You're using a free limited version of DrugPatentWatch: Upgrade for Complete Access

Last Updated: December 22, 2024

ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE Drug Patent Profile


✉ Email this page to a colleague

« Back to Dashboard


Which patents cover Ondansetron Hydrochloride Preservative Free, and when can generic versions of Ondansetron Hydrochloride Preservative Free launch?

Ondansetron Hydrochloride Preservative Free is a drug marketed by Accord Hlthcare, Am Regent, Apotex Inc, Avet Lifesciences, Baxter Hlthcare Corp, Eugia Pharma, Fresenius Kabi Usa, Hikma, Hikma Farmaceutica, Hospira, Sandoz, Steriscience Speclts, Sun Pharm Inds Ltd, Taro Pharms Ireland, Teva, and Wockhardt. and is included in twenty NDAs.

The generic ingredient in ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE 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 Preservative Free

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

  Subscribe

AI Research Assistant
Questions you can ask:
  • What is the 5 year forecast for ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE?
  • What are the global sales for ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE?
  • What is Average Wholesale Price for ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE?
Summary for ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE
Drug patent expirations by year for ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE
Recent Clinical Trials for ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE

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

SponsorPhase
University of PennsylvaniaPhase 3
Pacira Pharmaceuticals, IncPhase 4
Charles University, Czech RepublicPhase 4

See all ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE clinical trials

Pharmacology for ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE

US Patents and Regulatory Information for ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Accord Hlthcare ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE ondansetron hydrochloride INJECTABLE;INJECTION 206845-001 Mar 10, 2016 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Taro Pharms Ireland ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE ondansetron hydrochloride INJECTABLE;INJECTION 078014-001 Mar 21, 2008 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Eugia Pharma ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE ondansetron hydrochloride INJECTABLE;INJECTION 202600-001 Dec 21, 2012 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
Hikma Farmaceutica ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE ondansetron hydrochloride INJECTABLE;INJECTION 076780-001 Dec 26, 2006 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Wockhardt ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE ondansetron hydrochloride INJECTABLE;INJECTION 077716-001 Dec 26, 2006 AP 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 PRESERVATIVE FREE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Ondansetron Hydrochloride Preservative Free

Introduction to Ondansetron Hydrochloride

Ondansetron hydrochloride is a widely used antiemetic drug, belonging to the class of 5-HT3 receptor antagonists. It is commonly prescribed to prevent nausea and vomiting associated with chemotherapy, radiation therapy, and surgery.

Historical Context and Market Evolution

Initial Market Presence and Cost

When ondansetron was first introduced, it was a costly medication. In 1991, the inflation-adjusted cost of a unit of ondansetron was approximately $104[2]. However, with the expiration of market exclusivity for the brand name Zofran in 2006, generic versions of ondansetron became available in the United States in 2007. This led to a significant reduction in cost, with the price dropping more than 100-fold over a decade, from $28.7 per dose in 2006 to $0.24 per dose in 2015[2].

Current Market Dynamics

Global Market Size and Growth

The global ondansetron hydrochloride injection market is expected to see steady growth. The market size in 2023 was substantial, and it is forecasted to grow at a compound annual growth rate (CAGR) from 2024 to 2031. This growth is driven by increasing demand for antiemetic treatments across various regions, including North America, Europe, Asia Pacific, Middle East & Africa, and Latin America[3].

Regional Analysis

The market is segmented into several key regions, each contributing significantly to the global revenue. Asia Pacific is expected to be one of the dominant regions due to a large patient population and increasing healthcare expenditures[3].

Application and Segmentation

Ondansetron hydrochloride injection is used in various applications, including the prevention of chemotherapy-induced nausea and vomiting (CINV), postoperative nausea and vomiting (PONV), and other conditions. The market is segmented based on type (e.g., 2 mL and 20 mL vials) and application, with the 2 mL/vial segment having a significant impact due to its widespread use in clinical settings[3].

Financial Trajectory

Pricing and Cost Considerations

The cost of ondansetron hydrochloride injection has become relatively affordable. For instance, a 20 mL supply of the 2 mg/mL injectable solution can cost around $14, depending on the pharmacy[5].

