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. Nine 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	1,712,251
Ani Pharms	CASODEX	bicalutamide	TABLET;ORAL	020498-001	Oct 4, 1995	4,472,382
Ani Pharms	CASODEX	bicalutamide	TABLET;ORAL	020498-001	Oct 4, 1995	5,712,251
Ani Pharms	CASODEX	bicalutamide	TABLET;ORAL	020498-001	Oct 4, 1995	5,389,613
Ani Pharms	CASODEX	bicalutamide	TABLET;ORAL	020498-001	Oct 4, 1995	4,636,505*PED

International Patents for CASODEX

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

Country	Patent Number	Title	Estimated Expiration
Israel	69217	SUBSTITUTED ALKANOYLANILIDE DERIVATIVES,THEIR PREPARATION AND PHARMACEUTICAL COMPOSITIONS COMPRISING THEM
Australia	1693783
Portugal	77087	AMIDE DERIVATIVES
Japan	H0432061
Philippines	23546	TREATMENT OF ENDOMETRIOSIS
Greece	79232
Spain	8601106

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: February 2, 2026

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Executive Summary

CASODEX, generically known as bicalutamide, is a non-steroidal anti-androgen primarily used in prostate cancer therapy. This report analyzes current market forces, regulatory shifts, competitive landscape, and financial performance to inform strategic decision-making. The industry is characterized by gradual growth, patent expirations, emerging biosimilars, and increasing adoption in combination therapies, contrasted with regional variations driven by healthcare policies.

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1. Overview of CASODEX (Bicalutamide)

Attribute	Details
Generic Name	Bicalutamide
Brand Name	CASODEX
Manufacturers	AstraZeneca (initial), various generics globally
Therapeutic Class	Non-steroidal anti-androgen; androgen receptor antagonist
Indication	Hormone-dependent prostate cancer, primarily in advanced stages

Approval & Regulatory Status

• Approved by FDA (2000), EMA (2000), and numerous global regulatory bodies.
• Patent expired in key markets (e.g., US in 2014), leading to increased generic penetration.

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2. Market Size and Growth Trajectory

Parameter	Figures/Projections	Sources
Global prostate cancer market (2022)	$8.94 billion	[1]
CASODEX’s global market share (2022)	Estimated 15-20%	Industry estimates
Prostate cancer incidence (2022)	1.4 million new cases globally	[2]
CAGR (2022-2027)	7.2%	[3]

• Market Size (2023): Approx. $1.4-$1.7 billion, considering generic availability.
• Growth Drivers: Aging populations, increased screening, shift toward combination therapies, and expanding indications for hormonal therapy.

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3. Competitive Landscape and Market Dynamics

Competitors	Key Features	Market Share (Estimate, 2023)
Generic Bicalutamide	Cost-effective, widespread	70-80% (global)
Enzalutamide (Xtandi)	Newer, more effective in castration-resistant cases	10-15%
Apalutamide (Erleada)	Approved for non-metastatic castration-resistant prostate cancer	5-10%
Others (Nilutamide, Flutamide)	Less common, regional	5%

Key Market Dynamics:

• Patent Expiry: Led to proliferation of generics, reducing prices, expanding access.
• Pricing & Reimbursement: Cost remains a pivotal factor, especially in emerging markets.
• Regulatory Approvals: Ongoing approvals for expanded indications (e.g., adjuvant therapy) increase demand.
• Emerging Biosimilars: Although biosimilars typically target biologics, some research into alternative formulations may impact future markets.
• Combination Therapies: Growing adoption of bicalutamide with GnRH analogs and newer agent combinations drives volume.

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4. Regulatory and Policy Influences

Region	Key Regulations & Policies	Impact on Market Dynamics
United States	FDA approval, patent expirations, insurance coverage	Increased generic entry, price sensitivity
European Union	EMA approvals, HTA assessments	Focus on cost-effectiveness, therapy guidelines adherence
Emerging Markets (Asia, Latin America)	Regulatory approvals, healthcare infrastructure gaps	High growth potential, price-driven dynamics
Policies	Reimbursement policies, orphan drug status for specific indications	Affect market accessibility and pricing

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5. Financial Performance and Trajectory

