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:	102
Clinical Trials:	398
Patent Applications:	6,820
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
University of Washington	Phase 2
Merck Sharp & Dohme LLC	Phase 1/Phase 2
Nanjing Chia-tai Tianqing Pharmaceutical	Phase 1

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
Glenmark Pharms Inc	FULVESTRANT	fulvestrant	SOLUTION;INTRAMUSCULAR	207754-001	Aug 22, 2019	AO	RX	No	No
Fresenius Kabi Usa	FULVESTRANT	fulvestrant	SOLUTION;INTRAMUSCULAR	210326-001	May 20, 2019	AO	RX	No	No			Y
Alembic	FULVESTRANT	fulvestrant	SOLUTION;INTRAMUSCULAR	215077-001	Dec 22, 2022	AO	RX	No	No
Zydus Pharms	FULVESTRANT	fulvestrant	SOLUTION;INTRAMUSCULAR	215234-001	Jul 29, 2021	AO	RX	No	No
Fresenius Kabi Usa	FULVESTRANT	fulvestrant	SOLUTION;INTRAMUSCULAR	210326-001	May 20, 2019	AO	RX	No	No			Y
Sagent Pharms Inc	FULVESTRANT	fulvestrant	SOLUTION;INTRAMUSCULAR	205871-001	Aug 22, 2019	AO	RX	No	No

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/004649 Fulvestrant 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/000540 Faslodex 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

FULVESTRANT Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Fulvestrant

Introduction to Fulvestrant

Fulvestrant, marketed under the brand name Faslodex, is a selective estrogen receptor degrader (SERD) used primarily in the treatment of hormone receptor-positive breast cancer in postmenopausal women. Here, we delve into the market dynamics and financial trajectory of this crucial drug.

Market Size and Forecast

The global Fulvestrant market has been experiencing significant growth. As of 2023, the market size was valued at approximately $100 million and is projected to reach $379.74 million by 2030, growing at a compound annual growth rate (CAGR) of 25.8% during the forecast period of 2024-2030[3].

Key Drivers of the Market

Several factors are driving the demand for Fulvestrant:

Increasing Breast Cancer Incidence

The rising incidence of breast cancer, particularly hormone receptor-positive cases, is a major driver. As global breast cancer rates increase, the demand for effective treatment alternatives like Fulvestrant grows[3].

Ageing Population Growth

The ageing population, especially older women who are more likely to develop breast cancer, contributes to the increasing demand for Fulvestrant. This demographic trend is expected to continue, driving market growth[3].

Effectiveness in Breast Cancer Treatment

Positive clinical results and patient responses have made Fulvestrant a preferred treatment option for hormone receptor-positive breast cancer. This effectiveness enhances its market demand[3].

Research Developments

Fulvestrant’s market potential is further enhanced by approvals for new indications and wider use in other contexts. Increased regulatory approvals lead to higher adoption rates[3].

Patient Advocacy and Awareness

Patient advocacy initiatives and increased awareness of breast cancer and available treatment options facilitate early diagnosis and prompt treatment introduction, positively impacting market demand[3].

Healthcare Services Accessibility

Improvements in healthcare service accessibility, particularly in emerging economies, allow more patients to access advanced cancer treatments like Fulvestrant[3].

Market Restraints

Despite the growth drivers, several restraints affect the Fulvestrant market:

Regulatory Restrictions and Reimbursement Issues

Delays in regulatory approvals and problems with reimbursement procedures can impact the availability and cost of Fulvestrant, hindering its market growth[3].

Accessibility Issues in Developing Regions

Limited healthcare infrastructure, legislative restrictions, and economic considerations in developing regions restrict access to advanced cancer treatments like Fulvestrant, creating disparities in treatment accessibility[3].

Patient Understanding and Compliance

Lack of knowledge among patients and healthcare professionals about the benefits of Fulvestrant and the importance of treatment adherence can affect its use and overall effectiveness[3].

Development of New Therapies

The ongoing evolution of cancer treatments, including the development and marketing of new drugs with superior efficacy or fewer side effects, can challenge Fulvestrant’s market position[3].

Market Segmentation Analysis

The global Fulvestrant market is segmented based on several criteria:

By Application

• Metastatic Breast Cancer (MBC): Fulvestrant is commonly used to treat metastatic breast cancer in postmenopausal women whose cancer has progressed after anti-estrogen therapy.
• Hormone Receptor-Positive Breast Cancer: Specifically indicated for the treatment of hormone receptor-positive breast cancer[3].

