TOREMIFENE CITRATE - Generic Drug Details

What are the generic sources for toremifene citrate and what is the scope of patent protection?

Toremifene citrate is the generic ingredient in two branded drugs marketed by Kyowa Kirin, MSN, and Rising, and is included in three NDAs. Additional information is available in the individual branded drug profile pages.

There are five drug master file entries for toremifene citrate. Four suppliers are listed for this compound.

Summary for TOREMIFENE CITRATE

US Patents:	0
Tradenames:	2
Applicants:	3
NDAs:	3
Drug Master File Entries:	5
Finished Product Suppliers / Packagers:	4
Raw Ingredient (Bulk) Api Vendors:	70
Clinical Trials:	6
Patent Applications:	8,472
Drug Prices:	Drug price trends for TOREMIFENE CITRATE
What excipients (inactive ingredients) are in TOREMIFENE CITRATE?	TOREMIFENE CITRATE excipients list
DailyMed Link:	TOREMIFENE CITRATE at DailyMed

See drug prices for TOREMIFENE CITRATE

Recent Clinical Trials for TOREMIFENE CITRATE

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

Sponsor	Phase
Fred Hutchinson Cancer Research Center	Phase 4
National Cancer Institute (NCI)	Phase 4
Federal University of São Paulo	Phase 4

See all TOREMIFENE CITRATE clinical trials

Pharmacology for TOREMIFENE CITRATE

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

Medical Subject Heading (MeSH) Categories for TOREMIFENE CITRATE

Antineoplastic Agents, Hormonal

Bone Density Conservation Agents

Selective Estrogen Receptor Modulators

Anatomical Therapeutic Chemical (ATC) Classes for TOREMIFENE CITRATE

L02BA	Anti-estrogens
L02B	HORMONE ANTAGONISTS AND RELATED AGENTS
L02	ENDOCRINE THERAPY
L	Antineoplastic and immunomodulating agents

US Patents and Regulatory Information for TOREMIFENE CITRATE

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
Rising	TOREMIFENE CITRATE	toremifene citrate	TABLET;ORAL	208813-001	Dec 4, 2018	AB	RX	No	Yes
Msn	TOREMIFENE CITRATE	toremifene citrate	TABLET;ORAL	212818-001	Aug 18, 2020	AB	RX	No	No

Expired US Patents for TOREMIFENE CITRATE

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

TOREMIFENE CITRATE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Toremifene Citrate

Introduction

Toremifene citrate, a selective estrogen receptor modulator (SERM), has been a significant player in the treatment of metastatic breast cancer and other conditions since its approval in 1995. Here, we delve into the market dynamics and financial trajectory of this drug.

Mechanism of Action and Clinical Use

Toremifene citrate targets the estrogen receptor, exhibiting antiestrogenic effects in breast tissue, which makes it effective in treating hormone-sensitive breast cancer, particularly in postmenopausal women[3][5].

Market Size and Forecast

The global toremifene citrate market is anticipated to grow at a substantial rate during the forecast period of 2024-2031. The market size is categorized based on application (hospital pharmacies, retail pharmacies, and online pharmacies), product type (60mg/tablet and 40mg/tablet), and geographical regions (North America, Europe, Asia-Pacific, South America, and Middle-East and Africa)[1][4].

• Historical Period: The market has seen steady growth from 2019 to 2023, with 2023 serving as the base year for calculations.
• Forecast Period: The market is expected to expand significantly from 2024 to 2031, driven by increasing demand and advancements in healthcare infrastructure[1][4].

Key Market Segments

By Application

• Hospital Pharmacies: These remain a major distribution channel due to the need for controlled and monitored administration of the drug.
• Retail Pharmacies: Increasing accessibility and convenience for patients.
• Online Pharmacies: Growing in popularity due to ease of purchase and home delivery options[1][4].

By Product

• 60mg/Tablet: The most commonly prescribed dosage for metastatic breast cancer treatment.
• 40mg/Tablet: Used for other indications or as part of a dosage adjustment strategy[1][4].

By Geography

• North America: A significant market due to advanced healthcare systems and high awareness of breast cancer treatments.
• Europe: Another major market with a strong presence of pharmaceutical companies.
• Asia-Pacific: Rapidly growing due to increasing healthcare expenditure and population[1][4].

Competitive Landscape

The market for toremifene citrate is dominated by several key players:

• Orion Co., Ltd.: The originator of toremifene citrate, based in Japan.
• Tianheng Pharma: A significant player in the Asia-Pacific region.
• Kyowa Kirin: Known for its diverse portfolio of pharmaceutical products.
• Schering Plough: Although now part of Merck, it has historically been involved in the distribution and marketing of toremifene citrate[1][3][4].

