Ondansetron hydrochloride - Generic Drug Details

What are the generic drug sources for ondansetron hydrochloride and what is the scope of freedom to operate?

Ondansetron hydrochloride is the generic ingredient in six branded drugs marketed by Accord Hlthcare, Am Regent, Apotex Inc, Avet Lifesciences, Baxter Hlthcare Corp, Chartwell Molecular, Eugia Pharma, Fresenius Kabi Usa, Gland Pharma Ltd, Hikma, Hikma Farmaceutica, Hospira, Lannett Co Inc, Luitpold, Onesource Specialty, Pliva Hrvatska Doo, Qilu Pharm Hainan, Rising, Sagent Pharms, Sandoz, Sun Pharm Inds (in), Teva, Wockhardt Bio Ag, Sun Pharm Inds Ltd, Taro Pharms Ireland, Glaxosmithkline, Amneal Pharms, Aurobindo Pharma, Pharm Assoc, Taro, Apotex, Chartwell Molecules, Chartwell Rx, Dr Reddys Labs Ltd, Glenmark Pharms Ltd, Hikma Intl Pharms, Ipca Labs Ltd, and Natco Pharma Ltd, and is included in seventy-two NDAs. Additional information is available in the individual branded drug profile pages.

There are sixteen drug master file entries for ondansetron hydrochloride. Sixty-nine suppliers are listed for this compound. There are two tentative approvals for this compound.

Summary for ondansetron hydrochloride

US Patents:	0
Tradenames:	6
Applicants:	38
NDAs:	72
Drug Master File Entries:	16
Finished Product Suppliers / Packagers:	69
Raw Ingredient (Bulk) Api Vendors:	81
Clinical Trials:	702
What excipients (inactive ingredients) are in ondansetron hydrochloride?	ondansetron hydrochloride excipients list
DailyMed Link:	ondansetron hydrochloride at DailyMed

Recent Clinical Trials for ondansetron hydrochloride

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

Sponsor	Phase
Montefiore Medical Center	PHASE4
Centre Hospitalier Universitaire Vaudois	NA
Texas Scottish Rite Hospital for Children	PHASE2

See all ondansetron hydrochloride clinical trials

Generic filers with tentative approvals for ONDANSETRON HYDROCHLORIDE

Applicant	Application No.	Strength	Dosage Form
		EQ 2MG BASE/ML	INJECTABLE;INJECTION
		EQ 2MG BASE/ML	INJECTABLE;INJECTION

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for ondansetron hydrochloride

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

Anatomical Therapeutic Chemical (ATC) Classes for ondansetron hydrochloride

A04AA	Serotonin (5HT3) antagonists
A04A	ANTIEMETICS AND ANTINAUSEANTS
A04	ANTIEMETICS AND ANTINAUSEANTS
A	Alimentary tract and metabolism

Paragraph IV (Patent) Challenges for ONDANSETRON HYDROCHLORIDE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
ZOFRAN	Oral Solution	ondansetron hydrochloride	4 mg/5 mL	020605	1	2004-12-20

US Patents and Regulatory Information for ondansetron hydrochloride

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Sandoz	ZOFRAN PRESERVATIVE FREE	ondansetron hydrochloride	INJECTABLE;INJECTION	020007-003	Dec 10, 1993		DISCN	Yes	No
Teva	ONDANSETRON HYDROCHLORIDE	ondansetron hydrochloride	TABLET;ORAL	076252-002	Jun 25, 2007		DISCN	No	No
Chartwell Molecular	ONDANSETRON HYDROCHLORIDE	ondansetron hydrochloride	INJECTABLE;INJECTION	090116-001	Apr 14, 2010		DISCN	No	No

Expired US Patents for ondansetron hydrochloride

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Sandoz	ZOFRAN	ondansetron hydrochloride	TABLET;ORAL	020103-002	Dec 31, 1992	4,753,789*PED
Sandoz	ZOFRAN	ondansetron hydrochloride	TABLET;ORAL	020103-001	Dec 31, 1992	5,578,628*PED
Sandoz	ZOFRAN PRESERVATIVE FREE	ondansetron hydrochloride	INJECTABLE;INJECTION	020007-003	Dec 10, 1993	4,695,578*PED

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: Ondansetron Hydrochloride

Last updated: July 27, 2025

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Introduction

Ondansetron hydrochloride, a selective 5-HT3 receptor antagonist, is a cornerstone therapeutic agent used primarily to prevent and treat nausea and vomiting caused by chemotherapy, radiotherapy, and surgery. Since its approval in the 1990s, ondansetron has experienced dynamic shifts driven by clinical efficacy, regulatory landscapes, competitive innovations, and global health trends. This report delineates the current market dynamics and projects the financial trajectory of ondansetron hydrochloride within the broader pharmaceutical ecosystem.

