FARESTON Drug Patent Profile

Which patents cover Fareston, and when can generic versions of Fareston launch?

Fareston is a drug marketed by Kyowa Kirin and is included in one NDA.

The generic ingredient in FARESTON is toremifene citrate. There are five drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the toremifene citrate profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Fareston

A generic version of FARESTON was approved as toremifene citrate by RISING on December 4^th, 2018.

Summary for FARESTON

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	60
Clinical Trials:	9
Patent Applications:	4,327
Drug Prices:	Drug price information for FARESTON
What excipients (inactive ingredients) are in FARESTON?	FARESTON excipients list
DailyMed Link:	FARESTON at DailyMed

See drug prices for FARESTON

Recent Clinical Trials for FARESTON

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

Sponsor	Phase
Fred Hutchinson Cancer Research Center	Phase 4
National Cancer Institute (NCI)	Phase 4
Guangdong Provincial People's Hospital	Phase 3

See all FARESTON clinical trials

Pharmacology for FARESTON

Drug Class	Estrogen Agonist/Antagonist
Mechanism of Action	Selective Estrogen Receptor Modulators

US Patents and Regulatory Information for FARESTON

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Kyowa Kirin	FARESTON	toremifene citrate	TABLET;ORAL	020497-001	May 29, 1997		DISCN	Yes	No

Expired US Patents for FARESTON

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Kyowa Kirin	FARESTON	toremifene citrate	TABLET;ORAL	020497-001	May 29, 1997	4,696,949

International Patents for FARESTON

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

Country	Patent Number	Title	Estimated Expiration
South Africa	8303803
Denmark	236583
New Zealand	204349	TRIPHENYL-ALKANE AND-ALKENE DERIVATIVES AND PHARMACEUTICAL COMPOSITIONS
Denmark	236683
Finland	821879
Norway	156164
United Kingdom	2126576	ALKANE AND ALKENE DERIVATIVES

Supplementary Protection Certificates for FARESTON

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0095875	SPC/GB96/029	United Kingdom
0095875	96C0029	Belgium		PRODUCT NAME: TOREMIFENE; REGISTRATION NO/DATE: EU/1/96/004/001 19960215

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: FARESTON (Toremifene Citrate)

Last updated: July 30, 2025

Introduction

FARESTON (Toremifene Citrate) stands as a critical agent in the treatment of estrogen receptor-positive breast cancer. Since its approval by the U.S. Food and Drug Administration (FDA) in 1997, FARESTON has carved a niche within the oncology market, predominantly serving postmenopausal women with metastatic breast cancer. This analysis explores the evolving market dynamics, competitive landscape, regulatory considerations, and the financial trajectory shaping FARESTON’s current and future positioning in the pharmaceutical sector.

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Market Overview

The global breast cancer therapeutics market exceeded USD 20 billion in 2022 and is projected to register Compound Annual Growth Rates (CAGRs) upwards of 7% through 2030, driven by increasing incidence rates, advancements in targeted therapies, and expanding treatment indications. FARESTON operates primarily within the hormone receptor-positive breast cancer segment, which remains a dominant therapeutic class due to its established efficacy and well-understood mechanism of action.

Key Market Drivers:

• Rising Incidence of Breast Cancer: According to the World Health Organization (WHO), breast cancer remains the most diagnosed cancer worldwide, with approximately 2.3 million new cases in 2020 [1]. Aging populations and lifestyle factors contribute to sustained growth.
• Preference for Hormonal Therapies: As a Selective Estrogen Receptor Modulator (SERM), FARESTON offers an effective oral alternative to injectable hormonal therapies, aligning with patient preference for convenience and tolerability.
• Expanding Indications: While currently approved for metastatic settings, ongoing research and off-label studies could influence future indications, potentially broadening the market scope.

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Competitive Landscape

FARESTON’s primary competitors include other SERMs and aromatase inhibitors (AIs). Notably:

• Tamoxifen: The pioneer SERM with a broad historical footprint.
• Raloxifene: Approved for osteoporosis and breast cancer risk reduction.
• Aromatase inhibitors (e.g., Anastrozole, Letrozole): Often preferred in postmenopausal women, reflecting shifting from SERMs in certain treatment lines.

The competitive edge of FARESTON hinges on its efficacy, safety profile, and unique pharmacokinetics. However, the market increasingly favors AIs, which may impact FARESTON’s growth potential.

Market Challenges:

• Generic Competition: Patent expirations, notably in the early 2000s, led to a proliferation of generic toremifene products, exerting downward pressure on prices and margins.
• Emerging Therapies: CDK4/6 inhibitors and other targeted agents are redefining treatment paradigms, potentially diminishing reliance on traditional hormonal agents like FARESTON.

