FULVESTRANT - Generic Drug Details

What are the generic sources for fulvestrant and what is the scope of freedom to operate?

Fulvestrant is the generic ingredient in two branded drugs marketed by Astrazeneca, Accord Hlthcare, Alembic, Amneal, Apotex, Avyxa Holdings, Chia Tai Tianqing, Dr Reddys, Eugia Pharma, Fresenius Kabi Usa, Glenmark Pharms Inc, Hbt Labs Inc, Jiangsu Hansoh Pharm, Sagent Pharms Inc, Sandoz, Xiromed, and Zydus Pharms, and is included in eighteen NDAs. There are three patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

There are twelve drug master file entries for fulvestrant. Twenty suppliers are listed for this compound.

Summary for FULVESTRANT

US Patents:	3
Tradenames:	2
Applicants:	17
NDAs:	18
Drug Master File Entries:	12
Finished Product Suppliers / Packagers:	20
Raw Ingredient (Bulk) Api Vendors:	86
Clinical Trials:	454
Patent Applications:	6,412
Drug Prices:	Drug price trends for FULVESTRANT
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for FULVESTRANT
What excipients (inactive ingredients) are in FULVESTRANT?	FULVESTRANT excipients list
DailyMed Link:	FULVESTRANT at DailyMed

See drug prices for FULVESTRANT

Recent Clinical Trials for FULVESTRANT

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

Sponsor	Phase
Risen (Suzhou) Pharma Tech Co., Ltd.	PHASE3
Gilead Sciences	PHASE1
Eli Lilly and Company	PHASE3

See all FULVESTRANT clinical trials

Pharmacology for FULVESTRANT

Drug Class	Estrogen Receptor Antagonist
Mechanism of Action	Estrogen Receptor Antagonists Selective Estrogen Receptor Modulators

Anatomical Therapeutic Chemical (ATC) Classes for FULVESTRANT

L02BA	Anti-estrogens
L02B	HORMONE ANTAGONISTS AND RELATED AGENTS
L02	ENDOCRINE THERAPY
L	Antineoplastic and immunomodulating agents

Paragraph IV (Patent) Challenges for FULVESTRANT

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
FASLODEX	Injection	fulvestrant	50 mg/mL, 2.5 mL and 5 mL syringe	021344	1	2009-10-01

US Patents and Regulatory Information for FULVESTRANT

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Apotex	FULVESTRANT	fulvestrant	SOLUTION;INTRAMUSCULAR	211730-001	Jun 11, 2021		DISCN	No	No
Astrazeneca	FASLODEX	fulvestrant	SOLUTION;INTRAMUSCULAR	021344-001	Apr 25, 2002	AO	RX	Yes	Yes
Dr Reddys	FULVESTRANT	fulvestrant	SOLUTION;INTRAMUSCULAR	209246-001	Aug 7, 2020	AO	RX	No	No
Accord Hlthcare	FULVESTRANT	fulvestrant	SOLUTION;INTRAMUSCULAR	211689-001	Nov 17, 2020	AO	RX	No	No
Fresenius Kabi Usa	FULVESTRANT	fulvestrant	SOLUTION;INTRAMUSCULAR	210326-001	May 20, 2019	AO	RX	No	No			Y

Expired US Patents for FULVESTRANT

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Astrazeneca	FASLODEX	fulvestrant	SOLUTION;INTRAMUSCULAR	021344-001	Apr 25, 2002
Astrazeneca	FASLODEX	fulvestrant	SOLUTION;INTRAMUSCULAR	021344-001	Apr 25, 2002
Astrazeneca	FASLODEX	fulvestrant	SOLUTION;INTRAMUSCULAR	021344-001	Apr 25, 2002
Astrazeneca	FASLODEX	fulvestrant	SOLUTION;INTRAMUSCULAR	021344-001	Apr 25, 2002
Astrazeneca	FASLODEX	fulvestrant	SOLUTION;INTRAMUSCULAR	021344-001	Apr 25, 2002