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Regulatory Landscape and Approval Timeline

Initially approved by the U.S. Food and Drug Administration (FDA) in 1991 for chemotherapy-induced nausea and vomiting (CINV), ondansetron quickly gained widespread clinical acceptance owing to its superior efficacy over earlier antiemetics [1]. Regulatory approvals extended to other markets, including Europe and Asia, solidifying its global footprint.

Recent regulatory scrutiny has centered on safety concerns such as QT prolongation, leading to revised prescribing information and monitoring requirements, particularly in vulnerable populations [2]. These safety considerations influence formulary decisions and prescribing patterns, subtly impacting market growth.

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Market Drivers

1. Rising Cancer Incidence and Advanced Therapies
The global cancer burden continues to escalate, with an estimated 19.3 million new cases in 2020, according to WHO data [3]. Chemotherapy regimens are increasingly potent and targeted, heightening the demand for effective antiemetics like ondansetron. As supportive care improves, patient compliance and quality of life are enhanced, further reinforcing ondansetron's role.

2. Increased Use in Surgical and Postoperative Settings
Surgical procedures often induce postoperative nausea and vomiting (PONV), with incidences reaching 30-50% in high-risk groups [4]. Ondansetron's proven efficacy in PONV prophylaxis elevates its utilization in perioperative protocols, widening its market base.

3. Expanding Patient Demographics
Population aging in developed countries and rising chemotherapy access in emerging economies expand ondansetron's target demographic. Geriatric populations are particularly susceptible to nausea, amplifying demand.

4. Competitive and Novel Formulations
While oral and injectable forms dominate, extended-release formulations and combination therapies with other antiemetics (e.g., dexamethasone) have improved therapeutic outcomes, fostering sustained clinical relevance.

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Market Challenges

1. Generic Competition and Price Erosion
The expiration of key patents in the early 2000s ushered in a wave of generic ondansetron products, exerting significant downward pressure on prices [5]. Multiple manufacturers now offer bioequivalent formulations, intensifying market competition.

2. Emerging Alternative Agents
Agents such as palonosetron, a second-generation 5-HT3 antagonist, demonstrate longer half-life and potentially superior efficacy [6]. The adoption of these alternatives slightly cannibalizes ondansetron’s market share, especially in institutions prioritizing advanced therapeutics.

3. Safety and Regulatory Constraints
Concerns over QT interval prolongation have led to increased monitoring protocols, potentially affecting prescribing convenience and hospital formulary decisions [2].

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Distribution Channels and Market Segments

• Hospital and Oncology Centers: Major usage in chemotherapy and surgical settings, with procurement driven by institutional formularies.
• Retail Pharmacies: Oral formulations used by outpatient populations, especially in developed markets.
• Biotechnology and Contract Manufacturing: A significant portion of generic supply, with contract manufacturers expanding capacities to meet global demand.

Emerging markets in Asia-Pacific and Latin America present growth opportunities owing to increasing healthcare infrastructure and cancer treatment access, despite price sensitivity.

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Financial Trajectory and Market Forecast

Historical Sales Performance:
Global ondansetron sales approximated USD 1.2 billion in 2020, with steady CAGR of 3-4% over the past decade, primarily driven by existing formulations and expanding indications [7].

Projected Growth Dynamics (2023-2030):
Analysts project a compound annual growth rate (CAGR) of approximately 2-3%, influenced by patent expirations, generic proliferation, and healthcare access improvements in emerging economies [8]. However, growth may be modest in mature markets due to price pressures and alternative agents.

Key growth regions:

• Asia-Pacific: Rapid infrastructure expansion and increasing cancer incidence forecast a CAGR of 4-5%.
• Latin America: Growing penetration in outpatient care and tumor management strategies support sustained demand.
• Europe and North America: Market maturity suggests stabilization, though innovations and combination therapies may catalyze selective growth.

