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Last Updated: March 16, 2025

ERGOTAMINE TARTRATE - Generic Drug Details


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What are the generic sources for ergotamine tartrate and what is the scope of freedom to operate?

Ergotamine tartrate is the generic ingredient in four branded drugs marketed by 3M, Pangea, Watson Labs Inc, and Organon Usa Inc, and is included in four NDAs. Additional information is available in the individual branded drug profile pages.

There are six drug master file entries for ergotamine tartrate. Two suppliers are listed for this compound.

Summary for ERGOTAMINE TARTRATE
Drug Prices for ERGOTAMINE TARTRATE

See drug prices for ERGOTAMINE TARTRATE

Pharmacology for ERGOTAMINE TARTRATE
Anatomical Therapeutic Chemical (ATC) Classes for ERGOTAMINE TARTRATE

US Patents and Regulatory Information for ERGOTAMINE TARTRATE

ApplicantTradenameGeneric NameDosageNDAApproval DateTETypeRLDRSPatent No.Patent ExpirationProductSubstanceDelist Req.Exclusivity Expiration
3m MEDIHALER ERGOTAMINE ergotamine tartrate AEROSOL, METERED;INHALATION 012102-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Organon Usa Inc WIGRETTES ergotamine tartrate TABLET;SUBLINGUAL 086750-001 Jul 29, 1982 DISCN No No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Pangea ERGOMAR ergotamine tartrate TABLET;SUBLINGUAL 087693-001 Feb 24, 1983 RX No Yes ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Watson Labs Inc ERGOSTAT ergotamine tartrate TABLET;SUBLINGUAL 088337-001 Jun 8, 1984 DISCN No No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
>Applicant>Tradename>Generic Name>Dosage>NDA>Approval Date>TE>Type>RLD>RS>Patent No.>Patent Expiration>Product>Substance>Delist Req.>Exclusivity Expiration
Showing 1 to 4 of 4 entries

Market Dynamics and Financial Trajectory for Ergotamine Tartrate

Introduction

Ergotamine tartrate is a medication widely used for the treatment of migraines and cluster headaches. Understanding its market dynamics and financial trajectory is crucial for stakeholders, including manufacturers, suppliers, and healthcare providers.

Global Import Trends

The global import market for ergotamine tartrate has seen significant fluctuations. Between February 2023 and January 2024, the world imported 26 shipments of ergotamine tartrate, supplied by 15 exporters to 18 global buyers. This period marked a decline of 42% in imports compared to the preceding twelve months. Notably, in January 2024, there were no shipments of ergotamine tartrate, indicating a year-on-year decline of 100% from January 2023[1].

Leading Importers and Exporters

Ecuador is the largest importer of ergotamine tartrate, accounting for 93 shipments and a 24% market share. India and Paraguay follow closely, with 76 and 49 shipments, respectively, holding 19% and 12% market shares. On the supply side, the Czech Republic, India, and Italy are the top exporters. The Czech Republic leads with 279 shipments, representing a 54% market share, followed by India with 196 shipments (38% market share), and Italy with 12 shipments (3% market share)[1].

Market Growth and Decline

The recent decline in imports can be attributed to various factors, including changes in demand, supply chain disruptions, and regulatory issues. The absence of shipments in January 2024 suggests a potential shortage or temporary halt in production or distribution. This volatility highlights the need for robust market analysis and strategic planning in the pharmaceutical industry.

Pricing and Cost Analysis

The cost of ergotamine tartrate varies significantly depending on the form and quantity. For instance, ergotamine tartrate powder can cost around $224.35 per unit, while tablets and suppositories range from $1.14 to $8.97 per unit. These prices are indicative and can fluctuate based on market conditions, supplier agreements, and regulatory changes[3].

