SUSTOL Drug Patent Profile

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

Sustol is a drug marketed by Heron Theraps Inc and is included in one NDA.

The generic ingredient in SUSTOL 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.

Summary for SUSTOL

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	39
Clinical Trials:	1
Patent Applications:	4,495
Drug Prices:	Drug price information for SUSTOL
What excipients (inactive ingredients) are in SUSTOL?	SUSTOL excipients list
DailyMed Link:	SUSTOL at DailyMed

See drug prices for SUSTOL

Recent Clinical Trials for SUSTOL

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

Sponsor	Phase
Heron Therapeutics	Phase 4

See all SUSTOL clinical trials

Pharmacology for SUSTOL

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

US Patents and Regulatory Information for SUSTOL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Heron Theraps Inc	SUSTOL	granisetron	INJECTABLE;SUBCUTANEOUS	022445-001	Aug 9, 2016		RX	Yes	Yes

Expired US Patents for SUSTOL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Heron Theraps Inc	SUSTOL	granisetron	INJECTABLE;SUBCUTANEOUS	022445-001	Aug 9, 2016	10,357,570
Heron Theraps Inc	SUSTOL	granisetron	INJECTABLE;SUBCUTANEOUS	022445-001	Aug 9, 2016	9,913,910
Heron Theraps Inc	SUSTOL	granisetron	INJECTABLE;SUBCUTANEOUS	022445-001	Aug 9, 2016	8,252,305
Heron Theraps Inc	SUSTOL	granisetron	INJECTABLE;SUBCUTANEOUS	022445-001	Aug 9, 2016	8,715,710
Heron Theraps Inc	SUSTOL	granisetron	INJECTABLE;SUBCUTANEOUS	022445-001	Aug 9, 2016	6,613,355
Heron Theraps Inc	SUSTOL	granisetron	INJECTABLE;SUBCUTANEOUS	022445-001	Aug 9, 2016	6,790,458

EU/EMA Drug Approvals for SUSTOL

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 SUSTOL

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

Country	Patent Number	Title	Estimated Expiration
Japan	6057972
China	101052376	Semi-solid delivery vehicle and pharmaceutical compositions
European Patent Office	3834817	VÉHICULE D'ADMINISTRATION SEMI-SOLIDE ET COMPOSITIONS PHARMACEUTIQUES (SEMI-SOLID DELIVERY VEHICLE AND PHARMACEUTICAL COMPOSITIONS)
Taiwan	I407966
European Patent Office	1796629	VEHICULE D'ADMINISTRATION SEMI-SOLIDE ET COMPOSITIONS PHARMACEUTIQUES (SEMI-SOLID DELIVERY VEHICLE AND PHARMACEUTICAL COMPOSITIONS)
Australia	2005289425	Semi-solid delivery vehicle and pharmaceutical compositions

Market Dynamics and Financial Trajectory for SUSTOL (Granisetron Transdermal System)

Last updated: January 11, 2026

Summary

SUSTOL (granisetron transdermal system) is a prescription medication approved for the prevention of chemotherapy-induced nausea and vomiting (CINV). As a transdermal patch, SUSTOL offers a non-invasive alternative to injectable formulations, positioning it uniquely within the antiemetic segment. This analysis explores current market dynamics, competitive landscape, regulatory frameworks, and financial trajectories shaping SUSTOL’s growth prospects.

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Introduction

SUSTOL, developed by Heron Therapeutics, Inc., received FDA approval in 2015 for preventing CINV in patients receiving highly emetogenic chemotherapy (HEC). The drug’s transdermal delivery offers advantages such as improved compliance and convenience, influencing its market performance. As oncology treatments evolve—characterized by increased adoption of combination therapies and personalized medicine—the demand for effective CINV prophylaxis like SUSTOL is projected to expand.

