Ondansetron - Generic Drug Details

What are the generic drug sources for ondansetron and what is the scope of freedom to operate?

Ondansetron is the generic ingredient in nine branded drugs marketed by Aquestive, 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, Taro Pharms Ireland, Glaxosmithkline, Amneal Pharms, Pharm Assoc, Taro, Apotex, Chartwell Rx, Dr Reddys Labs Ltd, Hikma Intl Pharms, and Natco Pharma Ltd, and is included in eighty-five NDAs. There are two patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Ondansetron has eighteen patent family members in fourteen countries.

There are twenty-eight drug master file entries for ondansetron. Thirty-six suppliers are listed for this compound. There are three tentative approvals for this compound.

Summary for ondansetron

International Patents:	18
US Patents:	2
Tradenames:	9
Applicants:	43
NDAs:	85
Drug Master File Entries:	28
Finished Product Suppliers / Packagers:	36
Raw Ingredient (Bulk) Api Vendors:	136
Clinical Trials:	615
Patent Applications:	7,408
Drug Prices:	Drug price trends for ondansetron
Drug Sales Revenues:	Drug sales revenues for ondansetron
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ondansetron
What excipients (inactive ingredients) are in ondansetron?	ondansetron excipients list
DailyMed Link:	ondansetron at DailyMed

See drug prices for ondansetron

See drug sales revenues for ondansetron

Recent Clinical Trials for ondansetron

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 clinical trials

Generic filers with tentative approvals for ONDANSETRON

Applicant	Application No.	Strength	Dosage Form
		EQ 2MG BASE/ML	INJECTABLE;INJECTION
		EQ 2MG BASE/ML	INJECTABLE;INJECTION
		8MG	TABLET, ORALLY DISINTEGRATING;ORAL

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

Drug Class	Serotonin-3 Receptor Antagonist
Mechanism of Action	Serotonin 3 Receptor Antagonists

Medical Subject Heading (MeSH) Categories for ondansetron

Anti-Anxiety Agents

Antiemetics

Antipruritics

Antipsychotic Agents

Serotonin Antagonists

Anatomical Therapeutic Chemical (ATC) Classes for ondansetron

A04AA	Serotonin (5HT3) antagonists
A04A	ANTIEMETICS AND ANTINAUSEANTS
A04	ANTIEMETICS AND ANTINAUSEANTS
A	Alimentary tract and metabolism

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
Teva	ONDANSETRON HYDROCHLORIDE	ondansetron hydrochloride	TABLET;ORAL	076252-001	Jun 25, 2007		DISCN	No	No
Ipca Labs Ltd	ONDANSETRON	ondansetron	TABLET, ORALLY DISINTEGRATING;ORAL	209389-001	Oct 30, 2023	AB	RX	No	No
Dr Reddys Labs Ltd	ONDANSETRON HYDROCHLORIDE	ondansetron hydrochloride	TABLET;ORAL	076183-004	Dec 26, 2006		DISCN	No	No
Aurobindo Pharma	ONDANSETRON HYDROCHLORIDE	ondansetron hydrochloride	TABLET;ORAL	078539-001	Jul 31, 2007	AB	RX	No	No
Hospira	ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE	ondansetron hydrochloride	INJECTABLE;INJECTION	076696-001	Dec 26, 2006		DISCN	No	No
Eugia Pharma	ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE	ondansetron hydrochloride	INJECTABLE;INJECTION	202600-001	Dec 21, 2012		DISCN	No	No

Expired US Patents for ondansetron

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
Sandoz	ZOFRAN ODT	ondansetron	TABLET, ORALLY DISINTEGRATING;ORAL	020781-001	Jan 27, 1999
Sandoz	ZOFRAN ODT	ondansetron	TABLET, ORALLY DISINTEGRATING;ORAL	020781-002	Jan 27, 1999
Sandoz	ZOFRAN ODT	ondansetron	TABLET, ORALLY DISINTEGRATING;ORAL	020781-001	Jan 27, 1999
Sandoz	ZOFRAN ODT	ondansetron	TABLET, ORALLY DISINTEGRATING;ORAL	020781-002	Jan 27, 1999
Sandoz	ZOFRAN ODT	ondansetron	TABLET, ORALLY DISINTEGRATING;ORAL	020781-002	Jan 27, 1999

International Patents for ondansetron

Country	Patent Number	Title	Estimated Expiration
European Patent Office	2444072	Formes galéniques de film non mucoadhésifs (Non-mucoadhesive film dosage forms)
Canada	2664986	FORMES PHARMACEUTIQUES A BASE DE FILM NON MUCO-ADHESIF (NON-MUCOADHESIVE FILM DOSAGE FORMS)
Mexico	2009003372	FORMAS DE DOSIFICACION DE PELICULA NO MUCOADHESIVA. (NON-MUCOADHESIVE FILM DOSAGE FORMS.)
Australia	2007304425	Non-mucoadhesive film dosage forms
China	105168186	Non-mucoadhesive film dosage forms
South Korea	20090080037	NON-MUCOADHESIVE FILM DOSAGE FORMS

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]