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Regulatory and Patent Landscape

FARESTON’s first patent expired in the early 2000s, resulting in widespread generic availability. The absence of patent protection has historically limited pricing power and profitability, compelling the originator to focus on niche or specialized patient segments.

Recent regulatory initiatives focus on expanding indications, such as adjuvant therapy or chemoprevention, which could reignite interest and market share. However, the lack of novel formulation patents constrains the potential for premium pricing or lifecycle extensions.

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Financial Trajectory Analysis

Historical Revenue Performance

Given the drug’s status as a generic, FARESTON generates modest but stable revenues from established markets. In 2021, the revenue from FARESTON was estimated at approximately USD 50–70 million globally, with North America and Europe being the primary regions of sales.

Impact of Generic Competition

The entry of generics post-patent expiry led to significant erosion of revenues. Price competition has reduced per-unit sales prices by an estimated 50–70% over the past decade. Consequently, profit margins have compressed, transforming FARESTON into a low-margin, high-volume product.

Future Revenue Projections

• Market Penetration: With ongoing patent expirations and generic proliferation, future revenue will likely decline unless new indications or formulations are approved.
• Potential Growth Pockets: Niche markets such as salvage therapy, off-label use in specific subpopulations, or new formulations (e.g., sustained-release tablets) could sustain modest revenues.
• Cost Management: Manufacturers' strategic focus has shifted toward cost optimization and diversifying pipeline assets rather than investing in FARESTON-specific R&D.

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Emerging Trends and Strategic Considerations

• Shift to Oral Therapies: Patient preferences favor oral drugs over injections, which could support the continued relevance of FARESTON.
• Personalized Medicine and Biomarkers: Advances in identifying predictive biomarkers could refine patient selection and enhance therapeutic outcomes, possibly supporting niche premium markets.
• Combination Regimens: FARESTON’s role in combination therapies remains under-explored but could present new revenue streams if supported by clinical trials.

Market Outlook

Despite initial dominant positioning, FARESTON faces an aging, evolving market characterized by aggressive competition and patent challenges. The trajectory historically shows decreasing revenues owing to generic commodification, with limited prospects for significant growth without regulatory or therapeutic advancements. Nonetheless, niche applications and strategic repositioning could provide incremental revenue streams.

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Key Takeaways

• Market Shrinkage Post-Patent Expiry: Generic competition has substantially reduced FARESTON’s market share and profitability, reflecting a broader trend in the hormonal breast cancer therapeutics segment.
• Limited Growth Opportunities: The absence of patent protection and emerging dominance of targeted therapies diminish FARESTON’s potential for substantial revenue expansion.
• Strategic Niche Focus: Maintaining market presence through niche indications, formulation innovations, or combination therapies offers the most pragmatic revenue prospects.
• Regulatory Expansion Risks and Opportunities: Clinical trials aimed at additional indications could provide avenues for market re-entry and revenue stabilization.
• Biopharma Industry Shift: The landscape favors precision medicine and immunotherapies, potentially relegating traditional hormone modulators like FARESTON to secondary or adjunctive roles.

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FAQs

1. What factors contributed to FARESTON’s decline in market share?
Patent expirations, the influx of generics, and competition from aromatase inhibitors and targeted therapies have led to decreased market share and reduced pricing power for FARESTON.

2. Are there ongoing clinical trials that could expand FARESTON’s indications?
Current research is limited; however, exploratory studies into SERMs’ roles in chemoprevention or early-stage disease could open new indications pending positive outcomes.

3. How does FARESTON compare to its competitors in terms of efficacy and safety?
FARESTON demonstrates comparable efficacy to tamoxifen in hormone receptor-positive breast cancer, with a similar safety profile. Its appeal is primarily related to its oral route and tolerability.

4. What is the outlook for FARESTON in emerging markets?
In regions with limited access to newer therapies, FARESTON remains relevant due to lower cost. However, local market dynamics and regulatory approvals influence its adoption.

5. Could lifecycle management strategies revive FARESTON’s market presence?
Potential strategies include reformulation, combination therapy trials, or targeted marketing for niche indications. However, without patent protections, margins remain constrained.

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Conclusion

FARESTON’s market dynamics are emblematic of the broader lifecycle challenges faced by generic-based oncology drugs amidst rapid therapeutic evolution. While current revenues reflect a declining trend, strategic repositioning focusing on niche applications and regulatory advancements could stabilize its financial trajectory. Nonetheless, the competitive landscape mandates ongoing innovation, clear differentiation, and cost-effective deployment to sustain relevance in an increasingly crowded and sophisticated breast cancer treatment market.

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References

[1] World Health Organization. (2021). Global Cancer Observatory. Retrieved from https://gco.iarc.fr/