Clinical Use and Demand

Ergotamine tartrate is nominated for inclusion on the 503B Bulks List for use in topical or mucosal creams, gels, and ointments to treat migraines and headaches. This nomination is driven by the temporary unavailability of the drug from manufacturers and the inappropriateness of excipients from tablets for topical application. The demand for ergotamine tartrate remains strong, particularly in neurology, primary care, and internal medicine specialties[2].

Mechanism of Action and Therapeutic Benefits

Ergotamine tartrate acts as a vasoconstrictor and alpha adrenoreceptor antagonist, reducing extracranial blood flow and the amplitude of pulsations in cranial arteries. This mechanism is crucial for alleviating migraine pain. Despite its therapeutic benefits, ergotamine tartrate can lead to physical dependency, characterized by a self-sustaining headache-medication cycle, which complicates treatment strategies[3][5].

Regulatory Environment

The regulatory landscape for ergotamine tartrate involves scrutiny from various global health authorities. The FDA, EMA, and other regulatory bodies monitor its use, availability, and safety. The nomination for the 503B Bulks List is part of ongoing efforts to ensure its availability and appropriate use in clinical settings[2].

Market Segmentation

The global ergotamine market is segmented into different types, including ergotamine tartrate, dichloroergotamine, and ergotamine-caffeine combinations. This segmentation helps in understanding the diverse needs of the market and tailoring strategies to meet these needs[4].

Financial Implications

The financial trajectory of ergotamine tartrate is influenced by several factors, including production costs, market demand, and regulatory compliance. The decline in imports and potential shortages can lead to increased costs and reduced profitability for manufacturers and suppliers. Conversely, a stable supply chain and consistent demand can stabilize prices and enhance financial performance.

Future Outlook

The future outlook for ergotamine tartrate depends on addressing current market challenges. This includes ensuring a stable supply chain, managing regulatory hurdles, and mitigating the risk of physical dependency. As the global healthcare landscape evolves, the demand for effective migraine treatments is likely to remain strong, providing opportunities for growth and innovation in the ergotamine tartrate market.

Key Takeaways

  • Global Import Trends: Significant decline in ergotamine tartrate imports between February 2023 and January 2024.
  • Leading Importers and Exporters: Ecuador, India, and Paraguay are top importers, while the Czech Republic, India, and Italy are leading exporters.
  • Pricing and Cost Analysis: Variable costs depending on the form and quantity of the drug.
  • Clinical Use and Demand: Strong demand in neurology and primary care specialties.
  • Mechanism of Action and Therapeutic Benefits: Effective vasoconstrictor for migraine treatment but with potential for physical dependency.
  • Regulatory Environment: Scrutiny from global health authorities like the FDA and EMA.
  • Market Segmentation: Segmented into ergotamine tartrate, dichloroergotamine, and ergotamine-caffeine combinations.

FAQs

Q: What are the primary uses of ergotamine tartrate? A: Ergotamine tartrate is primarily used to treat migraines with or without aura and cluster headaches.

Q: Which countries are the largest importers of ergotamine tartrate? A: Ecuador, India, and Paraguay are the largest importers of ergotamine tartrate.

Q: What are the potential risks associated with ergotamine tartrate? A: Ergotamine tartrate can lead to physical dependency and a self-sustaining headache-medication cycle.

Q: How does ergotamine tartrate work to alleviate migraine pain? A: It acts as a vasoconstrictor, reducing extracranial blood flow and the amplitude of pulsations in cranial arteries.

Q: What is the current market trend for ergotamine tartrate imports? A: There has been a significant decline in imports between February 2023 and January 2024, with no shipments in January 2024.

Sources

  1. Volza: Ergotamine Tartrate Imports in World - Volza.
  2. University of Maryland, Baltimore: Ergotamine tartrate - University of Maryland, Baltimore.
  3. DrugBank: Ergotamine: Uses, Interactions, Mechanism of Action - DrugBank.
  4. DataIntelo: Ergotamine Sales Market Report | Global Forecast From 2023 To 2032.
  5. PubMed: Ergotamine tartrate dependency: features and possible mechanisms.

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