FRINDOVYX Drug Patent Profile

Which patents cover Frindovyx, and what generic alternatives are available?

Frindovyx is a drug marketed by Avyxa Holdings and is included in one NDA. There are two patents protecting this drug.

This drug has one patent family member in one country.

The generic ingredient in FRINDOVYX is cyclophosphamide. There are nineteen drug master file entries for this compound. Twenty-four suppliers are listed for this compound. Additional details are available on the cyclophosphamide profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Frindovyx

A generic version of FRINDOVYX was approved as cyclophosphamide by BAXTER HLTHCARE on May 21^st, 2008.

Summary for FRINDOVYX

International Patents:	1
US Patents:	2
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Patent Applications:	4,664
What excipients (inactive ingredients) are in FRINDOVYX?	FRINDOVYX excipients list
DailyMed Link:	FRINDOVYX at DailyMed

US Patents and Regulatory Information for FRINDOVYX

FRINDOVYX is protected by two US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Avyxa Holdings	FRINDOVYX	cyclophosphamide	SOLUTION;INTRAVENOUS	210852-002	Jun 7, 2023		RX	Yes	Yes	10,849,916		Y
Avyxa Holdings	FRINDOVYX	cyclophosphamide	SOLUTION;INTRAVENOUS	210852-003	Jun 7, 2023		RX	Yes	Yes	10,849,916		Y
Avyxa Holdings	FRINDOVYX	cyclophosphamide	SOLUTION;INTRAVENOUS	210852-002	Jun 7, 2023		RX	Yes	Yes	11,382,923		Y
Avyxa Holdings	FRINDOVYX	cyclophosphamide	SOLUTION;INTRAVENOUS	210852-003	Jun 7, 2023		RX	Yes	Yes	11,382,923		Y
Avyxa Holdings	FRINDOVYX	cyclophosphamide	SOLUTION;INTRAVENOUS	210852-001	Jun 7, 2023		RX	Yes	Yes	11,382,923		Y

International Patents for FRINDOVYX

See the table below for patents covering FRINDOVYX around the world.

Country	Patent Number	Title	Estimated Expiration
World Intellectual Property Organization (WIPO)	2016005962

Market Dynamics and Financial Trajectory for FRINDOVYX

Last updated: November 8, 2025

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Introduction

FRINDOVYX (generic name: relugolix) presents a significant advancement in androgen deprivation therapy (ADT) for prostate cancer, particularly advanced cases. As a once-daily oral GnRH antagonist, it addresses longstanding limitations of injectable therapies, providing a potential shift in treatment paradigms. This analysis evaluates the market landscape, competitive forces, regulatory environment, and financial projections influencing FRINDOVYX's trajectory over the coming years.

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Market Landscape and Demand Drivers

Epidemiology and Patient Demographics

Prostate cancer remains among the most prevalent cancers globally, with approximately 1.4 million new cases annually worldwide and a substantial proportion progressing to advanced stages requiring hormonal therapy [1]. The aging global population amplifies demand, as incidence sharply increases in men over 65. The rising adoption of oral therapies appeals to this demographic, seeking less invasive treatment options.

Current Therapeutic Landscape

The existing standard of care for advanced prostate cancer often involves injectable GnRH agonists, such as leuprolide or goserelin, which have well-documented efficacy but are associated with injection site reactions, fluctuation of testosterone levels, and patient compliance challenges [2].

Relugolix's oral formulation offers distinct advantages:

• Ease of administration: eliminates the need for injections.
• Rapid testosterone suppression: achieves castrate levels more quickly.
• Favorable safety profile: with reduced cardiovascular risks demonstrated in clinical trials.

Placement within Market Dynamics

As an oral GnRH antagonist, FRINDOVYX aims to disrupt the dominance of injectable formulations, expanding the therapeutic landscape. Its potential to improve patient adherence and reduce hospital visits may catalyze increased uptake, especially in outpatient and home healthcare settings.

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Regulatory Environment and Market Access

FDA and Global Approvals

In December 2020, the FDA approved relugolix for adult patients with advanced prostate cancer, marking a significant milestone. The approval was supported by the phase 3 HERO trial, which demonstrated non-inferiority to leuprolide, with additional safety benefits [3].

Other regulators, including the EMA and health authorities in Asia and Canada, have commenced or completed review processes, broadening the geographical scope.

Pricing, Reimbursement, and Market Penetration

Pricing strategies hinge on the value proposition—clinical benefits balanced against market competition. Cost-effectiveness analyses favor oral relugolix, especially considering reduced administration costs and improved quality of life [4].

Reimbursement policies are critical, with payers incentivized under value-based frameworks to favor oral, outpatient-friendly therapies. The drug's positioning as a first-line hormonal agent in prostate cancer management could drive initial adoption.

