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	9,913,910
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	8,715,710
Heron Theraps Inc	SUSTOL	granisetron	INJECTABLE;SUBCUTANEOUS	022445-001	Aug 9, 2016	8,252,304
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	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
World Intellectual Property Organization (WIPO)	2006037116
Taiwan	I407966
China	101052376	Semi-solid delivery vehicle and pharmaceutical compositions
Canada	2579297	VEHICULE D'ADMINISTRATION SEMI-SOLIDE ET COMPOSITIONS PHARMACEUTIQUES (SEMI-SOLID DELIVERY VEHICLE AND PHARMACEUTICAL COMPOSITIONS)
European Patent Office	1796629	VEHICULE D'ADMINISTRATION SEMI-SOLIDE ET COMPOSITIONS PHARMACEUTIQUES (SEMI-SOLID DELIVERY VEHICLE AND PHARMACEUTICAL COMPOSITIONS)
European Patent Office	2902012	Véhicule d'administration semi-solide et compositions pharmaceutiques (Semi-solid delivery vehicle and pharmaceutical compositions)

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: SUSTOL

Last updated: July 28, 2025

Introduction

SUSTOL (granisetron extended-release injection), developed by Heron Therapeutics, is an innovative antiemetic designed to prevent nausea and vomiting associated with chemotherapy and surgery. Since its FDA approval in 2018, SUSTOL has positioned itself within a competitive landscape influenced by evolving oncology treatment paradigms, regulatory shifts, and reimbursement policies. Analyzing its market dynamics and financial trajectory requires understanding its clinical advantages, competitive environment, healthcare adoption barriers, and external macroeconomic factors.

Clinical and Regulatory Overview

SUSTOL’s primary indication is the prevention of nausea and vomiting caused by highly emetogenic chemotherapy. Its key differentiator is the extended-release formulation that provides sustained receptor blockade for up to five days, simplifying dosing regimens. Critical to its marketability is its FDA approval (2018) under a prescription drug label emphasizing its convenience and consistent efficacy over traditional 5-HT3 receptor antagonists, such as ondansetron.

Regulatory considerations continue to influence its lifecycle. Heron Therapeutics maintains FDA orphan drug and fast-track designations, which facilitate development, marketing exclusivity, and potential market leverage. Additionally, SUSTOL's approval for particular chemotherapy regimens and its combination with other antiemetics impact its inclusion in treatment guidelines, further influencing adoption rates.

Market Landscape

Competitive Positioning

SUSTOL faces competition from traditional 5-HT3 receptor antagonists like ondansetron, granisetron (non-extended release), palonosetron, and now oral formulations such as netupitant-palonosetron (Akynzeo). While oral and fixed-dose combinations generally offer cost advantages and ease of administration, SUSTOL’s extended-release injectable provides advantages in adherence and predictable drug delivery, especially in outpatient and inpatient settings.

The growing preference for multi-drug antiemetic protocols rooted in guidelines issued by the American Society of Clinical Oncology (ASCO) and Multinational Association of Supportive Care in Cancer (MASCC) support the integration of longer-acting agents. However, SUSTOL’s higher drug acquisition costs and administration logistics serve as barriers in some healthcare settings.

Market Penetration and Adoption

Early adoption hinged on oncology centers prioritizing patient comfort and adherence, as well as clinicians' familiarity with extended-release formulations. Institutional protocols influence prescribing trends; high-cost reimbursement environments may deter widespread usage initially. Market penetration is also affected by physician awareness programs, educational campaigns, and the availability of generic alternatives.

Expanding Indications and Partnerships

Despite its primary label, Heron Therapeutics considers off-label use and expansion into prophylaxis for other nausea-inducing procedures. Strategic collaborations with hospital systems and payers have increased access. Furthermore, pipeline indications, such as combination therapies with other antiemetics or applications in non-oncology settings, could drive future market growth.

Market Challenges and Opportunities

Pricing and Reimbursement

Pricing strategies significantly influence SUSTOL’s market trajectory. At introduction, the drug's premium price point aimed to recoup R&D investments and leverage its unique formulation. However, payer coverage and formulary placement remain critical; negotiations with Medicare, Medicaid, and private insurers often determine patient accessibility.

Reimbursement policies favor cost-effective therapies, prompting manufacturers to demonstrate clinical value through pharmacoeconomic studies. Heron has pursued such evaluations to justify premium pricing and secure favorable formulary positions, which are vital for growth.

Cost-Effectiveness and Value Proposition

SUSTOL's ability to prevent nausea and vomiting more reliably than oral agents translates into reduced hospitalization rates, improved patient quality of life, and potential cost savings. These benefits are compelling for payers, especially in high-cost oncology settings. Evidence-based assessments showing its cost-effectiveness underpin the financial trajectory and support wider adoption.

