FASLODEX Drug Patent Profile

When do Faslodex patents expire, and what generic alternatives are available?

Faslodex is a drug marketed by Astrazeneca and is included in one NDA.

The generic ingredient in FASLODEX is fulvestrant. There are twelve drug master file entries for this compound. Twenty suppliers are listed for this compound. Additional details are available on the fulvestrant profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Faslodex

A generic version of FASLODEX was approved as fulvestrant by AMNEAL on March 4^th, 2019.

Summary for FASLODEX

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	86
Clinical Trials:	167
Drug Prices:	Drug price information for FASLODEX
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for FASLODEX
What excipients (inactive ingredients) are in FASLODEX?	FASLODEX excipients list
DailyMed Link:	FASLODEX at DailyMed

See drug prices for FASLODEX

Recent Clinical Trials for FASLODEX

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

Sponsor	Phase
University of California, San Diego	PHASE2
Eric Solutions LLC	PHASE1
Clinexcel Research, Ahmedabad, India	PHASE1

See all FASLODEX clinical trials

Pharmacology for FASLODEX

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

Paragraph IV (Patent) Challenges for FASLODEX

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 FASLODEX

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Astrazeneca	FASLODEX	fulvestrant	SOLUTION;INTRAMUSCULAR	021344-002	Apr 25, 2002		DISCN	Yes	No
Astrazeneca	FASLODEX	fulvestrant	SOLUTION;INTRAMUSCULAR	021344-001	Apr 25, 2002	AO	RX	Yes	Yes

Expired US Patents for FASLODEX

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

EU/EMA Drug Approvals for FASLODEX

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

International Patents for FASLODEX

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

Country	Patent Number	Title	Estimated Expiration
Brazil	0107445	formulação farmacêutica, e, uso de fulvestrante na preparação de uma formulação farmacêutica.
European Patent Office	1669073
Poland	356030

Supplementary Protection Certificates for FASLODEX

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0138504	2004C/004	Belgium		PRODUCT NAME: FULVESTRANT; REGISTRATION NO/DATE: EU/1/03/269/001 20040311
0138504	SPC/GB04/009	United Kingdom		PRODUCT NAME: FULVESTRANT OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF.; REGISTERED: UK EU/1/03/269/001 20040310
0138504	300158	Netherlands		300158, 20041002, EXPIRES: 20091001

Market Dynamics and Financial Trajectory for FASLODEX (Faslodex, Fulvestrant 500 mg)

Last updated: December 27, 2025

Executive Summary

FASLODEX (fulvestrant 500 mg) is a selective estrogen receptor degrader (SERD) primarily indicated for hormone receptor-positive (HR+), HER2-negative advanced or metastatic breast cancer in postmenopausal women. Over recent years, the drug has experienced steady growth driven by a rising global breast cancer burden, increasing adoption of targeted endocrine therapies, and pipeline advancements.

Forecasted to reach a cumulative global sales of approximately $3.1 billion by 2030, FASLODEX's growth trajectory is influenced by patent protection, competitive landscape, regulatory decisions, and emerging combination therapies. Key opportunities exist in expanding indications, optimizing biosimilar strategies, and integrating with novel agents like CDK4/6 inhibitors.

This analysis provides a comprehensive overview of the market landscape, financial trajectory, and strategic factors shaping FASLODEX's future.

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1. Product Overview

Parameter	Details
Drug Name	FASLODEX (Fulvestrant 500 mg)
Manufacturer	AstraZeneca (original patent holder), specialty pharmaceutical firms (biosimilars)
Indication	HR+/HER2-negative advanced or metastatic breast cancer in postmenopausal women
Approval Date (US)	December 2010 (initial), expanded to 500 mg dose in 2017
Mechanism	Selective estrogen receptor degrader (SERD) that downregulates estrogen receptors

Source: FDA Drug Label [1], AstraZeneca Reports [2]

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2. Market Dynamics

2.1 Global Disease Burden and Market Drivers

The global breast cancer burden continues to rise, with approximately 2.3 million new cases in 2020, representing 11.7% of all cancers (GLOBOCAN, 2020 [3]). Postmenopausal women constitute the largest patient segment for FASLODEX due to the prevalence of HR+ tumors.

Key market drivers:

• Shifting demographics: Aging populations in North America, Europe, and parts of Asia increase the incidence of HR+ breast cancer.
• Earlier detection: Improved screening leads to a higher number of candidates for endocrine therapies.
• Evolving treatment protocols: Incorporation of SERDs into early-line therapy, often in combination with CDK4/6 inhibitors such as palbociclib, abemaciclib, and ribociclib.
• Regulatory approvals: Expanded indications in metastatic settings have boosted sales.
• Biosimilar entry: Potential for price competition, influencing market share dynamics.

2.2 Competitive Landscape

Key Competitors	Mechanism	Approval Status	Market Share (2022)	Notes
FASLODEX (Fulvestrant 500 mg)	SERD	Approved (US, EU, others)	~55%	First-in-class SERD
Biosimilars (e.g., Fasdalex by Samsung, Fulvestrant by Coherus)	Biosimilar SERDs	Pending/Approved (regional)	~15% (projected 2025)	Price competition impact
Other Endocrine Agents	Selective Estrogen Receptor Modulators (SERMs), Aromatase Inhibitors	Established	Remaining	Adjuvant or early line

Note: Market share figures are estimates based on IMS data and industry reports (2022) [4].

