ZOFRAN Drug Patent Profile

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

Zofran is a drug marketed by Sandoz and Glaxosmithkline and is included in five NDAs.

The generic ingredient in ZOFRAN 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

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

Summary for ZOFRAN

US Patents:	0
Applicants:	2
NDAs:	5
Raw Ingredient (Bulk) Api Vendors:	136
Clinical Trials:	163
Drug Prices:	Drug price information for ZOFRAN
What excipients (inactive ingredients) are in ZOFRAN?	ZOFRAN excipients list
DailyMed Link:	ZOFRAN at DailyMed

See drug prices for ZOFRAN

See drug sales revenues for ZOFRAN

Recent Clinical Trials for ZOFRAN

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 clinical trials

Paragraph IV (Patent) Challenges for ZOFRAN

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 ZOFRAN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Sandoz	ZOFRAN	ondansetron hydrochloride	INJECTABLE;INJECTION	020007-001	Jan 4, 1991		DISCN	Yes	No
Sandoz	ZOFRAN ODT	ondansetron	TABLET, ORALLY DISINTEGRATING;ORAL	020781-001	Jan 27, 1999		DISCN	Yes	No
Sandoz	ZOFRAN	ondansetron hydrochloride	TABLET;ORAL	020103-002	Dec 31, 1992		DISCN	Yes	No
Sandoz	ZOFRAN ODT	ondansetron	TABLET, ORALLY DISINTEGRATING;ORAL	020781-002	Jan 27, 1999		DISCN	Yes	No
Sandoz	ZOFRAN	ondansetron hydrochloride	SOLUTION;ORAL	020605-001	Jan 24, 1997		DISCN	Yes	No
Sandoz	ZOFRAN	ondansetron hydrochloride	TABLET;ORAL	020103-001	Dec 31, 1992		DISCN	Yes	No
Glaxosmithkline	ZOFRAN AND DEXTROSE IN PLASTIC CONTAINER	ondansetron hydrochloride	INJECTABLE;INJECTION	020403-001	Jan 31, 1995		DISCN	Yes	No

Expired US Patents for ZOFRAN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Sandoz	ZOFRAN	ondansetron hydrochloride	TABLET;ORAL	020103-003	Aug 27, 1999
Sandoz	ZOFRAN	ondansetron hydrochloride	TABLET;ORAL	020103-003	Aug 27, 1999
Sandoz	ZOFRAN	ondansetron hydrochloride	SOLUTION;ORAL	020605-001	Jan 24, 1997
Sandoz	ZOFRAN	ondansetron hydrochloride	TABLET;ORAL	020103-002	Dec 31, 1992
Sandoz	ZOFRAN	ondansetron hydrochloride	TABLET;ORAL	020103-002	Dec 31, 1992
Sandoz	ZOFRAN	ondansetron hydrochloride	INJECTABLE;INJECTION	020007-001	Jan 4, 1991
Sandoz	ZOFRAN	ondansetron hydrochloride	TABLET;ORAL	020103-001	Dec 31, 1992

International Patents for ZOFRAN

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

Country	Patent Number	Title	Estimated Expiration
Italy	8547600
Israel	94888	Process for reducing the crystal size of ondansetron hydrochloride dihydrate and pharmaceutical compositions containing them.
Australia	5787490
Australia	583343
Ireland	60908	Pharmaceutical compositions for treating gastric disorders
Hungary	T37784
Slovenia	0792149

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: ZOFRAN

Last updated: July 30, 2025

---

Introduction

Zofran, the brand name for ondansetron, stands as a pivotal drug in the antiemetic market, primarily prescribed to prevent nausea and vomiting associated with chemotherapy, radiation therapy, and surgeries. Since its initial approval in the late 1980s, Zofran's market presence has evolved through regulatory approvals, patent protections, off-label uses, and competitive pressures. Understanding its current market dynamics and future financial trajectory is essential for stakeholders, including pharma companies, investors, and healthcare providers.

---

Historical Context and Regulatory Landscape

Zofran received FDA approval in 1991, rapidly becoming a standard in antidote therapy. Its mechanism involves selective 5-HT3 receptor antagonism, effectively reducing the emetic response in various clinical settings. As of 2006, GlaxoSmithKline (GSK) held the rights to Zofran, with subsequent licensing and generic entries shaping its market. Patent protections traditionally bolstered exclusivity, but patent expirations in the late 2000s and early 2010s opened the market to generics, drastically impacting revenue streams.

The drug's regulatory environment continues to influence its market, especially considering safety concerns about QT interval prolongation and potential links to birth defects—issues that prompted additional FDA warnings and generics' entry. Furthermore, off-label uses, including treatment for nausea in opioid overdose and other indications, have expanded its clinical utility over time.

---

Market Dynamics

1. Competition and Patent Expiry

The expiration of key patents in 2006–2008 facilitated the entry of multiple generic ondansetron formulations. Generics have captured substantial market share, reducing Zofran's brand-name revenues significantly. For example, GSK’s Zofran experienced a sharp decline in sales post-generic entry, which is consistent with typical pharmaceutical market behavior upon patent expiration.

2. Pricing Trends and Market Penetration

The availability of generics has driven prices downward, constraining profit margins for branded suppliers. According to IQVIA data, the average wholesale price of ondansetron has dropped by over 70% since patent expiry, prompting a shift towards cost-effective generic options in hospitals and outpatient settings.