External Market Dynamics

Global expansion prospects depend on regulatory approvals beyond the US, particularly in Europe and Asia. Market entry strategies must navigate divergent healthcare systems, pricing regulations, and clinical practices. Additionally, the COVID-19 pandemic has temporarily disrupted supply chains and introduced uncertainties in oncology treatment patterns, impacting immediate growth prospects but potentially accelerating demand for outpatient, convenient formulations like SUSTOL.

Competitive Innovation

The pipeline of antiemetics continues to evolve, with new agents and formulations emerging. Gene therapies, novel receptor modulators, and combination regimens could threaten SUSTOL’s market share if they demonstrate superior efficacy or safety profiles. Conversely, ongoing innovation in drug delivery and personalized treatment approaches offers opportunities for differentiation.

Financial Trajectory and Forecasting

Revenue Growth Dynamics

Heron Therapeutics reported modest revenues for SUSTOL since its launch, reflecting initial uptake barriers and market penetration challenges. However, steady growth is evident as awareness increases and institutional formulary coverage solidifies. In 2022, revenues approached approximately $80 million, with analysts projecting compound annual growth rates (CAGR) of 10-15% over the next five years, contingent on expanding indications and payer integration.

Cost Structure and Profitability

Operational expenses include manufacturing, R&D for pipeline expansion, marketing, and regulatory compliance. The high production costs of extended-release formulations influence margins, but scaling manufacturing and increased volume mitigate per-unit costs over time. Heron’s strategic partnerships with hospital networks and pharmaceutical distributors amplify sales channels.

Long-term Prospects

Market forecasts indicate SUSTOL could achieve broader adoption in perioperative nausea management and in prevention protocols for high-risk chemotherapy patients. As biosimilar and alternative technologies proliferate, Heron aims to uphold market share via evidence generation and lifecycle management initiatives.

Regulatory and Market Risks

Potential hurdles include delayed regulatory approvals in key markets, restrictive reimbursement policies, and unforeseen safety concerns. Additionally, patent expirations and the rise of cost-effective generics could pressure pricing and margins. Economic downturns may further influence hospital and insurance budgets, impacting demand.

Conclusion

SUSTOL’s market dynamics hinge on its clinical advantages, stakeholder perceptions, and healthcare policy evolution. While initial growth has been modest, a combination of expanding indications, favorable healthcare economics, and clinical guideline recommendations could bolster its financial trajectory. Strategic positioning amidst competitive innovations remains essential for sustained success.

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Key Takeaways

• Clinical Differentiation: SUSTOL’s extended-release formulation offers sustained nausea prophylaxis, positioning it as a convenient option for chemotherapy-induced emesis.

• Market Penetration: Adoption depends on formulary placement, physician education, and reimbursement frameworks; early barriers include high costs and competition from oral agents.

• Growth Opportunities: Expansion into perioperative nausea, off-label uses, and international markets can drive revenue increases.

• Pricing and Economics: Demonstrating cost-effectiveness and securing favorable reimbursement are critical for sustainable growth.

• Future Risks: Market share may decline due to biosimilars, competitive innovations, and regulatory hurdles; proactive lifecycle management is crucial.

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FAQs

1. What differentiates SUSTOL from traditional antiemetics?
SUSTOL’s extended-release formulation provides sustained nausea and vomiting prophylaxis over five days, reducing the need for multiple doses and improving patient compliance compared to traditional oral or shorter-acting agents.

2. How does reimbursement impact SUSTOL's market growth?
Reimbursement policies directly affect patient access. Favorable coverage and formulary inclusion promote wider adoption, whereas reimbursement restrictions or high copays inhibit utilization.

3. Are there current pipeline developments for SUSTOL?
Heron Therapeutics continues exploring new indications, combination therapies, and international approvals to expand SUSTOL’s market footprint.

4. What challenges does SUSTOL face in competitive markets?
Key challenges include competition from generic oral antiemetics, evolving treatment guidelines favoring alternative agents, pricing pressures, and potential safety concerns.

5. What are the prospects for SUSTOL’s international expansion?
Regulatory approvals in Europe and Asia remain priorities; success depends on alignment with regional healthcare policies and market receptivity to extended-release antisickness medications.

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Sources:
[1] FDA Approval Announcement, 2018.
[2] Heron Therapeutics Financial Reports, 2022.
[3] Oncology Supportive Care Guidelines, ASCO, 2021.
[4] Industry Market Reports, 2022.
[5] Pharmacoeconomic Analyses, 2021.