ERGOLOID MESYLATES - Generic Drug Details

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

Ergoloid mesylates is the generic ingredient in eight branded drugs marketed by Novartis, Mutual Pharm, Sun Pharm Industries, Watson Labs, Sandoz, 3M, Bristol Myers Squibb, Kv Pharm, Lederle, Superpharm, Vangard, and Ivax Pharms, and is included in thirty-four NDAs. Additional information is available in the individual branded drug profile pages.

There are four drug master file entries for ergoloid mesylates. One supplier is listed for this compound.

Summary for ERGOLOID MESYLATES

US Patents:	0
Tradenames:	8
Applicants:	12
NDAs:	34
Drug Master File Entries:	4
Finished Product Suppliers / Packagers:	1
Clinical Trials:	2
Patent Applications:	94
Drug Prices:	Drug price trends for ERGOLOID MESYLATES
DailyMed Link:	ERGOLOID MESYLATES at DailyMed

See drug prices for ERGOLOID MESYLATES

Recent Clinical Trials for ERGOLOID MESYLATES

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

Sponsor	Phase
Elizabeth Berry-Kravis	Phase 2
Sinphar Pharmaceutical Co., Ltd	Phase 2

See all ERGOLOID MESYLATES clinical trials

Medical Subject Heading (MeSH) Categories for ERGOLOID MESYLATES

Adrenergic alpha-Antagonists

Nootropic Agents

Vasodilator Agents

Anatomical Therapeutic Chemical (ATC) Classes for ERGOLOID MESYLATES

C04AE	Ergot alkaloids
C04A	PERIPHERAL VASODILATORS
C04	PERIPHERAL VASODILATORS
C	Cardiovascular system

US Patents and Regulatory Information for ERGOLOID MESYLATES

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Kv Pharm	ERGOLOID MESYLATES	ergoloid mesylates	TABLET;SUBLINGUAL	085899-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Bristol Myers Squibb	DEAPRIL-ST	ergoloid mesylates	TABLET;SUBLINGUAL	085020-002	Approved Prior to Jan 1, 1982		DISCN	No	No
Sun Pharm Industries	ERGOLOID MESYLATES	ergoloid mesylates	TABLET;ORAL	081113-001	Oct 31, 1991		DISCN	No	No
Sun Pharm Industries	ERGOLOID MESYLATES	ergoloid mesylates	TABLET;SUBLINGUAL	087407-001	Approved Prior to Jan 1, 1982		DISCN	No	No
3m	CIRCANOL	ergoloid mesylates	TABLET;SUBLINGUAL	085809-001	Approved Prior to Jan 1, 1982		DISCN	No	No

Expired US Patents for ERGOLOID MESYLATES

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Novartis	HYDERGINE LC	ergoloid mesylates	CAPSULE;ORAL	018706-001	Jan 18, 1983	4,366,145
Novartis	HYDERGINE	ergoloid mesylates	SOLUTION;ORAL	018418-001	Approved Prior to Jan 1, 1982	4,138,565

ERGOLOID MESYLATES Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory of Ergoloid Mesylates

Introduction

Ergoloid mesylates, a mixture of dihydrogenated ergot alkaloid derivatives, have been used for several decades in the treatment of various conditions, including senile dementia, hypertension, and peripheral vascular disease. Here, we delve into the market dynamics and financial trajectory of this drug.

Historical Context and Development

Ergoloid mesylates were first developed by Novartis and received FDA approval on November 5, 1953. However, the original formulation was later discontinued. In 1991, Sun Pharmaceutical Industries reacquired the rights to the drug and obtained FDA approval for its use[1].

Market Size and Growth

The global ergoloid mesylates market has shown a steady growth trajectory. As of 2023, the market size was valued at approximately USD 450 million. It is projected to reach around USD 650 million by 2032, indicating a significant growth rate over the next decade[4].

Clinical Use and Efficacy

Despite its long history, the efficacy of ergoloid mesylates in treating senile dementia remains a topic of debate. While there is evidence of short-term efficacy from numerous controlled trials, many clinicians still view it as a placebo. The drug is prescribed in doses ranging from 1.5 mg/day to 12 mg/day, but the optimal dose remains unknown[2].