Impact of Biosimilars & Patent Expiries:
The arrival of biosimilars and new formulations will likely suppress prices, but volume-driven growth could counterbalance margins, especially in price-sensitive regions [9].

Potential Opportunities:

• Development of targeted formulations with improved safety profiles.
• Strategic partnerships with healthcare providers to optimize formulary placement.
• Expansion into prophylactic, pediatric, and alternative anticancer regimens.

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Competitive Landscape

Major pharmaceutical players such as GlaxoSmithKline (original innovator), Teva, Mylan, and Sandoz drive the generic market. Innovator companies continue to innovate around formulations and combination therapies, e.g., ondansetron with dexamethasone. Regulatory data, patent portfolios, and manufacturing capabilities distinguish market leaders and influence their financial trajectories.

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Regulatory and Patent Outlook

While most patents have expired, certain formulation patents and secondary patents could delay generic entry in specific jurisdictions. Ongoing patent litigations and regulatory data exclusivities remain critical factors influencing market exclusivity and revenue consolidation.

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Conclusion and Future Outlook

Ondansetron hydrochloride remains a vital antiemetic amid evolving clinical and regulatory frameworks. Its global market is underpinned by increasing cancer prevalence, expanding indications, and ongoing innovation. However, price competition, emergence of superior agents, and safety considerations present challenges to sustained growth.

In the next decade, the financial trajectory for ondansetron is poised for modest, steady growth with regional disparities. Strategic adaptation—such as formulation innovation and market expansion—will determine the extent of its financial resilience.

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Key Takeaways

• Steady demand amid patent expiries: Despite significant generic competition, ondansetron's established clinical role ensures consistent demand, particularly in institutional settings.

• Regional growth opportunities: The Asia-Pacific and Latin America regions will likely spearhead growth driven by healthcare infrastructure improvements and rising cancer burdens.

• Competitive innovation imperative: Adoption of new formulations and combination therapies will influence market positioning and profitability.

• Regulatory vigilance: Safety concerns and evolving prescribing guidelines necessitate ongoing regulatory engagement and formulation refinement.

• Margin preservation strategies: Manufacturers must balance price pressures with value-based differentiation, including enhanced safety profiles and novel delivery methods.

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FAQs

1. How does patent expiry impact ondansetron's market dynamics?
Patent expiries in the early 2000s led to a surge in generic ondansetron products, significantly lowering prices and intensifying competition. While this resulted in revenue decline for original patent holders, it expanded access in many markets and stabilized overall volume sales.

2. Are there emerging alternatives that threaten ondansetron’s dominance?
Yes. Agents like palonosetron offer longer half-life and potentially superior efficacy, attracting adoption in specialized settings and limiting ondansetron’s growth potential in certain applications.

3. What regions are expected to drive future growth for ondansetron?
The Asia-Pacific and Latin America regions present the most promising opportunities due to increasing cancer cases, expanding healthcare infrastructure, and growing acceptance of supportive cancer care.

4. How do safety concerns influence ondansetron’s market trajectory?
QT prolongation risks lead to increased monitoring requirements, potentially restricting prescribing in vulnerable populations and influencing formulary decisions, thereby moderating growth in certain jurisdictions.

5. What strategic moves should manufacturers consider to sustain revenues?
Investing in formulation innovations, forming strategic partnerships, targeting expanding indications, and navigating regulatory landscapes effectively are essential for maintaining market share and profitability.

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References

[1] US FDA. “Ondansetron Tablets and Injectable.” 1991.
[2] EMA. “Ondansetron: European Public Assessment Report.” 2019.
[3] WHO. “Cancer Fact Sheet.” 2020.
[4] Apfel CC et al. “A simplified risk score for predicting postoperative nausea and vomiting.” Anesthesiology. 2010.
[5] IMS Health. “Global Oncology Market Report.” 2021.
[6] Hesketh PJ et al. “Palonosetron: A novel 5-HT3 receptor antagonist for prophylaxis of chemotherapy-induced nausea and vomiting.” Oncology. 2014.
[7] MarketWatch. “Ondansetron Market Size & Share, 2010-2022.” 2022.
[8] Grand View Research. “Anti-nausea Drugs Market Analysis.” 2022.
[9] EvaluatePharma. “Marketed Oncology Drugs and Biosimilars.” 2022.