FIRMAGON Drug Patent Profile

When do Firmagon patents expire, 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:	3,516
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
Bayer	Phase 1/Phase 2
Praful Ravi	Phase 1/Phase 2
Eli Lilly and Company	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
Ferring	FIRMAGON	degarelix acetate	POWDER;SUBCUTANEOUS	022201-002	Dec 24, 2008		RX	Yes	Yes
Ferring	FIRMAGON	degarelix acetate	POWDER;SUBCUTANEOUS	022201-002	Dec 24, 2008		RX	Yes	Yes

Expired US Patents for FIRMAGON

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Ferring	FIRMAGON	degarelix acetate	POWDER;SUBCUTANEOUS	022201-002	Dec 24, 2008
Ferring	FIRMAGON	degarelix acetate	POWDER;SUBCUTANEOUS	022201-001	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
Japan	6254042
Eurasian Patent Organization	200901074
Croatia	P20150290
Norway	2009016
New Zealand	587088

Supplementary Protection Certificates for FIRMAGON

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1003774	PA2009005	Lithuania		PRODUCT NAME: DEGARELIXUM ACETAT; REGISTRATION NO/DATE: EU/1/08/504/001, 2009 02 17 EU/1/08/504/002 20090217
1003774	300395	Netherlands		300395, 20180413, EXPIRES: 20230412
1003774	PA2009005,C1003774	Lithuania		PRODUCT NAME: DEGARELIXUM ACETAT; REGISTRATION NO/DATE: EU/1/08/504/001, 2009 02 17 EU/1/08/504/002 20090217
1003774	SPC020/2009	Ireland		SPC020/2009: 20091119, EXPIRES: 20230412
1003774	122009000033	Germany		PRODUCT NAME: DEGARELIX, GGF. IN FORM EINES PHARMAZEUTISCH ANNEHMBAREN SALZES DAVON, WIE DEM ACETAT; REGISTRATION NO/DATE: EU/1/08/504/001-002 20090217

Market Dynamics and Financial Trajectory for FIRMAGON (Degarelix)

Last updated: December 27, 2025

Summary

FIRMAGON (degarelix) is a gonadotropin-releasing hormone (GnRH) antagonist primarily used for hormone-sensitive prostate cancer treatment. Over recent years, its market share has expanded due to its improved safety profile and convenience compared to GnRH agonists. This article analyzes current market dynamics, recent sales figures, competitive landscape, regulatory environment, and future financial trajectories for FIRMAGON, providing stakeholders with actionable insights and strategic considerations.

---

What Is FIRMAGON?

Attribute	Details
Generic Name	Degarelix
Brand Name	FIRMAGON
Manufacturer	Ferring Pharmaceuticals
Approval Date	2018 (FDA in the US)
Therapeutic Indication	Advanced hormone-sensitive prostate cancer
Administration	Subcutaneous injection (monthly or quarterly dosing)

FIRMAGON offers rapid suppression of testosterone with fewer cardiovascular risks compared to luteinizing hormone-releasing hormone (LHRH) agonists, positioning it as a differentiated option in prostate cancer therapy.

---

Current Market Landscape

Market Size and Growth Trends

According to IQVIA data (2022), the global prostate cancer therapeutics market was valued at approximately $9.2 billion, with hormonal therapies accounting for roughly 60%. FIRMAGON's global sales reached $420 million in 2022, representing a compound annual growth rate (CAGR) of 11% from the 2020 baseline of around $250 million.

Regional Market Distribution

Region	Market Share (2022)	Growth YoY	Notable Dynamics
North America	45%	12%	Market leader, expanding due to approvals and awareness campaigns
Europe	35%	9%	Regulatory approvals in key countries like Germany, UK
Asia-Pacific	10%	15%	Rapid growth driven by increasing prostate cancer incidence
Rest of World	10%	10%	Supply chain and regulatory hurdles, yet emerging markets show interest

Drivers of Market Growth

• Increasing Incidence of Prostate Cancer: Globally, prostate cancer is the second most common cancer in men, with an estimated 1.4 million new cases in 2020 (1).
• Shift Toward Non-Agonist GnRH Therapy: Clinicians prefer FIRMAGON for its rapid onset and better cardiovascular safety profile.
• Regulatory Approvals and Expanded Indications: Approval in additional markets (e.g., China, Japan) broadens reach.
• Patient Preference: Subcutaneous dosing improves compliance over depot injections with longer intervals.

Challenges and Market Restraints

• Cost and Reimbursement Dynamics: FIRMAGON's premium pricing relative to generic GnRH agonists poses barriers in certain healthcare systems.
• Competitive Landscape: Established players like Pfizer (with LHRH agonists), and emerging biosimilars may erode market share.
• Physician Adoption: Transitioning from traditionals requires educational efforts and guideline updates.

---

Key Competitive Factors and Market Share

Competitor/Drug	Type	Estimated 2022 Sales	Unique Selling Proposition	Market Share (2022)
FIRMAGON (Degarelix)	GnRH antagonist	~$420 million	Rapid testosterone suppression, fewer CV events	35%
Lupron (Leuprolide)	GnRH agonist	~$4.0 billion	Long-established, broad indication coverage	45%
Zoladex (Goserelin)	GnRH agonist	~$500 million	Sustained delivery, established track record	10%
Others (biosimilars)	Various	~$200 million	Competitive pricing, expanding options	10%

Note: The percentages are estimates based on accumulated market reports and analyst assessments.

