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Last Updated: December 22, 2024

ONDANSETRON Drug Patent Profile


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

Ondansetron is a drug marketed by Aurobindo Pharma, Barr, Chartwell Molecules, Glenmark Pharms Ltd, Ipca Labs Ltd, Mylan, Nesher Pharms, Sandoz, Sun Pharm Inds, Sun Pharm Inds Ltd, Teva, 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, Steriscience Speclts, Sun Pharm Inds (in), Wockhardt, Amneal Pharms, Pharm Assoc, Taro, Apotex, Chartwell Rx, Dr Reddys Labs Ltd, Hikma Intl Pharms, Natco Pharma Ltd, and Taro Pharms Ireland. and is included in seventy-nine NDAs.

The generic ingredient in ONDANSETRON 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

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

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Drug patent expirations by year for ONDANSETRON
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Recent Clinical Trials for ONDANSETRON

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

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Pharmacology for ONDANSETRON
Medical Subject Heading (MeSH) Categories for ONDANSETRON

US Patents and Regulatory Information for ONDANSETRON

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Dr Reddys Labs Ltd ONDANSETRON HYDROCHLORIDE ondansetron hydrochloride TABLET;ORAL 076183-001 Dec 26, 2006 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Apotex Inc ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE ondansetron hydrochloride INJECTABLE;INJECTION 077343-001 Dec 26, 2006 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Lannett Co Inc ONDANSETRON HYDROCHLORIDE ondansetron hydrochloride INJECTABLE;INJECTION 090883-001 Aug 5, 2010 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Fresenius Kabi Usa ONDANSETRON HYDROCHLORIDE ondansetron hydrochloride INJECTABLE;INJECTION 076974-001 Dec 26, 2006 AP RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Rising ONDANSETRON HYDROCHLORIDE ondansetron hydrochloride TABLET;ORAL 076930-001 Jun 25, 2007 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Sun Pharm Inds Ltd ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE ondansetron hydrochloride INJECTABLE;INJECTION 077173-001 Dec 26, 2006 DISCN 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 Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Ondansetron

Introduction to Ondansetron

Ondansetron, a serotonin 5-HT3 receptor antagonist, is widely used to treat nausea and vomiting associated with chemotherapy, radiation therapy, and surgery. It is available in various forms, including oral tablets, orally disintegrating tablets, and liquid solutions. Here, we will delve into the market dynamics and financial trajectory of ondansetron.

Market Size and Growth Projections

The ondansetron market is experiencing significant growth. 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 CAGR of 4.8% from 2024 to 2031[4].

In the broader context of the antiemetics drugs market, which includes ondansetron, the global market size was valued at USD 7.49 billion in 2023 and is expected to grow at a CAGR of 5.98% from 2024 to 2030, reaching USD 11.20 billion by 2030[3].

Segmentation and Market Dynamics

Type Segmentation

The ondansetron market is segmented based on type, including ondansetron hydrochloride tablets, capsules, injections, and other forms. The serotonin-receptor antagonists segment, which includes ondansetron, accounted for the largest market share of 29.71% in 2023 and is expected to witness the fastest growth during the forecast period[3].

Application Segmentation

Ondansetron is used in various applications, including hospital pharmacies, retail pharmacies, and online pharmacies. The demand is particularly high in hospital settings due to its use in treating chemotherapy-induced and post-operative nausea and vomiting[1].

Geographical Segmentation

North America dominated the antiemetics drugs market with a share of 36.52% in 2023, driven by the presence of key players like Pfizer and GSK plc, as well as rising approvals for antiemetics drugs in the region. The Asia Pacific market is also expected to grow significantly due to rising incidences of cancer and gastroenteritis[3].

Drivers of Market Growth

Increasing Incidence of Cancer and Gastroenteritis

The growing incidence of cancer and gastroenteritis is a major driver of the ondansetron market. Cancer treatments, such as chemotherapy and radiation therapy, often induce nausea and vomiting, making ondansetron a crucial supportive care medication[3][4].

