TAMOXIFEN CITRATE - Generic Drug Details

What are the generic sources for tamoxifen citrate and what is the scope of freedom to operate?

Tamoxifen citrate is the generic ingredient in three branded drugs marketed by Mayne Pharma Commrcl, Astrazeneca, Actavis Labs Fl Inc, Aegis Pharms, Apotex, Dr Reddys Labs Sa, Eugia Pharma, Ivax Sub Teva Pharms, Mylan, Pharmachemie, Roxane, Teva, and Zydus Pharms, and is included in fourteen NDAs. Additional information is available in the individual branded drug profile pages.

There are fifteen drug master file entries for tamoxifen citrate. Fourteen suppliers are listed for this compound.

Summary for TAMOXIFEN CITRATE

US Patents:	0
Tradenames:	3
Applicants:	13
NDAs:	14
Drug Master File Entries:	15
Finished Product Suppliers / Packagers:	14
Raw Ingredient (Bulk) Api Vendors:	93
Clinical Trials:	125
Patent Applications:	8,060
Drug Prices:	Drug price trends for TAMOXIFEN CITRATE
What excipients (inactive ingredients) are in TAMOXIFEN CITRATE?	TAMOXIFEN CITRATE excipients list
DailyMed Link:	TAMOXIFEN CITRATE at DailyMed

See drug prices for TAMOXIFEN CITRATE

See drug sales revenues for TAMOXIFEN CITRATE

Recent Clinical Trials for TAMOXIFEN CITRATE

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

Sponsor	Phase
Sharif Medical Research Center	Phase 2
Baylor College of Medicine	Early Phase 1
Myotubular Trust	Phase 1/Phase 2

See all TAMOXIFEN CITRATE clinical trials

Pharmacology for TAMOXIFEN CITRATE

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

Medical Subject Heading (MeSH) Categories for TAMOXIFEN CITRATE

Antineoplastic Agents, Hormonal

Bone Density Conservation Agents

Estrogen Antagonists

Selective Estrogen Receptor Modulators

Anatomical Therapeutic Chemical (ATC) Classes for TAMOXIFEN CITRATE

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

US Patents and Regulatory Information for TAMOXIFEN CITRATE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Eugia Pharma	TAMOXIFEN CITRATE	tamoxifen citrate	TABLET;ORAL	213358-002	Aug 14, 2020	AB	RX	No	No
Eugia Pharma	TAMOXIFEN CITRATE	tamoxifen citrate	TABLET;ORAL	213358-001	Aug 14, 2020	AB	RX	No	No
Actavis Labs Fl Inc	TAMOXIFEN CITRATE	tamoxifen citrate	TABLET;ORAL	070929-001	Feb 20, 2003	AB	RX	No	No
Roxane	TAMOXIFEN CITRATE	tamoxifen citrate	TABLET;ORAL	076027-001	Feb 20, 2003		DISCN	No	No
Dr Reddys Labs Sa	TAMOXIFEN CITRATE	tamoxifen citrate	TABLET;ORAL	075797-002	Feb 20, 2003	AB	RX	No	Yes

Expired US Patents for TAMOXIFEN CITRATE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Mayne Pharma Commrcl	SOLTAMOX	tamoxifen citrate	SOLUTION;ORAL	021807-001	Oct 29, 2005	6,127,425
Astrazeneca	NOLVADEX	tamoxifen citrate	TABLET;ORAL	017970-002	Mar 21, 1994	4,536,516*PED
Astrazeneca	NOLVADEX	tamoxifen citrate	TABLET;ORAL	017970-001	Approved Prior to Jan 1, 1982	4,536,516*PED

TAMOXIFEN CITRATE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Tamoxifen Citrate

Market Overview

Tamoxifen citrate, a selective estrogen receptor modulator (SERM), is a crucial medication in the treatment and prevention of breast cancer. The global market for tamoxifen citrate is driven by several key factors that influence its growth and financial trajectory.

Increasing Prevalence of Breast Cancer

One of the primary drivers of the tamoxifen citrate market is the rising incidence of breast cancer globally. As breast cancer cases increase, so does the demand for effective treatments and preventive measures, leading to higher uptake rates of tamoxifen citrate[3][4].

Public Awareness and Health Initiatives

Public awareness campaigns and health initiatives, particularly in developing countries, play a significant role in boosting market growth. These campaigns help in early diagnosis and treatment, which in turn increases the demand for tamoxifen citrate[3][4].