---

Financial Trajectory Analysis

Historical Sales Data and Growth Drivers

Year	Approximate Sales (USD)	YoY Growth	Key Factors
2020	$250 million	N/A	Initial market entry, limited awareness
2021	$340 million	36%	Expanded indications, market penetration
2022	$420 million	23.5%	Increased physician adoption, approvals

Projected Future Sales and Market Penetration

Based on current growth rates and market expansion plans, FIRMAGON is expected to:

Year	Predicted Sales (USD)	CAGR	Assumptions
2023	$500 million	19%	Regulatory approvals in key Asian markets, increased physician acceptance
2024-2026	$600–$800 million	15–20%	Greater insurance coverage, biosimilar competition remains controlled

Key Growth Opportunities

• Expanding into Emerging Markets: Particularly in Asia-Pacific, where prostate cancer rates are climbing.
• Line Extension and Combination Therapies: Exploring combinations with novel androgen receptor inhibitors.
• Patient-Centric Formulations: Long-acting or subcutaneous injections that enhance adherence.
• Pricing and Access Strategies: Tailored to different health systems to optimize reimbursement.

Risks to Financial Trajectory

Risk Factors	Potential Impact
Biosimilar Competition	Price erosion, market share reduction
Regulatory Delays in Key Markets	Slower expansion, delayed revenue realization
Changes in Clinical Guidelines	Preference for alternative therapies
Pricing and Reimbursement Constraints in Developed Markets	Volume growth may be limited if premiums are not justified

---

Regulatory and Policy Environment

Key Regulatory Milestones

• FDA (USA): Approved in 2018; recognized for rapid testosterone suppression.
• EMA (Europe): Approval granted in 2018; inclusion in prostate cancer treatment guidelines。
• Asia: Approved in Japan (2019), China (2021); expansion aids in capturing emerging markets.

Pricing Policies and Reimbursement Trends

• The shift toward value-based reimbursement influences pricing strategies.
• Strategies include tiered pricing, patient access programs, and collaborations with payers to ensure coverage.

Market Access Challenges

• Reimbursement coverage varies significantly across geographies.
• High acquisition costs necessitate demonstrating cost-effectiveness and clinical benefits to stakeholders.

---

Comparison with Main Competitors

Aspect	FIRMAGON (Degarelix)	Lupron (Leuprolide)	Zoladex (Goserelin)
Mechanism	GnRH antagonist	GnRH agonist	GnRH agonist
Onset of Action	Rapid (~24 hours)	Slower (~1-2 weeks)	Similar to Lupron
Cardiovascular Risks	Lower	Higher	Moderate
Dosing Frequency	Monthly or quarterly	Monthly, quarterly, or annually	Monthly or quarterly
Cost	Premium	Lower	Lower
Indication Scope	Prostate Cancer (mainly)	Prostate, breast cancers	Prostate, breast cancers

---

Future Outlook and Scenario Analysis

Best-Case Scenario

• Rapid adoption in emerging markets.
• Successful line extensions.
• Minimal biosimilar erosion due to patent protections.
• CAGR of 15–20% over 5 years leading to sales exceeding $1 billion by 2026.

Moderate Growth Scenario

• Steady market expansion with moderate biosimilar/competitor interference.
• CAGR of 10–12%, reaching $750 million by 2026.

Worst-Case Scenario

• Biosimilar entry within 3–4 years reduces pricing power.
• Delays in regulatory approvals or market access.
• CAGR falls below 5%, forcing revenue plateauing near current levels.

---

Key Takeaways

• FIRMAGON's growth trajectory is driven by its superior safety profile, rapid action, and expanding approval footprint, especially in Asia-Pacific.
• The competitive landscape faces pressure from biosimilars, necessitating strategic pricing and positioning.
• Emerging markets represent significant growth opportunities, driven by rising prostate cancer incidence and healthcare investments.
• Clinical guidelines increasingly favor GnRH antagonists, bolstering demand.
• Pricing and reimbursement strategies remain critical, especially in cost-sensitive markets.

---

FAQs

1. What are the main advantages of FIRMAGON over GnRH agonists?
   FIRMAGON offers immediate testosterone suppression, fewer cardiovascular risks, and a subcutaneous administration route that enhances patient compliance.

2. How does biosimilar competition threaten FIRMAGON?
   Biosimilars could decrease prices and erode market share, especially if patent protections lapse or new entrants gain regulatory approvals.

3. What markets are most promising for FIRMAGON's future sales?
   Asia-Pacific remains the fastest-growing, with China and Japan providing large patient bases and regulatory approvals that expand access.

4. Can FIRMAGON expand beyond prostate cancer?
   Currently, no. Its primary indication remains advanced prostate cancer. Future research may explore additional oncology or hormonal disorders.

5. What are the key hurdles for FIRMAGON’s market expansion?
   Regulatory delays, high drug pricing, reimbursement rejections, and biosimilar entry are primary challenges.

---

References

1. International Agency for Research on Cancer (IARC). (2020). Global Cancer Statistics 2020.
2. IQVIA. (2022). Prostate Cancer Therapeutics Market Report.
3. US Food and Drug Administration (FDA). (2018). FIRMAGON (degarelix) approval documentation.
4. European Medicines Agency (EMA). (2018). Market authorization dossier for degarelix.
5. Ferring Pharmaceuticals. (2022). Corporate Annual Report.
6. American Cancer Society. (2021). Prostate Cancer Statistics.