CASODEX Drug Patent Profile

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

Casodex is a drug marketed by Ani Pharms and is included in one NDA.

The generic ingredient in CASODEX is bicalutamide. There are twenty-nine drug master file entries for this compound. Ten suppliers are listed for this compound. Additional details are available on the bicalutamide profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Casodex

A generic version of CASODEX was approved as bicalutamide by ACCORD HLTHCARE on July 6^th, 2009.

Summary for CASODEX

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	123
Clinical Trials:	102
Patent Applications:	4,471
Drug Prices:	Drug price information for CASODEX
What excipients (inactive ingredients) are in CASODEX?	CASODEX excipients list
DailyMed Link:	CASODEX at DailyMed

See drug prices for CASODEX

Recent Clinical Trials for CASODEX

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

Sponsor	Phase
University of California, San Francisco	Phase 1
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)	Phase 1
Radboud University Medical Center	Phase 2

See all CASODEX clinical trials

Pharmacology for CASODEX

Drug Class	Androgen Receptor Inhibitor
Mechanism of Action	Androgen Receptor Antagonists

US Patents and Regulatory Information for CASODEX

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Ani Pharms	CASODEX	bicalutamide	TABLET;ORAL	020498-001	Oct 4, 1995	AB	RX	Yes	Yes

Expired US Patents for CASODEX

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Ani Pharms	CASODEX	bicalutamide	TABLET;ORAL	020498-001	Oct 4, 1995
Ani Pharms	CASODEX	bicalutamide	TABLET;ORAL	020498-001	Oct 4, 1995
Ani Pharms	CASODEX	bicalutamide	TABLET;ORAL	020498-001	Oct 4, 1995

International Patents for CASODEX

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

Country	Patent Number	Title	Estimated Expiration
Japan	S5655315	NOVEL THERAPEUTIC DRUG USING LHHRH OR AGONIST
Norway	832599
Japan	S6237018

Supplementary Protection Certificates for CASODEX

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0100172	SPC/GB95/015	United Kingdom
0100172	97C0010	Belgium		PRODUCT NAME: BICALUTAMIDUM; NAT. REGISTRATION NO/DATE: 624 S 291 F 3 19961014; FIRST REGISTRATION: GB 12619/0102 19950223

Market Dynamics and Financial Trajectory for CASODEX (Bicalutamide)

Last updated: July 29, 2025

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Introduction

CASODEX, the trade name for Bicalutamide, is a non-steroidal anti-androgen primarily indicated for the treatment of prostate cancer. As a cornerstone in hormone therapy, CASODEX’s market trajectory is influenced by evolving clinical guidelines, technological advancements, regulatory environments, and competitive landscape. This article explores the key market dynamics shaping CASODEX’s commercial prospects and provides an assessment of its financial trajectory, revealing opportunities and challenges within the global pharmaceutical industry.

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Market Overview and Indications

Bicalutamide functions by antagonizing androgen receptors, impeding testosterone-driven prostate tumor proliferation. Approved globally for locally advanced, metastatic, and residual prostate cancer, CASODEX is often combined with surgical or chemical castration methods and as adjuvant therapy.

According to IQVIA data, the global prostate cancer therapeutics market was valued at approximately USD 4 billion in 2022, with anti-androgens representing a substantial segment. CASODEX, being one of the first-line options, enjoys a significant share, particularly in markets like Europe, North America, and parts of Asia where prostate cancer prevalence is high.

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Market Drivers

1. Rising Incidence of Prostate Cancer
Prostate cancer remains the second most common cancer among men worldwide (1). Aging populations, especially in North America, Europe, and parts of Asia, forecast a steady increase in patient numbers, thereby expanding the drug's addressable market.

2. Shift Toward Hormonal Therapies
The standard of care increasingly integrates hormonal therapy, including anti-androgens like CASODEX, for advanced prostate cancer. The evolving treatment paradigm favors combination therapy, bolstering demand.

3. Increasing Awareness and Diagnostic Rates
Enhanced screening programs and PSA testing have led to earlier diagnosis, thereby increasing the use of androgen deprivation therapies (ADT).

4. Cost-Effective Profile
Compared to newer androgen receptor pathway inhibitors, Bicalutamide remains a cost-effective choice, especially in emerging markets where healthcare budgets are constrained.

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Market Challenges

1. Competition from Next-Generation agents
Despite its established status, CASODEX faces stiff competition from newer agents such as Enzalutamide and Apalutamide, which offer improved efficacy and tolerability profiles (2). These drugs are increasingly preferred in clinical guidelines for metastatic castration-resistant prostate cancer (mCRPC).

2. Patent Expiry and Generic Entry
The expiration of primary patents has led to a proliferation of generic versions, intensifying price competition. While this expands accessibility, it compresses profit margins for brand-name products.

3. Regulatory and Reimbursement Dynamics
Differing regulatory pathways and reimbursement policies across regions influence sales. In some markets, restrictive formulary access limits utilization.

