Icatibant acetate - Generic Drug Details

What are the generic drug sources for icatibant acetate and what is the scope of patent protection?

Icatibant acetate is the generic ingredient in two branded drugs marketed by Takeda Pharms Usa, Alembic, Cipla, Dr Reddys, Eugia Pharma, Fresenius Kabi Usa, Glenmark Pharms Ltd, Jiangsu Hansoh Pharm, Nang Kuang Pharm Co, Teva Pharms Usa, and Wilshire Pharms Inc, and is included in eleven NDAs. Additional information is available in the individual branded drug profile pages.

There are thirteen drug master file entries for icatibant acetate. Eleven suppliers are listed for this compound.

Summary for icatibant acetate

US Patents:	0
Tradenames:	2
Applicants:	11
NDAs:	11
Drug Master File Entries:	13
Finished Product Suppliers / Packagers:	11
Raw Ingredient (Bulk) Api Vendors:	14
Patent Applications:	39
What excipients (inactive ingredients) are in icatibant acetate?	icatibant acetate excipients list
DailyMed Link:	icatibant acetate at DailyMed

Pharmacology for icatibant acetate

Drug Class	Bradykinin B2 Receptor Antagonist
Mechanism of Action	Bradykinin B2 Receptor Antagonists

Anatomical Therapeutic Chemical (ATC) Classes for icatibant acetate

B06AC	Drugs used in hereditary angioedema
B06A	OTHER HEMATOLOGICAL AGENTS
B06	OTHER HEMATOLOGICAL AGENTS
B	Blood and blood forming organs

Paragraph IV (Patent) Challenges for ICATIBANT ACETATE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
FIRAZYR	Injection	icatibant acetate	10 mg/mL	022150	2	2015-08-25

US Patents and Regulatory Information for icatibant acetate

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Dr Reddys	ICATIBANT ACETATE	icatibant acetate	INJECTABLE;SUBCUTANEOUS	213054-001	Oct 5, 2020		DISCN	No	No
Eugia Pharma	ICATIBANT ACETATE	icatibant acetate	INJECTABLE;SUBCUTANEOUS	213521-001	Aug 14, 2023	AP	RX	No	No
Takeda Pharms Usa	FIRAZYR	icatibant acetate	INJECTABLE;SUBCUTANEOUS	022150-001	Aug 25, 2011	AP	RX	Yes	Yes
Glenmark Pharms Ltd	ICATIBANT ACETATE	icatibant acetate	INJECTABLE;SUBCUTANEOUS	213222-001	May 21, 2021		DISCN	No	No
Nang Kuang Pharm Co	ICATIBANT ACETATE	icatibant acetate	INJECTABLE;SUBCUTANEOUS	212081-001	Dec 16, 2020	AP	RX	No	No

Expired US Patents for icatibant acetate

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Takeda Pharms Usa	FIRAZYR	icatibant acetate	INJECTABLE;SUBCUTANEOUS	022150-001	Aug 25, 2011

Icatibant acetate Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory of Icatibant Acetate

Introduction to Icatibant Acetate

Icatibant acetate, marketed under the brand name Firazyr, is a synthetic decapeptide that acts as a bradykinin B2 receptor antagonist. It is primarily used for the treatment of hereditary angioedema (HAE) in patients 18 years old and older[2].

Market Size and Growth Projections

The global pharmaceutical grade icatibant acetate market is experiencing significant growth. As of 2023, the market size was estimated at USD 460.99 million and is projected to reach USD 635.63 million by 2029, indicating a steady increase in demand[1][4].

Compound Annual Growth Rate (CAGR)

The market is expected to grow at a Compound Annual Growth Rate (CAGR) of 5.5% from 2024 to 2030, reaching a forecasted market size of USD 634.3 million by 2030[4].

Market Drivers

Several factors are driving the growth of the icatibant acetate market:

Increasing Demand for Healthcare

The global healthcare sector is expanding due to an increasing demand for effective treatments, particularly for rare and chronic conditions like HAE. This demand is fueled by a growing population and an aging demographic[4].

Technological Advancements

Advancements in pharmaceutical technology and manufacturing processes are improving the production efficiency and quality of icatibant acetate. This leads to better product availability and reduced costs[4].

Rising Prevalence of Chronic Diseases

The rising prevalence of chronic diseases, including rare genetic disorders like HAE, is driving the need for specialized treatments. Icatibant acetate, being a targeted therapy, benefits from this trend[4].

Funding and R&D Activities

Increased funding from both private and government organizations for pharmaceutical research and development is supporting the growth of the icatibant acetate market. This funding enables companies to invest in clinical trials, manufacturing improvements, and market expansion[4].

Market Challenges

Despite the growth, the market faces several challenges:

Stringent Regulations

Pharmaceutical companies must comply with stringent regulatory requirements, which can delay product approvals and increase development costs. For icatibant acetate, initial NDA submissions were not approvable due to deficiencies in pharmacology and toxicology data[2].

