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, Pliva Hrvatska Doo, Qilu Pharm Hainan, Rising, Sagent Pharms, Sandoz, Steriscience Speclts, Sun Pharm Inds (in), Teva, Wockhardt, 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-seven 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:	67
Raw Ingredient (Bulk) Api Vendors:	81
Clinical Trials:	615
Patent Applications:	2,331
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
Yongtao Sun	Phase 4
King Saud Medical City	Phase 3
Ain Shams University	N/A

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
Chartwell Molecular	ONDANSETRON HYDROCHLORIDE	ondansetron hydrochloride	INJECTABLE;INJECTION	090116-001	Apr 14, 2010		DISCN	No	No
Teva	ONDANSETRON HYDROCHLORIDE	ondansetron hydrochloride	TABLET;ORAL	076252-001	Jun 25, 2007		DISCN	No	No
Baxter Hlthcare Corp	ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE	ondansetron hydrochloride	INJECTABLE;INJECTION	078287-001	Feb 22, 2013	AP	RX	No	Yes
Pharm Assoc	ONDANSETRON HYDROCHLORIDE	ondansetron hydrochloride	SOLUTION;ORAL	078127-001	Jun 25, 2007		DISCN	No	No
Sandoz	ZOFRAN	ondansetron hydrochloride	TABLET;ORAL	020103-001	Dec 31, 1992		DISCN	Yes	No
Sandoz	ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE	ondansetron hydrochloride	INJECTABLE;INJECTION	077551-001	Jun 27, 2007	AP	RX	No	No

Expired US Patents for ONDANSETRON HYDROCHLORIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Sandoz	ZOFRAN PRESERVATIVE FREE	ondansetron hydrochloride	INJECTABLE;INJECTION	020007-003	Dec 10, 1993	4,695,578*PED
Sandoz	ZOFRAN	ondansetron hydrochloride	TABLET;ORAL	020103-002	Dec 31, 1992	4,695,578*PED
Sandoz	ZOFRAN	ondansetron hydrochloride	TABLET;ORAL	020103-001	Dec 31, 1992	5,344,658*PED
Sandoz	ZOFRAN	ondansetron hydrochloride	INJECTABLE;INJECTION	020007-001	Jan 4, 1991	4,695,578*PED
Sandoz	ZOFRAN	ondansetron hydrochloride	TABLET;ORAL	020103-003	Aug 27, 1999	5,578,628*PED
Sandoz	ZOFRAN	ondansetron hydrochloride	SOLUTION;ORAL	020605-001	Jan 24, 1997	4,753,789*PED

ONDANSETRON HYDROCHLORIDE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory of Ondansetron Hydrochloride

Market Overview

Ondansetron hydrochloride, an antiemetic drug, is widely used to prevent nausea and vomiting, particularly in patients undergoing chemotherapy. The market for this drug is experiencing significant growth driven by several key factors.

Market Size and Forecast

The global ondansetron hydrochloride market is projected to grow substantially over the coming years. As of 2023, the market size was valued at $755.73 million and is expected to reach $1,229.64 million by 2031, growing at a Compound Annual Growth Rate (CAGR) of 6.26% from 2024 to 2031[4].

Growth Drivers

Increasing Incidence of Nausea and Vomiting

The global incidence of nausea and vomiting is rising due to factors such as changing lifestyles, food habits, and environmental pollution. This increase in incidence is propelling the demand for ondansetron hydrochloride products[1].

Rising Awareness and Product Approvals

There is a growing awareness among people about the benefits of using ondansetron hydrochloride for treating various types of nausea and vomiting conditions. Additionally, the increasing number of product approvals for ondansetron hydrochloride products globally is boosting their demand in both developed and developing countries[1].

Emerging Markets

The Asia-Pacific region, particularly countries like India and China, is witnessing lucrative growth due to rising healthcare expenditure, growing population, and improving economic conditions. Efforts to reduce the price of the medication have also expanded its market in these emerging economies[4].

Segmentation

By Type

The global ondansetron hydrochloride market can be segmented based on purity levels: greater than or equal to 97%, greater than or equal to 98%, and greater than or equal to 99%. The segment with purity greater than or equal to 97% is expected to account for the largest share and is projected to grow at a CAGR of 6.8% during the forecast period[1].