By End-User

• Hospitals: Fulvestrant is often administered in hospital settings for cancer patients undergoing treatment and monitoring.
• Cancer Treatment Centers: Specialized centers are significant users of Fulvestrant.
• Clinics: Outpatient clinics also administer Fulvestrant injections to patients[3].

By Distribution Channel

• Hospital Pharmacies: Fulvestrant is distributed through hospital pharmacies, especially for inpatient treatments.
• Retail Pharmacies: For outpatient treatments, Fulvestrant is distributed through retail pharmacies.
• Online Pharmacies: Available through online pharmacies for patient convenience[3].

Financial Performance and Projections

Revenue Growth

The revenue from Fulvestrant is expected to grow significantly, driven by its increasing adoption in the treatment of hormone receptor-positive breast cancer. The market is projected to reach $379.74 million by 2030, with a CAGR of 25.8% from 2024 to 2030[3].

Competitive Landscape

Key competitors in the Fulvestrant market include AstraZeneca, Teva, Amneal Pharmaceuticals, Novartis, Intas Pharmaceuticals, and others. AstraZeneca, in particular, has shown strong performance and pipeline progress, which underpins its outlook for continued revenue growth through 2025 and beyond[2].

Regional Analysis

The market is segmented into five major regions: North America, Europe, Asia-Pacific, Middle East & Africa, and Latin America. Each region provides insights into revenue share, current trends, and future prospects. For instance, the Asia-Pacific region is expected to see significant growth due to increasing healthcare infrastructure and awareness of breast cancer treatments[1].

Impact of SERD Market Trends

The broader SERD market, which includes Fulvestrant, is also expected to exhibit remarkable growth. Factors such as the increasing cancer diagnosis, high unmet need in the ESR1 mutation space, and the strong performance of other SERDs like ORSERDU contribute to this growth. The total market size of SERDs in key markets is expected to rise significantly, with ORSERDU and other oral SERDs generating substantial revenue by 2034[4].

Key Takeaways

• Growing Market Size: The Fulvestrant market is projected to grow from $100 million in 2023 to $379.74 million by 2030.
• Increasing Demand: Driven by rising breast cancer incidence, ageing population, and effectiveness in treatment.
• Regulatory and Accessibility Challenges: Despite growth, the market faces restraints such as regulatory delays and limited access in developing regions.
• Competitive Landscape: AstraZeneca and other pharmaceutical companies play significant roles in the market.
• Regional Growth: Significant growth expected in regions like Asia-Pacific due to improving healthcare infrastructure.

FAQs

What is Fulvestrant used for?

Fulvestrant is used to treat hormone receptor-positive breast cancer in postmenopausal women, particularly for metastatic breast cancer that has progressed after anti-estrogen therapy.

What is the projected market size of Fulvestrant by 2030?

The Fulvestrant market is projected to reach $379.74 million by 2030, growing at a CAGR of 25.8% from 2024 to 2030.

What are the key drivers of the Fulvestrant market?

Key drivers include increasing breast cancer incidence, ageing population, effectiveness in treatment, research developments, patient advocacy, and improvements in healthcare services accessibility.

What are the main restraints affecting the Fulvestrant market?

Main restraints include regulatory restrictions, reimbursement issues, accessibility problems in developing regions, patient understanding and compliance, and the development of newer therapies.

Which regions are expected to see significant growth in the Fulvestrant market?

Regions such as North America, Europe, and Asia-Pacific are expected to see significant growth, with the Asia-Pacific region being particularly notable due to improving healthcare infrastructure and increasing awareness of breast cancer treatments.

Sources

1. Cognitivemarketresearch.com: Fulvestrant Market Report 2024 (Global Edition)
2. AstraZeneca.com: Full year and Q4 2022 results announcement
3. Verifiedmarketresearch.com: Fulvestrant Market Size, Share, Scope, Trends, Growth & Forecast
4. Globenewswire.com: SERD Market is Predicted to Exhibit Remarkable Growth Owing to the Usage of Faslodex in Combination, Strong Performance of ORSERDU, and Speedy Progress of Other Oral SERDs, During the Study Period (2020–2034)