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Last Updated: December 22, 2024

ONDANSETRON HYDROCHLORIDE Drug Patent Profile


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When do Ondansetron Hydrochloride patents expire, and when can generic versions of Ondansetron Hydrochloride launch?

Ondansetron Hydrochloride is a drug 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, 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, Natco Pharma Ltd, Sun Pharm Inds Ltd, and Taro Pharms Ireland. and is included in sixty-eight NDAs.

The generic ingredient in ONDANSETRON HYDROCHLORIDE is ondansetron hydrochloride. There are twenty-eight drug master file entries for this compound. Sixty-seven suppliers are listed for this compound. Additional details are available on the ondansetron hydrochloride profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Ondansetron Hydrochloride

A generic version of ONDANSETRON HYDROCHLORIDE was approved as ondansetron hydrochloride by FRESENIUS KABI USA on December 26th, 2006.

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  • What is the 5 year forecast for ONDANSETRON HYDROCHLORIDE?
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  • What is Average Wholesale Price for ONDANSETRON HYDROCHLORIDE?
Drug patent expirations by year for ONDANSETRON HYDROCHLORIDE
Recent Clinical Trials for ONDANSETRON HYDROCHLORIDE

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

SponsorPhase
Yongtao SunPhase 4
King Saud Medical CityPhase 3
Ain Shams UniversityN/A

See all ONDANSETRON HYDROCHLORIDE clinical trials

Pharmacology for ONDANSETRON HYDROCHLORIDE
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
Teva ONDANSETRON HYDROCHLORIDE ondansetron hydrochloride TABLET;ORAL 076252-003 Jun 25, 2007 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Chartwell Molecules ONDANSETRON HYDROCHLORIDE ondansetron hydrochloride TABLET;ORAL 077303-004 Jun 25, 2007 RX No Yes ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Pharm Assoc ONDANSETRON HYDROCHLORIDE ondansetron hydrochloride SOLUTION;ORAL 078127-001 Jun 25, 2007 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Hospira ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE ondansetron hydrochloride INJECTABLE;INJECTION 076696-001 Dec 26, 2006 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Glenmark Pharms Ltd ONDANSETRON HYDROCHLORIDE ondansetron hydrochloride TABLET;ORAL 077535-001 Jun 25, 2007 AB RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Pliva Hrvatska Doo ONDANSETRON HYDROCHLORIDE ondansetron hydrochloride TABLET;ORAL 077112-002 Jun 25, 2007 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Dr Reddys Labs Ltd ONDANSETRON HYDROCHLORIDE ondansetron hydrochloride TABLET;ORAL 076183-003 Dec 26, 2006 AB RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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 ...

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