BICALUTAMIDE - Generic Drug Details

What are the generic drug sources for bicalutamide and what is the scope of patent protection?

Bicalutamide is the generic ingredient in two branded drugs marketed by Accord Hlthcare, Adaptis, Apotex, Chartwell Rx, Fresenius Kabi Usa, Kudco Ireland, Rising, Roxane, Sandoz, Sun Pharm, Synthon Pharms, Teva, Watson Labs Teva, and Ani Pharms, and is included in fourteen NDAs. Additional information is available in the individual branded drug profile pages.

There are twenty-nine drug master file entries for bicalutamide. Eight suppliers are listed for this compound.

Summary for BICALUTAMIDE

US Patents:	0
Tradenames:	2
Applicants:	14
NDAs:	14
Drug Master File Entries:	29
Finished Product Suppliers / Packagers:	8
Raw Ingredient (Bulk) Api Vendors:	144
Clinical Trials:	184
Patent Applications:	5,303
Drug Prices:	Drug price trends for BICALUTAMIDE
What excipients (inactive ingredients) are in BICALUTAMIDE?	BICALUTAMIDE excipients list
DailyMed Link:	BICALUTAMIDE at DailyMed

See drug prices for BICALUTAMIDE

Recent Clinical Trials for BICALUTAMIDE

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

Sponsor	Phase
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)	Phase 1
University of California, San Francisco	Phase 1
Changhai Hospital	N/A

See all BICALUTAMIDE clinical trials

Pharmacology for BICALUTAMIDE

Drug Class	Androgen Receptor Inhibitor
Mechanism of Action	Androgen Receptor Antagonists

Anatomical Therapeutic Chemical (ATC) Classes for BICALUTAMIDE

L02BB	Anti-androgens
L02B	HORMONE ANTAGONISTS AND RELATED AGENTS
L02	ENDOCRINE THERAPY
L	Antineoplastic and immunomodulating agents

US Patents and Regulatory Information for BICALUTAMIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Kudco Ireland	BICALUTAMIDE	bicalutamide	TABLET;ORAL	077995-001	Jul 6, 2009		DISCN	No	No
Adaptis	BICALUTAMIDE	bicalutamide	TABLET;ORAL	079089-001	Jul 6, 2009	AB	RX	No	No
Ani Pharms	CASODEX	bicalutamide	TABLET;ORAL	020498-001	Oct 4, 1995	AB	RX	Yes	Yes
Apotex	BICALUTAMIDE	bicalutamide	TABLET;ORAL	200274-001	May 21, 2015	AB	RX	No	No
Synthon Pharms	BICALUTAMIDE	bicalutamide	TABLET;ORAL	077973-001	Jul 6, 2009		DISCN	No	No
Accord Hlthcare	BICALUTAMIDE	bicalutamide	TABLET;ORAL	078917-001	Jul 6, 2009	AB	RX	No	No
Sandoz	BICALUTAMIDE	bicalutamide	TABLET;ORAL	078575-001	Jul 6, 2009	AB	RX	No	No

Expired US Patents for BICALUTAMIDE

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
Ani Pharms	CASODEX	bicalutamide	TABLET;ORAL	020498-001	Oct 4, 1995
Ani Pharms	CASODEX	bicalutamide	TABLET;ORAL	020498-001	Oct 4, 1995

BICALUTAMIDE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory of Bicalutamide

Market Overview

Bicalutamide, a medication used to treat prostate cancer by blocking the function of male hormones like testosterone, is poised for significant growth in the global market. The bicalutamide market is projected to develop at a compound annual growth rate (CAGR) of 8.11% from 2024 to 2034, reaching a value of USD 4.52 Billion by 2034, up from USD 1.92 Billion in 2024[1].

Driving Factors

Several key factors are driving the growth of the bicalutamide market:

• Increasing Prostate Cancer Cases: The global rise in prostate cancer incidence, particularly among older populations, increases the demand for effective treatments like bicalutamide[1].
• Advancements in Cancer Therapies: Continuous research and development aimed at improving the safety and efficacy of bicalutamide contribute to market expansion[1].
• Proactive Screening and Early Detection: Improved screening programs and increased awareness lead to early detection and treatment initiation, further driving the market[1].
• Healthcare Access in Emerging Nations: Enhanced healthcare access in emerging economies such as China and India is a significant driver of market growth[1].

Regional Market Analysis

North America

North America dominates the bicalutamide market, accounting for more than 48% of the global market share. This dominance is attributed to the region's robust healthcare system, high incidence of prostate cancer, and favorable reimbursement policies[1].

