DOLASETRON MESYLATE - Generic Drug Details

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

Dolasetron mesylate is the generic ingredient in one branded drug marketed by Validus Pharms and is included in two NDAs. Additional information is available in the individual branded drug profile pages.

There are five drug master file entries for dolasetron mesylate. One supplier is listed for this compound.

Summary for DOLASETRON MESYLATE

US Patents:	0
Tradenames:	1
Applicants:	1
NDAs:	2
Drug Master File Entries:	5
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	185
Clinical Trials:	4
Patent Applications:	5,521
What excipients (inactive ingredients) are in DOLASETRON MESYLATE?	DOLASETRON MESYLATE excipients list
DailyMed Link:	DOLASETRON MESYLATE at DailyMed

Recent Clinical Trials for DOLASETRON MESYLATE

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

Sponsor	Phase
University of Washington	N/A
Vanderbilt University	N/A
University of Southern California	N/A

See all DOLASETRON MESYLATE clinical trials

Pharmacology for DOLASETRON MESYLATE

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

Anatomical Therapeutic Chemical (ATC) Classes for DOLASETRON MESYLATE

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

US Patents and Regulatory Information for DOLASETRON MESYLATE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Validus Pharms	ANZEMET	dolasetron mesylate	TABLET;ORAL	020623-001	Sep 11, 1997		DISCN	Yes	No
Validus Pharms	ANZEMET	dolasetron mesylate	TABLET;ORAL	020623-002	Sep 11, 1997		DISCN	Yes	No
Validus Pharms	ANZEMET	dolasetron mesylate	INJECTABLE;INJECTION	020624-002	Sep 11, 1997		DISCN	Yes	No
Validus Pharms	ANZEMET	dolasetron mesylate	INJECTABLE;INJECTION	020624-003	Dec 11, 2001		DISCN	No	No
Validus Pharms	ANZEMET	dolasetron mesylate	INJECTABLE;INJECTION	020624-001	Sep 11, 1997		DISCN	Yes	No

Expired US Patents for DOLASETRON MESYLATE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Validus Pharms	ANZEMET	dolasetron mesylate	TABLET;ORAL	020623-001	Sep 11, 1997
Validus Pharms	ANZEMET	dolasetron mesylate	INJECTABLE;INJECTION	020624-002	Sep 11, 1997
Validus Pharms	ANZEMET	dolasetron mesylate	TABLET;ORAL	020623-002	Sep 11, 1997
Validus Pharms	ANZEMET	dolasetron mesylate	TABLET;ORAL	020623-002	Sep 11, 1997
Validus Pharms	ANZEMET	dolasetron mesylate	INJECTABLE;INJECTION	020624-003	Dec 11, 2001
Validus Pharms	ANZEMET	dolasetron mesylate	INJECTABLE;INJECTION	020624-001	Sep 11, 1997

DOLASETRON MESYLATE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Dolasetron Mesylate

Introduction

Dolasetron mesylate, a 5-HT3 receptor antagonist, has been a significant player in the market for managing chemotherapy-induced nausea and vomiting (CINV) and postoperative nausea and vomiting (PONV). Here, we delve into the market dynamics and financial trajectory of this drug.

Pharmacological Overview

Dolasetron mesylate is converted in vivo to its active metabolite, hydrodolasetron, which is responsible for its pharmacological activity. It has been effective in clinical trials for preventing CINV and PONV, and its efficacy is comparable to other 5-HT3 antagonists like granisetron and ondansetron[3].

Market Size and Growth

The global dolasetron mesylate market has shown promising growth. As of 2023, the market size was valued at approximately USD 1.5 billion. It is projected to reach around USD 2.3 billion by 2032, indicating a steady growth trajectory over the next decade[4].

Revenue Streams

Dolasetron mesylate generates revenue primarily through its use in oncology and surgical settings. Oncologists can make substantial profits from administering and selling chemotherapy drugs, including dolasetron mesylate, directly to patients. For instance, the approximate price paid by doctors for dolasetron mesylate can be around $387, with an approximate reimbursement of $455, resulting in a significant margin[2].

