EMBOLEX Drug Patent Profile

Which patents cover Embolex, and what generic alternatives are available?

Embolex is a drug marketed by Novartis and is included in one NDA.

The generic ingredient in EMBOLEX is dihydroergotamine mesylate; heparin sodium; lidocaine hydrochloride. There are six drug master file entries for this compound. Additional details are available on the dihydroergotamine mesylate; heparin sodium; lidocaine hydrochloride profile page.

Summary for EMBOLEX

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	131
Clinical Trials:	1
Patent Applications:	4,535
DailyMed Link:	EMBOLEX at DailyMed

Recent Clinical Trials for EMBOLEX

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

Sponsor	Phase
Novartis	Phase 3

See all EMBOLEX clinical trials

US Patents and Regulatory Information for EMBOLEX

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Novartis	EMBOLEX	dihydroergotamine mesylate; heparin sodium; lidocaine hydrochloride	INJECTABLE;INJECTION	018885-001	Nov 30, 1984		DISCN	No	No
Novartis	EMBOLEX	dihydroergotamine mesylate; heparin sodium; lidocaine hydrochloride	INJECTABLE;INJECTION	018885-002	Nov 30, 1984		DISCN	No	No

Expired US Patents for EMBOLEX

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Novartis	EMBOLEX	dihydroergotamine mesylate; heparin sodium; lidocaine hydrochloride	INJECTABLE;INJECTION	018885-001	Nov 30, 1984
Novartis	EMBOLEX	dihydroergotamine mesylate; heparin sodium; lidocaine hydrochloride	INJECTABLE;INJECTION	018885-002	Nov 30, 1984
Novartis	EMBOLEX	dihydroergotamine mesylate; heparin sodium; lidocaine hydrochloride	INJECTABLE;INJECTION	018885-002	Nov 30, 1984
Novartis	EMBOLEX	dihydroergotamine mesylate; heparin sodium; lidocaine hydrochloride	INJECTABLE;INJECTION	018885-001	Nov 30, 1984

International Patents for EMBOLEX

See the table below for patents covering EMBOLEX around the world.

Country	Patent Number	Title	Estimated Expiration
European Patent Office	0028813	STABLE SOLUTIONS OF HYDROGENATED ERGOTALCALOIDS OR THEIR SALTS AND HEPARIN OR ITS SALTS,AND PROCESS FOR THEIR PREPARATIONS
Australia	6426580
Denmark	477880
Greece	72128
Israel	61447
Belgium	886008

EMBOLEX Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for the Drug: Embolex

Introduction

Embolex, a product in the pharmaceutical sector, is part of a broader landscape influenced by various market dynamics, regulatory environments, and financial factors. To understand the market dynamics and financial trajectory of Embolex, it is essential to delve into the broader pharmaceutical industry trends, the specific market segments it operates in, and the financial performance of its parent company.

Pharmaceutical Industry Overview

The pharmaceutical industry is characterized by intense competition, stringent regulatory requirements, and significant research and development (R&D) investments. Companies in this sector often face challenges such as patent expirations, pricing pressures, and the need for continuous innovation[3].

Market Segment Analysis

Embolex, being a part of the pharmaceutical portfolio, likely falls under a specific therapeutic category. For instance, if it is related to cardiovascular or metabolic diseases, it would be part of a highly competitive and dynamic market.

Cardiovascular Market

In the cardiovascular market, drugs like Eliquis (apixaban) and Xarelto (rivaroxaban) dominate the anticoagulant segment, with significant market shares and growth rates. These drugs have seen substantial growth, particularly in the atrial fibrillation and embolism markets[1].

Metabolic Market

In the metabolic market, particularly for diabetes, drugs such as Ozempic/Rybelsus (semaglutide) and Trulicity (dulaglutide) have been major growth drivers. New entrants like Mounjaro (tirzepatide) have also shown impressive growth since their launch[1].

Financial Performance of Parent Company

Embolex is mentioned in the context of Aspen Pharmacare Holdings Limited, a global pharmaceutical company. Here are some key financial and operational insights related to Aspen:

Revenue and Profit Trajectory

Aspen Pharmacare experienced a mixed financial performance in recent years. For instance, in the 2019 financial year, the company saw a decline in revenue and profit from its commercial pharmaceuticals segment, particularly in developed markets. The revenue growth from commercial pharmaceuticals in emerging markets was marginally positive, but overall, the segment saw a decline at constant exchange rates (CER)[2].