High R&D Costs

The high costs associated with research and development, including the need for extensive toxicology and carcinogenicity studies, pose a significant challenge. For example, icatibant acetate required 6-month rat and 9-month dog chronic toxicology studies to support its approval[2].

Patent Expirations

Patent expirations can lead to increased competition from generic versions, potentially reducing market share for the original manufacturers. Companies must continuously innovate to maintain their competitive edge[4].

Market Segmentation

The global pharmaceutical grade icatibant acetate market is segmented based on several criteria:

By Type

• Purity ≥ 99%: This segment is expected to dominate the market due to the high demand for high-purity pharmaceutical-grade icatibant acetate.
• Purity < 99%: This segment, while smaller, still serves specific applications where lower purity is acceptable[4].

By Application

• Injection: Icatibant acetate is primarily administered via subcutaneous injection for the treatment of HAE.
• Others: Other applications, though less common, may include research and development uses[4].

Regional Analysis

The market is analyzed across various regions:

Europe

Europe is a significant market for icatibant acetate, with countries like Germany, France, and the UK contributing substantially to the regional demand[4].

Asia Pacific

The Asia Pacific region, including countries like China, Japan, and South Korea, is growing rapidly due to increasing healthcare spending and a large patient population[4].

North America

North America, particularly the U.S., is a major market due to high healthcare expenditure and a well-established pharmaceutical industry[4].

Middle East, Africa, and Latin America

These regions are also growing, driven by increasing healthcare needs and investments in pharmaceutical infrastructure[4].

Key Players

Several companies are prominent in the icatibant acetate market:

Alembic Pharmaceuticals Ltd

Alembic Pharmaceuticals Ltd is one of the key manufacturers, known for its capacity, sales, and revenue in the pharmaceutical grade icatibant acetate market[4].

Financial Performance

The financial performance of the icatibant acetate market is robust, with steady revenue growth:

Revenue Forecast

The market revenue is forecasted to increase from USD 460 million in 2024 to USD 634.3 million by 2030, reflecting a consistent growth trajectory[4].

Production and Sales

The production and sales of icatibant acetate are expected to rise, driven by increasing demand and improved manufacturing capabilities. The report covers detailed sales data by region and company from 2019 to 2030[4].

Regulatory Landscape

The regulatory landscape plays a crucial role in the market dynamics of icatibant acetate:

FDA Approval

Icatibant acetate was approved by the FDA in 2011 after the submission of comprehensive pharmacology and toxicology data, including chronic toxicity studies in rats and dogs[2].

Post-Marketing Requirements

The FDA has mandated post-marketing requirements, including carcinogenicity studies, to ensure long-term safety and efficacy[2].

Conclusion

The market for pharmaceutical grade icatibant acetate is poised for significant growth, driven by increasing healthcare demands, technological advancements, and rising prevalence of chronic diseases. However, the market must navigate challenges such as stringent regulations, high R&D costs, and patent expirations.

Key Takeaways

• Market Growth: The global pharmaceutical grade icatibant acetate market is projected to grow from USD 460 million in 2024 to USD 634.3 million by 2030.
• CAGR: The market is expected to grow at a CAGR of 5.5% from 2024 to 2030.
• Market Drivers: Increasing demand for healthcare, technological advancements, and rising prevalence of chronic diseases are key drivers.
• Challenges: Stringent regulations, high R&D costs, and patent expirations are significant challenges.
• Market Segmentation: The market is segmented by type (purity ≥ 99% and purity < 99%) and application (injection and others).
• Regional Analysis: Europe, Asia Pacific, North America, and Middle East, Africa, and Latin America are key regions.

FAQs

Q: What is the primary use of icatibant acetate?

A: Icatibant acetate is primarily used for the treatment of hereditary angioedema (HAE) in patients 18 years old and older[2].

Q: What is the projected market size of icatibant acetate by 2030?

A: The global pharmaceutical grade icatibant acetate market is projected to reach USD 634.3 million by 2030[4].

Q: What are the key drivers of the icatibant acetate market?

A: Key drivers include increasing demand for healthcare, technological advancements, and the rising prevalence of chronic diseases[4].

Q: What are the main challenges faced by the icatibant acetate market?

A: The market faces challenges such as stringent regulations, high R&D costs, and patent expirations[4].

Q: Who are some of the key players in the icatibant acetate market?

A: Companies like Alembic Pharmaceuticals Ltd are prominent in the market[4].

Sources

1. MarketResearch.com: Global Pharmaceutical Grade Icatibant Acetate Market Research.
2. FDA: 022150Orig1s000 | FDA.
3. MarketResearchReports.com: Global Pharmaceutical Grade Icatibant Acetate Market 2023 by Manufacturers, Regions, Type and Application, Forecast to 2029.
4. QYResearch: Global Pharmaceutical Grade Icatibant Acetate Market Insights, Forecast to 2030.