Impact of Generic Availability

The availability of generic ondansetron has significantly reduced costs for patients and healthcare systems. However, some newer antiemetics are still available only as costly brand-name formulations, which can influence market dynamics and pricing strategies[2].

Payer-Imposed Quantity Limits

Despite the cost-effectiveness of ondansetron, payer-imposed quantity limits can sometimes restrict its use. These limits are often based on historical cost concerns and may not reflect the current affordability of the drug. This can lead to misinterpretation of clinical guidelines and unnecessary restrictions on patient access[2].

Market Trends and Opportunities

Technological and Regulatory Trends

The market is influenced by technological advancements and regulatory changes. For example, the analysis of market trends includes factors such as patent analysis, technological trends, and regulatory updates, which can impact the future prospects of ondansetron hydrochloride injection[3].

Competitive Analysis

The global ondansetron hydrochloride injection market is competitive, with several key players. The market analysis includes competitor analysis, regional analysis, and segment analysis to provide a comprehensive understanding of the market landscape[3].

Challenges and Restraints

Quantity Limits and Formulary Management

One of the significant challenges is the imposition of quantity limits by payers, which can restrict the use of ondansetron despite its cost-effectiveness. Additionally, formulary management and coverage decisions by payers can influence the availability of the drug, often favoring more costly alternatives due to rebates and discounts[2].

Clinical Guidelines and Misinterpretation

Clinical guidelines sometimes get misinterpreted, leading to blanket restrictions on all antiemetics. For instance, the use of ondansetron for 3 days after chemotherapy might be misunderstood as the only requirement, ignoring the broader clinical context[2].

Future Prospects

Market Growth and Opportunities

The ondansetron hydrochloride injection market is expected to grow due to increasing demand for effective antiemetic treatments. The analysis of market trends and opportunities highlights the potential for growth in various segments, including hospital and outpatient settings[3].

Regional Expansion

The market is expected to expand in regions with growing healthcare needs, such as Asia Pacific and Latin America. This expansion will be driven by increasing healthcare expenditures and a rising patient population[3].

Key Takeaways

  • Cost Reduction: The cost of ondansetron hydrochloride has significantly decreased since the introduction of generic versions.
  • Global Growth: The market is expected to grow at a steady CAGR from 2024 to 2031, driven by increasing demand.
  • Regional Dominance: Asia Pacific is expected to be a dominant region in the global market.
  • Application Segmentation: The market is segmented based on type and application, with the 2 mL/vial segment being significant.
  • Challenges: Payer-imposed quantity limits and formulary management can restrict the use of ondansetron.

FAQs

What is the current cost of ondansetron hydrochloride injection?

The cost for ondansetron (2 mg/mL) injectable solution is around $14 for a supply of 20 milliliters, depending on the pharmacy[5].

How has the cost of ondansetron changed over time?

The cost of ondansetron has dropped more than 100-fold over a decade, from $28.7 per dose in 2006 to $0.24 per dose in 2015[2].

What are the main applications of ondansetron hydrochloride injection?

The main applications include the prevention of chemotherapy-induced nausea and vomiting (CINV), postoperative nausea and vomiting (PONV), and other conditions[3].

Why do payer-imposed quantity limits exist for ondansetron?

Payer-imposed quantity limits exist due to historical cost concerns and incentives for PBMs to demonstrate cost-cutting measures, despite the current affordability of the drug[2].

What regions are expected to dominate the global ondansetron hydrochloride injection market?

Asia Pacific and other regions with growing healthcare needs are expected to dominate the market in the forecast period[3].

Sources

  1. FDA: N20-007S035 Ondansetron Clinical BPCA - FDA[1].
  2. ASCO: Payer-Imposed Quantity Limits for Antiemetics: Everybody Hurts[2].
  3. Cognitive Market Research: Global Ondansetron Hydrochloride Injection Market Report 2024[3].
  4. Health Canada: 2 mg/mL ondansetron (as ondansetron hydrochloride dihydrate)[4].
  5. Drugs.com: Ondansetron Prices, Coupons, Copay Cards & Patient Assistance[5].

More… ↓

⤷  Subscribe

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.