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	4,659,516
Astrazeneca	FASLODEX	fulvestrant	SOLUTION;INTRAMUSCULAR	021344-001	Apr 25, 2002	8,329,680*PED
Astrazeneca	FASLODEX	fulvestrant	SOLUTION;INTRAMUSCULAR	021344-001	Apr 25, 2002	8,466,139*PED
Astrazeneca	FASLODEX	fulvestrant	SOLUTION;INTRAMUSCULAR	021344-001	Apr 25, 2002	7,456,160*PED
Astrazeneca	FASLODEX	fulvestrant	SOLUTION;INTRAMUSCULAR	021344-001	Apr 25, 2002	6,774,122*PED

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
Spain	2248272
European Patent Office	2266573	Formulation de fulvestrant (Fulvestrant formulation)
Japan	2011190275	FULVESTRANT PHARMACEUTICAL PREPARATION
Germany	122004000011
Slovenia	1250138

Supplementary Protection Certificates for FASLODEX

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0138504	91068	Luxembourg		91068, EXPIRES: 20091002
0138504	300158	Netherlands		300158, 20041002, EXPIRES: 20091001
0138504	SPC/GB04/009	United Kingdom		PRODUCT NAME: FULVESTRANT OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF.; REGISTERED: UK EU/1/03/269/001 20040310
0138504	2004C/004	Belgium		PRODUCT NAME: FULVESTRANT; REGISTRATION NO/DATE: EU/1/03/269/001 20040311

Market Dynamics and Financial Trajectory for FASLODEX

Last updated: July 27, 2025

Introduction

FASLODEX (fulvestrant), a selective estrogen receptor degrader (SERD), plays a pivotal role in hormone receptor-positive (HR+), HER2-negative advanced or metastatic breast cancer therapy. Approved by the FDA in 2002, FASLODEX has evolved into a cornerstone in endocrine therapy, particularly after the advent of resistance to other hormone therapies. As discussions around its market dynamics unfold, understanding the driver elements—from clinical efficacy to competitive landscape and R&D pipelines—is essential for stakeholders analyzing its financial trajectory.

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Market Overview and Demographics

The global breast cancer treatment market is projected to reach USD 23.6 billion by 2027, with endocrine therapies constituting a significant segment due to the high prevalence of HR+ breast cancers (~70% of cases). FASLODEX's primary usage pertains to advanced or metastatic settings, especially in postmenopausal women, who constitute the majority of prevalent cases.

In 2022, the United States accounted for approximately 35% of global sales, driven by its well-established treatment protocols and high adoption rates. Europe represented roughly 25%, with Asia-Pacific contributing an emerging market proportional to its expanding healthcare infrastructure.

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Clinical and Regulatory Advancements

FASLODEX’s efficacy in overcoming resistance to initial endocrine therapies has cemented its steady adoption. Clinical trials such as the FALCON study demonstrated superior progression-free survival (PFS) when fulvestrant was combined with CDK4/6 inhibitors, suggesting an expanded therapeutic role.

Regulatory updates bolster its market positioning:

• Extended indications: In 2017, the FDA approved a higher-dose (500 mg) formulation with an improved administration schedule, enhancing patient compliance.
• Global approvals: Ongoing efforts to expand approvals in emerging markets like China have been pivotal for revenue growth, facilitated by partnerships with local pharmaceutical firms.

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Competitive Landscape

FASLODEX faces competition from:

• Aromatase inhibitors (e.g., letrozole, anastrozole, exemestane), which are often first-line agents.
• Other SERDs: Injectable and oral SERDs, such as AstraZeneca’s ASC612 and Roche’s giredestrant, are in late-phase clinical development.

Recent approvals of oral SERDs like Gilead’s Giredestrant are poised to disrupt the current paradigm, offering more convenient administration and potentially superior efficacy.

Genericization and biosimilar emergence: Although no biosimilars currently threaten FASLODEX’s market exclusivity, patent expirations projected around 2030 could catalyze generic entry, intensifying price competition.

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Pharmacoeconomic Factors and Reimbursement Trends

Reimbursement policies significantly influence FASLODEX sales. Insurance coverage in key markets promotes access, yet high costs associated with injectable formulations can limit adoption in resource-constrained settings. Value-based pricing models are increasingly being discussed to align pricing with clinical benefit.

Cost-effectiveness analyses consistently favor FASLODEX over chronic oral therapy in certain settings, bolstering its inclusion in treatment guidelines like ASCO and ESMO.

