NOLVADEX Drug Patent Profile

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

Nolvadex is a drug marketed by Astrazeneca and is included in one NDA.

The generic ingredient in NOLVADEX is tamoxifen citrate. There are sixteen drug master file entries for this compound. Fourteen suppliers are listed for this compound. Additional details are available on the tamoxifen citrate profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Nolvadex

A generic version of NOLVADEX was approved as tamoxifen citrate by ACTAVIS LABS FL INC on February 20^th, 2003.

Summary for NOLVADEX

US Patents:	0
Applicants:	1
NDAs:	1
Clinical Trials:	75
DailyMed Link:	NOLVADEX at DailyMed

Recent Clinical Trials for NOLVADEX

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

Sponsor	Phase
Eli Lilly and Company	Phase 2
Jose Pablo Leone	Phase 2
Translational Breast Cancer Research Consortium (TBCRC)	Phase 2

See all NOLVADEX clinical trials

US Patents and Regulatory Information for NOLVADEX

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Astrazeneca	NOLVADEX	tamoxifen citrate	TABLET;ORAL	017970-001	Approved Prior to Jan 1, 1982		DISCN	Yes	No
Astrazeneca	NOLVADEX	tamoxifen citrate	TABLET;ORAL	017970-002	Mar 21, 1994		DISCN	Yes	No

Expired US Patents for NOLVADEX

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Astrazeneca	NOLVADEX	tamoxifen citrate	TABLET;ORAL	017970-001	Approved Prior to Jan 1, 1982
Astrazeneca	NOLVADEX	tamoxifen citrate	TABLET;ORAL	017970-002	Mar 21, 1994

International Patents for NOLVADEX

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

Country	Patent Number	Title	Estimated Expiration
Denmark	127777
Denmark	124677
Brazil	6678265
United Kingdom	1013907
Denmark	118655
France	6841
Switzerland	441286	Verfahren zur Herstellung von Alkenderivaten

NOLVADEX Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Tamoxifen (NOLVADEX)

Introduction

Tamoxifen, commonly known by the brand name NOLVADEX, is a selective estrogen receptor modulator (SERM) widely used in the treatment of estrogen receptor-positive breast cancer. Here, we delve into the market dynamics and financial trajectory of tamoxifen, highlighting key drivers, challenges, and regional insights.

Market Size and Growth

The tamoxifen market has shown a stable yet modest growth trajectory. As of 2017, the market was valued at USD 676.6 million and is projected to reach USD 687.44 million by 2032, with a Compound Annual Growth Rate (CAGR) of 0.07%[1].

However, other reports suggest a slightly more optimistic outlook. For instance, the tamoxifen citrate market was valued at USD 208.89 million in 2023 and is expected to grow at a CAGR of 2.2% from 2024 to 2030, reaching nearly USD 243.26 million by 2030[4].

Key Drivers

Several factors are driving the demand for tamoxifen:

Increasing Prevalence of Breast Cancer

The rising prevalence of breast cancer is a significant driver. Initiatives by government and private organizations to raise public awareness about breast cancer screening and prevention are expected to boost market growth[1][4].

Expanding Therapeutic Indications

Tamoxifen is not only used for breast cancer but also for other conditions such as McCune-Albright syndrome, infertility, gynecomastia, and bipolar disorder. This broad range of applications contributes to its market growth[1].

Government Initiatives and Healthcare Spending

Increased healthcare expenditure and government initiatives to improve healthcare infrastructure, particularly in emerging markets, are expected to drive the demand for tamoxifen[1][4].

Research and Development

Ongoing research and development efforts aimed at minimizing side effects and enhancing drug delivery mechanisms are crucial for the market's growth. Innovations in safer formulations and combination therapies are expected to expand the market[3].

Challenges

Despite the positive drivers, there are several challenges that could inhibit the growth of the tamoxifen market:

High Cost of Medication

The high cost of tamoxifen is a significant barrier, especially in developing countries where affordability is a major concern[1][4].

Side Effects

Tamoxifen is associated with several side effects, including menstrual changes, hot flashes, nausea, vaginal discharge, weight loss, blurred vision, and liver problems. These side effects can limit patient compliance and market growth[1][4].

Emergence of Tamoxifen-Resistant Malignancies

The rise of tamoxifen-resistant malignancies and the drug's role in causing endometrial cancer are additional challenges that could limit market expansion[1].

Regional Insights

The demand for tamoxifen varies significantly across different regions:

North America

North America dominates the tamoxifen market, driven by a well-developed healthcare system, high healthcare spending, and increased awareness of breast cancer. The United States is the largest market in this region, with a high prevalence of breast cancer[1][4].

Asia-Pacific

The Asia-Pacific region is expected to show significant growth due to increasing research and development activities, rising healthcare expenditure, and expanding government support. Countries like China, India, and Japan are key contributors to this growth[1].

Rest of the World

In the Middle East and Africa, increasing awareness and a high prevalence of late-stage breast cancer, along with the rapid expansion of healthcare infrastructure, are driving the demand for tamoxifen[1].

Financial Performance

The financial performance of the tamoxifen market is influenced by several factors:

Revenue Growth

Despite a modest CAGR, the market is expected to see stable revenue growth driven by the increasing prevalence of breast cancer and expanding therapeutic indications[1][4].

Pharmaceutical Company Performance

Companies like AstraZeneca, which have a strong presence in the oncology segment, are expected to contribute to the growth of the tamoxifen market through their R&D efforts and market expansion strategies[2].

Innovations and Future Outlook

The future of the tamoxifen market is tied to innovations aimed at improving the drug's efficacy and reducing its side effects. Key areas include:

Safer Formulations

Developing safer formulations and combination therapies is crucial for expanding the market. Ongoing R&D efforts are focused on minimizing side effects and enhancing drug delivery mechanisms[3].

Cost-Effective Treatment Options

Developing cost-effective treatment options and enhancing patient accessibility in emerging markets can further accelerate market penetration and growth[3].

Public Awareness and Education

Initiatives to raise public awareness about breast cancer diagnosis and treatment are expected to continue driving market growth, especially in developing countries[4].

Key Takeaways

• The tamoxifen market is driven by the increasing prevalence of breast cancer, government initiatives, and expanding therapeutic indications.
• High medication costs and side effects are significant challenges.
• North America dominates the market, with the Asia-Pacific region showing promising growth.
• Innovations in safer formulations and cost-effective treatment options are crucial for future growth.
• Public awareness and education campaigns continue to play a vital role in market expansion.

FAQs

What is the primary use of tamoxifen?

Tamoxifen is primarily used to treat estrogen receptor-positive breast cancer and to reduce the risk of invasive breast cancer.

What are the common side effects of tamoxifen?

Common side effects include menstrual changes, hot flashes, nausea, vaginal discharge, weight loss, blurred vision, and liver problems.

Which region dominates the tamoxifen market?

North America dominates the tamoxifen market, driven by a well-developed healthcare system and high healthcare spending.

What are the key drivers of the tamoxifen market?

Key drivers include the increasing prevalence of breast cancer, expanding therapeutic indications, government initiatives, and rising healthcare expenditure.

How is the tamoxifen market expected to grow in the future?

The market is expected to grow modestly, driven by innovations in safer formulations, cost-effective treatment options, and increasing public awareness about breast cancer.

Sources

1. Future Market Insights: Tamoxifen Market | Global Sales Analysis Report – 2032
2. AstraZeneca: Full year and Q4 2022 results
3. 360iResearch: Tamoxifen Drugs Market Size & Share 2025-2030
4. Maximize Market Research: Tamoxifen Citrate Market: Industry Analysis and Forecast