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:	74
Clinical Trials:	9
Patent Applications:	326
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

International Patents for FIRAZYR

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

Country	Patent Number	Title	Estimated Expiration
Portugal	91692	PROCESSO PARA A PREPARACAO DE PEPTIDEOS COM ACTIVIDADE ANTAGONISTA DA BRADIQUININA
South Africa	9006381
Japan	H04225997	PEPTIDE WITH BRADYKININ ANTAGONISM

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	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

FIRAZYR Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Firazyr

Introduction to Firazyr

Firazyr, also known by its generic name icatibant, is a selective bradykinin B2 receptor antagonist used primarily for the treatment of acute attacks of hereditary angioedema (HAE). Here, we will delve into the market dynamics and financial trajectory of this drug.

Market Classification and Segmentation

By Drug Class

The global plasma protease C1-inhibitor market, which includes Firazyr, is segmented into several drug classes. Firazyr falls under the category of selective bradykinin B2 receptor antagonists. This segment is anticipated to display a leading growth rate due to expanding R&D activities and the preference for subcutaneous administration[1].

By Dosage Type

Firazyr is administered subcutaneously, which is part of the liquid/injectable segment. This segment is expected to hold significant market share by 2025 due to factors such as rising demand for subcutaneous administration, fewer adverse effects, and cost effectiveness[1].

By Distribution Channel

The market for Firazyr is distributed through hospital pharmacies and independent pharmacies & outlets. Independent pharmacies & outlets have dominated the market and are expected to continue their dominance through 2025[1].

Market Growth Drivers

Increasing Preference for Subcutaneous Administration

The preference for subcutaneous administration over intravenous administration is a significant driver for the growth of Firazyr. This method is more convenient and has fewer adverse effects, making it a preferred choice among patients and physicians[1].

Cost Effectiveness

Firazyr is often associated with lower costs for training, administration, monitoring, and supportive care compared to other treatments like Berinert. This cost-effectiveness can lead to cost savings, although the extent can vary based on several factors such as patient weight and administration frequency[3].

R&D Activities

Continuous R&D activities aimed at developing new C1-inhibitor deficiency drugs that can be administered subcutaneously are driving the growth of Firazyr. These efforts are expected to enhance the drug's market position further[1].

Financial Performance and Trajectory

Revenue and Sales

Firazyr, as part of Shire's product portfolio, contributed to the company's strong financial performance. Shire reported an 8% pro forma product sales growth in 2017, with total revenues reaching $15,161 million. The acquisition of Baxalta and Dyax significantly boosted Shire's financials, which indirectly benefited the sales and revenue of Firazyr[2].

Operating Income and Cash Flow

The operating income from continuing operations for Shire increased by 155% in 2017, driven by higher revenues and the realization of operating synergies. This strong financial performance also reflected in the net cash provided by operating activities, which increased by 60% to $4,257 million. Such robust cash flow indicates a stable financial trajectory for the company and its products, including Firazyr[2].

Competitive Landscape

Firazyr competes with other HAE treatments such as Berinert, Cinryze, and Kalbitor. However, its unique profile as a selective bradykinin B2 receptor antagonist and its subcutaneous administration route give it a competitive edge. The expected launch of subcutaneous variants of other drugs may pose some competition, but Firazyr's established market presence and preference among physicians and patients are likely to sustain its market share[1][4].

Regional Market Analysis

Europe and North America

In Europe and North America, Firazyr has a strong market presence. The drug is part of the market forecasts in these regions, with significant growth anticipated due to the increasing preference for subcutaneous administration and the expanding R&D activities[1][4].

Latin America and Asia Pacific

In emerging markets such as Latin America and Asia Pacific, the demand for intravenous C1 esterase inhibitor drugs is high, but there is a growing trend towards subcutaneous administration. This trend is expected to positively influence the market for Firazyr in these regions[1].

Pharmacoeconomic Analysis

Cost Savings and Administration

The pharmacoeconomic review of Firazyr indicates that it is likely to be associated with lower costs for training, administration, monitoring, and supportive care compared to other treatments. However, the cost impact can vary based on factors such as patient weight and the number of injections required[3].

Sensitivity Analysis

Sensitivity analyses conducted by the manufacturer suggest that Firazyr is associated with cost savings in most scenarios, except when the number of injections is increased. This underscores the need for careful management of treatment protocols to maximize cost-effectiveness[3].

Key Takeaways

• Market Growth: Firazyr is expected to show significant growth due to its subcutaneous administration route, cost-effectiveness, and increasing preference among physicians and patients.
• Financial Performance: The drug contributes to the strong financial performance of its parent company, driven by robust sales and operating income.
• Competitive Edge: Firazyr's unique mechanism of action and administration route give it a competitive edge in the HAE treatment market.
• Regional Presence: The drug has a strong presence in Europe, North America, and is growing in emerging markets.
• Pharmacoeconomic Benefits: Firazyr is associated with lower costs for administration and supportive care, although cost impact can vary based on several factors.

FAQs

What is Firazyr used for?

Firazyr is used for the treatment of acute attacks of hereditary angioedema (HAE).

How is Firazyr administered?

Firazyr is administered subcutaneously.

What are the key drivers for the growth of Firazyr?

The key drivers include the increasing preference for subcutaneous administration, cost-effectiveness, and ongoing R&D activities.

How does Firazyr compare to other HAE treatments?

Firazyr has a competitive edge due to its unique mechanism of action and subcutaneous administration route, although other treatments like Berinert and Kalbitor are also available.

What is the financial outlook for Firazyr?

The financial outlook for Firazyr is positive, driven by strong sales and operating income, as well as robust cash flow from its parent company.

Sources

1. Transparency Market Research: Plasma Protease C1-inhibitor Treatment Market Survey Report 2025
2. BioSpace: Shire plc: Final Results - Feb. 14, 2018
3. CADTH: CDR Pharmacoeconomic Review Report for Firazyr
4. Transparency Market Research: Hereditary Angioedema Treatment Market Trends 2027