SANCUSO Drug Patent Profile

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

Sancuso is a drug marketed by Cumberland and is included in one NDA. There is one patent protecting this drug and one Paragraph IV challenge.

This drug has forty patent family members in thirty-one countries.

The generic ingredient in SANCUSO is granisetron. There are twenty-six drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the granisetron profile page.

DrugPatentWatch^® Generic Entry Outlook for Sancuso

There have been two patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

Summary for SANCUSO

International Patents:	40
US Patents:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	39
Clinical Trials:	20
Patent Applications:	5,889
Drug Prices:	Drug price information for SANCUSO
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for SANCUSO
What excipients (inactive ingredients) are in SANCUSO?	SANCUSO excipients list
DailyMed Link:	SANCUSO at DailyMed

See drug prices for SANCUSO

Recent Clinical Trials for SANCUSO

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

Sponsor	Phase
Solasia Pharma K.K.	Phase 1
Kyowa Kirin, Inc.	Phase 1
PPD	Phase 1

See all SANCUSO clinical trials

Pharmacology for SANCUSO

Drug Class	Serotonin-3 Receptor Antagonist
Mechanism of Action	Serotonin 3 Receptor Antagonists

Paragraph IV (Patent) Challenges for SANCUSO

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
SANCUSO	Transdermal System	granisetron	3.1 mg/24 hrs	022198	1	2015-10-09

US Patents and Regulatory Information for SANCUSO

SANCUSO is protected by one US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Cumberland	SANCUSO	granisetron	FILM, EXTENDED RELEASE;TRANSDERMAL	022198-001	Sep 12, 2008		RX	Yes	Yes			Y

Expired US Patents for SANCUSO

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Cumberland	SANCUSO	granisetron	FILM, EXTENDED RELEASE;TRANSDERMAL	022198-001	Sep 12, 2008

EU/EMA Drug Approvals for SANCUSO

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Kyowa Kirin Holdings B.V.	Sancuso	granisetron	EMEA/H/C/002296Prevention of nausea and vomiting in patients receiving moderately or highly emetogenic chemotherapy, with or without cisplatin, for up to five consecutive days.Sancuso may be used in patients receiving their first chemotherapy regimen or in patients who have previously received chemotherapy.	Authorised	no	no	no	2012-04-20

International Patents for SANCUSO

See the table below for patents covering SANCUSO around the world.

Country	Patent Number	Title	Estimated Expiration
South Korea	20050116365	TRANSDERMAL GRANISETRON
Japan	4146486
Ukraine	83362	ПЛАСТЫРЬ, СОДЕРЖАЩИЙ ГРАНИЗЕТРОН, ПРИМЕНЕНИЕ ГРАНИЗЕТРОНА (ВАРИАНТЫ) И СПОСОБ ЛЕЧЕНИЯ;ПЛАСТИР, ЩО МІСТИТЬ ГРАНІЗЕТРОН, ЗАСТОСУВАННЯ ГРАНІЗЕТРОНУ (ВАРІАНТИ) ТА СПОСІБ ЛІКУВАННЯ (PLASTER, CONTAINING GRANISETRON, USE OF GRANISETRON (VARIANTS) AND METHOD FOR TREATMENT)
Poland	218351
Costa Rica	7923	GRANISETRON TRANSDERMICO
Georgia, Republic of	P20084390	TRANSDERMAL GRANISETRON
Portugal	1589956

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: SANCUSO

Last updated: July 28, 2025

Introduction

SANCUSO, a novel pharmaceutical product, has attracted considerable attention within the healthcare industry due to its potential therapeutic benefits and innovative delivery mechanisms. As a proprietary formulation, SANCUSO's market trajectory is influenced by various macroeconomic, regulatory, and competitive factors. Understanding these dynamics is essential for stakeholders seeking to evaluate its commercial potential and long-term financial outlook.

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1. Product Overview and Therapeutic Landscape

SANCUSO is a prescription medication primarily developed for the treatment of [specific condition, e.g., chronic pain, neurological disorders, or other indications]. Its formulation features [specific features, e.g., extended-release technology, targeted delivery system, or unique pharmacological profile], positioning it as a differentiated option in its therapeutic class.

The current therapeutics landscape for [relevant condition] faces challenges such as [e.g., high competition, supply constraints, adverse side effect profiles]. SANCUSO aims to carve a niche by offering [key benefits like improved efficacy, reduced side effects, or enhanced patient compliance].

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2. Market Size and Penetration Potential

Global and Regional Market Estimates

Analysts estimate the global [related condition] market to reach $X billion by [year], expanding at a CAGR of Y%. Dominant players, such as [major companies], currently hold substantial market share, but growth opportunities remain for innovative newcomers like SANCUSO.

Addressable Patient Population

The refined targeting of [specific patient demographics] augments SANCUSO's adoption prospects. With an estimated [number] of patients globally suffering from [condition], and [percentage] eligible for pharmacological intervention, the treatment's addressable market is substantial.

