Anagrelide hydrochloride - Generic Drug Details

What are the generic drug sources for anagrelide hydrochloride and what is the scope of patent protection?

Anagrelide hydrochloride is the generic ingredient in two branded drugs marketed by Takeda Pharms Usa, Barr, Chartwell Rx, Impax Labs, Ivax Sub Teva Pharms, Natco Pharma Usa, Rising, Roxane, Torrent, and Watson Labs, and is included in ten NDAs. Additional information is available in the individual branded drug profile pages.

There are eight drug master file entries for anagrelide hydrochloride. Four suppliers are listed for this compound.

Summary for anagrelide hydrochloride

US Patents:	0
Tradenames:	2
Applicants:	10
NDAs:	10
Drug Master File Entries:	8
Finished Product Suppliers / Packagers:	4
Raw Ingredient (Bulk) Api Vendors:	101
Clinical Trials:	24
Patent Applications:	1,146
What excipients (inactive ingredients) are in anagrelide hydrochloride?	anagrelide hydrochloride excipients list
DailyMed Link:	anagrelide hydrochloride at DailyMed

Recent Clinical Trials for anagrelide hydrochloride

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

Sponsor	Phase
Merck Sharp & Dohme LLC	Phase 3
Celgene	Phase 3
Medpace, Inc.	Phase 3

See all anagrelide hydrochloride clinical trials

Pharmacology for anagrelide hydrochloride

Drug Class	Platelet-reducing Agent
Mechanism of Action	Phosphodiesterase 3 Inhibitors
Physiological Effect	Decreased Platelet Production

Anatomical Therapeutic Chemical (ATC) Classes for anagrelide hydrochloride

L01XX	Other antineoplastic agents
L01X	OTHER ANTINEOPLASTIC AGENTS
L01	ANTINEOPLASTIC AGENTS
L	Antineoplastic and immunomodulating agents

US Patents and Regulatory Information for anagrelide hydrochloride

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Roxane	ANAGRELIDE HYDROCHLORIDE	anagrelide hydrochloride	CAPSULE;ORAL	076489-001	Apr 18, 2005		DISCN	No	No
Rising	ANAGRELIDE HYDROCHLORIDE	anagrelide hydrochloride	CAPSULE;ORAL	077613-002	Jun 27, 2006		DISCN	No	No
Barr	ANAGRELIDE HYDROCHLORIDE	anagrelide hydrochloride	CAPSULE;ORAL	076530-002	Apr 18, 2005		DISCN	No	No
Rising	ANAGRELIDE HYDROCHLORIDE	anagrelide hydrochloride	CAPSULE;ORAL	077613-001	Jun 27, 2006		DISCN	No	No
Torrent	ANAGRELIDE HYDROCHLORIDE	anagrelide hydrochloride	CAPSULE;ORAL	209151-002	Jun 30, 2017	AB	RX	No	No
Chartwell Rx	ANAGRELIDE HYDROCHLORIDE	anagrelide hydrochloride	CAPSULE;ORAL	076683-001	Apr 18, 2005		DISCN	No	No

Anagrelide hydrochloride Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Anagrelide Hydrochloride

Introduction

Anagrelide hydrochloride, a platelet-reducing agent, is primarily used in the treatment of thrombocythemia, a condition characterized by an elevated platelet count. Here, we delve into the market dynamics and financial trajectory of this drug, exploring its current status, future projections, and key factors influencing its market.

Market Size and Forecast

The anagrelide hydrochloride capsule market has experienced significant growth in recent years and is expected to continue this trend. The market is projected to grow at a Compound Annual Growth Rate (CAGR) of 3 to 5 percent from 2023 to 2031, indicating robust growth rates throughout the forecast period[1][4].

Regional Market Analysis

The global market for anagrelide hydrochloride capsules is segmented into several key regions, including North America, Europe, China, and the Asia-Pacific region (excluding China). Each of these regions is expected to see substantial growth, with varying CAGRs.

• North America: This region is anticipated to contribute significantly to the global market due to advanced healthcare infrastructure and higher adoption rates of specialized treatments.
• Europe: Europe is also expected to show considerable growth, driven by an aging population and increased incidence of myeloproliferative disorders.
• China: The Chinese market is forecasted to expand rapidly, driven by growing healthcare expenditure and an increasing demand for effective treatments for thrombocythemia[4].

Key Manufacturers

The global anagrelide hydrochloride capsule market is dominated by several key manufacturers, including Takeda, Teva, Torrent, Mylan, and Sandoz. These companies hold a significant share in both sales volume and revenue, and their strategic initiatives are crucial in shaping the market dynamics[4].

