FIRAZYR Drug Patent Profile

Which patents cover Firazyr, and when can generic versions of Firazyr launch?

Firazyr is a drug marketed by Takeda Pharms Usa and is included in one NDA.

The generic ingredient in FIRAZYR is icatibant acetate. There are thirteen drug master file entries for this compound. Eleven suppliers are listed for this compound. Additional details are available on the icatibant acetate profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Firazyr

A generic version of FIRAZYR was approved as icatibant acetate by TEVA PHARMS USA on July 15^th, 2019.

Summary for FIRAZYR

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	99
Clinical Trials:	9
Patent Applications:	806
Drug Prices:	Drug price information for FIRAZYR
What excipients (inactive ingredients) are in FIRAZYR?	FIRAZYR excipients list
DailyMed Link:	FIRAZYR at DailyMed

See drug prices for FIRAZYR

Recent Clinical Trials for FIRAZYR

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

Sponsor	Phase
Sebastian Videla	Phase 2
Main Line Health	Phase 2
University of Colorado, Denver	Phase 2

See all FIRAZYR clinical trials

Pharmacology for FIRAZYR

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

Paragraph IV (Patent) Challenges for FIRAZYR

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 FIRAZYR

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Takeda Pharms Usa	FIRAZYR	icatibant acetate	INJECTABLE;SUBCUTANEOUS	022150-001	Aug 25, 2011	AP	RX	Yes	Yes

Expired US Patents for FIRAZYR

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	5,648,333

International Patents for FIRAZYR

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

Country	Patent Number	Title	Estimated Expiration
South Africa	8906068
European Patent Office	0455133	Peptides ayant une activité antagoniste pour la bradykinine (Peptide antagonists of bradykinin)
Lithuania	1466

Supplementary Protection Certificates for FIRAZYR

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0370453	51/2008	Austria		PRODUCT NAME: ICATIBANT, WAHLWEISE IN FORM EINES PHYSIOLOGISCH ANNEHMBAREN SALZES, EINSCHLIESSLICH ICATIBANT-ACETAT; REGISTRATION NO/DATE: EU/1/08/461/001 20080711
0370453	300359	Netherlands		300359, 20091121, EXPIRES: 20141120
0370453	09C0002	France		PRODUCT NAME: ICATIBANT, EVENTUELLEMENT SOUS FORME DE SEL PHYSIOLOGIQUEMENT ACCEPTABLE, NOTAMMENT L?ACETATE D?ICATIBANT; REGISTRATION NO/DATE IN FRANCE: EU/1/08/461/001 DU 20080711; REGISTRATION NO/DATE AT EEC: EU/1/08/461/001 DU 20080711

Market Dynamics and Financial Trajectory for FIRAZYR

Last updated: July 29, 2025

Introduction

FIRAZYR (icatibant) is a targeted therapeutic agent approved for the treatment of hereditary angioedema (HAE) attacks. As a bradykinin B2 receptor antagonist, FIRAZYR offers rapid symptom relief, revolutionizing management protocols for HAE patients. This analysis explores the market landscape, competitive environment, regulatory trends, and financial prospects shaping FIRAZYR’s trajectory over the next decade.

Market Landscape and Epidemiological Drivers

Hereditary angioedema is a rare, genetic disorder characterized by recurrent acute episodes of swelling affecting subcutaneous and mucosal tissues. The global prevalence is approximately 1 in 50,000, with an estimated patient population of roughly 10,000–15,000 in the United States alone (as per USHAA data) [1]. Despite its rarity, HAE presents significant morbidity, prompting a high-value therapeutic market.

The incidence and prevalence predominantly dictate the market size. The increasing awareness among healthcare providers, improved diagnostic tools, and expanded genetic testing are fueling diagnosis rates—directly impacting FIRAZYR's potential market penetration. Additionally, the rising global adoption of targeted biologics supports an optimistic outlook for FIRAZYR, particularly as the preferred on-demand treatment in acute HAE episodes.

Patient Demographics and Geographic Variability

The majority of HAE cases are diagnosed in North America and Europe, where healthcare infrastructure and awareness are advanced. However, emerging markets in Asia-Pacific and Latin America are witnessing increasing diagnoses, fueled by heightened medical literacy and improved healthcare access. Consequently, FIRAZYR’s revenue growth will likely track these demographic shifts.

Regulatory and Approval Trends

Since its FDA approval in 2011 for acute HAE attacks, FIRAZYR has expanded approvals across multiple jurisdictions, including the European Medicines Agency (EMA) and Japanese PMDA. Broader regulatory acceptance enhances its market penetration, with conditional approvals and orphan drug designations stimulating commercialization efforts.

Regulatory developments facilitate the entry of biosimilars and novel competitors, potentially exerting downward pressure on pricing but also encouraging innovation. The ongoing development of subcutaneous formulations and potential expanded indications (such as prophylactic use) also influence FIRAZYR’s future trajectory.

Competitive Landscape

FIRAZYR competes primarily with other on-demand HAE treatments such as Berinert (C1 esterase inhibitor), Cinryze, and newer agents like ecallantide (Kalbitor). In prophylactic therapy, options include lanadelumab (Takhzyro) and garadacimab, which may threaten FIRAZYR’s market share.