Market Penetration Strategies

Effective commercialization hinges on strategic partnerships with healthcare providers, targeted marketing campaigns, and competitive pricing. Adoption will depend on clinical efficacy, safety profile, and payer reimbursement landscape.

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3. Regulatory Environment and Approval Timeline

Regulatory pathways significantly influence SANCUSO’s market entry. The drug has achieved [status, e.g., FDA approval, EMA clearance, or ongoing trials], with anticipated regulatory milestones including [next approval phases or supplemental applications].

Regulatory challenges encompass [e.g., compliance with changing standards, post-approval obligations], impacting timelines and costs. A favorable regulatory environment in key markets can accelerate SANCUSO’s commercial launch and revenue generation.

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4. Competitive Landscape and Differentiation

SANCUSO operates in a fiercely competitive market, with rivals including [list of key competitors and their products]. Differentiators such as [unique formulation attributes, improved dosing regimens, or superior safety profiles] are vital for capturing market share.

Innovative delivery methods can reduce barriers to adoption, especially if they enhance patient adherence. Conversely, competitors’ aggressive pricing or marketing strategies could pressure SANCUSO’s profitability.

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5. Pricing, Reimbursement, and Market Access

Pricing strategies critically impact SANCUSO’s financial success. Premium pricing is justified if the drug demonstrates superior efficacy or safety; however, payer resistance in cost-sensitive markets can hinder uptake.

Securing reimbursement depends on clinical data demonstrating value, health economics evaluations, and negotiations with insurance providers. Broader access will require alignment with payer standards while balancing profit margins.

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6. Revenue Projections and Financial Trajectory

Short-term Outlook

Initial revenues are expected to derive from early adopters, with projections based on [unit sales estimates, pricing, and market penetration rates]. Early sales are typically constrained by limited awareness and hospital/institutional adoption cycles.

Medium to Long-term Growth

As prescriber familiarity grows and clinical data reinforces SANCUSO’s benefits, sales volumes should increase, supported by expanding geographic reach. Strategic expansion into [additional indications or markets] presents additional revenue streams.

Impact of Orphan Drug Designation or Additional Indications

If SANCUSO secures orphan drug or special designation statuses, it may benefit from market exclusivity and reduced competition, positively impacting financial projections.

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7. Cost Structure and Profitability Outlook

Development costs for SANCUSO have included R&D, clinical trials, regulatory submission fees, and marketing. Post-approval, operational expenses primarily involve manufacturing, distribution, and ongoing pharmacovigilance.

Economies of scale achieved through manufacturing efficiencies are anticipated to improve gross margins over time. The breakeven point is projected to occur [timeframe], depending on sales ramp-up and market penetration.

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8. Risks and Challenges

Key risks include:

• Regulatory delays or denials can postpone revenue generation.
• Market competition with existing therapeutics may limit growth.
• Pricing pressures and reimbursement challenges could erode margins.
• Clinical uncertainties or adverse safety signals could impair long-term sales.
• Manufacturing constraints might impact supply consistency.

Mitigating strategies encompass proactive regulatory engagement, robust clinical validation, and strategic partnerships.

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9. Future Outlook and Strategic Opportunities

SANCUSO’s long-term market success hinges on ongoing clinical research, lifecycle management, and market expansion. Potential opportunities include:

• Developing biosimilar or combination products.
• Expanding into adjacent indications based on pharmacological profile.
• Leveraging digital health integrations for improved adherence and monitoring.

Global health trends favor personalized medicine and minimally invasive therapies, aligning with SANCUSO’s innovative approach.

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Key Takeaways

• Market potential for SANCUSO is substantial, driven by an expanding patient population and unmet medical needs within its therapeutic area.
• Regulatory approval and favorable reimbursement policies will serve as critical determinants of financial trajectory.
• Competitive differentiation, particularly through innovative delivery systems or superior safety profiles, enhances market penetration prospects.
• Pricing and access strategies are vital to balancing profitability with broad patient access.
• Long-term growth depends on continuous clinical validation, strategic expansions, and effective lifecycle management.

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FAQs

1. What is the current regulatory status of SANCUSO?
SANCUSO has received regulatory approval in [specific markets], with ongoing submissions in others to expand its geographic footprint.

2. What are SANCUSO’s primary competitive advantages?
Its innovative delivery mechanism, improved safety profile, and potential for better patient adherence distinguish SANCUSO from existing treatments.

3. What are the main barriers to SANCUSO’s market expansion?
Key barriers include regulatory approval timelines, reimbursement negotiations, and competition from established players.

4. How does pricing influence SANCUSO’s adoption?
Pricing must reflect clinical benefits while remaining accessible to payers; premium pricing can be justified by superior outcomes but risks reimbursement hurdles.

5. What future opportunities exist for SANCUSO?
Potential expansion into additional indications, biosimilar development, and integration with digital health tools offer growth avenues.

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References

1. [Insert detailed citations related to market analysis, regulatory status, competitive landscape, etc.]