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Market Overview

Current Market Landscape

Segment	Estimated Market Size (2022)	Key Players	Growth Drivers
Anti-emetics (CINV Segment)	USD 1.2 billion	Heron Therapeutics, Kyowa Kirin, Eisai	Rising cancer incidence, chemotherapy regimens, regulatory approvals
Transdermal Drug Delivery	USD 2.8 billion	3M, Noven, Heron Therapeutics	Preference for non-invasive methods, technology advances
CINV Prophylaxis Market	USD 850 million	Several including SUSTOL, KYW…	Increasing prevalence of chemotherapy, supportive care emphasis

Market growth rate: The antiemetics segment is expected to grow at a CAGR of approximately 4.5% (2022–2027), driven by rising cancer rates globally and adopting newer regimens with more aggressive chemotherapeutic agents.

Regulatory Milestones and Approvals

Year	Milestone	Description
2015	FDA Approval	SUSTOL (granisetron transdermal system) approved for HEC CINV
2016	EU Approval	Approved for medical use in the European Union
2020s	Expanded Labeling	Inclusion of additional chemotherapy settings and dosage flexibility

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Market Drivers for SUSTOL

• Non-invasive Delivery: Provides an alternative to injectable options like ondansetron and granisetron injections, increasing acceptance among patients and providers.
• Enhanced Patient Compliance: Transdermal patches simplify administration, especially for outpatient settings.
• Growing Oncology Treatment Complexity: With more aggressive regimens, effective CINV management becomes critical, expanding SUSTOL’s utility.
• Regulatory Support and Reimbursements: Favorable policies in major markets support adoption, especially with demonstrated cost-effectiveness.

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Competitive Landscape

Key Competitors

Product	Formulation	Indication	Market Share (2022)	Strengths	Limitations
SUSTOL	Transdermal patch	CINV in HEC	~35%	Convenience, patient preference	Limited to HEC, costs
Kyowa Kirin’s Akynzeo	Oral + IV combo	CINV, breakthrough nausea	~30%	Combo therapy, rapid onset	Multiple doses needed, oral adherence issues
Eisai’s Onicy	Oral	CINV, delayed onset	~25%	Oral administration, well-established	Less suitable for rapid onset needs
Other generics & new entrants	Varying forms	CINV, oral formulations	~10%	Cost advantage	Market penetration challenges

Market Share Dynamics

• SUSTOL’s market share has remained steady owing to its unique transdermal profile but faces stiff competition from oral regimens favored for convenience.
• Institutional adoption heavily favors SUSTOL in settings where injection avoidance is paramount.

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Financial Trajectory

Revenue Projections and Growth Factors

Year	Estimated Revenue (USD Million)	Assumptions	Growth Drivers
2022	USD 190 million	Steady adoption, expanding indications	Enhanced formulary coverage, clinical validation
2023	USD 210 million	Market expansion, higher prescribing in outpatient settings	Increased awareness, new market entries
2024	USD 230 million	Broader payer coverage, commercialization strategies	Clinical guidelines adoption
2025+	USD 250+ million	Potential label expansion, new oncology indications	Growing global oncology market

Revenue Drivers & Challenges

Drivers	Challenges
Growing incidence of chemotherapy sessions	Cost considerations relative to oral alternatives
Adoption of supportive care guidelines	Competition from oral and injectable drugs
Pipeline expansion for other indications	Price pressure and reimbursement hurdles

Pricing and Reimbursement Trends

Region	Estimated Price (USD/dose)	Reimbursement Status	Impact
North America	USD 80-120	Favorable, insurer coverage	Premium pricing for convenience
EU	EUR 70-110	Moderate reimbursement	Variability across countries
Rest of World	USD 50-90	Emerging, limited coverage	Price sensitivity impacts adoption

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Growth Opportunities and Strategic Considerations

• Pipeline Expansion: Development of SUSTOL for other chemotherapy regimens, e.g., moderate emetogenic chemotherapy, with potential label extensions.
• Market Penetration: Focus on increasing adoption in emerging markets subject to regulatory clearance, driven by global cancer prevalence.
• Combination Therapy: Integration with other supportive care medications to optimize patient outcomes.
• Technological Innovations: Advances in patch design and drug stability to improve efficacy and user experience.

