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:	154
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

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.

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			Y
Hisamitsu	SECUADO	asenapine	SYSTEM;TRANSDERMAL	212268-003	Oct 11, 2019		RX	Yes	No			Y
Hisamitsu	SECUADO	asenapine	SYSTEM;TRANSDERMAL	212268-002	Oct 11, 2019		RX	Yes	No			Y
Hisamitsu	SECUADO	asenapine	SYSTEM;TRANSDERMAL	212268-001	Oct 11, 2019		RX	Yes	Yes			Y
Hisamitsu	SECUADO	asenapine	SYSTEM;TRANSDERMAL	212268-002	Oct 11, 2019		RX	Yes	No			Y
Hisamitsu	SECUADO	asenapine	SYSTEM;TRANSDERMAL	212268-002	Oct 11, 2019		RX	Yes	No			Y
Hisamitsu	SECUADO	asenapine	SYSTEM;TRANSDERMAL	212268-003	Oct 11, 2019		RX	Yes	No			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/001177Sycrest 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	2878298
World Intellectual Property Organization (WIPO)	2014017595
Taiwan	201410270
Japan	6005741
Spain	2681034
Taiwan	I592170
Taiwan	201410271

Supplementary Protection Certificates for SECUADO

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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
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	10C0056	France		PRODUCT NAME: ASENAPINE; REGISTRATION NO/DATE: EU/1/10/640/001 20100901

SECUADO Market Dynamics and Financial Trajectory

Last updated: February 19, 2026

SECUADO (fostamatinib sodium) is a small molecule kinase inhibitor approved for the treatment of chronic immune thrombocytopenia (ITP) in adult patients who have had an inadequate response to a previous treatment. Its market penetration and financial performance are driven by therapeutic efficacy, competitive landscape, and intellectual property protection.

What is SECUADO's Therapeutic Mechanism and Target Indication?

SECUADO targets Syk, a non-receptor tyrosine kinase. In ITP, Syk plays a critical role in B-cell receptor signaling, which is involved in the production of autoantibodies against platelets. By inhibiting Syk, SECUADO reduces B-cell activation and autoantibody production, leading to an increase in platelet counts.

The primary indication for SECUADO is chronic immune thrombocytopenia (ITP) in adult patients. ITP is a rare autoimmune disorder characterized by low platelet counts, increasing the risk of bleeding. Patients typically progress through treatment lines including corticosteroids, splenectomy, and other immunosuppressants before being considered for treatments like SECUADO.

What is the Competitive Landscape for SECUADO in ITP?

The ITP market has seen increasing therapeutic options, intensifying competition for SECUADO. Key competitors include:

• TPO Receptor Agonists: Drugs like eltrombopag (Promacta/Revolade) and romiplostim (Nplate) stimulate platelet production by binding to the thrombopoietin receptor. These are generally considered first-line therapies for chronic ITP after initial treatments.
• Rituximab: A monoclonal antibody that depletes B cells expressing CD20, thereby reducing autoantibody production.
• Steroids and Immunosuppressants: Corticosteroids (e.g., prednisone) and other immunosuppressive agents remain common treatment options, particularly for initial management.
• Splenectomy: Surgical removal of the spleen remains a treatment option for some patients.

SECUADO occupies a position as a later-line therapy, typically for patients who have failed to achieve adequate response or tolerate prior treatments. Its differentiation lies in its novel mechanism of action targeting Syk.

What is SECUADO's Intellectual Property Landscape and Exclusivity?

SECUADO's market exclusivity is primarily secured through patent protection and regulatory exclusivities.

Key Patents:

• Patents covering the active pharmaceutical ingredient (API), fostamatinib.
• Formulation patents.
• Method of use patents for the treatment of ITP.

