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:	102
Clinical Trials:	165
Patent Applications:	3,240
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 Washington	Phase 2
Breast Cancer Research Foundation	Phase 2
Carrick Therapeutics Limited	Phase 2

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	021344-001	Apr 25, 2002	AO	RX	Yes	Yes
Astrazeneca	FASLODEX	fulvestrant	SOLUTION;INTRAMUSCULAR	021344-002	Apr 25, 2002		DISCN	Yes	No

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	6,774,122*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

EU/EMA Drug Approvals for FASLODEX

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
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
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

International Patents for FASLODEX

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

Country	Patent Number	Title	Estimated Expiration
Czech Republic	304689	Farmaceutický přípravek obsahující fulvestrant a jeho použití pro výrobu léčiva (Pharmaceutical preparation containing fulvestrant and its use for the preparation of a medicament)
Egypt	24074	Formulation
Germany	60114145
Mexico	PA02006698	FORMULACION DE FULVESTRANT. (FULVESTRANT FORMULATION.)
Taiwan	I259086

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	300158	Netherlands		300158, 20041002, EXPIRES: 20091001
0138504	91068	Luxembourg		91068, EXPIRES: 20091002
0138504	SPC/GB04/009	United Kingdom		PRODUCT NAME: FULVESTRANT OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF.; REGISTERED: UK EU/1/03/269/001 20040310

Market Dynamics and Financial Trajectory for Faslodex

Introduction

Faslodex, developed by AstraZeneca, is a significant player in the treatment of hormone receptor-positive (HR-positive) metastatic breast cancer. Here, we delve into the market dynamics and financial trajectory of this drug, highlighting its successes, challenges, and future prospects.

Historical Success and Blockbuster Status

Faslodex, or fulvestrant, achieved blockbuster status for the first time in 2018, with global revenues exceeding $1 billion and U.S. sales reaching $537 million. This success was driven by positive phase 3 trial data, which demonstrated its efficacy as a solo treatment and in combination with CDK 4/6 inhibitors for post-menopausal women with HR-positive, HER2-negative breast cancer[1].

Impact of Generic Competition

The launch of a generic version of Faslodex by Novartis’ Sandoz unit in March 2019 marked a significant turning point. This generic competition threatened AstraZeneca’s U.S. sales, which were $541 million as of March 2019. The generic launch followed a court settlement that delayed U.S. generic competition until March 2019[1].

Financial Performance Post-Generic Launch

Despite the generic competition, AstraZeneca's oncology portfolio continued to perform well. In the first quarter of 2019, the company's oncology sales, led by the EGFR inhibitor Tagrisso, reached $1.89 billion, a 59% increase year-over-year. However, Faslodex's sales were impacted by the generic entry, leading to a decline in brand revenue[1].

Emerging Market Performance

AstraZeneca has also seen significant growth in emerging markets, particularly in China. The company outperformed Pfizer in pharma sales in China during the first quarter of 2019, with drugs like Iressa showing a strong performance in this region[1].

Current Market Dynamics

The market for Selective Estrogen Receptor Degraders (SERDs), which includes Faslodex, is expected to exhibit remarkable growth. Factors driving this growth include increasing incidences of ER+ breast cancer, the strong performance of newer SERDs like ORSERDU, and the progress of other oral SERDs in clinical trials[4].

Increasing Demand and New Entrants

The SERD market is anticipated to grow significantly due to the high unmet need in the ESR1 mutation space and the acceptance of newer therapies. Drugs like camizestrant, giredestrant, and imlunestrant are in late-stage trials, targeting broader patient segments and potentially generating substantial revenue by 2034[4].

Regulatory and Reimbursement Factors

Regulatory pathways and reimbursement policies play crucial roles in the market dynamics of SERDs. The approval processes for new SERDs and the willingness of insurance and healthcare systems to cover these therapies can significantly impact their adoption rates and market access[4].

Future Prospects and Pipeline

AstraZeneca is positioning itself for continued growth in the oncology sector. The company has a robust pipeline, with several high-potential medicines in late-stage trials, including camizestrant, which is expected to be a key player in both metastatic and early-stage HR+/HER2- breast cancer[2][4].

Camizestrant and Other Pipeline Drugs

Camizestrant, an oral SERD, is in late-stage trials and is anticipated to cover a broader patient segment, including those with and without ESR1 mutations. This drug, along with others like datopotamab deruxtecan and volrustomig, is part of AstraZeneca's strategy to deliver industry-leading revenue growth through 2025 and beyond[2].

Financial Trajectory

AstraZeneca's financial performance has been strong, driven by its oncology portfolio. Excluding COVID-19 medicines, the company's total revenue increased by 17% in the fourth quarter of 2022, with oncology product sales rising by 19%. The company expects double-digit revenue growth in 2023, excluding COVID-19 medicines, and plans to initiate over thirty Phase III trials, with ten of these trials having the potential to deliver peak year sales over $1 billion[2].

Key Takeaways

• Blockbuster Status: Faslodex achieved blockbuster status in 2018 with over $1 billion in global revenue.
• Generic Competition: The launch of a generic version in 2019 impacted AstraZeneca's U.S. sales.
• Oncology Portfolio: AstraZeneca's oncology portfolio, led by Tagrisso, continues to drive revenue growth.
• Emerging Markets: Strong performance in emerging markets, particularly China.
• SERD Market Growth: The SERD market is expected to grow significantly due to increasing cancer diagnoses and new therapies.
• Pipeline Strength: AstraZeneca's pipeline includes high-potential medicines like camizestrant, positioning the company for continued growth.

FAQs

What is Faslodex used for?

Faslodex (fulvestrant) is used as a treatment for hormone receptor-positive (HR-positive) metastatic breast cancer, often in combination with CDK 4/6 inhibitors.

How did the launch of a generic version affect Faslodex sales?

The launch of a generic version by Novartis’ Sandoz unit in March 2019 threatened AstraZeneca’s U.S. sales, which were $541 million as of March 2019, leading to a decline in brand revenue.

What are the key drivers of the SERD market growth?

The SERD market growth is driven by increasing incidences of ER+ breast cancer, the strong performance of newer SERDs like ORSERDU, and the progress of other oral SERDs in clinical trials.

What is AstraZeneca's strategy for future growth in oncology?

AstraZeneca is focusing on its robust pipeline, including high-potential medicines like camizestrant, and plans to initiate over thirty Phase III trials, with ten of these trials having the potential to deliver peak year sales over $1 billion.

How has AstraZeneca performed in emerging markets?

AstraZeneca has seen significant growth in emerging markets, particularly in China, where it outperformed Pfizer in pharma sales in the first quarter of 2019.

Sources

1. FiercePharma: "Bye-bye, blockbuster? AstraZeneca's Faslodex gets U.S. generic on heels of record sales year"
2. AstraZeneca: "Full year and Q4 2022 results announcement"
3. Eagle Pharmaceuticals: "Eagle Pharmaceuticals Announces Positive Type C Meeting with FDA for EA-114"
4. GlobeNewswire: "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"