CASODEX Drug Patent Profile

Which patents cover Casodex, and what generic alternatives are available?

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

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

International Patents for CASODEX

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

Country	Patent Number	Title	Estimated Expiration
Norway	832599
Philippines	23546	TREATMENT OF ENDOMETRIOSIS
Norway	164974
Australia	556328
Japan	H059129	NEW THERAPEUTIC DRUG USING LH-RH OR AGONIST
Spain	8601106
Japan	S5655315	NOVEL THERAPEUTIC DRUG USING LHHRH OR AGONIST

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

CASODEX Market Analysis and Financial Projection

Last updated: February 3, 2026

What Is CASODEX and How Does Its Market Position Look?

CASODEX, generic name bicalutamide, is a non-steroidal antiandrogen mainly approved for prostate cancer treatment. It was developed by AstraZeneca and approved by the FDA in 1995. The drug functions by blocking androgen receptors, inhibiting testosterone-driven tumor growth.

Market presence: CASODEX is a leading antiandrogen therapy, with global sales reaching approximately $400 million annually before patent expirations. It competes with other antiandrogens like enzalutamide and apalutamide, which have gained market share post-2010s.

What Are the Investment Fundamentals of CASODEX?

Patent Expiry and Generic Competition

AstraZeneca's primary patent for CASODEX expired in 2008 in the US, with subsequent patent expiries worldwide by 2015. This led to a significant decline in branded sales, replaced by generic versions, which reduced revenue by approximately 60% in the subsequent years.

Revenue and Market Share Trends

With patent expiration, revenue shifted to generics, which sell at a 50-70% discount. The current global market share for bicalutamide sits below 10%, with the remaining share held by newer agents like enzalutamide, which reported global sales of $3.1 billion in 2022.

R&D Investment and Pipeline Status

AstraZeneca’s pipeline for prostate cancer includes next-gen androgen receptor inhibitors and combination therapies. While the company has not announced new indications for CASODEX, research indicates ongoing studies into resistance mechanisms, which could revive the drug’s relevance.

Regulatory Environment and Patent Strategies

Patent strategies primarily involved secondary patents on formulations and manufacturing processes, which have since expired. Patent cliffs led to pricing pressures, although regulatory pathways for biosimilar filings could impact future pricing and market dynamics.

Pricing and Reimbursement Landscape

Pricing for CASODEX has converged with generics, leading to marginal margins. Reimbursement rates vary by country, with most developed markets favoring newer agents due to clinical guidelines and reimbursement policies.

How Does CASODEX Compare to Competitors?

Aspect	CASODEX (Bicalutamide)	Enzalutamide (Xtandi)	Apalutamide (Erleada)
Approval Year	1995	2012	2018
Indications	Prostate cancer (monotherapy, combination)	Prostate cancer (metastatic, castration-resistant)	Non-metastatic, castration-resistant prostate cancer
Annual Sales (2022)	~$150 million (marketed drugs)	$3.1 billion	$162 million
Patent Status	Expired worldwide	Patents active until early 2030	Patents active until 2030+
Pricing (US)	~$50 per tablet (generic)	~$10,000 per month (brand)	~$8,500 per month (brand)

CASODEX’s lower efficacy profile and prevalent generic competition limit its market growth potential relative to newer agents.

What Are the Key Investment Risks?

• Continued erosion of market share due to generics and new therapies.
• Regulatory shifts favoring innovative agents.
• Limited pipeline development for CASODEX itself.
• Pricing pressures intensified by healthcare cost containment.

What Is the Long-term Outlook for CASODEX?

Without new indications or formulation improvements, CASODEX faces obsolescence in developed markets. Its role remains limited to generic use in cost-sensitive settings or countries with delayed regulatory approval for newer drugs.

Investors and companies should consider licensing opportunities, or potential for repurposing in niche indications, possibly linked to resistance pathways or combination strategies explored in ongoing clinical research.

Key Takeaways

• Patent expiries diminished CASODEX’s revenue, replaced by generics.
• The drug's niche has shifted toward cost-effective, generic antiandrogens in developing markets.
• Market expansion is constrained by competition from newer, branded agents.
• Future value hinges on drug repositioning and pipeline integration into broader prostate cancer treatment regimens.
• Regulatory trends favoring molecularly targeted therapies threaten CASODEX’s continued relevance.

FAQs

1. What is the primary use of CASODEX? CASODEX is used to treat prostate cancer, either alone or in combination with other therapies.

2. When did CASODEX lose patent protection? Its primary patent expired in 2008 in the US, with global patent protections expiring by 2015.

3. How does the current market for CASODEX look? It is dominated by generics; market share has decreased significantly since patent loss.

4. Are there ongoing clinical trials involving CASODEX? Limited ongoing studies focus on resistance mechanisms, but no major new indications or formulations are in late-stage development.

5. What future strategies could sustain CASODEX’s relevance? Potential for repurposing in resistant prostate cancer or combining with targeted therapies remains under investigation.

References

[1] AstraZeneca Annual Reports 1995–2022.

[2] IQVIA, "Prostate Cancer Market Analysis," 2022.

[3] FDA Drug Approval Database.

[4] EvaluatePharma, "Oncology Market Trends," 2022.

[5] ClinicalTrials.gov, current research on androgen receptor inhibitors.