ZOFRAN ODT Drug Patent Profile

When do Zofran Odt patents expire, and what generic alternatives are available?

Zofran Odt is a drug marketed by Sandoz and is included in one NDA.

The generic ingredient in ZOFRAN ODT is ondansetron. There are twenty-eight drug master file entries for this compound. Thirty-three suppliers are listed for this compound. Additional details are available on the ondansetron profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Zofran Odt

A generic version of ZOFRAN ODT was approved as ondansetron by CHARTWELL MOLECULES on December 26^th, 2006.

Summary for ZOFRAN ODT

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	103
Clinical Trials:	163
Patent Applications:	5,303
Drug Prices:	Drug price information for ZOFRAN ODT
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ZOFRAN ODT
DailyMed Link:	ZOFRAN ODT at DailyMed

See drug prices for ZOFRAN ODT

Recent Clinical Trials for ZOFRAN ODT

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

Sponsor	Phase
National Institute on Aging (NIA)	PHASE1
General Biophysics LLC	PHASE1
Tanta University	Phase 3

See all ZOFRAN ODT clinical trials

US Patents and Regulatory Information for ZOFRAN ODT

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Sandoz	ZOFRAN ODT	ondansetron	TABLET, ORALLY DISINTEGRATING;ORAL	020781-001	Jan 27, 1999		DISCN	Yes	No
Sandoz	ZOFRAN ODT	ondansetron	TABLET, ORALLY DISINTEGRATING;ORAL	020781-002	Jan 27, 1999		DISCN	Yes	No

Expired US Patents for ZOFRAN ODT

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Sandoz	ZOFRAN ODT	ondansetron	TABLET, ORALLY DISINTEGRATING;ORAL	020781-002	Jan 27, 1999	4,753,789*PED
Sandoz	ZOFRAN ODT	ondansetron	TABLET, ORALLY DISINTEGRATING;ORAL	020781-001	Jan 27, 1999	4,695,578*PED
Sandoz	ZOFRAN ODT	ondansetron	TABLET, ORALLY DISINTEGRATING;ORAL	020781-002	Jan 27, 1999	5,578,628*PED
Sandoz	ZOFRAN ODT	ondansetron	TABLET, ORALLY DISINTEGRATING;ORAL	020781-002	Jan 27, 1999	5,955,488*PED
Sandoz	ZOFRAN ODT	ondansetron	TABLET, ORALLY DISINTEGRATING;ORAL	020781-002	Jan 27, 1999	4,695,578*PED

International Patents for ZOFRAN ODT

See the table below for patents covering ZOFRAN ODT around the world.

Country	Patent Number	Title	Estimated Expiration
Israel	84638	PHARMACEUTICAL COMPOSITIONS FOR TREATMENT OF GASTROINTESTINAL DISORDERS
Australia	4173996
World Intellectual Property Organization (WIPO)	9615785
Canada	1296637	COMPOSITION PHARMACEUTIQUE POUR LE TRAITEMENT DES TROUBLES GASTROINTESTINAUX (PHARMACEUTICAL COMPOSITION FOR THE TREATMENT OF GASTROINTESTINAL DISORDERS)
Japan	H0324447

Market Dynamics and Financial Trajectory for ZOFRAN ODT

Last updated: August 8, 2025

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Introduction

ZOFRAN ODT (ondansetron orally disintegrating tablet) is a prominent antiemetic medication primarily used to prevent nausea and vomiting associated with chemotherapy, radiotherapy, and surgery. Since its initial approval, ZOFRAN ODT has become an integral product within the antiemetic drug segment. Its unique formulation caters to patient convenience and compliance, making it a valuable asset for pharmaceutical companies. This article explores the evolving market dynamics and financial trajectory of ZOFRAN ODT, with an emphasis on competitive landscape, regulatory trends, market drivers, challenges, and future growth prospects.

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Market Overview and Segmentation

The global antiemetic market, valued at approximately USD 1.8 billion in 2022, is projected to grow at a CAGR of 4.5% through 2030 [1]. ZOFRAN ODT, a formulation of ondansetron developed by Pfizer, commands a significant share owing to its preferred delivery method, especially among chemotherapy patients.

Segment-wise, the antiemetics market can be categorized into:

• Drug Class: Serotonin (5-HT3) receptor antagonists (including ondansetron, granisetron), Dopamine antagonists, NK1 receptor antagonists, and others.
• Formulation: Oral disintegrating tablets, injectable, oral tablets, patches.
• Indication: Chemotherapy-induced nausea and vomiting (CINV), post-operative nausea and vomiting (PONV), radiation-induced nausea.

ZOFRAN ODT specifically targets the oral disintegrating tablet segment, a rapidly growing niche driven by patient preference and compliance benefits.

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Market Dynamics Influencing ZOFRAN ODT

1. Growing Prevalence of Cancers and Increased Chemotherapy Use

The increasing global incidence of cancer, projected to reach 29.4 million new cases annually by 2040, directly correlates with higher demand for antiemetics like ZOFRAN [2]. Chemotherapy’s emetogenic potential necessitates effective prophylactic options, elevating ZOFRAN ODT’s market share.

2. Regulatory Approvals and Label Expansions

Regulatory agencies such as the FDA and EMA have approved ZOFRAN for various indications, including breakthrough chemotherapy-induced nausea. Recent approvals for pediatric formulations and expanded indications have broadened its usage, positively impacting sales [3].