Parameter	2022	2023 Projection	Notes
Global Sales	~$1.2 billion	$1.4 - $1.7 billion	Driven by generics, expanding indications
Brand vs. Generic Revenue	20% branded, 80% generic	Expected to stabilize at 15-25% branded	Price competition, patent status
Average Price per Unit	Varies by region (~$20-$50 per 50mg tablet)	Slight decline expected due to increased generics	Price erosion influenced by market competition
Research & Development (R&D) Investment	Minimal for generics; some for new formulations and combinations	Stable or declining	Generics diminish R&D need; focus shifts to combination therapies

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6. SWOT Analysis

Strengths	Weaknesses	Opportunities	Threats
Widely recognized, established efficacy	Patent expiration led to commoditization	Growing prostate cancer prevalence	Price erosion due to generics
Cost-effective	Limited differentiation in generics	New combination therapies	Competition from newer agents (e.g., enzalutamide)
Regulatory approvals globally	Market saturation in mature markets	Expansion into emerging markets	Regulatory delays or restrictions

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7. Comparative Analysis with Competitors

Parameter	CASODEX (Bicalutamide)	Enzalutamide (Xtandi)	Apalutamide (Erleada)
Mechanism of Action	Non-steroidal antiandrogen	Androgen receptor inhibitor	Androgen receptor inhibitor
Indications	Locally advanced/metastatic prostate cancer	Castration-resistant prostate cancer	Non-metastatic, castration-resistant prostate cancer
Pricing (USD)	~$20-$50/month	~$10,000+/month	~$7,000+/month
Patent Status	Expired in key markets	Patents active (until ~2028)	Patents active (until ~2028)
Market Penetration	High in generic markets	High in developed markets	Growing but limited

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8. Future Market Trends and Projections

Trend	Implication	Projected Impact (Next 5 Years)
Increased use of combination regimens	Higher volumes	Market expansion (estimated CAGR 7-8%)
Biosimilar entry/innovator competition	Price erosion, commoditization	Marginal profit margins, need for differentiation
Personalized medicine	Targeted therapies, biomarkers	Potential for niche markets and premium pricing
Regulatory streamlining	Faster approvals	Accelerated market entry for new formulations

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9. Key Considerations for Market Participants

Focus Area	Strategic Insight
Pricing Strategy	Balance between affordability and margins in generic markets
Regulatory Compliance	Stay ahead with evolving guidelines; consider indications expansion
Portfolio Diversification	Invest in combination therapies, diagnostics, or niche indications
Geographic Expansion	Target emerging markets with growing prostate cancer burdens
Innovation & Differentiation	Explore new delivery forms, formulations, or combination regimens

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10. Key Takeaways

• Market Maturity: After patent expiration, CASODEX's market is largely commoditized with high generic penetration, but demand persists driven by prostate cancer prevalence.
• Growth Potential: The compound annual growth rate (~7.2%) is propelled by growing aging populations, therapeutic advancements, and expanding indications.
• Competitive Pressure: Price erosion remains significant; differentiation primarily through combination and niche indications.
• Regulatory Landscape: Easier approvals and expanding indications support continued market expansion, especially in emerging economies.
• Strategic Focus: Companies should prioritize cost-effective manufacturing, regional expansion, and innovation in combination therapies to maintain profitability.

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FAQs

Q1: How does patent expiry impact CASODEX's market?
Patent expiry in major markets led to a surge in generic approvals, dramatically reducing prices and increasing accessibility. This shift intensified competition but expanded the overall market size.

Q2: What are the primary competitors to CASODEX in prostate cancer therapy?
Key competitors include enzalutamide (Xtandi) and apalutamide (Erleada), which target castration-resistant prostate cancer with newer mechanisms, typically at higher prices but potentially more effective in specific patient subsets.

Q3: What is the outlook for biosimilars or alternative formulations of CASODEX?
While biosimilars target biologics and are less relevant for small molecules like bicalutamide, innovative formulations or combination therapies could enhance market share and patient compliance.

Q4: Which regions exhibit the highest growth prospects for CASODEX?
Emerging markets in Asia, Latin America, and parts of Africa display strong growth prospects due to increasing prostate cancer awareness, improving healthcare infrastructure, and affordability.

Q5: How should companies strategize to optimize profits amidst price erosion?
Focus on expanding indications, developing combination regimens, entering new markets, and differentiating through formulation innovations or personalized medicine approaches.

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References

[1] MarketsandMarkets, "Prostate cancer drugs market," 2022.
[2] World Health Organization, "Global prostate cancer statistics," 2022.
[3] ResearchAndMarkets.com, "Prostate cancer therapeutics market forecast," 2022-2027.