Europe

Europe is the second-largest region in the bicalutamide market. The region's sizable patient base, aging population, and ongoing research and development efforts are key factors driving the industry. Government initiatives to raise cancer awareness and improve healthcare accessibility also contribute to market growth[1].

Asia Pacific

The Asia Pacific region is expected to be the fastest-growing segment during the forecast period. Increasing healthcare spending, rising prostate cancer cases, and improving healthcare infrastructure in countries like China and India are driving this growth[1].

Key Market Players

The bicalutamide market is dominated by several major pharmaceutical companies, including:

• AstraZeneca
• CORDEN PHARMA GMBH
• Zeneca GmbH
• Actavis Pharma
• Sivem Pharmaceuticals
• Sorres Pharma
• Fresenius Kabi
• ANI Pharmaceuticals
• Accel Pharma[1].

Financial Performance and Projections

Revenue Growth

The bicalutamide market is expected to grow significantly, with a projected CAGR of 8.11% from 2024 to 2034. This growth is driven by the increasing demand for effective prostate cancer treatments and the expanding reach of healthcare services in emerging markets[1].

Cost-Effectiveness

Studies have shown that bicalutamide is a cost-effective option for the adjuvant treatment of early prostate cancer. For instance, a cost-effectiveness analysis revealed that bicalutamide provided an incremental cost-effectiveness ratio of 27,059 euros per quality-adjusted life year (QALY) over a 15-year time horizon[3].

Comparative Cost-Effectiveness

A comparison between bicalutamide and rezvilutamide, another anti-androgen medication, highlights the economic aspects of these treatments. Rezvilutamide plus androgen deprivation therapy (ADT) was found to be more costly than bicalutamide plus ADT, with an incremental cost-effectiveness ratio (ICER) of $26,656.94 per QALY. However, after price negotiations, rezvilutamide became a cost-effective option, especially with a 70% reduction in its retail price[5].

Regulatory and Reimbursement Environment

Favorable reimbursement and regulatory approval policies play a crucial role in the market expansion of bicalutamide. For example, the coverage of rezvilutamide by the National Health Insurance in China after a price agreement significantly improved its cost-effectiveness[5].

Research and Development

Continuous innovation and research are vital for the growth of the bicalutamide market. Pharmaceutical companies like AstraZeneca are investing heavily in research and development, which is reflected in their financial reports. For instance, AstraZeneca's oncology segment saw a 20% increase in total revenue, including milestone receipts, in 2022, indicating strong R&D success[2].

Market Challenges and Opportunities

While the bicalutamide market is poised for growth, it also faces challenges such as potential side effects and drug interactions, which necessitate strict adherence to healthcare provider instructions. However, the increasing awareness and proactive screening programs offer significant opportunities for market expansion.

Key Takeaways

• The bicalutamide market is projected to grow at a CAGR of 8.11% from 2024 to 2034.
• North America dominates the market, followed by Europe and the Asia Pacific region.
• Key drivers include the rise in prostate cancer cases, advancements in cancer therapies, and improved healthcare access.
• Bicalutamide is a cost-effective option for adjuvant treatment of early prostate cancer.
• Favorable reimbursement and regulatory policies are crucial for market growth.

Frequently Asked Questions (FAQs)

Q1: What is the primary use of bicalutamide? Bicalutamide is primarily used to treat prostate cancer by blocking the function of male hormones like testosterone.

Q2: Which region dominates the bicalutamide market? North America dominates the bicalutamide market with the highest revenue share.

Q3: What is the projected CAGR of the bicalutamide market from 2024 to 2034? The bicalutamide market is projected to grow at a CAGR of 8.11% from 2024 to 2034.

Q4: Is bicalutamide a cost-effective treatment option? Yes, bicalutamide is considered a cost-effective option for the adjuvant treatment of early prostate cancer, as indicated by various cost-effectiveness analyses.

Q5: Which companies are major players in the bicalutamide market? Major players include AstraZeneca, CORDEN PHARMA GMBH, Zeneca GmbH, Actavis Pharma, and others.

Sources:

1. We Market Research: Bicalutamide Market Research Report.
2. AstraZeneca: Full year and Q4 2022 results announcement.
3. PubMed: Cost-effectiveness analysis of bicalutamide (Casodex) for adjuvant treatment of early prostate cancer.
4. Market Research Intellect: Global Bicalutamide Market Size and Projections.
5. BMJ Open: Cost-effectiveness analysis of rezvilutamide versus bicalutamide in patients with metastatic hormone-sensitive prostate cancer.