Manufacturing and Operational Efficiency

Aspen Pharmacare invested significantly in manufacturing and operational efficiency. The company completed serialization projects to meet regulatory requirements and invested in new technology to enhance operational efficiency. However, manufacturing revenue declined by 11% (CER) in 2019, contributing to the overall negative CER growth[2].

Product Portfolio and Market Focus

Aspen Pharmacare has focused on niche, specialty medicines to drive sustainable revenue growth. The company has pursued targeted acquisitions, internal product development, and line extensions into new geographies. This strategy aims to capitalize on its intellectual and manufacturing advantages[2].

Specifics on Embolex

While detailed financial data specifically for Embolex is not provided in the available sources, here are some general insights that can be inferred:

Market Position

Embolex, as part of Aspen Pharmacare's portfolio, would need to compete in its respective therapeutic market. The success of Embolex would depend on factors such as its efficacy, pricing strategy, and market penetration.

Financial Impact

Given the broader financial trends of Aspen Pharmacare, Embolex's financial performance would be influenced by the company's overall revenue and profit trajectory. Any decline in manufacturing revenue or profitability in the parent company could impact the financial health of Embolex.

Regulatory and Competitive Environment

The pharmaceutical industry is heavily regulated, and companies must comply with stringent regulatory requirements. Embolex would need to meet these standards to maintain market approval and competitiveness.

Pricing Dynamics

The US pharmaceutical market, for example, is characterized by complex pricing dynamics, with significant bargaining power held by Pharmacy Benefit Managers (PBMs). This can lead to increased price pressure on pharmaceutical manufacturers, affecting their profitability[3].

Conclusion

The market dynamics and financial trajectory of Embolex are intertwined with the broader trends in the pharmaceutical industry and the financial performance of its parent company, Aspen Pharmacare. Here are the key takeaways:

• Market Competition: Embolex operates in a highly competitive market segment, whether it be cardiovascular or metabolic diseases.
• Financial Performance: The financial health of Embolex is tied to Aspen Pharmacare's overall revenue and profitability, which have seen declines in certain segments.
• Regulatory Environment: Compliance with regulatory requirements is crucial for maintaining market approval.
• Pricing Dynamics: The pharmaceutical market is subject to pricing pressures, particularly from PBMs in the US market.

Key Takeaways

• Competitive Landscape: Embolex must compete with established and new entrants in its therapeutic category.
• Financial Health: The drug's financial performance is influenced by Aspen Pharmacare's overall financial trajectory.
• Regulatory Compliance: Adherence to regulatory standards is essential for market presence.
• Pricing Strategies: Effective pricing strategies are critical in a market with significant bargaining power held by PBMs.

FAQs

What is the current market trend for cardiovascular drugs like Embolex?

The cardiovascular market, particularly for anticoagulants, is dominated by drugs like Eliquis and Xarelto, with significant growth rates and market shares[1].

How does the regulatory environment impact Embolex?

The regulatory environment is stringent, and compliance with regulatory requirements is crucial for maintaining market approval and ensuring the drug's safety and efficacy.

What are the key financial challenges faced by Aspen Pharmacare, the parent company of Embolex?

Aspen Pharmacare has faced declines in manufacturing revenue and profitability in certain segments, along with the impact of exchange rate movements and reduced revenue from discontinued operations[2].

How does the pricing dynamics in the US pharmaceutical market affect Embolex?

The US market is characterized by significant bargaining power held by PBMs, leading to increased price pressure on pharmaceutical manufacturers, which can affect their profitability[3].

What are the growth prospects for Embolex in emerging markets?

Emerging markets have shown marginally positive revenue growth for Aspen Pharmacare's commercial pharmaceuticals segment, suggesting potential growth opportunities for Embolex in these regions[2].

Sources

1. IQVIA: Finding the growth engines of the endocrine & metabolic ... - IQVIA
2. Aspen Pharmacare Holdings Limited: 2019 Integrated Report
3. Copenhagen Business School: The Price Dynamics of the US Pharmaceutical Market
4. Fortune Business Insights: Heparin Market Size, Share & Global Forecast Report [2030]