Pricing and Reimbursement

The pricing of dolasetron mesylate varies based on the dosage form and the region. In the United States, for example, the cost can range significantly, with doctors often purchasing the drug at a lower price than they are reimbursed for by Medicare and patient copayments. This pricing dynamic contributes to the profitability of dolasetron mesylate for healthcare providers[2].

Competitive Landscape

The market for 5-HT3 antagonists is competitive, with several drugs available, including ondansetron, granisetron, and palonosetron. Dolasetron mesylate competes by offering similar efficacy and a tolerable side effect profile. Its effectiveness in preventing CINV and PONV, as well as its use in radiotherapy-induced nausea and vomiting, helps it maintain a strong market position[3].

Regulatory Considerations

The use of dolasetron mesylate has been subject to regulatory scrutiny, particularly regarding its cardiovascular safety. The FDA has issued warnings about the risk of abnormal heart rhythms, such as torsade de pointes, associated with the intravenous form of the drug. This has led to restrictions on its use, especially in patients with underlying heart conditions[1].

Safety Concerns and Market Impact

The FDA's safety warnings have had a significant impact on the market dynamics of dolasetron mesylate. The agency has advised against using the injection form for preventing CINV in pediatric and adult patients due to the risk of QT prolongation and associated heart rhythm abnormalities. This has likely affected sales and usage, particularly in settings where alternative 5-HT3 antagonists are available[1].

Clinical Utilization

Despite the safety concerns, dolasetron mesylate remains a viable option for managing nausea and vomiting in certain clinical settings. It is often used in conjunction with other antiemetic agents to enhance efficacy. For example, guidelines may recommend using a 5-HT3 antagonist such as dolasetron, ondansetron, or granisetron as part of a comprehensive antiemetic regimen[5].

Future Outlook

The projected growth of the dolasetron mesylate market to USD 2.3 billion by 2032 indicates a continued demand for this drug. However, this growth will likely be influenced by ongoing safety monitoring, regulatory updates, and the introduction of new antiemetic agents. The market will also be shaped by changes in healthcare policies and reimbursement structures[4].

Key Takeaways

• Market Growth: The global dolasetron mesylate market is expected to grow from USD 1.5 billion in 2023 to USD 2.3 billion by 2032.
• Revenue Streams: Significant revenue is generated through oncology and surgical settings.
• Pricing and Reimbursement: Profit margins are substantial due to the difference between purchase and reimbursement prices.
• Competitive Landscape: Dolasetron mesylate competes with other 5-HT3 antagonists but maintains a strong position due to its efficacy.
• Regulatory Considerations: Safety concerns related to cardiovascular risks have impacted its use, particularly for the intravenous form.
• Clinical Utilization: It remains a viable option in certain clinical settings, often used in combination with other antiemetics.

FAQs

1. What is dolasetron mesylate used for? Dolasetron mesylate is used to prevent chemotherapy-induced nausea and vomiting (CINV) and postoperative nausea and vomiting (PONV).

2. What are the safety concerns associated with dolasetron mesylate? The primary safety concern is the risk of abnormal heart rhythms, such as torsade de pointes, particularly with the intravenous form of the drug.

3. How does dolasetron mesylate compare to other 5-HT3 antagonists? Dolasetron mesylate has similar efficacy to other 5-HT3 antagonists like ondansetron and granisetron but may have different safety profiles.

4. What is the projected market size of dolasetron mesylate by 2032? The global dolasetron mesylate market is projected to reach around USD 2.3 billion by 2032.

5. Why has the FDA issued warnings about dolasetron mesylate? The FDA has issued warnings due to the risk of QT prolongation and associated heart rhythm abnormalities, particularly with the intravenous form of the drug.

Sources

1. FDA Drug Safety Communication: Abnormal heart rhythms associated with use of Anzemet (dolasetron mesylate)
2. Drug Sales Bring Huge Profits, And Scrutiny, to Cancer Doctors
3. Dolasetron. A review of its pharmacology and therapeutic use
4. Dolasetron Mesylate Market Research Report 2032
5. Colorado Department of Health Care Policy and Financing: DUR Board Minutes