EU/EMA Drug Approvals for FULVESTRANT

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Mylan Pharmaceuticals Limited	Fulvestrant Mylan	fulvestrant	EMEA/H/C/004649Fulvestrant is indicated for the treatment of estrogen receptor positive, locally advanced or metastatic breast cancer in postmenopausal women:not previously treated with endocrine therapy, orwith disease relapse on or after adjuvant anti-estrogen therapy, or disease progression on antiestrogen therapy.	Authorised	yes	no	no	2018-01-08
AstraZeneca AB	Faslodex	fulvestrant	EMEA/H/C/000540Faslodex is indicated, , , as monotherapy for the treatment of estrogen receptor positive, locally advanced or metastatic breast cancer in postmenopausal women:, , not previously treated with endocrine therapy, or, with disease relapse on or after adjuvant antiestrogen therapy, or disease progression on antiestrogen therapy., , , in combination with palbociclib for the treatment of hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer in women who have received prior endocrine therapy., , , In pre- or perimenopausal women, the combination treatment with palbociclib should be combined with a luteinizing hormone releasing hormone (LHRH) agonist.,	Authorised	no	no	no	2004-03-09

Market Dynamics and Financial Trajectory for Fulvestrant: A Strategic Industry Analysis

Last updated: August 14, 2025

Introduction

Fulvestrant, marketed under the brand name Faslodex among others, is a selective estrogen receptor degrader (SERD) used primarily in the treatment of hormone receptor-positive metastatic breast cancer in postmenopausal women. Since its approval by the FDA in 2002, fulvestrant has established a substantial niche within the oncology therapeutics segment. This analysis explores key market dynamics, competitive landscape, regulatory factors, commercialization strategies, and financial trends shaping the trajectory of fulvestrant within the pharmaceutical industry.

Pharmacological Profile and Clinical Use

Fulvestrant operates by binding competitively to estrogen receptors (ERα), facilitating receptor degradation, and thus inhibiting estrogen-driven cancer cell proliferation. Its mechanism makes it a critical option for patients resistant to selective estrogen receptor modulators (SERMs) like tamoxifen or aromatase inhibitors (AIs). Clinical trials consistently demonstrate its efficacy in extending progression-free survival (PFS) and overall survival (OS), positioning fulvestrant as an integral part of the treatment paradigm for advanced hormone receptor-positive breast cancer.

Market Size and Growth Drivers

Global Oncology Therapeutics Market

The global breast cancer therapeutics market was valued at approximately USD 17.8 billion in 2022 and is projected to grow at a compound annual growth rate (CAGR) of 6-8% through 2030 [1]. Fulvestrant holds a significant share owing to its role in late-line therapy, especially in treatment-resistant cases. The expanding prevalence of breast cancer—estimated to affect over 2.3 million women annually worldwide—serves as a primary growth catalyst.

Patient Demographics and Epidemiological Trends

The rising incidence of hormone receptor-positive breast cancers among aging populations and increased awareness initiatives contribute to expanding indications and prescriptions. The postmenopausal demographic, which predominantly receives fulvestrant, is increasing globally, especially in developing markets, further boosting demand.

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Competitive Landscape

Major Players and Market Share

Pfizer's Faslodex remains the dominant brand, with a strong presence in North America and Europe. Other significant competitors include AstraZeneca, which markets oral SERDs like fulvestrant analogs in development, and emerging biosimilars. Patent expirations in key regions, including the expiry of Pfizer’s patent in 2028, threaten to erode market share but also open opportunities for biosimilar entrants.

Innovations and Pipeline Developments

The development of oral SERDs (e.g., AMG 319, AZD9833) offers potential to supplant injectable fulvestrant, promising better patient compliance and convenience. Moreover, combination therapies pairing fulvestrant with CDK4/6 inhibitors (e.g., palbociclib, abemaciclib) have demonstrated improved clinical outcomes, fostering new growth avenues.

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Regulatory and Reimbursement Factors

Regulatory Approvals and Labeling

Regulatory bodies in key markets such as the FDA, EMA, and China's NMPA regularly review fulvestrant for expanded indications, including earlier lines of therapy. The approval of higher-dose formulations (e.g., 500 mg vs. 250 mg) enhances dosing flexibility and potentially improves efficacy.

Reimbursement Dynamics

Reimbursement policies influence access and sales volume. Favorable reimbursement status in developed markets sustains revenue, while ongoing negotiations and drug price pressures in emerging economies pose challenges.

