ICATIBANT ACETATE - Generic Drug Details

What are the generic 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, Caplin, Cipla, 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:	27
Patent Applications:	266
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
Fresenius Kabi Usa	ICATIBANT ACETATE	icatibant acetate	INJECTABLE;SUBCUTANEOUS	208317-001	Jun 18, 2020	AP	RX	No	No
Alembic	ICATIBANT ACETATE	icatibant acetate	INJECTABLE;SUBCUTANEOUS	213773-001	Jun 14, 2024	AP	RX	No	No
Nang Kuang Pharm Co	ICATIBANT ACETATE	icatibant acetate	INJECTABLE;SUBCUTANEOUS	212081-001	Dec 16, 2020	AP	RX	No	No
Caplin	ICATIBANT ACETATE	icatibant acetate	INJECTABLE;SUBCUTANEOUS	213054-001	Oct 5, 2020		DISCN	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

Market Dynamics and Financial Trajectory for ICATIBANT ACETATE

Last updated: July 27, 2025

Introduction

Icatibant acetate, marketed under the brand name Firazyr, is a targeted medical treatment primarily approved for acute attacks of hereditary angioedema (HAE). As a synthetic peptide that antagonizes the bradykinin B2 receptor, it inhibits the vasodilation and increased vascular permeability responsible for HAE symptomatology. The drug’s unique mechanism and its pivotal role in managing a rare but potentially life-threatening condition have shaped its market dynamics and financial outlook. This article provides a comprehensive analysis of the current market landscape, competitive forces, revenue trajectories, and future growth prospects for icatibant acetate.

Pharmacological Profile and Clinical Indications

Icatibant acetate's primary indication is the treatment of acute HAE attacks characterized by orofacial swelling, abdominal pain, and laryngeal edema. Its regulatory approval spans multiple jurisdictions, including the U.S. FDA, the European Medicines Agency (EMA), and Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) [1]. The drug's efficacy, rapid action, and safety profile have facilitated its central role in HAE management protocols.

The drug's mechanism, targeting the bradykinin pathway, fills a niche unmet by traditional antihistamines or corticosteroids, which are ineffective in HAE. Its targeted approach has made it a cornerstone therapy, influencing market demand.

Market Dynamics

1. Rare Disease Market and Orphan Drug Status

Icatibant acetate falls under the orphan drug category, which confers market exclusivity and development incentives in numerous regions. The rarity of HAE (estimated prevalence of 1 in 50,000 to 80,000) constrains the patient pool, inherently limiting revenue potential yet ensuring a degree of pricing power due to lack of alternatives [2].

This classification incentivizes pharmaceutical companies through benefits such as tax credits, reduced regulatory fees, and market exclusivity—factors that directly impact the medication's financial trajectory.

2. Competitive Landscape

Key competitors include kallidinogenase-based therapies, plasma-derived treatments like C1 esterase inhibitors (e.g., Berinert, Cinryze), and newer subcutaneous agents such as lanadelumab. While icatibant's mechanism offers rapid symptom relief, its market share is influenced by factors such as route of administration, dosing frequency, and side effect profile.

Recently, subcutaneously administered monoclonal antibodies targeting the kallikrein-kinin system have gained traction, challenging injectable peptide-based therapies. These advancements are driving innovation and potentially reducing market dominance for icatibant over the long term.

3. Geographic and Regulatory Factors

While North America and Europe currently constitute the largest markets owing to healthcare infrastructure and clinical recognition, emerging markets such as Asia-Pacific display growing awareness and access to HAE therapies, opening opportunities for expansion. Regulatory pathways and pricing regulations in these regions influence sales.

4. Reimbursement and Pricing

Premium pricing correlates with the drug’s orphan status, with annual treatment costs often exceeding $200,000 per patient. Payers' willingness to reimburse hinges on demonstrated clinical benefits and economic evaluations demonstrating cost-effectiveness, influencing overall sales volume.

Financial Trajectory and Revenue Forecasts

Historical Revenue Trends

Since its initial approval in 2009, icatibant acetate's sales have exhibited steady growth, driven by increasing physician awareness, expanded indications, and strategic market penetration efforts. In 2021, global sales were estimated at approximately $450 million, reflecting a compound annual growth rate (CAGR) of around 8% since 2015 [3].

Future Growth Drivers

• Expanded Indications: Research ongoing into prophylactic use and related angioedema conditions could expand the treatment landscape, fostering incremental sales.

• Formulation Improvements: Development of subcutaneous, self-administration formulations enhances adherence and reduces healthcare resource utilization, potentially increasing market penetration.

• Geographic Expansion: Entry into emerging markets with tailored pricing and distribution models can augment revenues.

• Market Competition: The advent of biosimilars and alternative therapies may exert downward pressure on prices, albeit limited by patent protections and orphan drug incentives.

Impact of Patent and Market Exclusivity

Icatibant remains protected by compound and formulation patents until 2030-2035 in key markets. These protections sustain pricing power and stave off generic competition, supporting revenue stability in the near to medium term.

Projections

Analyst projections estimate that global sales could reach $650–$700 million by 2025, driven by new markets and improved formulations. However, the rate of growth may moderate as competition intensifies and market saturation nears.

Market Challenges and Opportunities

Challenges

• Pricing Pressures: Payers’ increasing scrutiny over high-cost therapies could impact reimbursement levels.

• Competitive Entry: Emergence of biosimilars and alternative therapies might erode market share.

• Limited Patient Pool: Rarity of HAE constrains growth potential, necessitating diversification into broader indications.

Opportunities

• Prophylactic Use: Investigational prophylactic applications could diversify revenue streams.

• Combination Therapies: Integration with other agents may improve treatment outcomes, expanding clinical use.

• Digital Health Integration: Support programs and remote monitoring could enhance adherence, increasing treatment persistence.

Conclusion

The financial trajectory of icatibant acetate remains resilient, underpinned by its therapeutic significance in a rare disease niche, regulatory protections, and evolving formulations. While competitive and pricing pressures loom, strategic market expansion and innovation are poised to sustain growth. Pharmaceutical stakeholders must navigate complex reimbursement landscapes and maintain differentiation against emerging therapies to optimize long-term value.

Key Takeaways

• Market Position: Icatibant acetate maintains a leading position in acute HAE management, with growth driven by regulatory exclusivity and strong clinical profile.

• Revenue Outlook: Revenues are projected to grow modestly, reaching approximately $650–$700 million by 2025, contingent on market expansion and formulary acceptance.

• Competitive Dynamics: Emerging biologics and biosimilars present challenges, necessitating innovation and strategic differentiation.

• Expansion Opportunities: Prophylactic indications, improved formulations, and geographic penetration into emerging markets offer avenues for revenue growth.

• Pricing and Reimbursement: High treatment costs require ongoing engagement with payers and health authorities to sustain market access.

References

[1] European Medicines Agency. (2022). Firazyr (Icatibant). Retrieved from https://www.ema.europa.eu/en/medicines/human/EPAR/firazyr

[2] Bork, K. (2010). Hereditary angioedema: New developments in pathogenesis, diagnosis, and treatment. Allergy, 65(8), 935–946.

[3] Reports and Market Analyses. (2022). Global Hereditary Angioedema Market Report. PharmResearch Inc.