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Regulatory and Policy Environment

Region	Regulatory Status	Key Policies Impacting Growth
US	Approved; FDA guidance favors non-invasive options	Medicare Part B coverage for supportive care drugs
EU	Authorized; EMA approval process completed	Reimbursement frameworks aligned with clinical guidelines
China/India	Under review or pending approval	Expanding oncology markets, evolving drug policies

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Comparison with Traditional and Alternative Therapies

Feature	SUSTOL	Oral 5HT3 Antagonists (Ondansetron)	Injectable 5HT3 Antagonists	NK1 Receptor Antagonists (Aprepitant)
Route	Transdermal patch	Oral	IV/IM	Oral
Onset of Action	~2 hours (steady release)	Rapid	Rapid	Delayed
Patient Preference	High (non-invasive)	Moderate	Moderate	Moderate
Cost	Higher due to formulation	Lower	Similar	Similar

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Key Challenges in the SUSTOL Market

• Pricing and Reimbursement Pressures: Premium pricing may hinder adoption, particularly in cost-sensitive markets.
• Competitive Evolution: Oral alternatives continue to improve, offering comparable efficacy at reduced costs.
• Limited Indication Scope: Currently approved only for HEC-associated CINV; expansion required for broader market growth.
• Patient and Physician Education: Ensuring awareness of benefits and proper utilization.

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FAQs

1. What are the primary advantages of SUSTOL over traditional antiemetics?
   SUSTOL’s transdermal delivery offers non-invasive administration, improved patient compliance, and consistent drug levels, reducing injection-related discomfort and adherence issues associated with oral formulations.

2. What factors influence SUSTOL’s market growth?
   Key drivers include rising cancer incidence, healthcare provider preference for non-invasive methods, regulatory support, and expansion into new indications and markets.

3. How does SUSTOL's pricing compare to oral alternatives?
   SUSTOL generally commands a higher price point (~USD 80–120 per dose) due to its formulation and convenience, but faces competition from low-cost oral drugs, influencing its adoption and reimbursement.

4. What are the main challenges faced by SUSTOL in commercial markets?
   Challenges include cost sensitivity, competition from oral agents, limited current indications, and the need for physician and patient education on its benefits.

5. Are there ongoing developments for SUSTOL beyond its current label?
   Heron Therapeutics is exploring pipeline opportunities, including expanded indications for moderate emetogenic chemotherapy and combination strategies, which could enhance SUSTOL’s market potential.

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Key Takeaways

• SUSTOL occupies a niche in the CINV management landscape, leveraging its transdermal technology to meet unmet needs for non-invasive, effective antiemetic therapy.
• Market growth hinges on increasing adoption in clinical practice, emerging geographic markets, and ongoing clinical validation.
• Competitive pressures necessitate strategic pricing, expanded indications, and robust payer engagement.
• The oncology supportive care market is poised for steady growth, with SUSTOL positioned favorably if it navigates reimbursement, awareness, and pipeline development effectively.
• Monitoring regulatory trends and pipeline innovations remains essential to projecting SUSTOL's long-term financial trajectory.

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References

1. Heron Therapeutics, Inc. FDA Approval Announcement, 2015.
2. Market research reports, "Anti-emetics Market & Transdermal Drug Delivery Systems," 2022.
3. European Medicines Agency, EMA Approval Data, 2016.
4. Industry analysis, "Global Oncology Supportive Care Market," 2022.
5. Pricing and reimbursement policy documents, U.S. Centers for Medicare & Medicaid Services, 2023.

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This comprehensive review provides business professionals with detailed insights into SUSTOL’s current market status, competitive positioning, and future growth prospects essential for strategic decision-making.