Degarelix acetate - Generic Drug Details

What are the generic sources for degarelix acetate and what is the scope of patent protection?

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 five patent family members in twenty-four countries.

One supplier is listed for this compound.

Summary for degarelix acetate

International Patents:	105
US Patents:	7
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	21
Clinical Trials:	36
Patent Applications:	120
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

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	022201-002	Dec 24, 2008		RX	Yes	Yes
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	022201-001	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

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	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
Russian Federation	2010133480	ЛЕЧЕНИЕ МЕТАСТАТИЧЕСКОЙ СТАДИИ РАКА ПРЕДСТАТЕЛЬНОЙ ЖЕЛЕЗЫ ДЕГАРЕЛИКСОМ
Mexico	2010008817
Japan	5876652
Japan	2019059726

Supplementary Protection Certificates for degarelix acetate

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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	SPC/GB09/028	United Kingdom		PRODUCT NAME: DEGARELIX OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT SUCH AS THE ACETATE; REGISTERED: UK EU/1/08/504/001 20090217; UK EU/1/08/504/002 20090217
1003774	91585	Luxembourg		PRODUCT NAME: DEGARELIX, EVENTUELLEMENT UN SEL PHARMACEUTIQUEMENT ACCEPTABE, TEL QUE L'ACETATE (FIRMAGON); REG. DATE: 20090217
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
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	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

Degarelix acetate Market Analysis and Financial Projection Experimental

Degarelix Acetate: Market Dynamics and Financial Trajectory

Introduction

Degarelix acetate, marketed under the brand name Firmagon, is a synthetic peptide antagonist of gonadotropin-releasing hormone (GnRH) primarily used in the treatment of advanced prostate cancer. This article delves into the market dynamics and financial trajectory of Degarelix acetate, highlighting its current status, growth drivers, and future outlook.

Market Overview

The Degarelix market is characterized by a positive outlook, driven by several key factors. The growing prevalence of prostate cancer and an increasing aging population are significant drivers of demand for this medication[1].

Clinical Use and Mechanism

Degarelix acetate works by inhibiting the action of GnRH, which effectively reduces testosterone levels. This rapid reduction in testosterone is crucial for managing hormone-sensitive prostate tumors, offering a distinct advantage over traditional GnRH agonists that can cause initial testosterone surges[2].

Market Segmentation

The Degarelix market can be segmented in several ways:

By Dosage

• 120 mg per vial: Offers a higher single-dose treatment, beneficial for patients requiring quicker hormonal suppression.
• 80 mg per vial: Provides a flexible dosing option, catering to varying patient needs. Both vial types influence pricing strategies, prescription patterns, and market accessibility[1].

By Application

• Hospital: Administered for its rapid action in reducing testosterone levels, essential for managing advanced prostate cancer.
• Drugstore: Available for outpatient prescriptions, providing patients with access to effective hormone therapy[1].

By Region

The market is geographically segmented into regions such as North America (including the United States and Canada), Europe (including Germany, France, U.K., Italy, and Russia), and emerging markets. These regions are expected to contribute significantly to the market growth due to increasing healthcare infrastructure and rising disposable incomes[1].

Growth Drivers

Several factors are driving the growth of the Degarelix market:

Increasing Prevalence of Prostate Cancer

The rising incidence of prostate cancer globally is a primary driver. As the population ages, the demand for effective treatments like Degarelix acetate is expected to increase[1].

Advancements in Healthcare Infrastructure

Emerging markets with improving healthcare infrastructure and increasing disposable incomes are anticipated to contribute significantly to market growth[1].

Research and Development

Ongoing research into potential applications and combination therapies is likely to enhance market growth. Innovations in drug delivery systems, such as long-acting injectables, improve drug adherence and patient outcomes[1].

Telemedicine Integration

The rise of telehealth services allows for remote monitoring and prescription, making it easier for patients to access Degarelix therapy[1].

Sustainability Focus

Pharmaceutical companies adopting eco-friendly manufacturing processes respond to consumer preferences for sustainable healthcare options, which can positively impact market perception[1].

Financial Trajectory

The financial outlook for Degarelix acetate is robust:

Market Size and Growth Rate

The Degarelix market is expected to grow at a Compound Annual Growth Rate (CAGR) of 18.50% during the forecast period from 2024 to 2031. This growth is driven by increasing demand and acceptance in oncology practices[1].