Financial Performance

Revenue and Sales

• Toremifene citrate has been a revenue generator for companies like GTx, Inc. (now part of Oncternal Therapeutics), with FARESTON® (toremifene citrate 60 mg) tablets accounting for a significant portion of their total revenue. For example, in 2007, FARESTON® net product sales accounted for 15% of GTx, Inc.'s total revenue[2].
• The global market size for toremifene citrate is projected to grow, with the compound annual growth rate (CAGR) expected to be substantial during the forecast period[1][4].

Licensing and Collaborations

• GTx, Inc. entered into an exclusive license and collaboration agreement with Merck in 2007, which included significant upfront payments and potential milestone payments. This agreement highlighted the financial potential of toremifene citrate and related compounds[2].

Regulatory Status and Incentives

Toremifene citrate is classified as an orphan drug, which provides special regulatory incentives and exclusivity periods to encourage its development and availability. This status has contributed to its market stability and growth[3].

Clinical Trials and Development

• Toremifene citrate has undergone extensive clinical trials, including Phase II and Phase III trials, to establish its efficacy and safety in treating breast cancer and other conditions. These trials have supported its continued use and expansion into new markets[2][5].

Market Trends and Drivers

• Increasing Incidence of Breast Cancer: The rising incidence of breast cancer, particularly in postmenopausal women, drives the demand for effective treatments like toremifene citrate.
• Advancements in Healthcare Infrastructure: Improvements in healthcare systems, especially in emerging markets, are facilitating better access to and distribution of the drug.
• Competitive Landscape: The presence of multiple players and ongoing research and development activities are driving innovation and competition in the market[1][4].

Challenges and Restraints

• Side Effect Profile: While toremifene citrate has a different side effect profile compared to other treatments like aromatase inhibitors, it still poses certain risks that can affect patient compliance and market growth.
• Regulatory Hurdles: Changes in regulatory environments and the need for continuous clinical trials to maintain approval can pose challenges to market stability[5].

Regional Analysis

• North America and Europe: These regions are expected to continue as major markets due to their advanced healthcare systems and high awareness of breast cancer treatments.
• Asia-Pacific: This region is anticipated to show rapid growth due to increasing healthcare expenditure and a large patient population[1][4].

Future Prospects

The market for toremifene citrate is poised for continued growth driven by its established efficacy, expanding distribution channels, and the increasing incidence of breast cancer. Here is a highlight from an industry report:

"The global toremifene citrate market size is anticipated to grow at a faster pace with substantial growth rates in the forecasted period"[1].

Key Takeaways

• Toremifene citrate is a significant drug in the treatment of metastatic breast cancer and other conditions.
• The market is segmented by application, product type, and geography.
• Key players include Orion Co., Ltd., Tianheng Pharma, Kyowa Kirin, and Schering Plough.
• The drug has a substantial financial trajectory with significant revenue and licensing agreements.
• Regulatory incentives and ongoing clinical trials support its market stability and growth.

FAQs

What is the primary use of toremifene citrate?

Toremifene citrate is primarily used in the treatment of metastatic breast cancer in postmenopausal women.

Who are the key players in the toremifene citrate market?

Key players include Orion Co., Ltd., Tianheng Pharma, Kyowa Kirin, and Schering Plough.

What are the main market segments for toremifene citrate?

The market is segmented by application (hospital pharmacies, retail pharmacies, online pharmacies), product type (60mg/tablet, 40mg/tablet), and geography (North America, Europe, Asia-Pacific, South America, Middle-East and Africa).

What is the regulatory status of toremifene citrate?

Toremifene citrate is classified as an orphan drug, which provides special regulatory incentives and exclusivity periods.

What are the future prospects for the toremifene citrate market?

The market is expected to grow significantly due to increasing demand, advancements in healthcare infrastructure, and the expanding distribution channels.

Sources

1. Market Research Intellect: Global Toremifene Citrate CAS 89778-27-8 Market Size and Forecast[1].
2. Annual Reports: GTx, Inc. - Annual Reports[2].
3. Synapse: Toremifene Citrate's R&D Progress and its Mechanism of Action[3].
4. Cognitive Market Research: Global Toremifene Citrate CAS 89778-27-8 Market Report 2024[4].
5. PubMed: Toremifene for breast cancer: a review of 20 years of data[5].