By Application

Ondansetron hydrochloride is used in various forms, including oral tablets, orally disintegrating tablets, and liquid solutions. The injection segment is also significant, accounting for a large share of the market[1].

By End Use

The market is segmented into human and veterinary uses. The human segment accounted for the largest market share of 67.30% in 2023 and is projected to grow at a CAGR of 5.86% during the forecast period. The veterinary segment, though smaller, is expected to grow at a higher CAGR of 7.06%[4].

Regional Analysis

North America

North America dominated the global market in recent years, driven by the presence of key manufacturers and suppliers, along with high demand for anti-nausea medications. This region is expected to continue growing at a CAGR of 5.95% during the forecast period[4].

Asia-Pacific

The Asia-Pacific region is the second-largest market and is expected to witness significant growth due to rising healthcare expenditure, a growing population, and improving economic conditions. This region is projected to grow at a CAGR of 6.75% during the forecast period[4].

Financial Trajectory

Cost Dynamics

The cost of ondansetron hydrochloride can vary based on several factors, including the treatment plan, insurance coverage, and the pharmacy used. Since ondansetron is available as a generic drug, it tends to be less expensive than brand-name drugs. However, prices can differ based on the form of the drug (e.g., oral tablets, orally disintegrating tablets, or liquid solutions)[2].

Historical Price Trends

The cost of ondansetron has significantly decreased since the market exclusivity for the brand-name version ended in 2006. By 2015, the cost per dose had dropped to $0.24 from $104 in 1991, a reduction of more than 100-fold[3].

Cost-Saving Strategies

Patients can lower the cost of ondansetron by getting a 90-day supply, using drug discount websites, or purchasing from big box pharmacies, which often offer the lowest prices[2][3].

Challenges and Opportunities

Regulatory and Insurance Challenges

Insurance formularies and quantity limits imposed by payers can restrict the use of ondansetron, particularly for patients receiving chemotherapy. These restrictions can lead to financial toxicity and may force patients to ration their medication or seek alternative, often more costly, treatments[3].

Innovative Formulations

Efforts to develop more patient-friendly formulations, such as extended-release solid dosage forms, are opening up new opportunities in the market. These formulations provide exposure to ondansetron for an extended period, enhancing patient compliance and efficacy[5].

Key Takeaways

• The global ondansetron hydrochloride market is expected to grow at a CAGR of 6.26% from 2024 to 2031.
• Rising incidence of nausea and vomiting, increasing awareness, and growing demand in emerging markets are key growth drivers.
• The market is segmented by purity levels, application forms, and end-use sectors, with the human segment dominating.
• North America and Asia-Pacific are the leading regions in terms of market share and growth.
• The cost of ondansetron has decreased significantly since it became available as a generic drug, but can vary based on several factors.
• Innovative formulations and cost-saving strategies are crucial for market expansion and patient affordability.

FAQs

1. What is the primary use of ondansetron hydrochloride?

Ondansetron hydrochloride is primarily used to prevent nausea and vomiting, especially in patients undergoing chemotherapy.

2. How has the cost of ondansetron hydrochloride changed over time?

The cost of ondansetron hydrochloride has decreased significantly since the market exclusivity for the brand-name version ended in 2006, dropping from $104 per dose in 1991 to $0.24 per dose in 2015.

3. What are the key growth drivers for the ondansetron hydrochloride market?

Key growth drivers include the increasing incidence of nausea and vomiting, rising awareness about the benefits of ondansetron hydrochloride, and growing demand in emerging markets.

4. How can patients reduce the cost of ondansetron hydrochloride?

Patients can reduce the cost by getting a 90-day supply, using drug discount websites, or purchasing from big box pharmacies.

5. What are the potential challenges in the ondansetron hydrochloride market?

Challenges include regulatory and insurance restrictions, such as quantity limits and prior authorization requirements, which can lead to financial toxicity and affect patient access to the medication.

Sources:

1. Industry Growth Insights: Ondansetron Hydrochloride Market Report | Global Forecast To 2028
2. Medical News Today: Ondansetron cost 2024: Coupons and more
3. ASCO Publications: Payer-Imposed Quantity Limits for Antiemetics: Everybody Hurts
4. Verified Market Research: Ondansetron Hydrochloride (HMB) Market Size, Forecast
5. Google Patents: Ondansetron extended release solid dosage forms for treating either ...