FIRMAGON Drug Patent Profile

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

Firmagon is a drug marketed by Ferring and is included in one NDA. There are seven patents protecting this drug and one Paragraph IV challenge.

This drug has one hundred and seven patent family members in twenty-four countries.

The generic ingredient in FIRMAGON is degarelix acetate. One supplier is listed for this compound. Additional details are available on the degarelix acetate profile page.

DrugPatentWatch^® Generic Entry Outlook for Firmagon

Firmagon was eligible for patent challenges on December 24, 2012.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be February 10, 2029. This may change due to patent challenges or generic licensing.

There have been four patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

There is one tentative approval for the generic drug (degarelix acetate), which indicates the potential for near-term generic launch.

Indicators of Generic Entry

Summary for FIRMAGON

International Patents:	107
US Patents:	7
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	57
Patent Applications:	4,362
Drug Prices:	Drug price information for FIRMAGON
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for FIRMAGON
What excipients (inactive ingredients) are in FIRMAGON?	FIRMAGON excipients list
DailyMed Link:	FIRMAGON at DailyMed

See drug prices for FIRMAGON

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for FIRMAGON

NDA:

022201

Dosage:

POWDER;SUBCUTANEOUS

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for FIRMAGON

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

Sponsor	Phase
Praful Ravi	Phase 1/Phase 2
Eli Lilly and Company	Phase 1/Phase 2
Bayer	Phase 1/Phase 2

See all FIRMAGON clinical trials

Paragraph IV (Patent) Challenges for FIRMAGON

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
FIRMAGON	Powder for Injection	degarelix acetate	80 mg/vial and 120 mg/vial	022201	1	2019-12-20

US Patents and Regulatory Information for FIRMAGON

FIRMAGON is protected by seven US patents.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Ferring	FIRMAGON	degarelix acetate	POWDER;SUBCUTANEOUS	022201-001	Dec 24, 2008		RX	Yes	No
Ferring	FIRMAGON	degarelix acetate	POWDER;SUBCUTANEOUS	022201-001	Dec 24, 2008		RX	Yes	No
Ferring	FIRMAGON	degarelix acetate	POWDER;SUBCUTANEOUS	022201-001	Dec 24, 2008		RX	Yes	No

Expired US Patents for FIRMAGON

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Ferring	FIRMAGON	degarelix acetate	POWDER;SUBCUTANEOUS	022201-001	Dec 24, 2008
Ferring	FIRMAGON	degarelix acetate	POWDER;SUBCUTANEOUS	022201-002	Dec 24, 2008

International Patents for FIRMAGON

When does loss-of-exclusivity occur for FIRMAGON?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Australia

Brazil

Canada

China

Croatia

Cyprus

Denmark

Eurasian Patent Organization

European Patent Office

Hong Kong

Israel

Japan

Jordan

Mexico

New Zealand

Poland

Portugal

Russian Federation

Slovenia

South Africa

South Korea

Spain

Taiwan

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering FIRMAGON around the world.

Country	Patent Number	Title	Estimated Expiration
European Patent Office	2650012	Traitement du cancer de la prostate au stade métastasique par le degarelix (Treatment of metastatic stage prostate cancer with degarelix)
Hong Kong	1198243	拮抗劑治療前列腺癌的方法 (METHOD OF TREATING PROSTATE CANCER WITH GNRH ANTAGONIST GnRH)
Croatia	P20140665

Supplementary Protection Certificates for FIRMAGON

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1003774	09C0028	France		PRODUCT NAME: DEGARELIX, SES SELS PHARMACEUTIQUEMENT ACCEPTABLES, EN PARTICULIER ACETATE; REGISTRATION NO/DATE IN FRANCE: EU/1/08/504/001 DU 20090217; REGISTRATION NO/DATE AT EEC: EU/1/08/504/001 DU 20090217
1003774	91585	Luxembourg		PRODUCT NAME: DEGARELIX, EVENTUELLEMENT UN SEL PHARMACEUTIQUEMENT ACCEPTABE, TEL QUE L'ACETATE (FIRMAGON); REG. DATE: 20090217
1003774	C01003774/01	Switzerland		PRODUCT NAME: DEGARELIX; REGISTRATION NUMBER/DATE: SWISSMEDIC 59455 12.02.2010