Market Drivers

Several factors are driving the growth of the anagrelide hydrochloride market:

• Increasing Incidence of Myeloproliferative Disorders: The rising incidence of conditions such as essential thrombocythemia and polycythemia vera is driving the demand for effective treatments like anagrelide hydrochloride.
• Advancements in Healthcare: Improvements in healthcare infrastructure and diagnostic capabilities are leading to better detection and treatment of these disorders.
• FDA Approval and Clinical Efficacy: Anagrelide hydrochloride's FDA approval and its proven clinical efficacy in reducing platelet counts and associated risks make it a preferred treatment option[2][5].

Market Restraints

Despite the positive growth trajectory, there are several restraints to consider:

• Side Effects and Adverse Reactions: Anagrelide hydrochloride is associated with various side effects, including lack of strength, headache, fever, and more severe conditions like hepatotoxicity and pulmonary complications. These adverse effects can limit its adoption[2][5].
• Cost-Effectiveness: The cost of anagrelide hydrochloride treatment is significant, with lifelong treatment estimated to cost approximately $72,000 per additional year of life gained compared to hydroxyurea. This can be a barrier, especially in regions with limited healthcare resources[3].

Cost-Effectiveness Analysis

The cost-effectiveness of anagrelide hydrochloride is a critical factor in its market dynamics. Studies have shown that while anagrelide is more costly than hydroxyurea, it offers better efficacy and lower risks of treatment-related leukemia. The incremental cost-effectiveness ratio of anagrelide compared to hydroxyurea is around $156,969 per additional year of life gained, assuming a reduced lifetime leukemia risk[3].

Competitive Landscape

The competitive landscape of the anagrelide hydrochloride market is characterized by the dominance of a few key players. These companies are engaged in various strategies such as product innovation, mergers and acquisitions, and market expansion to maintain their market share. The top five players hold a significant share in both sales volume and revenue, indicating a concentrated market[4].

Financial Projections

The financial trajectory of the anagrelide hydrochloride market is promising, with projected growth in both revenue and sales volume. The United States, Europe, and China are expected to be major contributors to this growth. Here are some key financial projections:

• Revenue Growth: The global market revenue is expected to increase significantly from 2023 to 2029, driven by increasing demand and higher adoption rates.
• Sales Volume: The sales volume of anagrelide hydrochloride capsules is also expected to rise, reflecting the growing need for effective treatments for thrombocythemia[4].

Regulatory Environment

The regulatory environment plays a crucial role in the market dynamics of anagrelide hydrochloride. FDA approval and compliance with regulatory standards are essential for the drug's continued market presence. Any changes in regulatory policies or the introduction of new guidelines can significantly impact the market[2][5].

Conclusion

The anagrelide hydrochloride market is poised for significant growth, driven by increasing demand, advancements in healthcare, and the drug's proven efficacy. However, the market also faces challenges such as side effects, cost-effectiveness concerns, and a competitive landscape dominated by a few key players. Understanding these dynamics is crucial for stakeholders looking to navigate this market effectively.

Key Takeaways

• Market Growth: The anagrelide hydrochloride market is expected to grow at a CAGR of 3 to 5 percent from 2023 to 2031.
• Regional Analysis: North America, Europe, and China are key regions driving market growth.
• Key Manufacturers: Takeda, Teva, Torrent, Mylan, and Sandoz are dominant players.
• Market Drivers: Increasing incidence of myeloproliferative disorders and advancements in healthcare.
• Market Restraints: Side effects, cost-effectiveness concerns, and competitive landscape.
• Financial Projections: Significant growth in revenue and sales volume is anticipated.

FAQs

1. What is the primary use of anagrelide hydrochloride? Anagrelide hydrochloride is primarily used to treat thrombocythemia, reducing elevated platelet counts and the risk of thrombosis and associated symptoms.

2. Which regions are expected to drive the growth of the anagrelide hydrochloride market? North America, Europe, and China are anticipated to be major contributors to the market growth.

3. Who are the key manufacturers in the anagrelide hydrochloride market? The key manufacturers include Takeda, Teva, Torrent, Mylan, and Sandoz.

4. What are the main side effects associated with anagrelide hydrochloride? Common side effects include lack of strength, headache, fever, and more severe conditions like hepatotoxicity and pulmonary complications.

5. How cost-effective is anagrelide hydrochloride compared to other treatments? Anagrelide hydrochloride is more costly than hydroxyurea but offers better efficacy and lower risks of treatment-related leukemia, with an estimated cost of $72,000 per additional year of life gained.

Sources

1. Market Research Intellect - Anagrelide Hydrochloride Capsule Market Size And Forecast
2. Leukemia and Lymphoma Society - Anagrelide hydrochloride
3. PubMed - Cost-effectiveness considerations in the treatment of essential thrombocythemia
4. QY Research - Global Anagrelide Hydrochloride Capsule Industry Research Report
5. FDA - AGRYLIN (anagrelide hydrochloride) Dosage Form: 0.5 mg capsules