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-six 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:	161
Patent Applications:	4,128
Drug Prices:	Drug price information for ZOFRAN
Drug Sales Revenues:	Drug sales revenues 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
Tanta University	Phase 3
Tanta University	Phase 2/Phase 3
Emory University	Phase 2

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

Expired US Patents for ZOFRAN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Sandoz	ZOFRAN	ondansetron hydrochloride	SOLUTION;ORAL	020605-001	Jan 24, 1997
Sandoz	ZOFRAN	ondansetron hydrochloride	TABLET;ORAL	020103-003	Aug 27, 1999
Sandoz	ZOFRAN	ondansetron hydrochloride	TABLET;ORAL	020103-003	Aug 27, 1999

International Patents for ZOFRAN

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

Country	Patent Number	Title	Estimated Expiration
Australia	583343
Luxembourg	85743
Japan	H0395178	METHOD

ZOFRAN Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Zofran (Ondansetron)

Introduction to Zofran (Ondansetron)

Zofran, known generically as ondansetron, is a widely used antiemetic medication that belongs to the class of serotonin 5-HT3 receptor antagonists. It is primarily used to prevent nausea and vomiting associated with chemotherapy, radiation therapy, and surgery.

Market Size and Growth Projections

The ondansetron market has been experiencing significant growth and is expected to continue this trend. As of 2023, the ondansetron hydrochloride market was valued at USD 1.45 billion and is projected to reach USD 2.35 billion by 2031, growing at a Compound Annual Growth Rate (CAGR) of 4.8% from 2024 to 2031[4].

Key Drivers of Market Growth

Several factors are driving the growth of the ondansetron market:

Increasing Incidence of Cancer

The rising global rates of cancer are a major driver, as ondansetron is widely used to treat chemotherapy-induced nausea and vomiting. The number of cancer cases in regions like India is expected to increase by 12.8% from 2020 to 2025, which will further boost the demand for ondansetron[3].

Expanding Healthcare Needs

The growing need for supportive care drugs, particularly in oncology, is another significant factor. Ondansetron's effectiveness and safety record make it a crucial medication in this context[4].

Pharmaceutical Innovations

Advancements in dosage forms and formulations, such as pediatric dose forms and sustained-release formulations, are enhancing market growth prospects. These innovations improve patient outcomes and increase the medication's appeal to healthcare providers[4].

Growing Awareness Among Medical Practitioners

There is an increasing awareness among medical practitioners about the benefits of early intervention in treating side effects associated with cancer treatments, which further boosts the demand for ondansetron[4].

Market Segmentation

The ondansetron market is segmented based on several criteria:

By Type

• Ondansetron Hydrochloride Tablets
• Ondansetron Hydrochloride Capsules
• Ondansetron Hydrochloride Injections
• Others[1]

By Application

• Hospital Pharmacies
• Retail Pharmacies
• Online Pharmacies[1]

By Geography

• North America
• Europe
• Asia-Pacific
• South America
• Middle-East and Africa[1]

Competitive Landscape

The ondansetron market is highly competitive, with several key players:

Major Players

• GSK
• Qilu Pharma
• CSPC
• Fuan Pharma
• PKU HealthCare
• Sino-Pharma
• Aosaikang Pharma
• Zhongbao Pharma
• Wockhardt
• Sun Pharma
• Aelida Healthcare
• Hospira
• Drums Healthcare
• SANDOZ[1]

These companies are actively involved in research, development, and the launch of new products, which contributes to the market's growth.

Financial Performance and Trends

The financial performance of companies involved in the ondansetron market is influenced by several factors:

Revenue Growth

Companies like GSK have seen strong sales growth in their Specialty Medicines segment, which includes antiemetics like ondansetron. For instance, GSK reported total sales of £29.3 billion in 2022, driven by strong commercial execution and favorable market conditions[2].

Operating Profit

GSK's adjusted operating profit increased by 21% at Actual Exchange Rates (AER) and 5% at Constant Exchange Rates (CER) in Q4 2022 compared to Q4 2021, partly due to higher royalty income and lower inventory adjustments[2].

Market Outlook

The market outlook for ondansetron is positive, with growth driven by increasing demand for antiemetic medications. The global antiemetics drugs market, which includes ondansetron, is expected to grow at a CAGR of 5.98% from 2024 to 2030, reaching USD 11.20 billion by 2030[3].

Regional Market Dynamics

North America

North America dominated the antiemetics drugs market with a share of 36.52% in 2023, driven by rising approvals for antiemetics and the presence of key players like Pfizer and GSK[3].

Asia-Pacific

The Asia-Pacific region is expected to grow significantly, driven by rising incidences of cancer and gastroenteritis, as well as the growing availability of various antiemetics medications[3].

Challenges and Opportunities

Challenges

• The market faces challenges such as the emergence of generic substitutes, which can impact the sales of branded products.
• Regulatory hurdles and the need for continuous innovation to stay competitive are other challenges[1][3].

Opportunities

• Growing research and development activities in the field of supportive care and oncology present significant opportunities.
• The increasing penetration of online pharmacies and e-commerce platforms offers new distribution channels for ondansetron[3].

Consumer Behavior and Distribution Channels

Retail Pharmacies

Retail pharmacies dominated the market in 2023 with a revenue share of 47.91%, driven by product availability and convenience. However, the online pharmacy segment is expected to register the fastest CAGR over the forecast period due to increasing internet penetration and awareness about online pharmacies[3].

Key Takeaways

• The ondansetron market is expected to grow significantly due to rising cancer rates and the need for supportive care drugs.
• Innovations in dosage forms and formulations are driving market growth.
• Key players are investing heavily in research and development to maintain market share.
• North America and the Asia-Pacific region are critical markets for ondansetron.
• Online pharmacies are emerging as a significant distribution channel.

FAQs

What is the primary use of Zofran (ondansetron)?

Zofran (ondansetron) is primarily used to prevent nausea and vomiting associated with chemotherapy, radiation therapy, and surgery.

Which segment dominates the ondansetron market by application?

Retail pharmacies currently dominate the market, but the online pharmacy segment is expected to grow at the fastest CAGR over the forecast period.

What is the projected CAGR for the ondansetron hydrochloride market from 2024 to 2031?

The ondansetron hydrochloride market is expected to grow at a CAGR of 4.8% from 2024 to 2031.

Which region is expected to see significant growth in the ondansetron market?

The Asia-Pacific region is expected to grow significantly due to rising incidences of cancer and gastroenteritis.

Who are some of the key players in the ondansetron market?

Key players include GSK, Qilu Pharma, CSPC, Fuan Pharma, PKU HealthCare, and others.

Sources

1. Market Research Intellect - Global Ondansetron Market Size, Trends and Projections
2. GSK - Full-year and fourth quarter 2022 results announcement
3. Grand View Research - Antiemetics Drugs Market Size & Share Analysis Report 2030
4. Market Research Intellect - Ondansetron Hydrochloride Market Size and Projections