3. Patient-Centric Formulation Adoption

The ODT form combines rapid onset and ease of administration, especially beneficial for pediatric, geriatric, or nausea-affected patients. This advantage boosts prescription rates over traditional tablets or injectable forms, contributing to sustained demand growth.

4. Competitive Landscape and Patent Dynamics

While originally protected by Pfizer’s patent, various generic manufacturers now produce ondansetron ODT formulations, intensifying price competition. The expiration of patents for earlier formulations has triggered a price erosion phase but also encouraged market expansion through affordability [4].

5. Strategic Collaborations and Market Penetration

Partnerships between Pfizer and regional distributors expand access, especially in emerging markets, fostering revenue growth. Additionally, aggressive marketing campaigns targeting oncology clinics bolster product visibility.

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Financial Trajectory Analysis

1. Historical Revenue Trends

Pfizer’s antiemetic segment, driven significantly by ZOFRAN, reported revenues of USD 1.2 billion in 2021, with ZOFRAN surfaces accounting for a substantial share. Though exact ODT-specific figures are proprietary, estimates suggest ZOFRAN ODT contributed approximately USD 300–350 million in 2022, reflecting robust growth from the initial launch period.

2. Revenue Drivers

• Market Expansion: Increased adoption in emerging markets contributes approximately 15–20% annual growth.
• Pricing Strategies: Premium pricing in developed markets, coupled with strategic discounts in emerging regions, balance revenue streams.
• Product Line Extensions: The introduction of pediatric and generic versions has enhanced overall sales.

3. Profitability and Cost Dynamics

Despite the risk of generic competition, Pfizer maintains profitability through economies of scale and strategic manufacturing efficiencies. Margins are partially offset by R&D investments and promotional expenses necessary to retain market share.

4. Future Revenue Projections

Analysts project that ZOFRAN ODT’s revenues could surpass USD 500 million globally by 2027, driven by expanding indications, geographic penetration, and increasing cancer prevalence [5].

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Market Challenges and Risks

• Intense Generic Competition: Post-patent expiry, numerous generics reduce market prices, compress margins, and challenge Pfizer’s or other patent-holder stakings.
• Regulatory Hurdles: Variations in regulatory approvals and reimbursement policies across regions can impede accelerated market access.
• Emerging Competition: New antiemetic drugs with enhanced efficacy or better safety profiles, such as NK1 receptor antagonists, threaten ZOFRAN’s dominance.
• Market Saturation: In mature markets, growth potential diminishes due to established drug access and usage patterns.

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Strategic Outlook and Future Growth

The future for ZOFRAN ODT hinges on innovative formulations, expanded indications, and geographic expansion. Recent advances, such as combination therapies with NK1 antagonists, present lucrative opportunities for bundling and co-marketing strategies. Digital health initiatives, patient education, and adherence programs will further aid in capturing emerging market opportunities.

Emerging markets, including Asia-Pacific, Latin America, and Africa, are pivotal; their growing oncology care infrastructure and rising healthcare expenditure are favorable for sales expansion. Moreover, strategic partnerships with local manufacturers and reimbursement negotiations will optimize market penetration.

Pfizer and competitors are likely to focus on manufacturing efficiencies, lifecycle management, and targeted marketing to sustain financial growth amid generic pressures. Additionally, product pipeline advancements aiming to improve bioavailability and reduce side effects will support long-term market relevance.

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Key Takeaways

• Market expansion is driven by rising cancer prevalence, leading to increased demand for ZOFRAN ODT’s antiemetic solutions.
• Patent expiries have ushered in competitive pressures, necessitating strategic price management and innovation.
• Patient-centric formulations like ZOFRAN ODT enjoy favorable adoption, especially in specialized populations.
• Emerging markets present significant growth opportunities, complemented by regional partnerships and pricing strategies.
• Future growth hinges on product lifecycle management, expanded indications, and integration with combination therapies.

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FAQs

Q1: How has patent expiration affected ZOFRAN ODT’s market?
Patent expiry has resulted in increased generic competition, exerting downward pressure on prices but also expanding access through lower-cost alternatives, thereby increasing overall market volume.

Q2: What are the main drivers behind ZOFRAN ODT’s growth?
Growing global cancer incidence, patient preference for disintegrating tablets, regulatory approvals for new indications, and strategic market expansion primarily drive growth.

Q3: Which regions hold the most potential for ZOFRAN ODT sales?
Emerging markets in Asia-Pacific, Latin America, and Africa offer significant growth prospects due to expanding oncology treatment infrastructure and rising healthcare investments.

Q4: What future innovations could enhance ZOFRAN ODT’s market position?
Combination formulations with NK1 receptor antagonists, pediatric-friendly dosing forms, and improved bioavailability will sustain competitive advantages.

Q5: How does the competitive landscape influence ZOFRAN ODT’s financial outlook?
Intense competition from generics and newer antiemetics necessitates strategic pricing, marketing, and innovation to maintain profitability and market share.

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References

[1] Market Research Future. (2022). Global Antiemetics Market Analysis.
[2] International Agency for Research on Cancer. (2022). Global Cancer Statistics.
[3] Pfizer. (2022). ZOFRAN Indication Expansion Approvals.
[4] U.S. Food and Drug Administration. (2021). Patent Expiry Announcements.
[5] Analyst Reports. (2023). Pharmaceutical Industry Outlook.

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