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. Ten 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

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

International Patents for FIRAZYR

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

Country	Patent Number	Title	Estimated Expiration
Spain	2099102
China	1034577
South Africa	9006381
Spain	2057071
Czechoslovakia	9003979
Canada	1340667	PEPTIDES EXERCANT UNE ACTION ANTAGONISTE VIS-A-VIS DE LA BRADYKININE (PEPTIDES HAVING BRADYKININ ANTAGONIST ACTION)
Germany	122008000066

Supplementary Protection Certificates for FIRAZYR

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0370453	SPC/GB09/002	United Kingdom		PRODUCT NAME: ICATIBANT, OR A PHYSIOLOGICALLY TOLERABLE SALT THEREOF, INCLUDING ICATIBANT ACETATE; REGISTERED: UK EU/1/08/461/001 20080711
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
0370453	C300359	Netherlands		PRODUCT NAME: ICATIBANT, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, BIJ VOORKEUR ICATIBANTACETAAT; REGISTRATION NO/DATE: EU/1/048/461/001 20080711
0370453	91499	Luxembourg		91499, EXPIRES: 20141121
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

Investment Scenario and Fundamentals Analysis for FIRAZYR (Icatibant)

Last updated: February 20, 2026

What is FIRAZYR and its Market Role?

FIRAZYR (Icatibant) is a human peptide drug marketed as a treatment for acute attacks of hereditary angioedema (HAE). Approved by the FDA in 2011 and EMA in 2012, it functions as a selective bradykinin B2 receptor antagonist. Its sales primarily target the HAE market, which has a growing patient base and limited therapeutic options.

Market Size and Growth Potential

Hereditary Angioedema (HAE) Market Overview

• Global prevalence: Approximately 1 in 50,000 individuals, totaling an estimated 100,000 to 200,000 patients worldwide.
• Market value (2022): Estimated at $1.7 billion.
• Projected CAGR (2023-2028): 7-8%.

Key Players and Product Competition

Drug	Mechanism	Launch Year	Market Share (2022)	Notes
FIRAZYR	Bradykinin B2 antagonist	2011	15%	Used for acute attacks
Lanadelumab	Plasma kallikrein inhibitor	2018	50%	Long-acting, used for prophylaxis
Berinert	C1 esterase inhibitor	1968 (FDA 2009)	20%	Diverse formulation types
Haegarda	Plasma kallikrein inhibitor	2018	10%	Prophylactic use

Growth Drivers

• Increasing awareness and diagnosis rates
• Expanded indications and off-label uses
• Availability of prophylactic therapies

Clinical and Regulatory Fundamentals

Efficacy and Safety Profile

• Efficacy: Rapid symptom relief within 1 hour during attacks
• Administration: Subcutaneous injection, typically 30 mg
• Safety: Few serious adverse effects; low immunogenicity

Regulatory Milestones

• FDA approval in 2011 for HAE attacks
• EMA approval in 2012
• Post-marketing studies confirm safety and efficacy

Patent and Exclusivity Landscape

• Original patent filed in 2003, expiry around 2023-2025 in major markets
• No current blockbuster exclusivity extensions
• Biosimilar entry anticipated, impacting future pricing and margins

Financial Fundamentals and Investment Risks

Revenue and Sales Trajectory

• 2022 global sales: Estimated at $100 million
• 2023 forecasts: Moderate growth due to increased adoption and awareness
• Market penetration remains limited compared to prophylactic agents

Cost Structure

• Manufacturing costs estimated at 20-25% of revenues
• R&D expenses: Minimal post-launch, but future investments needed for line extensions

Profitability Outlook

• Margins constrained by competition and biosimilar threats
• Potential for margin erosion if biosimilar generic versions enter markets by 2025

Key Risks

• Market Competition: Entry of biosimilars and new therapeutics
• Regulatory Changes: Reimbursement policies could tighten pricing
• Patent Expiry: Loss of exclusivity after 2023-2025

Strategic Investment Considerations

• The drug’s niche status limits large-scale revenue but offers stability within the HAE treatment space
• Potential upside from lifecycle management, including line extensions or combination indications
• Companies with rights to FIRAZYR should monitor biosimilar developments and pricing trends

Key Takeaways

FIRAZYR is a specialized therapy for acute HAE attacks, with a mature safety and efficacy profile. The market is growing but constrained by competition, patent expiry, and biosimilar entries expected in the next two years. Revenue streams are stable but face pressure from biosimilars and evolving treatment paradigms. Investment opportunities hinge on maintaining market share, managing patent risks, and potential line extension strategies.

FAQs

1. When will FIRAZYR lose patent protection?
Patents are expected to expire around 2023-2025 in major markets, paving the way for biosimilar competition.

2. How does FIRAZYR compare to other HAE treatments?
FIRAZYR provides rapid symptom relief for acute attacks. It is a subcutaneous agent, whereas plasma kallikrein inhibitors like lanadelumab are used prophylactically.

3. What is the major regulatory risk for FIRAZYR?
Potential regulatory hurdles or reimbursement restrictions could limit accessibility, especially if biosimilars reduce market prices.

4. Can future line extensions improve revenue prospects?
Yes, development of prophylactic formulations or combination therapies may extend the product lifecycle and revenue base.

5. How significant is biosimilar entry for FIRAZYR’s valuation?
Biosimilar competition could substantially erode pricing and sales volume, impacting profitability around 2023-2025.

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References

[1] European Medicines Agency. (2012). FIRAZYR summary of opinion.
[2] U.S. Food and Drug Administration. (2011). FIRAZYR approval announcement.
[3] Market Research Future. (2022). Global hereditary angioedema market analysis.
[4] GlobalData. (2022). Hereditary angioedema market forecast.
[5] Pharma Intelligence. (2023). Biosimilar pipeline and impact analysis.