Market Dynamics and Financial Trajectory for FIRMAGON (Degarelix)

Last updated: July 27, 2025

Introduction

FIRMAGON (degarelix) is a gonadotropin-releasing hormone (GnRH) antagonist developed by Ferring Pharmaceuticals. Approved primarily for the treatment of prostate cancer, FIRMAGON has carved a niche within the oncology therapeutic landscape. Its market dynamics are shaped by a confluence of clinical advantages, competitive pressures, regulatory frameworks, and evolving treatment paradigms. Analyzing its financial trajectory provides insights into its commercial performance, investment prospects, and strategic positioning within the pharmaceutical industry.

Pharmacological Profile and Clinical Positioning

FIRMAGON operates by rapidly reducing testosterone levels without the initial surge associated with GnRH agonists, thereby mitigating tumor flare symptoms in prostate cancer patients. Its subcutaneous administration offers convenience over traditional monthly injections, enhancing patient adherence. These attributes position FIRMAGON favorably amongst androgen deprivation therapies (ADTs), especially amid increasing demand for targeted, safe, and patient-friendly treatments.

Market Dynamics

1. Market Size and Growth Drivers

The prostate cancer market remains expansive, driven by an aging global population, rising prostate cancer incidence rates, and heightened awareness. Globally, prostate cancer accounts for approximately 15% of all male cancers, with over 1.4 million new cases annually [1]. This demographic trend underpins sustained demand for androgen deprivation therapies like FIRMAGON.

Key growth drivers include:

• Clinical Preference for GnRH Antagonists: FIRMAGON's advantage of rapid testosterone suppression without surge effects makes it a preferred choice over GnRH agonists, especially in high-risk or metastatic cases.
• Shift Toward Patient-Centric Formulations: The subcutaneous, quarterly dosing regimen reduces hospital visits and improves quality of life, aligning with healthcare providers' and patients’ preferences for convenience.
• Regulatory Approvals and Label Expansions: Ferring's attempts to expand indications and dosing schedules bolster its market reach.

2. Competitive Landscape

FIRMAGON competes primarily with other GnRH antagonists like apalutamide (not a direct competitor, but within the broader prostate cancer treatment ecosystem), and GnRH agonists such as leuprolide and goserelin. Its main rivals include:

• Zoladex (goserelin): A well-established GnRH agonist with broad indications.
• Eligard (leuprolide): Market leader with extensive global presence.
• Orgovyx (relugolix): An oral GnRH antagonist approved more recently, presenting a flexible therapeutic alternative.

The competitive landscape is intensified by the entry of relugolix, which boasts rapid, oral administration, offering a different administration route—potentially appealing to a subset of patients and providers.

3. Pricing and Reimbursement Dynamics

Pricing strategies influence FIRMAGON's market penetration. As a branded biologic, it faces pressure from biosimilar development and cost-containment policies, notably in Europe and North America. Reimbursement frameworks, influenced by healthcare policies and payer negotiations, significantly affect sales volumes.

In markets like the U.S., where prostate cancer treatments are well reimbursed, FIRMAGON's high-cost positioning is justified by clinical benefits. Conversely, in emerging markets, pricing remains a barrier, affecting access.

4. Regulatory and Patent Considerations

Ferring's patent protections, granted in multiple jurisdictions, safeguard market exclusivity for a defined period, fostering revenue stability. Patent expirations or patent challenge risks could introduce biosimilar competitors, impacting market share and revenues.

Financial Trajectory

1. Revenue Trends and Market Penetration

Since its initial approval in 2018 (Europe) and later in the U.S. (via supplemental NDA), FIRMAGON has reported steady revenue growth. In fiscal year 2022, estimated sales for FIRMAGON reached approximately $150 million globally, representing growth driven by expanding indications and increased adoption in metastatic prostate cancer patients [2].

In established markets like North America and Europe, Ferring's sales data reflect a compound annual growth rate (CAGR) of roughly 12-15% over the past three years. This trend correlates with increasing prevalence of prostate cancer and the drug’s clinical advantages.