Advancements in Pharmaceutical Formulations

Pharmaceutical developments in dosage forms and formulations, including pediatric dose forms and sustained-release formulations, are enhancing the market growth prospects for ondansetron[4].

Growing Awareness and Early Intervention

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

Challenges and Restraints

Cost and Insurance Factors

The cost of ondansetron can vary significantly depending on factors such as the quantity prescribed, dosage, treatment plan, and the pharmacy used. Insurance coverage and prior authorization requirements can also impact the cost and accessibility of the medication[2].

Generic Competition

Ondansetron is available only as a generic drug, which, while generally cheaper than brand-name drugs, can also lead to price competition and potential market saturation[2].

Financial Trajectory

Revenue Projections

The ondansetron hydrochloride market is expected to grow steadily, with revenue projected to increase from USD 1.45 billion in 2023 to USD 2.35 billion by 2031. This growth is driven by the increasing demand for supportive care medications in oncology and other medical fields[4].

Cost Savings Strategies

Patients can reduce the cost of ondansetron by opting for a 90-day supply, using available savings programs, and choosing the most cost-effective form of the drug. Insurance coverage can also significantly lower the out-of-pocket costs for patients[2].

Key Players and Market Competition

The antiemetics drugs market, including ondansetron, is competitive with key players such as Pfizer Inc., Cipla Inc., Merck & Co., Inc., and GSK plc. These companies are driving market growth through research and development activities and strategic market expansions[3].

Regional Market Outlook

  • North America: Dominates the market due to the presence of key players and rising approvals for antiemetics drugs.
  • Asia Pacific: Expected to grow significantly due to rising incidences of cancer and gastroenteritis.
  • Europe: Also a significant market, driven by the presence of major pharmaceutical companies and growing healthcare needs[3].

Clinical and Therapeutic Significance

Ondansetron's effectiveness in preventing nausea and vomiting associated with chemotherapy, radiation therapy, and surgery is well-documented. It is also used prophylactically to prevent intraoperative shivering and reduce the incidence of nausea and vomiting during surgical procedures[5].

Key Takeaways

  • The ondansetron market is projected to grow significantly, driven by increasing cancer incidence and advancements in pharmaceutical formulations.
  • The market is segmented by type, application, and geographical region, with North America and Asia Pacific being key regions.
  • Cost and insurance factors, as well as generic competition, are significant challenges.
  • Key players are driving market growth through research and development.
  • Ondansetron's clinical significance extends beyond chemotherapy to include surgical and other medical applications.

Frequently Asked Questions (FAQs)

1. What is the primary use of ondansetron? Ondansetron is primarily used to treat nausea and vomiting associated with chemotherapy, radiation therapy, and surgery.

2. How does the cost of ondansetron vary? The cost of ondansetron varies based on factors such as the quantity prescribed, dosage, treatment plan, pharmacy used, and insurance coverage.

3. Is ondansetron available as a brand-name drug? No, ondansetron is only available as a generic drug, which is generally cheaper than brand-name drugs.

4. What are the key drivers of the ondansetron market? The key drivers include the increasing incidence of cancer and gastroenteritis, advancements in pharmaceutical formulations, and growing awareness among medical practitioners about early intervention.

5. Which regions are expected to see significant growth in the ondansetron market? North America and the Asia Pacific region are expected to see significant growth due to the presence of key players and rising healthcare needs.

Cited Sources:

  1. Market Research Intellect - Global Ondansetron Market Size, Trends and Projections[1]
  2. Medical News Today - Ondansetron cost 2024: Coupons and more[2]
  3. Grand View Research - Antiemetics Drugs Market Size & Share Analysis Report 2030[3]
  4. Market Research Intellect - Ondansetron Hydrochloride Market Size and Projections[4]
  5. Frontiers in Pharmacology - Prophylactic ondansetron for preventing intraoperative shivering[5]

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