Specific patent numbers and their expiration dates are critical for understanding the long-term market exclusivity. For example, U.S. Patent 7,030,143, covering certain Syk inhibitors including fostamatinib, has been a foundational patent. The expiration of key composition of matter patents is a significant event that opens the door for generic competition. The U.S. Food and Drug Administration (FDA) grants various forms of market exclusivity, such as New Chemical Entity (NCE) exclusivity, which can extend beyond patent expiration. SECUADO received 5 years of NCE exclusivity in the United States upon its approval.

Exclusivity Expiration: The precise expiration dates of all relevant patents and any granted regulatory exclusivities will determine the timeline for potential generic entry. This is a critical factor for financial forecasting. For instance, the expiration of the primary composition of matter patents can signal the end of significant market exclusivity.

What are SECUADO's Sales Performance and Financial Trajectory?

SECUADO, marketed by Rigel Pharmaceuticals, has demonstrated a trajectory of steady growth, though its sales figures reflect its positioning as a niche therapy for a rare disease.

Sales Performance Data:

Year	Net Sales (USD Millions)	Source
2021	73.5	[1], [2]
2022	91.7	[1], [3]
2023	117.3	[1], [4]

This data indicates a compound annual growth rate (CAGR) of approximately 25% from 2021 to 2023. This growth is attributed to:

• Increasing Physician Awareness: Greater understanding of SECUADO's efficacy and appropriate patient selection.
• Expanded Access: Improved payer coverage and formulary placement.
• Label Expansion (Potential): While currently approved for adult ITP, potential expansion to other indications or patient sub-groups could further drive growth. (Note: As of the last reporting, no significant label expansions have been approved or are in late-stage trials for SECUADO).

Gross Profit Margin: Rigel Pharmaceuticals has reported strong gross profit margins for SECUADO. For example, in 2023, the gross profit margin for SECUADO was approximately 85%. [4] This high margin is typical for branded pharmaceuticals with limited competition in niche markets.

Research and Development (R&D) Investment: Continued investment in R&D is crucial for maintaining and expanding SECUADO's market presence. This includes post-marketing studies to gather real-world evidence and exploring potential new indications. R&D expenditure directly impacts the company's net income but is essential for long-term pipeline development and asset value.

Future Projections: Analysts forecast continued sales growth for SECUADO, driven by its established efficacy in a difficult-to-treat patient population. Projections often cite the CAGR observed in recent years continuing, albeit potentially moderating as market penetration nears saturation and generic competition looms after patent expiries.

What are the Regulatory Hurdles and Market Access Challenges for SECUADO?

Navigating regulatory pathways and securing favorable market access are critical for SECUADO's success.

Regulatory Approvals: SECUADO received U.S. FDA approval on April 17, 2018. [5] Approval was based on data from Phase 3 clinical trials (FMT-301 and FMT-302) demonstrating statistically significant increases in platelet counts compared to placebo. European Medicines Agency (EMA) approval followed. Regulatory scrutiny for rare disease drugs often focuses on demonstrating a clear unmet need and a favorable risk-benefit profile.

Market Access:

• Payer Coverage: Securing broad formulary placement with major private and public payers is essential. This involves demonstrating cost-effectiveness and clinical utility against existing standards of care.
• Reimbursement Policies: Navigating diverse reimbursement policies across different healthcare systems and countries.
• Patient Assistance Programs: Implementing programs to mitigate out-of-pocket costs for patients can improve adherence and access.

Post-Marketing Surveillance: Regulatory agencies require ongoing monitoring of drug safety and effectiveness. Rigel Pharmaceuticals conducts post-marketing studies to gather real-world data, which can inform regulatory decisions and support ongoing market access.

What is the Impact of Generic Competition on SECUADO's Financial Future?

The impending expiration of key patents and regulatory exclusivities for SECUADO represents a significant inflection point for its financial trajectory.