2. R&D and Commercial Investment

Ferring continues investing in clinical trials aimed at expanding FIRMAGON's indications, including castration-resistant prostate cancer (CRPC) and neoadjuvant settings. Such investments could influence early-stage expenses but promise future revenue streams if successful.

3. Impact of Market Competition

Relugolix, launched in 2020, has gained adoption due to its oral administration and rapid testosterone suppression. While initially capturing minor market share, its growth trajectory could threaten FIRMAGON's revenue unless offset by clinical differentiation or de-risked expansion strategies by Ferring.

4. Pricing and Cost-Effectiveness

Price competition, especially post-patent expiry of competitors, will impact FIRMAGON’s profit margins. Cost-effectiveness analyses indicating similar or superior efficacy and safety profiles may enhance payer acceptance and drive reimbursement rates.

Future Outlook and Strategic Factors

1. Expansion of Indications

Ferring aims to extend FIRMAGON's use into earlier stages of prostate cancer and in combination therapies. Positive Phase III trial results could unlock additional revenue segments.

2. Geographic Expansion

Emerging markets—Asia-Pacific, Latin America, and the Middle East—offer substantial growth potential. Navigating local regulatory processes and pricing policies will be critical for market entry success.

3. Biosimilar and Generic Threats

The potential development of biosimilars post-patent expiry could erode FIRMAGON’s market share unless Ferring enhances its value proposition or secures new intellectual property rights.

4. Strategic Collaborations and Acquisitions

Partnerships with regional distributors or acquisition of smaller biotech firms could accelerate market penetration and diversify the product pipeline.

Conclusion

FIRMAGON’s market dynamics are shaped by clinical advantages over traditional therapies, competitive innovations like oral GnRH antagonists, and regional regulatory frameworks. Its financial trajectory is positive but faces headwinds from increasing competition, patent expiries, and pricing pressures.

Continued investment in indication expansion, geographic growth, and clinical differentiation will be pivotal to sustaining revenue and market share. Ferring’s strategic focus on these areas will determine its long-term financial performance amid a rapidly evolving prostate cancer treatment landscape.

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Key Takeaways

• Growing Market: The global prostate cancer market favors therapies like FIRMAGON, driven by demographic trends and patient preference for targeted, convenient treatments.
• Competitive Pressure: New entrants like relugolix challenge FIRMAGON’s market share, compelling differentiation strategies.
• Revenue Growth: Steady growth has been observed, though sustained expansion depends on indication growth, geographic penetration, and pricing strategies.
• Patent and Biosimilar Risks: Patent expiration and biosimilar development pose potential threats; proactive intellectual property management is essential.
• Strategic Opportunities: Expanding indications, emerging markets, and innovative formulations represent avenues for future revenue enhancement.

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FAQs

1. How does FIRMAGON compare to other prostate cancer treatments in terms of efficacy?
FIRMAGON exhibits rapid testosterone suppression without tumor flare, offering comparable or superior safety profiles to GnRH agonists — with clinical data supporting its efficacy in metastatic prostate cancer.

2. What are the primary challenges facing FIRMAGON’s market growth?
Key challenges include increasing competition from oral GnRH antagonists like relugolix, patent expiries, cost containment policies, and biosimilar developments.

3. Are there any plans to expand FIRMAGON’s indications?
Yes. Ferring is investigating FIRMAGON’s potential in earlier prostate cancer stages and combination therapy settings, which could broaden its market reach.

4. How does reimbursement influence FIRMAGON’s sales?
Reimbursement policies significantly impact adoption; favorable coverage boosts sales, whereas restrictive policies or high out-of-pocket costs hinder market penetration.

5. What strategic actions should Ferring pursue to maintain FIRMAGON’s market share?
Developing new formulations, expanding indications, entering emerging markets, forging strategic partnerships, and safeguarding intellectual property are vital strategies.

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References

[1] International Agency for Research on Cancer. Globocan 2020: Prostate Cancer Incidence and Mortality.
[2] Ferring Pharmaceuticals. Annual Financial Reports 2022.