Government Initiatives and Health Awareness

Government policies and increased health awareness are projected to support the global tamoxifen citrate market. As health awareness grows, so does the demand for medications like tamoxifen citrate, especially in regions with rising disposable incomes[3].

Competitive Landscape and New Product Launches

The market is also driven by new product launches, including over-the-counter medications, by pharmaceutical companies. These launches are expected to grow significantly during the forecast period, contributing to the overall market growth[3].

Regional Insights

The tamoxifen citrate market is geographically diverse, with North America, particularly the United States, holding the largest market share. This is due to the high prevalence of breast cancer and increased awareness in these regions. The Asia Pacific and European regions also constitute significant market shares[3].

Market Size and Growth Projections

• The global tamoxifen citrate market was valued at approximately USD 600 million in 2023 and is projected to reach around USD 1.2 billion by 2032, indicating a substantial growth trajectory[1].
• Another estimate suggests the market size was USD 208.89 million in 2023, expected to grow at a CAGR of 2.2% to reach USD 243.26 million by 2030[3].

Segmentation

The market is segmented by type (tables and capsules) and application (breast cancer, ovarian cancer, and others). Breast cancer treatment remains the primary application driving the market[3].

Challenges and Constraints

Despite the growth drivers, the tamoxifen citrate market faces several challenges:

• Adverse Effects: Common side effects such as hot flashes, nausea, fatigue, mood swings, and increased risk of deep-vein thrombosis and pulmonary embolism can hinder market growth[2][5].
• Treatment Costs: Rising treatment costs and the economic impact of cancer therapies are significant constraints[3].
• COVID-19 Pandemic: The pandemic disrupted global supply chains, leading to lower sales of tamoxifen citrate during the lockdown periods[3].

Efficacy and Long-Term Benefits

Clinical trials have demonstrated the efficacy of tamoxifen citrate in reducing the risk of breast cancer. For instance, the IBIS-I trial showed a 31% reduction in invasive estrogen receptor-positive tumors and a 38% overall reduction in breast cancer incidence in high-risk women[2].

Comparative Analysis with Other Medications

Studies like the STAR trial have compared tamoxifen citrate with other SERMs like raloxifene. While tamoxifen citrate reduces the risk of invasive breast cancer by about 50%, raloxifene is about 76% as effective but with fewer side effects such as uterine cancer and blood clots[5].

Financial Impact of Side Effects

The side effects associated with tamoxifen citrate can have a financial impact on patients and healthcare systems. For example, the increased risk of uterine cancer and blood clots may lead to additional medical costs and complications[2][5].

Future Outlook

The future of the tamoxifen citrate market looks promising, driven by increasing awareness, government initiatives, and the development of more efficient combination drug regimens. However, addressing the adverse effects and reducing treatment costs will be crucial for sustained growth.

Key Takeaways

• The global tamoxifen citrate market is expected to grow significantly due to the increasing prevalence of breast cancer and public health initiatives.
• North America, particularly the United States, dominates the market.
• The market faces challenges such as adverse effects and rising treatment costs.
• Clinical trials have demonstrated the long-term efficacy of tamoxifen citrate in reducing breast cancer risk.
• Comparative studies with other SERMs highlight the need for balanced risk-benefit assessments.

FAQs

What is the projected market size of tamoxifen citrate by 2032?

The global tamoxifen citrate market is projected to reach around USD 1.2 billion by 2032[1].

What are the primary drivers of the tamoxifen citrate market?

The primary drivers include the increasing prevalence of breast cancer, public awareness campaigns, and government health initiatives[3][4].

Which region holds the largest market share for tamoxifen citrate?

North America, particularly the United States, holds the largest market share for tamoxifen citrate[3].

What are the common side effects associated with tamoxifen citrate?

Common side effects include hot flashes, nausea, fatigue, mood swings, and an increased risk of deep-vein thrombosis and pulmonary embolism[2][5].

How does tamoxifen citrate compare with raloxifene in reducing breast cancer risk?

Tamoxifen citrate reduces the risk of invasive breast cancer by about 50%, while raloxifene is about 76% as effective but with fewer side effects such as uterine cancer and blood clots[5].

Sources:

1. Dataintelo, Global Tamoxifen Citrate Market Research Report 2032.
2. Journal of the National Cancer Institute, Long-Term Results of Tamoxifen Prophylaxis for Breast Cancer—96 Months Follow-Up.
3. Maximize Market Research, Tamoxifen Citrate Market: Industry Analysis and Forecast.
4. Verified Market Research, Tamoxifen Citrate Market Size And Forecast.
5. National Cancer Institute, The Study of Tamoxifen and Raloxifene (STAR).