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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 five 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.

Indicators of Generic Entry

Summary for FIRMAGON

International Patents:	105
US Patents:	7
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	70
Clinical Trials:	57
Patent Applications:	1,795
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
Japan	2019218360	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 WITH GnRH ANTAGONIST DEGARELIX)
South Korea	20200001623	데가렐릭스를 이용한 전이 단계의 전립선암의 치료 방법 (TREATMENT OF METASTATIC STAGE PROSTATE CANCER WITH DEGARELIX)
China	103990107

Supplementary Protection Certificates for FIRMAGON

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1003774	SPC020/2009	Ireland		SPC020/2009: 20091119, EXPIRES: 20230412
1003774	300395	Netherlands		300395, 20180413, EXPIRES: 20230412
1003774	CA 2009 00022	Denmark

FIRMAGON Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for FIRMAGON (Degarelix)

Introduction to FIRMAGON

FIRMAGON (degarelix) is a gonadotropin-releasing hormone (GnRH) receptor antagonist approved for the treatment of advanced prostate cancer. It is administered via subcutaneous injection and works by immediately inhibiting GnRH receptors in the pituitary gland, thereby suppressing the secretion of luteinizing hormone (LH) and follicle-stimulating hormone (FSH), and subsequently reducing testosterone levels[2][4][5].

Market Positioning

Competitive Landscape

FIRMAGON competes in the market for androgen deprivation therapies (ADT), which are crucial for managing advanced prostate cancer. The primary competitors include other GnRH agonists like leuprolide (Lupron Depot) and goserelin (Zoladex). However, FIRMAGON stands out due to its unique mechanism of action as a GnRH receptor antagonist, which avoids the initial testosterone surge associated with GnRH agonists[2][4].

Clinical Advantages

Clinical studies have demonstrated that FIRMAGON is highly effective in achieving and maintaining castrate levels of testosterone. In a 1-year clinical study involving 620 men with advanced prostate cancer, FIRMAGON showed that 97.2% to 98.3% of patients achieved testosterone levels below 50 ng/dL, comparable to leuprolide[1].

Long-Term Efficacy and Safety

Long-term data published in the Journal of Urology indicate that FIRMAGON provides safe and effective testosterone and prostate-specific antigen (PSA) control over three years. This long-term efficacy reduces the risk of PSA failure, a significant indicator of the progression to castration-resistant prostate cancer (CRPC)[2].

Financial Trajectory

Approval and Market Entry

FIRMAGON was approved by the U.S. Food and Drug Administration (FDA) in 2009 for the treatment of advanced prostate cancer. Since its approval, it has been available through traditional and specialty pharmacy distributors, with its average monthly cost comparable to other hormone treatments for advanced prostate cancer[2].

Revenue and Market Share

While specific revenue figures for FIRMAGON are not publicly detailed in the sources, its market share is influenced by its clinical advantages and the growing demand for effective treatments for advanced prostate cancer. Prostate cancer is a significant health issue, with around 300,000 new cases diagnosed in Europe and 670,000 worldwide each year[2].

Cost and Reimbursement

The cost of FIRMAGON treatment is comparable to other hormone therapies for advanced prostate cancer. This parity in pricing helps in maintaining a competitive edge in the market. Reimbursement policies vary by region but generally cover GnRH receptor antagonists like FIRMAGON as part of standard treatment protocols for advanced prostate cancer[2].

Market Drivers

Increasing Incidence of Prostate Cancer

Prostate cancer is the second leading cause of cancer death among men in many Western countries. The increasing incidence and prevalence of prostate cancer drive the demand for effective treatments like FIRMAGON[2].

Preference for GnRH Receptor Antagonists

The preference for GnRH receptor antagonists over agonists is growing due to the avoidance of the initial testosterone surge, which can worsen symptoms and stimulate cancer cell growth. This preference is a significant market driver for FIRMAGON[4].

Long-Term Efficacy and Safety Data

The availability of long-term efficacy and safety data supports the use of FIRMAGON as a first-line treatment for advanced prostate cancer. This data reassures both clinicians and patients, contributing to its market traction[2].

Market Challenges

Competition from Established Treatments

FIRMAGON faces competition from well-established GnRH agonists like leuprolide and goserelin. These treatments have a longer market presence and may have stronger brand recognition and loyalty among clinicians and patients[1].

Side Effects and Safety Concerns

While FIRMAGON is generally well-tolerated, it can have significant side effects, including QT prolongation and osteoporosis, which are associated with androgen deprivation therapy. These safety concerns need to be managed and communicated effectively to maintain market confidence[3].

Future Outlook

Expanding Treatment Options

The future outlook for FIRMAGON is positive, given the ongoing need for effective treatments for advanced prostate cancer. As more data on its long-term benefits becomes available, it is likely to become a preferred option for many patients and clinicians.

Regulatory and Reimbursement Environment

Changes in regulatory and reimbursement environments can impact the market dynamics. However, given the clinical benefits and the critical need for effective prostate cancer treatments, FIRMAGON is likely to remain a viable option in the market.

Key Takeaways

• Clinical Efficacy: FIRMAGON is highly effective in achieving and maintaining castrate levels of testosterone, comparable to or better than traditional GnRH agonists.
• Market Positioning: It competes in the ADT market with a unique mechanism of action that avoids the initial testosterone surge.
• Financial Trajectory: Approved in 2009, FIRMAGON has a stable market presence with costs comparable to other hormone therapies.
• Market Drivers: Increasing incidence of prostate cancer, preference for GnRH receptor antagonists, and long-term efficacy data drive its market growth.
• Challenges: Competition from established treatments and side effects associated with androgen deprivation therapy are key challenges.

FAQs

What is FIRMAGON used for?

FIRMAGON (degarelix) is used for the treatment of advanced prostate cancer. It works by reducing testosterone levels to slow the growth of cancer cells.

How does FIRMAGON differ from other GnRH therapies?

FIRMAGON is a GnRH receptor antagonist, which means it directly blocks the GnRH receptors in the pituitary gland without causing an initial testosterone surge, unlike GnRH agonists.

What are the common side effects of FIRMAGON?

Common side effects include injection site reactions, hot flashes, and potential long-term effects such as QT prolongation and osteoporosis.

How is FIRMAGON administered?

FIRMAGON is administered via subcutaneous injection. The starting dose is 240 mg, followed by monthly maintenance doses of 80 mg.

Is FIRMAGON covered by insurance?

Generally, FIRMAGON is covered by insurance as part of standard treatment protocols for advanced prostate cancer, but reimbursement policies vary by region.

Sources

1. MedicalNewsToday: Firmagon: Side effects, dosage, uses, and more.
2. PR Newswire: New Data on Long-Term Use of FIRMAGON® (degarelix for injection) for Advanced Hormone-Dependent Prostate Cancer Published in Journal of Urology.
3. Health Canada: Summary Basis of Decision for Firmagon.
4. Firmagon.com: Antagonist vs agonist - Firmagon.
5. Firmagon.com: Advanced Prostate Cancer Treatment | Firmagon® (degarelix for injection).