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-two 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:	136
Clinical Trials:	161
Patent Applications:	4,848
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
Tanta University	Phase 3
Tanta University	Phase 2/Phase 3
Emory University	Phase 2

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	5,955,488*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	4,695,578*PED
Sandoz	ZOFRAN ODT	ondansetron	TABLET, ORALLY DISINTEGRATING;ORAL	020781-002	Jan 27, 1999	6,063,802*PED
Sandoz	ZOFRAN ODT	ondansetron	TABLET, ORALLY DISINTEGRATING;ORAL	020781-001	Jan 27, 1999	5,955,488*PED

International Patents for ZOFRAN ODT

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

Country	Patent Number	Title	Estimated Expiration
Australia	583343
China	1080118
Finland	84349
Finland	850323
Netherlands	8500202
United Kingdom	9523667

Market Dynamics and Financial Trajectory for ZOFRAN ODT

Introduction to ZOFRAN ODT

ZOFRAN ODT, or ondansetron orally disintegrating tablets, is a formulation of ondansetron, a selective 5-HT3 receptor antagonist. It is primarily used to prevent nausea and vomiting associated with cancer chemotherapy, radiotherapy, and postoperative nausea and vomiting[4].

Market Size and Growth

The orally disintegrating tablet (ODT) market, which includes ZOFRAN ODT, is experiencing significant growth. The global ODT market is projected to reach USD 29.0 billion by 2033, growing at a CAGR of 8.2% from 2024 to 2033. This growth is driven by the increasing acceptance of technologically advanced pharmaceutical products and the rising prevalence of Central Nervous System (CNS) diseases[3].

Regional Dominance

North America currently dominates the ODT market, holding a substantial 36% market share and generating USD 8.1 billion in revenue in 2023. This region is expected to maintain its leadership throughout the forecast period, largely due to the high adoption of advanced pharmaceutical products and the prevalence of CNS diseases[3].

Market Share of ZOFRAN ODT

ZOFRAN ODT, approved in North America, represents a significant portion of the ODT market. It is noted that ZOFRAN, in its various forms, holds half of the ODT market share in North America, indicating its strong market presence[1].

Drug Class and Disease Indication Analysis

Anti-psychotics and CNS diseases are key segments driving the ODT market. Anti-psychotics hold a substantial 42% market share, while CNS diseases account for 44% of the market. Given that ZOFRAN ODT is used for preventing nausea and vomiting, which can be associated with CNS-related treatments, it benefits from these market trends[3].

Distribution Channels

Hospital pharmacies are the primary distribution channels for ODTs, holding a 33% market share. This is significant for ZOFRAN ODT, as it is often prescribed in clinical settings for patients undergoing chemotherapy or radiotherapy[3].

Competitive Landscape

The ODT market is highly fragmented, with both established pharmaceutical giants and emerging companies. Key players such as AstraZeneca, Mylan, Pfizer, and Johnson & Johnson are active in this market. ZOFRAN ODT, being a product of Novartis Pharmaceuticals Corporation, competes within this diverse landscape[3].

Technological Advancements

Advanced ODT technologies are continuously evolving, with innovations such as 3D printing being applied to manufacturing. These advancements enhance the quality and effectiveness of ODTs, including ZOFRAN ODT, by improving dosing accuracy and patient compliance. New technologies are particularly beneficial for pediatric, geriatric, and mental health patients with dysphagia[1].

Financial Trajectory

The financial trajectory of ZOFRAN ODT is closely tied to the overall growth of the ODT market. With the market projected to grow at a CAGR of 8.2% from 2024 to 2033, ZOFRAN ODT is likely to see increased revenue. The ODT market's expansion is driven by factors such as cost-effectiveness, ease of use, and rising awareness among healthcare professionals and patients about the benefits of ODTs[3].

Generic and Brand-Name Trends

In Japan, there has been an increasing trend of generic ODT approvals starting from 2010. However, brand-name products like ZOFRAN ODT continue to hold significant market share due to their established reputation and efficacy. The balance between generic and brand-name products influences the financial performance of ZOFRAN ODT[1].

Patient Compliance and Quality of Life

ZOFRAN ODT's design, which allows it to rapidly disintegrate on the tongue without needing water, enhances patient compliance. This feature is particularly beneficial for patients who struggle with swallowing pills, such as those with dysphagia. Improved compliance can lead to better treatment outcomes and increased quality of life, contributing to the product's financial success[4].

Regulatory Approvals and Indications

ZOFRAN ODT has received various regulatory approvals, including those for the prevention of nausea and vomiting associated with highly emetogenic cancer chemotherapy and radiotherapy. These approvals are crucial for maintaining and expanding its market presence[2][4].

Key Takeaways

• Market Growth: The ODT market, including ZOFRAN ODT, is expected to grow significantly, reaching USD 29.0 billion by 2033.
• Regional Leadership: North America dominates the ODT market, with ZOFRAN ODT holding a substantial share.
• Technological Advancements: Innovations like 3D printing are enhancing ODT manufacturing and efficacy.
• Patient Compliance: ZOFRAN ODT's ease of use improves patient compliance, especially for those with dysphagia.
• Regulatory Approvals: ZOFRAN ODT has multiple regulatory approvals, ensuring its continued market relevance.

FAQs

1. What is the primary use of ZOFRAN ODT?

   • ZOFRAN ODT is primarily used to prevent nausea and vomiting associated with cancer chemotherapy, radiotherapy, and postoperative nausea and vomiting[4].

2. How does the ODT market's growth impact ZOFRAN ODT?

   • The ODT market's growth at a CAGR of 8.2% from 2024 to 2033 is expected to positively impact ZOFRAN ODT's revenue and market share[3].

3. What technological advancements are benefiting ZOFRAN ODT?

   • Advanced ODT technologies, including 3D printing, are enhancing the manufacturing and efficacy of ZOFRAN ODT[1].

4. Why is patient compliance important for ZOFRAN ODT?

   • Patient compliance is crucial as it ensures better treatment outcomes and increased quality of life, particularly for patients with dysphagia[4].

5. What are the key distribution channels for ZOFRAN ODT?

   • Hospital pharmacies are the primary distribution channels for ZOFRAN ODT, holding a significant market share[3].

Cited Sources

1. CMIC Group - Advanced ODT Technologies for Drug Development in Japan and the US
2. FDA - ZOFRAN (ondansetron hydrochloride) Tablets, Oral Solution, and ODT
3. Market.us - Orally Disintegrating Tablet Market Outlook
4. Mayo Clinic - Ondansetron (oral route, oromucosal route)