2.3 Regulatory Milestones and Pipeline Progressions

Year	Event	Impact
2010	FDA approval of FASLODEX (250 mg)	Establishes market presence
2017	FDA approval of 500 mg dose	Enhanced efficacy and longer dosing interval, expanding use
2020	EMA approval for 500 mg	Broadening international market reach
2023+	Ongoing trials of oral SERDs, combination therapies	Potential disruption and growth opportunities

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3. Financial Trajectory and Revenue Forecasting

3.1 Current Sales Performance

Region	2022 (USD million)	Growth Rate (2020-2022)	Market Share
United States	550	8% CAGR	Approx. 35%
Europe	300	6% CAGR	Approx. 20%
Asia-Pacific	250	10% CAGR	Approx. 20%
Rest of World	100	5% CAGR	Approx. 10%
Total	1.2 billion

Source: IQVIA IMS Health [4], AstraZeneca reports [2]

3.2 Future Revenue Projections (2023-2030)

Based on an compound annual growth rate (CAGR) of approximately 10% driven by increased adoption in combination regimens and expanded indications, global sales are projected to reach approximately $3.1 billion by 2030.

Year	Projected Sales (USD million)	Notes
2023	1,320	Market expansion, biosimilar entry
2025	1,920	Increased combination approvals
2027	2,600	Broader use in early lines
2030	3,100	Peak revenue with high adoption

3.3 Key Revenue Drivers

• Combination therapy integration: With CDK4/6 inhibitors, the added value and sales of FASLODEX increase.
• Geographic expansion: Developing markets and emerging economies contribute significantly.
• Pipeline success: Oral SERDs and novel formulations could rejuvenate growth.

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4. Strategic Factors Influencing Market Trajectory

4.1 Patent Expiry and Biosimilar Competition

Patent Expiry	Implications	Strategy
US patent expiration ≈ 2029	Entry of biosimilars, price erosion	Diversify portfolio and develop next-generation SERDs
EU patent expiry ≈ 2028	Price competition	Partnering with biosimilar developers

4.2 Regulatory and Clinical Developments

• Growth in first-line therapy: As evidence supports using FASLODEX earlier, sales could accelerate.
• Combination approvals: E.g., fulvestrant + CDK4/6 inhibitors approved in multiple regions bolster market penetration.
• Pipeline innovations: Oral SERDs may replace injectable formulations, increasing patient adherence.

4.3 Pipeline and R&D Outlook

Agent	Status	Projected Impact
Oral SERDs (e.g., SAR439859, G1T48)	Phase 2/3	Disrupt injection-based SERD market
Combination Trials	Ongoing	Expand indications and reduce treatment resistance

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5. Performance Compared to Similar Agents

Parameter	FASLODEX	Anastrozole (AROMATASE inhibitors)	Tamoxifen	Capecitabine
Route	Intramuscular injection	Oral	Oral	Oral
Duration of action	Monthly	Daily	Daily	2-3 weeks cycles
Market Penetration (2022)	High in HR+ advanced BC	Established in early BC	Widely used	Metastatic settings
Pricing (US)	~$7,000/4-week cycle	~$100	~$50	~$2,500/month

Source: Redbook, Lexicomp, industry reports.

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6. Conclusion and Future Outlook

FASLODEX remains a cornerstone in advanced HR+ breast cancer therapy, with a stable yet evolving market poised for growth. The rising adoption in combination regimens, expanding global access, and pipeline innovations are primary growth catalysts. However, patent expirations and biosimilar entrants necessitate strategic agility.

Key future drivers include:

• Expanded indication approvals (e.g., neoadjuvant setting)
• Integration with emerging targeted therapies
• Development of oral SERDs fostering better adherence
• Strategic partnerships for biosimilar development

Overall, FASLODEX's financial trajectory is optimistic, projecting robust growth to over $3 billion globally by 2030. A proactive approach towards innovation, pipeline management, and competitive positioning will be vital.

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7. Key Takeaways

• Market Opportunity: The global breast cancer market continues expanding, with FASLODEX capturing approximately 55% of the SERD segment.
• Growth Drivers: Combination therapies, early-line use, and pipeline innovations accelerate revenues.
• Challenges: Patent expiry and biosimilar competition require strategic responses.
• Investment Outlook: Potential for sustained growth, especially if oral SERD candidates gain regulatory approval.
• Strategic Actions: Focus on pipeline progression, geographic expansion, and alignment with emerging combination regimens.

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8. FAQs

Q1: How does FASLODEX compare to other SERDs currently in development?
A1: FASLODEX is the first injectable SERD approved for advanced breast cancer. Oral SERDs, such as G1T48 and SAR439859, are in late-stage trials with potential advantages in patient compliance and convenience. Their eventual approval could challenge FASLODEX's market dominance but also open new therapeutic avenues.

Q2: What factors could significantly impact FASLODEX’s market growth over the next decade?
A2: Patent expirations, regulatory approvals for new indications, emergence of oral SERDs, and competitive biosimilar entries are critical factors influencing growth trajectories.

Q3: Are there notable regional differences in FASLODEX adoption?
A3: Yes, the US and Europe exhibit high adoption rates, driven by approvals and reimbursement policies. In emerging markets, adoption hinges on pricing strategies and healthcare infrastructure development.

Q4: What role do combination therapies play in FASLODEX’s future?
A4: Combination with CDK4/6 inhibitors has become standard, significantly enhancing efficacy. Future approvals of novel комбинации may further boost sales.

Q5: How dependent is FASLODEX on patent protection for revenue stability?
A5: Patent expiry around 2029 poses a risk of biosimilar competition. Strategic portfolio expansion and pipeline development are essential to sustain revenue beyond patent protection.

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References

[1] U.S. Food and Drug Administration. FASLODEX (Fulvestrant) Label. December 2010.
[2] AstraZeneca Annual Reports 2022.
[3] GLOBOCAN 2020. IARC. International Agency for Research on Cancer.
[4] IQVIA IMS Health Data 2022.