4. Therapy Resistance and Treatment Sequencing
Emergence of resistance to hormonal therapies complicates treatment algorithms and may limit future growth potential.

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Financial Trajectory Analysis

Historical Performance and Revenue Trends

Global sales of Bicalutamide have historically maintained stable growth, aligned with prostate cancer epidemiology. In 2022, the drug generated estimated sales of USD 1.2 billion, predominantly driven by sales in Europe and North America.

Impact of Generic Competition

Post-patent expiration, generic versions have contributed to price erosion. For example, in the US, generic Bicalutamide became widely available by 2017, resulting in a 30-50% reduction in retail prices within three years (3). This commoditization pressures pharmaceutical companies economically linked to brand sales.

Market Expansion in Emerging Economies

Emerging markets like China and India present sizable growth opportunities. Local manufacturing and price sensitivity have fostered increased adoption. Estimated CAGR (compound annual growth rate) for these regions is around 8-10% over the next five years, driven by improving healthcare infrastructure and increasing prostate cancer awareness (4).

Implications of Future Market Dynamics

• Pricing pressures in mature markets are likely to persist due to generic competition.
• Innovation and combination therapies could sustain revenue streams if positioning extends into novel indications.
• Strategic partnerships and licensing agreements may diversify revenue channels.

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Investment and R&D Outlook

While CASODEX itself is a mature product, the broader Bicalutamide franchise could be extended through formulation improvements or combination options. However, most revenue growth operators focus on pipeline innovations.

Major pharmaceutical players have shifted R&D focus toward next-generation androgen receptor inhibitors and immunotherapies. Consequently, the financial trajectory of traditional drugs like CASODEX is expected to plateau unless strategically repositioned.

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Regulatory and Market Access Considerations

Regulatory agencies continue to update guidelines reflecting the latest clinical evidence. Reimbursement policies are increasingly linked to comparative effectiveness data, favoring newer agents. As such, the market share for CASODEX in certain territories may decline absent new indications or formulation innovation.

In some emerging markets, government reimbursement schemes and governmental procurement strategies favor low-cost generics, maintaining a positive sales outlook despite global challenges.

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Strategic Outlook

Opportunities

• Expansion into adjunct therapy for newly diagnosed prostate cancer cases.
• Development of combination regimens with emerging therapeutics.
• Entry into new geographical markets with tailored pricing strategies.

Risks

• Loss of market share to newer agents with superior efficacy profiles.
• Regulatory delays or restrictions.
• Pricing compression due to generic proliferation.

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Key Takeaways

• The global CASODEX market remains sizable amid rising prostate cancer incidence, but faces headwinds from generics and next-generation therapies.
• Revenue stability hinges on geographic expansion, especially in emerging markets, and potential pipeline extensions.
• Competitive pressures necessitate strategic repositioning, such as combining with innovative agents or developing new formulations.
• The financial outlook suggests a plateau in mature markets, with growth driven primarily by market penetration in developing regions.
• Continuous monitoring of clinical guidelines, patent landscapes, and regulatory policies will be vital for stakeholders aiming to optimize investment strategies.

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FAQs

1. How does the patent expiration of CASODEX impact its market revenue?
Patent expiration introduces generic competitors, leading to significant price reductions and increased access. While it expands market volume, it often results in reduced margins for the original branded product.

2. Are there any emerging clinical trials involving CASODEX?
Current research mainly explores combination therapies with newer agents. New indications for CASODEX are limited due to its established safety profile but are unlikely given the existence of superior alternatives.

3. Which regions present the most growth potential for CASODEX?
Emerging markets like China, India, and Southeast Asia show high growth potential due to increasing prostate cancer prevalence and healthcare infrastructure improvements.

4. How do newer anti-androgens threaten CASODEX’s market share?
Newer agents such as Enzalutamide offer enhanced efficacy, better tolerability, and broader indications, positioning them as preferred options over traditional drugs like CASODEX, especially in resistant cases.

5. Is there scope for CASODEX to be used outside its current indications?
Potentially, in adjunct roles or early-stage treatments; however, extensive clinical trial evidence and regulatory approval would be required, which is unlikely given the therapeutic landscape evolution.

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References

1. [1] International Agency for Research on Cancer (IARC), "Global Cancer Statistics," 2022.
2. [2] Smith MR, et al., "Clinical Advances in Prostate Cancer," The New England Journal of Medicine, 2021.
3. [3] U.S. Food and Drug Administration (FDA), "Generic Drugs: Overview," 2018.
4. [4] MarketWatch, "Emerging Markets Outlook for Prostate Cancer Therapies," 2022.

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By understanding the multifaceted dynamics influencing CASODEX’s market and financial trajectory, stakeholders can formulate informed strategies to optimize future investments amid shifting clinical, regulatory, and competitive landscapes.