FARESTON Drug Patent Profile

Which patents cover Fareston, and when can generic versions of Fareston launch?

Fareston is a drug marketed by Kyowa Kirin and is included in one NDA.

The generic ingredient in FARESTON is toremifene citrate. There are five drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the toremifene citrate profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Fareston

A generic version of FARESTON was approved as toremifene citrate by RISING on December 4^th, 2018.

Summary for FARESTON

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	70
Clinical Trials:	9
Patent Applications:	6,753
Drug Prices:	Drug price information for FARESTON
What excipients (inactive ingredients) are in FARESTON?	FARESTON excipients list
DailyMed Link:	FARESTON at DailyMed

See drug prices for FARESTON

Recent Clinical Trials for FARESTON

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

Sponsor	Phase
National Cancer Institute (NCI)	Phase 4
Fred Hutchinson Cancer Research Center	Phase 4
Southwest Hospital, China	Phase 3

See all FARESTON clinical trials

Pharmacology for FARESTON

Drug Class	Estrogen Agonist/Antagonist
Mechanism of Action	Selective Estrogen Receptor Modulators

US Patents and Regulatory Information for FARESTON

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Kyowa Kirin	FARESTON	toremifene citrate	TABLET;ORAL	020497-001	May 29, 1997		DISCN	Yes	No

Expired US Patents for FARESTON

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Kyowa Kirin	FARESTON	toremifene citrate	TABLET;ORAL	020497-001	May 29, 1997	4,696,949

International Patents for FARESTON

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

Country	Patent Number	Title	Estimated Expiration
Denmark	236683
Australia	1494683
Denmark	236583
Japan	H0678257
United Kingdom	2126576	ALKANE AND ALKENE DERIVATIVES
South Africa	8303803

Supplementary Protection Certificates for FARESTON

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0095875	SPC/GB96/029	United Kingdom
0095875	96C0029	Belgium		PRODUCT NAME: TOREMIFENE; REGISTRATION NO/DATE: EU/1/96/004/001 19960215

FARESTON Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for FARESTON

Overview of FARESTON

FARESTON, also known as toremifene citrate, is a selective estrogen receptor modulator (SERM) approved by the FDA for the treatment of metastatic breast cancer in postmenopausal women. Here, we delve into the market dynamics and financial trajectory of this drug.

Market Position and Approval

FARESTON was approved by the FDA for the treatment of hormone-dependent metastatic breast cancer in postmenopausal women. It has also received marketing authorization in the European Union, with the European Commission granting approval in 1996 and renewing it in 2001 and 2006[4].

Clinical Efficacy and Comparisons

Clinical studies have shown that FARESTON is equivalent in efficacy to tamoxifen, another widely used anti-estrogen for breast cancer treatment. The main measures of effectiveness, including response rate, time to progression, and survival rates, were similar between FARESTON and tamoxifen in several large studies[4].

Market Size and Growth

The US breast cancer therapeutics market, within which FARESTON operates, is expected to grow at a double-digit CAGR rate, exceeding 10%, over the next few years. This growth is driven by factors such as novel drug launches, increased research and development spending, and the use of fast-track and breakthrough designations to expedite drug approvals[1].

Competitive Landscape

The breast cancer drug market is highly competitive, with numerous drugs in various stages of clinical trials. As of the last report, there were over 350 drugs in the pipeline, with more than 130 in Phase II or higher phases of trials. FARESTON competes in the SERM class, which is one of the several drug classes used in breast cancer treatment, including chemotherapeutic drugs, hormonal therapies, immunotherapeutic drugs, and kinase inhibitors[1].

Sales and Revenue

FARESTON is marketed primarily through wholesale drug distributors such as McKesson Corporation, Cardinal Health, Inc., and AmerisourceBergen Corporation. These distributors accounted for approximately 93% of the gross product sales of FARESTON in 2007. The net product sales of FARESTON contributed significantly to the total revenue of GTx, Inc., the company that markets FARESTON, with figures ranging from 15% to 65% of total revenue in different years[3].

Licensing and Partnerships

GTx, Inc. acquired the right to market FARESTON from Orion in 2005, along with a license to toremifene for all indications in humans except breast cancer outside the United States. This licensing agreement has been crucial for the commercialization of FARESTON in the US market[3].

Financial Projections and Milestones

The financial trajectory of FARESTON is influenced by several factors, including research and development reimbursements, milestone payments, and royalties. For instance, GTx, Inc. was eligible to receive up to $422 million in future milestone payments associated with the development and regulatory approval of its product candidates, including OstarineTM, which is in clinical trials for other indications[3].

Side Effects and Safety Profile

The safety profile of FARESTON includes common side effects such as hot flushes and sweating, seen in more than 1 in 10 patients. The Committee for Medicinal Products for Human Use (CHMP) concluded that the benefits and risks of FARESTON are comparable to those of tamoxifen, supporting its marketing authorization[4].

Impact of Market Trends

The US breast cancer therapeutics market is driven by increased volumes and quality of data analytics, leading to faster drug approvals. The use of innovative clinical technologies, such as artificial intelligence, has reduced the cost of developing drugs and therapies, making the market more promising. The increase in novel drug applications and approvals by the US FDA also indicates a growing market capacity[1].

Future Outlook

Given the competitive landscape and the ongoing trends in the breast cancer therapeutics market, FARESTON is likely to maintain its position as a viable treatment option for hormone-dependent metastatic breast cancer. The continued growth of the market, driven by innovative technologies and regulatory support, suggests a stable financial trajectory for FARESTON.

Key Takeaways

• Market Approval: FARESTON is approved for the treatment of metastatic breast cancer in postmenopausal women in the US and EU.
• Clinical Efficacy: Equivalent in efficacy to tamoxifen in clinical studies.
• Market Growth: Part of a growing US breast cancer therapeutics market with a double-digit CAGR.
• Sales and Revenue: Significant contributor to GTx, Inc.'s revenue through wholesale distributors.
• Licensing and Partnerships: Licensed from Orion with potential for future milestone payments.
• Safety Profile: Common side effects include hot flushes and sweating, with benefits and risks comparable to tamoxifen.

FAQs

What is FARESTON used for?

FARESTON is used to treat hormone-dependent metastatic breast cancer in postmenopausal women.

How does FARESTON compare to tamoxifen?

FARESTON has been shown to be equivalent in efficacy to tamoxifen in clinical studies, with similar response rates, times to progression, and survival rates.

Who markets FARESTON in the US?

FARESTON is marketed by GTx, Inc., which acquired the right to market the drug from Orion in 2005.

What are the common side effects of FARESTON?

Common side effects include hot flushes and sweating, seen in more than 1 in 10 patients.

How is the financial trajectory of FARESTON influenced?

The financial trajectory is influenced by research and development reimbursements, milestone payments, and royalties, as well as the overall growth of the US breast cancer therapeutics market.

Sources

1. US Breast Cancer Drug Market Report 2021-2026 - GlobeNewswire
2. Fairstone Group Secures Major Investment with Global Private Equity House TA Associates - TA Associates
3. GTx, Inc. - Annual Reports - AnnualReports.com
4. Fareston | European Medicines Agency (EMA) - EMA
5. Consolidation or maintenance systemic therapy for newly diagnosed ... - Cancer Care Ontario