The competitive landscape is characterized by:

• Route of Administration: FIRAZYR's subcutaneous delivery offers convenience advantages over intravenous treatments.
• Efficacy and Safety Profiles: Demonstrated rapid symptom relief with favorable safety profile, crucial for adoption.
• Pricing Strategies: Market access is heavily influenced by reimbursement negotiations, especially in the US and Europe.
• Pipeline Developments: Emerging therapies with longer duration of action or oral formulations could reshape treatment paradigms.

Financial Trajectory and Revenue Projection

FIRAZYR’s financial success hinges on several factors:

• Market Penetration: Despite being the first approved on-demand HAE therapy, FIRAZYR’s market share growth remains constrained by the availability of alternatives and pricing pressures.
• Pricing Dynamics: Historically priced at premium levels due to orphan status, future adjustments may depend on competitive responses and healthcare payer policies.
• Expansion of Indications: Investigations for prophylactic use and potential off-label applications could generate additional revenue streams.
• Patient Access Programs: Insurance reimbursements, especially in fragmented healthcare markets, significantly impact revenue realization.

Analysts forecast that FIRAZYR’s revenues will grow modestly in the near term, with a compound annual growth rate (CAGR) of approximately 3–5% over the next five years. Longer-term, expansion into prophylactic indications and increased global distribution could accelerate growth, potentially reaching a CAGR of 6–8%, contingent on regulatory approvals and market penetration strategies.

Key Market Trends Impacting Revenue

Emerging Biologic and Gene-Silencing Therapies

Innovations like ViroPharma’s took place, with newer agents offering subcutaneous routes, longer duration, or oral options, challenging FIRAZYR's market position [2]. The pursuit of less invasive or more convenient treatments is a key trend affecting revenue streams.

Healthcare System Reforms and Reimbursement Policies

Price regulation, especially in Europe’s national health services and the US’s value-based reimbursement models, can influence profitability. Managed care organizations prioritize cost-effectiveness, which may lead to formulary restrictions affecting sales.

Advances in Diagnostic and Genetic Testing

Enhanced identification of HAE subjects is expected to enlarge the eligible patient pool over the coming decade, positively influencing FIRAZYR’s potential markets.

Market Expansion and Global Access

Geographical expansion into emerging markets unlocks revenue potential but faces challenges relating to pricing, regulatory approval timelines, and distribution logistics.

Future Outlook and Strategic Considerations

FIRAZYR’s future financial trajectory is also affected by strategic initiatives such as:

• Investments in Clinical Trials: Development of prophylactic formulations and novel delivery systems.
• Partnerships and Licensing: Collaborations with regional distributors to penetrate emerging markets.
• Cost-Control Initiatives: Streamlining manufacturing and reducing prices to ensure competitiveness without eroding margins.
• Market Education: Increasing awareness among healthcare providers to promote timely diagnosis and treatment adoption.

Conclusion

FIRAZYR stands at a crossroads of evolving market dynamics driven by diagnostic advancements, competitive innovation, and healthcare policy shifts. While it maintains an essential role in acute HAE management, its long-term financial trajectory depends on strategic positioning, pipeline expansion, and market access initiatives. Industry stakeholders should monitor regulatory developments, competitor trajectories, and demographic shifts for informed decision-making.

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Key Takeaways

• Market Potential: The HAE treatment market remains promising, with steady growth driven by increased diagnosis and expanding global access.
• Revenue Drivers: FIRAZYR’s revenues depend on market penetration, pricing strategies, and pipeline development.
• Competitive Threats: Emerging therapies and prophylactic options threaten market share; differentiation via convenience and efficacy is crucial.
• Regulatory Environment: Evolving approvals and reimbursement policies influence access and profitability.
• Growth Strategies: Focus on pipeline expansion, market expansion, and strategic collaborations will shape FIRAZYR’s financial future.

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FAQs

1. What are the primary factors influencing FIRAZYR’s revenue growth?
   Market share expansion, regulatory approvals, pricing strategies, pipeline growth, and global access significantly influence revenue.

2. How does FIRAZYR compare to other HAE treatments in terms of efficacy?
   FIRAZYR provides rapid symptom relief with a favorable safety profile, comparable or superior to other on-demand agents, emphasizing convenience through subcutaneous administration.

3. What are the key challenges facing FIRAZYR’s market expansion?
   Competition from newer agents, pricing pressures, reimbursement hurdles, and limited awareness in emerging markets pose significant challenges.

4. Are there upcoming regulatory milestones that could impact FIRAZYR's market size?
   Yes, approvals for prophylactic indications, new formulations, or expanded patient populations can substantially increase its market footprint.

5. What strategic initiatives could enhance FIRAZYR’s long-term financial sustainability?
   Investments in pipeline diversification, geographic expansion, strategic partnerships, and cost management will support sustained growth.

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Sources:

1. U.S. Hereditary Angioedema Association (USHAA). Hereditary Angioedema Epidemiology.
2. European Medicines Agency (EMA). FIRAZYR Summary of Product Characteristics.