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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. There are five patents protecting this drug.

This drug has eighteen patent family members in ten countries.

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.

DrugPatentWatch^® Generic Entry Outlook for Sustol

Indicators of Generic Entry

Summary for SUSTOL

International Patents:	18
US Patents:	5
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	51
Clinical Trials:	1
Patent Applications:	4,317
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

SUSTOL is protected by five US patents.

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	10,357,570
Heron Theraps Inc	SUSTOL	granisetron	INJECTABLE;SUBCUTANEOUS	022445-001	Aug 9, 2016		RX	Yes	Yes	8,715,710		Y
Heron Theraps Inc	SUSTOL	granisetron	INJECTABLE;SUBCUTANEOUS	022445-001	Aug 9, 2016		RX	Yes	Yes	8,252,305

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	8,252,305
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

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/002296 Prevention 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	2008514646
Hong Kong	1213477	半固體遞送載體和藥物組合物 (SEMI-SOLID DELIVERY VEHICLE AND PHARMACEUTICAL COMPOSITIONS)
China	101052376	Semi-solid delivery vehicle and pharmaceutical compositions

SUSTOL Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for SUSTOL

Introduction

SUSTOL, developed by Heron Therapeutics, is an extended-release, injectable 5-HT3 receptor antagonist designed to prevent chemotherapy-induced nausea and vomiting (CINV). Here, we will delve into the market dynamics and financial trajectory of SUSTOL, highlighting its performance, challenges, and future outlook.

Product Overview

SUSTOL utilizes Heron's Biochronomer® drug delivery technology to maintain therapeutic levels of granisetron over several days, providing prolonged protection against CINV[1].

Historical Sales Performance

2019

In 2019, SUSTOL saw a significant decline in net product sales. For the three and twelve months ended December 31, 2019, net product sales were $0.5 million and $13.8 million, respectively, down from $5.4 million and $21.3 million in the same periods of 2018. This decline was largely due to the company's decision to discontinue all discounting of SUSTOL on October 1, 2019[1].

2022

By 2022, SUSTOL's sales began to stabilize. For the three and twelve months ended December 31, 2022, net product sales were $3.0 million and $10.2 million, respectively, compared to $2.5 million and $9.9 million in the same periods of 2021[4].

2023

In 2023, SUSTOL continued to show modest growth. For the three and twelve months ended December 31, 2023, net product sales were $3.8 million and $13.0 million, respectively, up from $3.0 million and $10.2 million in the same periods of 2022[3].

2024

As of the third quarter of 2024, SUSTOL's net product sales were $2.8 million and $10.6 million for the three and nine months ended September 30, 2024, respectively. This is a slight decrease from the $3.4 million and $9.3 million in the same periods of 2023[2].

Market Dynamics

Competitive Landscape

The CINV market is competitive, with several other products available, including CINVANTI (aprepitant) injectable emulsion, also from Heron Therapeutics. CINVANTI has consistently shown stronger sales performance compared to SUSTOL, indicating a competitive edge within the same company's portfolio[1][2][3].

Regulatory Environment

The regulatory environment has not significantly impacted SUSTOL's sales trajectory. However, any changes in FDA regulations or approvals of new CINV treatments could influence market dynamics.

Patient and Physician Preferences

Patient and physician preferences play a crucial role in the adoption of SUSTOL. The extended-release nature of SUSTOL can be a significant advantage, but it must compete with other convenient and effective CINV treatments.

Financial Trajectory

Revenue Trends

Despite the initial decline in 2019, SUSTOL has shown a gradual recovery and stabilization in subsequent years. However, the sales figures remain relatively low compared to other products in Heron Therapeutics' portfolio.

Cost and Expense Management

The cost of product sales and operating expenses are critical factors in SUSTOL's financial performance. Heron Therapeutics has been managing these costs to optimize profitability, but the overall impact on SUSTOL's financial trajectory is still modest[1][2][5].

Guidance and Projections

Heron Therapeutics has not provided specific guidance for SUSTOL's future sales performance in isolation but has outlined overall expectations for the oncology care franchise, which includes SUSTOL. The company expects continued growth in the oncology care franchise, which could indirectly benefit SUSTOL[3].

Challenges and Opportunities

Challenges

• Discounting and Pricing: The decision to discontinue discounting in 2019 significantly impacted SUSTOL's sales. Managing pricing strategies effectively is crucial.
• Competition: Strong competition from other CINV treatments, including CINVANTI, poses a challenge.
• Market Penetration: Increasing market penetration and adoption rates among physicians and patients is essential.

Opportunities

• Extended-Release Technology: The unique Biochronomer® technology offers a prolonged therapeutic effect, which can be a selling point.
• Expanding Indications: Potential expansion of indications or approvals for new uses could increase SUSTOL's market share.
• Marketing and Education: Enhanced marketing and educational efforts could improve physician and patient awareness and preference for SUSTOL.

Key Takeaways

• SUSTOL's sales have been volatile, with a significant decline in 2019 due to pricing changes but gradual recovery in subsequent years.
• The product faces strong competition within the CINV market.
• Heron Therapeutics' overall financial health and guidance for the oncology care franchise suggest potential for growth.
• Effective management of pricing, competition, and market penetration is crucial for SUSTOL's future success.

FAQs

What is SUSTOL used for?

SUSTOL is used to prevent chemotherapy-induced nausea and vomiting (CINV).

How does SUSTOL work?

SUSTOL uses Heron's Biochronomer® drug delivery technology to maintain therapeutic levels of granisetron over several days.

Why did SUSTOL's sales decline in 2019?

The decline in 2019 was due to the company's decision to discontinue all discounting of SUSTOL.

How has SUSTOL's sales performance been in recent years?

SUSTOL has shown modest growth and stabilization in sales since 2022, but at lower levels compared to other products in Heron Therapeutics' portfolio.

What are the main challenges facing SUSTOL?

The main challenges include competition from other CINV treatments, pricing strategies, and market penetration.

Sources

1. Heron Therapeutics Announces Financial Results for the Three and Twelve Months Ended December 31, 2019.
2. Heron Therapeutics Announces Third Quarter 2024 Financial Results.
3. Heron Therapeutics Announces Fourth Quarter and Full-Year 2023 Financial Results and Highlights Recent Corporate Updates.
4. Heron Therapeutics Announces Financial Results for the Three and Twelve Months Ended December 31, 2022.
5. Heron Therapeutics Announces First Quarter 2024 Financial Results.