1. U.S. FDA Approves SECUADO® (asenapine) Transdermal System - Biospace
2. Secuado Prices, Coupons, Copay Cards & Patient Assistance - Drugs.com
3. Parkinson's Disease Drug Market Size, Share, Trends & Forecast - SkyQuestT
4. Secuado Transdermal System Approved for Schizophrenia - MPR
5. Clinical Summary: Secuado (asenapine) - DHCFP (nv.gov)