Revenue and Market Share

Key players like Ferring Pharmaceuticals, which markets Degarelix under the brand name Firmagon, have seen significant revenue. Ferring Pharmaceuticals reported sales revenue of around $2.5 billion, with a substantial portion attributed to its oncology segment, including Firmagon[1].

Competitive Landscape

The competitive landscape includes other major players such as AstraZeneca and Johnson & Johnson, which offer alternative treatments for prostate cancer. However, Degarelix acetate's unique mechanism of action and rapid onset of medical castration position it favorably in the market[1].

Regional Performance

• North America: The United States and Canada are significant markets due to high healthcare spending and advanced medical infrastructure.
• Europe: Countries like Germany, France, and the U.K. contribute substantially to the market, driven by strong healthcare systems and high patient awareness.
• Emerging Markets: Regions with improving healthcare infrastructure and rising incomes are expected to drive future growth[1].

Innovations and Trends

• Personalized Medicine: Increasing demand for tailored therapies encourages the development of customized Degarelix formulations, enhancing efficacy and patient satisfaction.
• Advanced Drug Delivery Systems: Innovations in delivery mechanisms improve drug adherence and patient outcomes.
• Market Consolidation: Mergers and acquisitions among biotech firms drive research and development, facilitating the introduction of novel treatments and combinations[1].

Regulatory and Clinical Policy

Degarelix acetate is FDA-approved for the treatment of advanced prostate cancer. Clinical policies, such as those outlined by health plans affiliated with Centene Corporation, require documentation supporting the medical necessity of the treatment. These policies ensure that the medication is used effectively and responsibly[5].

Financial Performance of Key Players

• Ferring Pharmaceuticals: Reported sales revenue of around $2.5 billion, with a significant portion from its oncology segment.
• AstraZeneca: Reported revenues of approximately $37 billion, with oncology products making up a notable share. AstraZeneca's strong financial performance and pipeline progress indicate robust competition in the prostate cancer treatment market[1][3].

Future Outlook

The future of Degarelix acetate looks promising, with several factors contributing to its growth:

• Increasing Demand: Growing prevalence of prostate cancer and an aging population.
• Research and Development: Ongoing research into new applications and combination therapies.
• Market Expansion: Emerging markets with improving healthcare infrastructure.
• Innovative Delivery Systems: Advancements in drug delivery mechanisms.

"Degarelix acetate has been shown to produce a significantly more rapid medical castration (without testosterone surge) and prostate-specific antigen response compared with GnRH agonists."[2]

Key Takeaways

• Degarelix acetate is a GnRH antagonist used primarily for treating advanced prostate cancer.
• The market is driven by a growing prevalence of prostate cancer and an increasing aging population.
• The drug is available in 120 mg and 80 mg vial options, catering to different patient needs.
• Emerging markets and advancements in healthcare infrastructure are significant growth drivers.
• The market is expected to grow at a CAGR of 18.50% from 2024 to 2031.
• Key players like Ferring Pharmaceuticals and AstraZeneca play a crucial role in the competitive landscape.

FAQs

What is Degarelix acetate used for?

Degarelix acetate is used for the treatment of advanced prostate cancer. It works by inhibiting the action of gonadotropin-releasing hormone (GnRH), reducing testosterone levels.

What are the key drivers of the Degarelix market?

The key drivers include the growing prevalence of prostate cancer, an increasing aging population, advancements in healthcare infrastructure, and ongoing research into new applications and combination therapies.

What is the expected CAGR of the Degarelix market from 2024 to 2031?

The Degarelix market is expected to grow at a CAGR of 18.50% during the forecast period from 2024 to 2031.

Who are the key players in the Degarelix market?

Key players include Ferring Pharmaceuticals, AstraZeneca, and Johnson & Johnson, among others.

How does Degarelix acetate differ from traditional GnRH agonists?

Degarelix acetate produces a rapid medical castration without the initial testosterone surge associated with GnRH agonists, offering a distinct clinical advantage.

Sources

1. OpenPR: Degarelix Market Size & Share Analysis - Growth Trends & Forecasts (2024 - 2031)
2. PubMed: Degarelix acetate for the treatment of prostate cancer
3. AstraZeneca: Full year and Q4 2022 results
4. Business Research Insights: Prostate Cancer Drugs Market Report, 2024 | Forecast, 2031
5. Ambetter Health: Clinical Policy: Degarelix Acetate (Firmagon)