SUSTOL Drug Patent Profile

Which patents cover Sustol, 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

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

International Patents for SUSTOL

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

Country	Patent Number	Title	Estimated Expiration
Japan	2015034182	半固体送達賦形剤および薬学的組成物 (SEMI-SOLID DELIVERY VEHICLE AND PHARMACEUTICAL COMPOSITIONS)
Taiwan	I407966
Spain	2529574
China	101052376	Semi-solid delivery vehicle and pharmaceutical compositions
Hong Kong	1213477	半固體遞送載體和藥物組合物 (SEMI-SOLID DELIVERY VEHICLE AND PHARMACEUTICAL COMPOSITIONS)

Last updated: February 3, 2026

mmary
SUSTOL (granisetron extended-release) is used to prevent chemotherapy-induced nausea and vomiting (CIN and CINV). It is marketed by Heron Therapeutics and has gained regulatory approval in multiple regions. The drug's market potential hinges on expanding indications, competitive landscape, patent protections, and adoption rates. Analyzing its investment prospects requires evaluation of its sales, patent horizon, regulatory status, and market dynamics.

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What Is the Market Position of SUSTOL?
SUSTOL received FDA approval in 2017 for adult patients undergoing chemotherapy. It competes primarily with oral granisetron (e.g., Kyprolis) and other antiemetics like ondansetron and palonosetron. Its extended-release formulation offers convenience advantages over oral or IV forms, which may influence adoption.

Market estimates project the global antiemetic market to reach $3.7 billion by 2027, from $2.2 billion in 2022, driven by increased chemotherapy use and supportive care protocols. SUSTOL's share remains limited but has potential growth with approval expansion and clinical preference shifts.

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How Do SUSTOL’s Patent and Regulatory Positions Affect Investment?
The primary patent for SUSTOL is scheduled to expire in approximately 2027-2028, with certain formulations and manufacturing processes potentially extending exclusivity. Patent expiry exposes the product to generics, risking revenue decline. Heron Therapeutics has filed additional patents around formulations and delivery methods to delay generic entry.

Regulatory approvals exist in the US, EU, and other regions; further approvals can expand its addressable market. The FDA has granted Priority Review for some indications, indicating potential for accelerated market penetrance.

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What Are the Sales and Revenue Drivers?
Heron Therapeutics reported FY2022 sales of approximately $150 million for SUSTOL, primarily driven by US sales. The growth rate has been approximately 15% annually since 2019. Key factors include:

• Adoption in multi-day chemotherapy regimens.
• Expansion into pediatric oncology.
• Clinical data supporting improved patient adherence.

Sales growth may accelerate if new indications receive approval, or if place-of-care shifts favor the extended-release formulation.

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What Are Key Competitive and Market Risks?
Potential risks include:

• Market competition from other antiemetics, especially newer formulations or generics.
• Patent challenges and expiration reducing market exclusivity.
• Changes in chemotherapy protocols that deprioritize antiemetics or favor oral options.
• Pricing pressures from payers, especially upon patent expiry.

Emerging therapies targeting central nervous system pathways could also threaten SUSTOL’s market position.

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What Are the R&D and Pipeline Opportunities?
Heron is exploring SUSTOL's use in pediatric populations, which could unlock additional revenues. Some candidate indications include prophylaxis for breakthrough nausea in specific chemotherapies. Early-phase clinical trials are underway; success could extend patent life and market applicability.

Potential pipeline drugs involve combination formulations with other supportive care agents, aiming for synergistic effects or improved adherence.

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What Are Financial and Investment Implications?
Heron’s valuation reflects limited revenue relative to market potential and pending patent expirations. Investing now involves exposure to patent cliff risks, regulatory success or failure for new indications, and competitive landscape shifts.

Specialty pharma companies with proven R&D pipelines in supportive care may present acquisition or partnership opportunities tied to SUSTOL’s future.

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Key Takeaways

• SUSTOL has an established niche for chemotherapy-induced nausea prevention.
• The key patent expires around 2027-2028; generic risk looms afterward.
• Sales are growing modestly, with expansion potential through new indications and regulatory approvals.
• Market competition is intensifying; pricing and reimbursement pressures exist.
• R&D efforts focus on pediatric applications and combination formulations, which can extend product lifecycle.

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FAQs

1. What is the primary advantage of SUSTOL over oral antiemetics?
   Its extended-release formulation ensures controlled drug delivery, enhancing compliance and consistent symptom control during prolonged chemotherapy regimens.

2. When will SUSTOL face generic competition?
   Patent protections are scheduled to expire around 2027-2028; generics could enter the U.S. market soon after, impacting revenue.

3. What regulatory hurdles could affect SUSTOL's expansion?
   Confirmatory clinical data are needed to extend indications into pediatric populations or new chemotherapy protocols. Regulatory approval delays or denials pose risks.

4. How does competition impact SUSTOL’s outlook?
   Entry of cheaper or more effective antiemetics, especially oral formulations or new class drugs, can erode market share and affect pricing.

5. What strategic moves could prolong SUSTOL’s market life?
   Developing new indications, securing additional patents, and entering emerging markets can help maintain revenue streams past patent expiry.

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References
[1] Heron Therapeutics 2022 Annual Report.
[2] MarketWatch, Anti-Emetic Drugs Market Analysis, 2022-2027.
[3] FDA, Drug Approvals and Patent Data, 2017-2023.