DEGARELIX ACETATE - Generic Drug Details

What are the generic drug sources for degarelix acetate and what is the scope of freedom to operate?

Degarelix acetate is the generic ingredient in one branded drug marketed by Ferring and is included in one NDA. There are seven patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Degarelix acetate has one hundred and seven patent family members in twenty-four countries.

One supplier is listed for this compound. There is one tentative approval for this compound.

Summary for DEGARELIX ACETATE

International Patents:	107
US Patents:	7
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	21
Clinical Trials:	36
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for DEGARELIX ACETATE
DailyMed Link:	DEGARELIX ACETATE at DailyMed

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

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 DEGARELIX ACETATE

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

Sponsor	Phase
Fudan University	Phase 2
Alliance for Clinical Trials in Oncology	Phase 3
Myovant Sciences GmbH	Phase 1

See all DEGARELIX ACETATE clinical trials

Generic filers with tentative approvals for DEGARELIX ACETATE

Applicant	Application No.	Strength	Dosage Form
		80MG	NJECTION, POWDER, LYOPHILIZED, FOR SOLUTION

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Anatomical Therapeutic Chemical (ATC) Classes for DEGARELIX ACETATE

L02BX	Other hormone antagonists and related agents
L02B	HORMONE ANTAGONISTS AND RELATED AGENTS
L02	ENDOCRINE THERAPY
L	Antineoplastic and immunomodulating agents

Paragraph IV (Patent) Challenges for DEGARELIX ACETATE

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 DEGARELIX ACETATE

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	022201-002	Dec 24, 2008		RX	Yes	Yes

Expired US Patents for DEGARELIX ACETATE

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 DEGARELIX ACETATE

Country	Patent Number	Title	Estimated Expiration
Japan	2016216455	ＧＮＲＨアンタゴニストであるデガレリクスを用いる前立腺癌の治療方法 (METHOD OF TREATING PROSTATE CANCER USING GNRH ANTAGONIST, DEGARELIX)
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)

Supplementary Protection Certificates for DEGARELIX ACETATE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1003774	C01003774/01	Switzerland		PRODUCT NAME: DEGARELIX; REGISTRATION NUMBER/DATE: SWISSMEDIC 59455 12.02.2010
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	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

Market Dynamics and Financial Trajectory for Degarelix Acetate

Last updated: July 30, 2025

Introduction

Degarelix acetate has emerged as a pivotal agent in the treatment of advanced prostate cancer, disrupting traditional androgen deprivation therapy (ADT). As a gonadotropin-releasing hormone (GnRH) antagonist, degarelix offers significant advantages over GnRH agonists, including rapid testosterone suppression and absence of tumor flare. This analysis explores the evolving market landscape, key drivers, competitive dynamics, and the financial trajectory shaping degarelix acetate's pathway within the pharmaceutical sector.

Market Overview

Therapeutic Context

Prostate cancer remains one of the most prevalent malignancies among men globally, with an estimated 1.4 million new cases in 2020 [1]. Advanced prostate cancer necessitates aggressive hormonal therapy, wherein androgen deprivation plays a foundational role. Historically, GnRH agonists, such as leuprolide, fueled the market but brought challenges like initial testosterone surge, tumor flare, and potential cardiovascular risks.

Degarelix acetate, approved by the FDA in 2010, addresses these limitations as a GnRH antagonist. It provides immediate testosterone suppression without the transient flare associated with agonists, significantly improving patient outcomes and quality of life [2].

Market Size and Growth Projections

The global prostate cancer drug market is projected to reach approximately USD 16 billion by 2025, with a compounded annual growth rate (CAGR) of 8-10% [3]. Degarelix's share, although modest relative to GnRH agonists, is poised for growth driven by increasing adoption and expanding indications. The rise in aging populations and heightened awareness further propel market expansion.

Key Market Drivers

Clinical Advantages and Patient Outcomes

Degarelix's rapid testosterone suppression and reliable efficacy position it favorably among clinicians. Its minimal risk of tumor flare reduces hospitalization and complications during initiation, a critical consideration for high-risk patients [4].

Regulatory Landscape

While initial approval was in advanced prostate cancer, recent approvals exploring its utility in hormone-sensitive settings and combination therapies could expand its market footprint. Regulatory agencies are emphasizing patient safety, further favoring GnRH antagonists due to their safety profile.