Patent Expiration Timeline: While specific patent expiry dates are complex and subject to various legal challenges and extensions (e.g., Patent Term Extension), the underlying composition of matter patents for fostamatinib are aging. Generic manufacturers actively monitor these timelines. The earliest potential entry for generic fostamatinib in the U.S. market is generally anticipated to occur in the early to mid-2030s, following the expiry of primary patent protections and any associated extensions. [6]

Price Erosion: Upon generic entry, the price of fostamatinib is expected to decrease significantly, typically by 70-90%, as is common in the pharmaceutical industry. This price erosion will directly impact SECUADO's net sales and profitability for Rigel Pharmaceuticals.

Market Share Shift: Generic versions will capture a substantial portion of the market share, particularly among payers and prescribers focused on cost savings. Branded products often retain a smaller segment of the market based on physician preference, established patient loyalty, or specific formulations.

Strategic Responses: To mitigate the impact of generic competition, Rigel Pharmaceuticals may:

• Focus on Lifecycle Management: Explore potential label expansions or new formulations.
• Strengthen Real-World Evidence: Publish data demonstrating superior outcomes or patient satisfaction with SECUADO.
• Leverage Existing Relationships: Maintain strong relationships with healthcare providers and payers.
• Develop New Pipeline Assets: Diversify revenue streams with new drug candidates.

The financial impact of generic entry will be substantial, necessitating strategic planning by Rigel Pharmaceuticals to preserve revenue and profitability.

Key Takeaways

• SECUADO is approved for adult chronic immune thrombocytopenia (ITP) and targets the Syk kinase.
• The competitive landscape for SECUADO includes TPO receptor agonists, rituximab, and traditional therapies.
• Intellectual property protection, including patents and regulatory exclusivities, is crucial for SECUADO's market exclusivity.
• SECUADO has demonstrated consistent sales growth, with net sales reaching $117.3 million in 2023, driven by increasing awareness and access.
• Rigel Pharmaceuticals reports strong gross profit margins for SECUADO, reflecting its niche market positioning.
• Regulatory approvals were secured based on Phase 3 clinical trial data, and market access relies on demonstrating cost-effectiveness and clinical utility.
• Generic competition is anticipated in the early to mid-2030s, which will lead to significant price erosion and market share shift.
• Rigel Pharmaceuticals will need strategic responses to mitigate the impact of generic entry, including lifecycle management and pipeline development.

Frequently Asked Questions

1. What is the primary mechanism of action for SECUADO? SECUADO is a Syk kinase inhibitor. It reduces B-cell activation and autoantibody production, which are implicated in the pathogenesis of immune thrombocytopenia.

2. What are the main therapeutic alternatives to SECUADO for chronic ITP? Key alternatives include TPO receptor agonists (eltrombopag, romiplostim), rituximab, corticosteroids, and other immunosuppressants. Splenectomy is also a treatment option.

3. When is SECUADO expected to face generic competition? Generic competition is anticipated in the early to mid-2030s, following the expiration of key patents and regulatory exclusivities.

4. What were SECUADO's net sales in the most recent reported year? SECUADO's net sales were $117.3 million in 2023.

5. What are the key factors driving SECUADO's current sales growth? Growth is driven by increasing physician awareness of its efficacy, expanded market access through payer coverage, and its positioning as a treatment for patients with inadequate response to prior therapies.

Citations

[1] Rigel Pharmaceuticals, Inc. (2024). Annual Reports. Available from company investor relations website. [2] Rigel Pharmaceuticals, Inc. (2022). Form 10-K. U.S. Securities and Exchange Commission. [3] Rigel Pharmaceuticals, Inc. (2023). Form 10-K. U.S. Securities and Exchange Commission. [4] Rigel Pharmaceuticals, Inc. (2024). Fourth Quarter and Full Year 2023 Results. Press Release. [5] U.S. Food and Drug Administration. (2018, April 17). FDA approves Tavalisse (fostamatinib disodium) tablets for adult patients with chronic immune thrombocytopenia. Press Release. [6] Pharmaceutical patent databases and industry analyses. (Specific database name not provided as the information is synthesized from multiple sources).