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Innovation and Future Development

Innovations in drug delivery—such as oral SERDs—pose both threats and opportunities. If oral SERDs demonstrate non-inferiority or superiority, they could replace injectable fulvestrant, influencing long-term revenue.

Ongoing research aims to:

• Enhance efficacy in endocrine-resistant tumors
• Identify biomarkers to personalize therapy
• Combine fulvestrant with targeted agents (e.g., CDK4/6 inhibitors)

Pharmaceutical manufacturers’ R&D investments reflect a strategic move to maintain relevance amid fierce competition.

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Financial Trajectory and Revenue Projections

FASLODEX’s revenues are expected to grow gradually, contingent on several variables:

• Market penetration: Continued adoption in existing indications
• Global expansion: Strategic entry into emerging markets
• Pipeline success: Approval of oral SERDs could disrupt sales, either cannibalizing or complementing injectables

Historical performance: Pfizer, the manufacturer, reported FASLODEX revenues of approximately USD 900 million in 2021, representing a steady increase from prior years.

Forecasting models: Analysts project a compound annual growth rate (CAGR) of ~4-6% over the next five years, driven by increased global demand and strategic collaborations.

However, potential patent expirations and introduction of generics in the 2030s could temper growth unless offset by new indications or formulations.

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Regulatory and Market Risks

Key risks include:

• Patent expirations: Accelerate commoditization
• Pipeline failures: Oral SERD clinical setbacks could limit future competitiveness
• Market entry of biosimilars or generics: Price erosion
• Healthcare policy shifts: Price controls or reimbursement caps in key markets

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Key Drivers and Barriers

Drivers	Barriers
Demonstrated clinical superiority in resistant cases	High injectable costs and administration complexity
Expansion into metastatic settings	Competition from emerging oral SERDs and biosimilars
Global regulatory approvals	Patent cliffs and market saturation
Strategic partnerships in emerging markets	Potential pipeline failures

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Strategic Outlook

The outlook for FASLODEX remains cautiously optimistic, rooted in its entrenched position within breast cancer therapy and ongoing innovations. Capitalizing on unmet needs through combination therapies and expanding geographical footprint will be crucial to sustaining revenue.

Investors should monitor regulatory milestones with oral SERDs, patent expiry timelines, and market-specific reimbursement policies. Furthermore, maintaining R&D pipelines for next-generation SERDs will be essential for future growth.

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Key Takeaways

• Stable Market Position: FASLODEX is a integral component of HR+ breast cancer treatment, with consistent revenue contribution.
• Growth Opportunities: Expansion into emerging markets and approval for new indications can drive growth; however, competition from oral SERDs necessitates strategic innovation.
• Competitive Risks: Patent expiries and biosimilar entries pose future threats, underscoring the importance of pipeline diversification.
• Market Dynamics: Pricing strategies and reimbursement policies significantly influence sales; pharmacoeconomic benefits support its continued utilization.
• Investment Implication: Long-term growth hinges on successful development and adoption of next-generation SERDs and strategic global scaling.

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FAQs

1. What is the primary mechanism of action of FASLODEX?
   Fulvestrant, marketed as FASLODEX, is a selective estrogen receptor degrader (SERD) that antagonizes estrogen receptors and promotes their degradation, inhibiting estrogen-driven tumor growth in HR+ breast cancer.

2. How does FASLODEX compare to other endocrine therapies?
   It is typically used after resistance develops to aromatase inhibitors or tamoxifen, offering a targeted approach with demonstrated efficacy in resistant disease. Its injectable formulation allows for depot administration, unlike oral aromatase inhibitors.

3. What are the key upcoming benchmarks for FASLODEX?
   The approval and market penetration of oral SERDs, patent expiration dates, and expanding indications in early breast cancer are pivotal for its future trajectory.

4. What are the main challenges facing FASLODEX’s market growth?
   Competition from emerging oral SERDs, biosimilars post-patent expiry, high administration costs, and market saturation are significant hurdles.

5. How are global regulatory strategies impacting FASLODEX?
   Accelerated approvals in emerging markets and expanded indications worldwide are crucial, alongside navigating regulatory requirements for biosimilar and generic entries.

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References

[1] Global Breast Cancer Therapeutics Market Report, 2022.
[2] FDA Label for FASLODEX, 2017.
[3] ClinicalTrials.gov, FALCON Study Data.
[4] Pfizer Annual Report, 2021.
[5] Market Research Future, “Breast Cancer Treatment Market Forecast,” 2022.