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Market Challenges and Risks

• Patent Expiry and Biosimilars: Patent expiration risks commoditization, pressure on pricing, and erosion of profit margins.
• Competition from Oral SERDs: The emerging class of oral SERDs offers oral administration, potentially outperforming injectables in acceptance.
• Clinical Efficacy of New Therapies: Efficacy and safety of new combination regimens or novel agents might diminish fulvestrant’s market share.
• Pricing Regulations and Cost-Containment: Governments' focus on drug affordability and cost containment could constrain revenues.
• Regulatory Delays: Delays in approval processes for new formulations or indications could slow market expansion.

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Financial Trajectory and Revenue Outlook

Historical Financial Performance

Pfizer’s Faslodex generated approximately USD 800 million in global sales in 2022, with North America accounting for around 60% of revenues. Growth has been steady, supported by expanded indications and combination therapies.

Future Revenue Projections

With patent protections set to expire in key markets by 2028, revenues may plateau or decline absent biosimilar or generic entrants. However, strategic moves—such as developing oral SERDs, combination therapies, or liquid formulations—may offset erosion by capturing new patient segments.

Analysts forecast a CAGR of 3-5% for fulvestrant’s global sales until 2030, driven by increased adoption in combination regimens and expanded indications, especially in emerging markets where breast cancer rates are rising rapidly.

Pricing Trends

Pricing remains sensitive; innovative formulations or combination therapies command premium pricing but face reimbursement hurdles. The advent of biosimilars could precipitate significant price reductions, necessitating strategic value demonstration to payers.

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Strategic Opportunities

• Development of Oral SERDs: Oral formulations promise enhanced patient compliance; investment in clinical trials could establish early-market advantage.
• Combination Regimens: Partnering with targeted therapies (CDK4/6 inhibitors, PI3K inhibitors) can elevate treatment efficacy and expand market share.
• Geographic Expansion: Tailored market entry strategies for low- and middle-income countries, leveraging increased breast cancer prevalence.
• Biosimilar Development: Preparing for biosimilar entry to sustain revenue trajectory post-patent expiry.
• Personalized Medicine: Integrating genomic profiling to identify suitable patient subgroups increases prescription precision and drug efficacy perception.

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Conclusion

The fulvestrant molecule remains a cornerstone in advanced hormone receptor-positive breast cancer therapy. While patent expirations and emerging therapies create headwinds, strategic diversification—through formulation innovation, combination treatments, and geographic expansion—can sustain its market relevance. Careful navigation of regulatory landscapes and reimbursement policies will be crucial to optimizing long-term financial outcomes.

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Key Takeaways

• Fulvestrant’s market is poised for steady growth driven by rising breast cancer incidence and its efficacy in resistant cases.
• Patent expirations necessitate strategic planning to mitigate biosimilar competition and preserve revenue streams.
• Innovation in drug formulations (oral SERDs) and combination therapies offers substantial growth opportunities.
• Emerging markets present significant expansion potential due to increasing disease burden and evolving healthcare infrastructure.
• Collaboration with payers, regulatory bodies, and strategic planning around biosimilar pathways are essential for sustained profitability.

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FAQs

1. When will biosimilars of fulvestrant enter the market, and how will they impact revenues?
Biosimilars typically enter the market 8-10 years post-approval, aligning with Pfizer's patent expiration in 2028. Biosimilars will likely reduce sales prices, potentially shrinking Pfizer’s revenues unless differentiated through value-added strategies.

2. Are there ongoing clinical trials exploring oral SERDs as alternatives to fulvestrant?
Yes. Several oral SERDs, such as AMG 510 and AZD9833, are in advanced clinical phases, with some already approved for specific indications. They pose a direct challenge but also offer opportunities when used in combination with fulvestrant.

3. How does combination therapy influence fulvestrant’s market share?
Combination regimens with CDK4/6 inhibitors have shown superior efficacy, leading to increased prescriptions of fulvestrant as part of combination therapy, especially in first-line treatment settings.

4. What are the key regulatory hurdles for expanding fulvestrant indications?
Regulatory agencies require robust clinical evidence demonstrating safety and efficacy for new indications or formulations. Delays in trial approvals or data submission can hinder expansion plans.

5. What strategies can pharmaceutical companies adopt to extend fulvestrant’s commercial lifespan?
Investing in oral formulations, developing combination therapies, entering emerging markets, and preparing for biosimilar competition are critical strategies. Additionally, leveraging personalized medicine approaches can enhance drug positioning.

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Sources:

[1] MarketWatch, "Global Oncology Therapeutics Market Size and Forecast," 2022.