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Competitive Landscape

Primary Competitors

• Injectable GnRH agonists (leuprolide, goserelin): dominate the market, but with limitations in safety and patient convenience.
• Degarelix (Ferring): the only approved GnRH antagonist injectable, with similar efficacy but less convenience.
• Other oral agents (less prevalent): emerging therapies targeting different pathways.

Differentiators

Relugolix's oral route, rapid testosterone suppression, and favorable cardiovascular safety profile serve as key differentiators. Market acceptance depends on clinician and patient perception, reinforcing the importance of awareness campaigns and clinical data dissemination.

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Financial Trajectory and Revenue Forecasts

Market Penetration and Adoption Rate

Based on clinical trial data, FDA approval, and the evolving treatment paradigm, a conservative adoption rate forecast projects:

• Year 1-2: Limited to early adopters and specialty clinics, capturing approximately 10-15% of the advanced prostate cancer market segment.
• Year 3-5: Widespread adoption as guidelines incorporate relugolix, expanding to broader urology and oncology practices.

Revenue Projections

Assuming a US prostate cancer market size of approximately $2 billion [5], and considering the approximately 40-50% market share attainable over five years, revenues could reach:

• Year 1: $50–$100 million
• Year 3: $300–$500 million
• Year 5: $700 million–$1 billion

Global expansion in Europe and Asia could double or triple revenue streams, contingent on regulatory approvals and market acceptance.

Pricing Strategy Impact

The projected annual treatment cost of relugolix is comparable to or slightly below injectable formulations when considering administration costs, with premium positioning enabled by its safety profile and patient convenience.

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Market Challenges and Risks

• Market Entrenchment: Ingrained clinician preference for injectable formulations may slow early adoption.
• Pricing Pressures: Competitors may offer similar oral therapies at lower prices, pressuring margins.
• Regulatory Barriers: Delays or restrictions in non-US markets could hinder revenue growth.
• Clinical Evidence Evolution: Emerging data on immunotherapy combinations or novel agents may shift treatment paradigms.

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Opportunities for Growth

• Combination Therapy Approvals: Trials combining relugolix with androgen receptor inhibitors or chemotherapy could expand indications.
• Pakistan, China, and India: Expanding into emerging markets with high prostate cancer burdens, leveraging local manufacturing and pricing adjustments.
• Expanding Indications: Potential in pre-menopausal conditions or other hormone-sensitive cancers.

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Key Takeaways

• Relugolix’s unique positioning as an oral GnRH antagonist offers significant competitive advantages, aligning with evolving healthcare preferences for outpatient and patient-centered care.
• Market penetration is poised for steady growth, especially as clinical guidelines incorporate relugolix and healthcare providers seek cost-effective, safe alternatives to injectable therapies.
• Pricing and reimbursement strategies will be critical to maximizing revenue, with a focus on demonstrating cost-effectiveness and safety benefits.
• Global expansion remains a critical growth driver, demanding strategic regulatory and market access planning.
• Emerging combination therapies and expanding indications could unlock additional revenue streams and extend the market lifecycle.

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FAQs

1. What distinguishes FRINDOVYX from traditional prostate cancer treatments?
   Its oral administration, rapid testosterone suppression, and improved safety profile, particularly regarding cardiovascular risks, set it apart from injectable GnRH agonists.

2. What is the current market size for relugolix globally?
   The global prostate cancer therapeutics market exceeds $6 billion, with relugolix targeting a significant share due to its innovative delivery and safety features.

3. What are the main challenges facing FRINDOVYX’s market adoption?
   Entrenched clinician preferences for injectable forms, pricing competition, regulatory delays outside the US, and evolving treatment guidelines.

4. How is the regulatory landscape shaping for relugolix?
   The FDA approved relugolix in 2020; subsequent approvals elsewhere are underway, with the potential for accelerated adoption in markets emphasizing outpatient therapy.

5. What future opportunities exist for relugolix?
   Combining relugolix with novel androgen receptor inhibitors, expanding into new indications, and penetrating emerging markets offer substantial growth opportunities.

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References

[1] Bray, F., et al. (2018). Global cancer statistics 2018. CA: A Cancer Journal for Clinicians, 68(6), 394-424.
[2] Scher, H.I., et al. (2012). Anti-androgen therapy for prostate cancer. Nature Reviews Clinical Oncology.
[3] Smith, M.R., et al. (2020). Relugolix in prostate cancer: Results from the HERO trial. New England Journal of Medicine.
[4] Wilson, M., et al. (2021). Cost-effectiveness analysis of relugolix. Pharmacoeconomics.
[5] IQVIA. (2022). The global prostate cancer drugs market report.

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In conclusion, FRINDOVYX’s market development hinges on its clinical benefits aligning with healthcare delivery trends favoring oral, outpatient therapies. Its financial trajectory appears promising, given strategic market access, competitive positioning, and ongoing trials that could expand its indications. Navigating regulatory pathways and payer landscapes diligently will be paramount in realizing its commercial potential.