Competitive Landscape

Degarelix faces competition primarily from GnRH agonists like leuprolide and goserelin, which dominate due to established use and extensive marketing. However, new entrants and formulations, including subcutaneous and depot versions, threaten to erode market share.

Pharmacoeconomic Factors

While initial costs of degarelix are higher, savings from reduced adverse events, decreased need for hospitalization, and improved quality of life may offset expenses. Insurance coverage and healthcare policies increasingly favor drugs demonstrating improved safety and efficacy profiles.

Physician and Patient Preferences

Growth hinges on clinician awareness and comfort. A shift toward understanding its clinical benefits can accelerate adoption, particularly among high-risk and elderly patients with comorbidities.

Market Challenges

Pricing and Reimbursement

High drug costs pose barriers, especially in markets with constrained healthcare budgets. Negotiations and formulary placements impact sales volume.

Physician Familiarity

Despite clinical advantages, entrenched prescribing habits favor GnRH agonists. Education and evidence dissemination are essential to alter prescribing patterns.

Manufacturing and Supply Chain

Ensuring reliable supply chains, especially with complex manufacturing processes, remains critical. Disruptions could hinder market growth.

Financial Trajectory

Revenue Generation and Growth Projections

In its initial years, degarelix achieved steady but incremental sales. As awareness increases and formulation options expand, global sales are expected to grow at a CAGR of approximately 10-12%, reaching USD 1.2-1.5 billion by 2030 [5].

Market Penetration Strategies

Pharmaceutical companies leverage direct-to-physician marketing, clinical evidence publishing, and patient advocacy to improve adoption. Expansion into emerging markets presents opportunities, given rising healthcare expenditures and increasing prostate cancer burden.

Research and Development Investment

Ongoing clinical trials exploring combination therapies and new indications will likely enhance its market trajectory. Investment in biosimilar development could also influence future pricing and competitiveness.

Impact of Competitive and Regulatory Factors

Patent expirations, regulatory approvals of alternative therapies, and potential biosimilars could pressure pricing. However, strong clinical data and demonstrated safety profile maintain its appeal.

Future Outlook

The landscape for degarelix acetate is anticipated to evolve with increased clinical validation and broader application. Personalized medicine approaches and combination regimens will shape its role. Market growth depends heavily on regulatory support, payer acceptance, and physician advocacy.

Key Takeaways

• Clinical Superiority: Degarelix's rapid testosterone suppression without tumor flare positions it as a preferred option for high-risk patients.
• Market Expansion: With increasing prostate cancer incidence and awareness, the drug's market share is poised for growth, especially in emerging economies.
• Price and Reimbursement: Cost considerations remain barriers; strategic negotiations and demonstrated value could enhance access.
• Competitive Dynamics: Continuous innovation and education are essential to capture market share from established GnRH agonists.
• Research Opportunities: Expanding indications and combination therapies will drive future revenue streams.

---

FAQs

1. What are the primary clinical advantages of degarelix acetate over traditional GnRH agonists?
Degarelix provides immediate testosterone suppression without the initial testosterone surge and tumor flare associated with GnRH agonists, reducing symptomatic complications and hospitalization risks.

2. How does the pricing of degarelix acetate compare with GnRH agonists?
Degarelix generally has higher acquisition costs, but pharmacoeconomic benefits through reduced adverse events and hospitalizations may offset higher prices over time.

3. What are the key challenges in increasing degarelix's market penetration?
Barriers include high drug costs, entrenched clinician preferences for GnRH agonists, limited awareness, and reimbursement hurdles.

4. Are there new formulations or combination therapies involving degarelix in development?
Yes, ongoing clinical trials are exploring combination regimens and novel formulations to improve administration convenience and broaden indications.

5. How might regulatory changes impact degarelix's market growth?
Regulatory approvals for new indications and biosimilar entries could influence pricing strategies, market competition, and overall revenue potential.

---

References

[1] International Agency for Research on Cancer. Global Cancer Observatory (GCO). 2020.
[2] Smith MR, et al. "Degarelix: a GnRH antagonist for prostate cancer." Drugs of Today, 2010.
[3] MarketsandMarkets. "Prostate Cancer Drugs Market Analysis," 2021.
[4] Crawford ED, et al. "Clinical benefits of degarelix in prostate cancer." Journal of Urology, 2012.
[5] Grand View Research. "Prostate Cancer Therapeutics Market Size & Trends," 2022.