3. Off-Label Uses and Expanded Indications

Off-label applications, including nausea management in diverse clinical situations—such as postoperative nausea and pediatric cases—have sustained demand beyond oncology. This diversification somewhat cushions revenue declines due to generic competition.

4. Market Segments and Geographic Spread

North America remains the dominant market, driven by high chemotherapy volumes and healthcare infrastructure. Europe and Asia-Pacific are emerging markets, with growth fueled by increasing cancer prevalence and expanding healthcare access. However, market heterogeneity and regulatory hurdles continue to influence growth trajectories.

5. Safety Concerns and Regulatory Impact

Increased safety warnings and the legal landscape, including litigation over adverse events—particularly birth defect allegations—have impacted market outlooks. Such factors may introduce barriers to sales expansion and influence physician prescribing behavior.

---

Financial Trajectory Analysis

1. Revenue Trends

Post-2006, Zofran’s revenue experienced a steep decline due to patent expiry and rising generic competition. GSK’s annual sales plummeted from a peak of approximately $1.4 billion (2004) to under $300 million by 2010. Despite the downturn, certain segments, especially in hospital settings, continue to generate steady revenues owing to supply chain loyalty and physician prescribing habits.

2. Impact of Generic Competition

The proliferation of generics has led to a price erosion trend, significantly diminishing per-unit profits for original patent holders. The market is now characterized by narrow margins, emphasizing volume over price.

3. Future Revenue Projections

Forecast models suggest a continued decline in branded sales. However, niche markets—such as pediatric or specific off-label uses—may offer incremental growth opportunities, especially if new formulations or delivery methods (e.g., oral disintegrating tablets) are introduced.

4. Research and Development (R&D) Investment

Limited R&D investments are observed for branded ondansetron, with efforts focused instead on next-generation antiemetics and combination therapies. This shift reflects the commodity status of ondansetron in mature markets.

5. Legal and Regulatory Risks’ Financial Implication

Lawsuits targeting adverse effects could impose substantial costs or restrict usage, impacting future sales. Conversely, enhanced safety profiles or reformulations could rejuvenate market interest, influencing long-term revenue streams.

---

Emerging Market Opportunities

• Innovative Formulations: Developing novel delivery systems, such as sustained-release or nasal sprays, could expand patient compliance and market share.
• Combination Therapies: Pairing ondansetron with other agents might open new treatment pathways.
• Geographical Expansion: Penetrating emerging markets through partnerships and localized regulatory strategies presents growth potential.
• Regulatory Pathways: Fast-tracking approvals for new indications or formulations could mitigate revenue erosion.

---

Conclusion & Strategic Outlook

Zofran’s market landscape exemplifies a typical post-patent expiry scenario characterized by significant generic competition and declining revenues. Nonetheless, stable demand driven by established clinical utility and ongoing healthcare needs sustains its relevance. The critical success factors moving forward include innovation in formulation, expansion into emerging markets, and effective legal risk management.

Investment strategies should weigh the decline in branded revenues against the potential for niche growth and diversification efforts within the antiemetic space. Companies that adapt through product innovation and strategic partnerships can optimize the financial trajectory of ondansetron in this mature market environment.

---

Key Takeaways

• Patent expiry in the late 2000s led to intense generic competition, drastically reducing branded Zofran’s revenues.
• Pricing erosion from generics has compressed profit margins, compelling stakeholders to focus on volume and emerging markets.
• Despite declining sales, demand remains stable in core segments—oncology and surgery—due to its proven efficacy.
• Safety concerns and litigation risks present both challenges and opportunities for reformulation and market repositioning.
• Future growth hinges on innovative delivery mechanisms, geographic expansion, and regulatory strategies that capitalize on unmet needs.

---

FAQs

1. How has patent expiration affected Zofran’s market share?
Patent expiration in 2006–2008 opened the market to generics, leading to a dramatic decline in Zofran’s branded sales and a shift toward commoditized generic options.

2. Are there new formulations of ondansetron in development?
While limited, some companies are exploring alternative delivery methods, such as orally disintegrating tablets and nasal sprays, to enhance patient compliance and extend product lifecycle.

3. What are the primary safety concerns associated with Zofran?
Studies link ondansetron to QT interval prolongation and potential birth defects, prompting regulatory warnings and influencing prescribing behaviors.

4. Which markets present the most growth opportunities for ondansetron?
Emerging markets in Asia-Pacific and Latin America, due to increasing cancer prevalence and expanding healthcare infrastructure, offer promising growth potential.

5. What strategies can pharmaceutical companies adopt to maximize ondansetron’s future financial performance?
Innovating formulations, exploring new indications, expanding geographically, and proactively managing regulatory and legal risks can help sustain revenues.

---

References

[1] IQVIA, “Global Oncology Market Reports,” 2022.
[2] FDA, “Zofran (ondansetron) Labeling and Safety Warnings,” 2021.
[3] GlaxoSmithKline Annual Reports, 2004–2010.
[4] MarketResearch.com, “Anti-Emetics Market Analysis,” 2021.
[5] Statista, “Ondansetron Market Revenue Trends,” 2022.