Competitive Landscape

The pharmaceutical industry is highly competitive, and the development of follow-on drugs has become a common practice. However, the distinction between breakthrough and 'me-too' drugs is often blurred. The entry barriers for new drug introductions have fallen over time, leading to increased competitiveness in the market. This competitiveness could influence the pricing and market share of ergoloid mesylates[3].

Pricing and Dosage Forms

Ergoloid mesylates are available in various dosage forms, including tablets, capsules, and oral solutions. The pricing varies depending on the form and manufacturer. For instance, the cost of ergoloid mesylates powder is around USD 87.5 per gram, while the 1 mg tablet can cost approximately USD 1.3 per tablet[1].

Pharmacoeconomics

The pharmacoeconomic aspects of ergoloid mesylates are crucial in understanding its market dynamics. The drug's low oral bioavailability and extensive first-pass metabolism affect its pricing and usage. The high plasma protein binding (81%) and the complex metabolism pathway, where the drug is mainly excreted via bile in feces, also play a role in its pharmacoeconomic profile[1].

Manufacturers and Distribution

Several manufacturers, including Sun Pharmaceutical Industries, Gallipot, and Prescript Pharmaceuticals, are involved in the production and distribution of ergoloid mesylates. The drug is marketed under various brand names and is available in different regions, contributing to its global market presence[1].

Regulatory Environment

The regulatory environment plays a significant role in the market dynamics of ergoloid mesylates. Changes in FDA regulations and the approval process can impact the drug's market trajectory. For instance, the period of marketing exclusivity for breakthrough drugs has fallen dramatically over time, which could affect the competitive landscape for ergoloid mesylates[3].

Future Outlook

Given the increasing prevalence of senile dementia and the ongoing search for more effective treatments, the demand for ergoloid mesylates is likely to continue. However, the drug's efficacy and optimal dosage remain areas of ongoing research and debate. As new treatments emerge, the market dynamics for ergoloid mesylates may shift, but its current growth trajectory suggests a stable financial future in the short to medium term[2][4].

Key Takeaways

• Market Growth: The global ergoloid mesylates market is projected to grow from USD 450 million in 2023 to USD 650 million by 2032.
• Clinical Use: Despite debates on its efficacy, ergoloid mesylates continue to be used for treating senile dementia and other conditions.
• Competitive Landscape: The pharmaceutical market is highly competitive, with falling entry barriers for new drug introductions.
• Pricing and Dosage Forms: Available in various forms with varying prices, influenced by manufacturers and regulatory factors.
• Pharmacoeconomics: Low oral bioavailability, extensive first-pass metabolism, and high plasma protein binding affect its market dynamics.

FAQs

Q: What are the primary components of ergoloid mesylates? A: Ergoloid mesylates are composed of dihydrogenated ergot alkaloid derivatives, specifically dihydroergocornine, dihydroergocristine, and dihydroergocryptine[1].

Q: What conditions is ergoloid mesylates used to treat? A: Ergoloid mesylates are used to treat senile dementia, hypertension, and peripheral vascular disease[2].

Q: What is the current market size and projected growth of ergoloid mesylates? A: The global market size was approximately USD 450 million in 2023 and is projected to reach USD 650 million by 2032[4].

Q: How is ergoloid mesylates metabolized and excreted? A: The drug is mainly excreted via bile in feces, with a small amount excreted in urine. It undergoes extensive first-pass metabolism[1].

Q: What are the key factors influencing the pricing of ergoloid mesylates? A: Pricing is influenced by the drug's low oral bioavailability, high plasma protein binding, and the competitive landscape of the pharmaceutical market[1][3].

Sources

1. DrugBank: Ergoloid mesylate: Uses, Interactions, Mechanism of Action.
2. PubMed: Ergoloid mesylates for senile dementias: unanswered questions.
3. PubMed: The economics of follow-on drug research and development.
4. Dataintelo: Ergoloid Mesylates Market Research Report 2032.