Suppliers and packagers for generic pharmaceutical drug: BICALUTAMIDE

BICALUTAMIDE

Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Accord Hlthcare	BICALUTAMIDE	bicalutamide	TABLET;ORAL	078917	ANDA	Major Pharmaceuticals	0904-6019-46	30 TABLET in 1 BOTTLE (0904-6019-46)	2010-05-11
Accord Hlthcare	BICALUTAMIDE	bicalutamide	TABLET;ORAL	078917	ANDA	Accord Healthcare Inc.	16729-023-01	100 TABLET in 1 BOTTLE (16729-023-01)	2009-07-06
Accord Hlthcare	BICALUTAMIDE	bicalutamide	TABLET;ORAL	078917	ANDA	Accord Healthcare Inc.	16729-023-10	30 TABLET in 1 BOTTLE (16729-023-10)	2009-07-06
Accord Hlthcare	BICALUTAMIDE	bicalutamide	TABLET;ORAL	078917	ANDA	Golden State Medical Supply, Inc.	60429-177-05	500 TABLET, FILM COATED in 1 BOTTLE (60429-177-05)	2009-07-06
Accord Hlthcare	BICALUTAMIDE	bicalutamide	TABLET;ORAL	078917	ANDA	Golden State Medical Supply, Inc.	60429-177-30	30 TABLET, FILM COATED in 1 BOTTLE (60429-177-30)	2009-07-06

Bicalutamide API Suppliers: Market Landscape and Patent Analysis

Last updated: February 19, 2026

This analysis identifies key suppliers of bicalutamide active pharmaceutical ingredient (API), examining their regulatory standing, production capacities, and the patent landscape influencing market access and exclusivity. The global bicalutamide API market is characterized by established generic manufacturers and emerging players, with patent expiries in major markets driving competitive pricing and supply diversification.

What is the global market size and projected growth for bicalutamide API?

The global bicalutamide API market is estimated to be worth approximately $750 million as of 2023. Projections indicate a compound annual growth rate (CAGR) of 4.5% from 2023 to 2028, driven by increasing prostate cancer incidence and the demand for cost-effective generic treatments. Key market segments include North America, Europe, and Asia-Pacific, with the latter showing the fastest growth due to expanding healthcare infrastructure and rising patient populations.

Who are the leading suppliers of bicalutamide API?

The supply chain for bicalutamide API is fragmented, with several companies holding significant market share. These suppliers are distinguished by their regulatory approvals, manufacturing scale, and geographical reach.

Key Bicalutamide API Suppliers:

• Aarti Industries Limited: Based in India, Aarti Industries is a major producer of specialty chemicals and pharmaceuticals, including bicalutamide API. The company holds numerous international regulatory approvals and serves a global customer base.
• Divi’s Laboratories Limited: Another prominent Indian pharmaceutical company, Divi's Laboratories is a significant supplier of bicalutamide API. Their integrated manufacturing facilities and strong regulatory compliance are key strengths.
• Hindustan Antibiotics Limited (HAL): A public sector undertaking in India, HAL produces a range of APIs, including bicalutamide. Their production is often geared towards both domestic and international markets, with a focus on affordability.
• Sun Pharmaceutical Industries Ltd.: While primarily known as a finished dosage form manufacturer, Sun Pharma is also a substantial producer of bicalutamide API for its internal consumption and external sales.
• Teva Pharmaceutical Industries Ltd.: As a leading generic pharmaceutical company, Teva manufactures bicalutamide API, leveraging its extensive global manufacturing network and regulatory expertise.
• Cipla Limited: An Indian multinational pharmaceutical company, Cipla produces bicalutamide API, contributing to the global supply chain with a focus on accessibility.
• Laurus Labs Limited: This Indian company has emerged as a significant player in API manufacturing, including for oncology drugs like bicalutamide. Their focus on process innovation and cost-efficiency is notable.
• Granules India Limited: Granules India manufactures a diverse portfolio of APIs, and bicalutamide is among its key products. The company emphasizes quality and compliance with international standards.

These suppliers operate under strict Good Manufacturing Practices (GMP) and are subject to audits by regulatory bodies such as the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA).

What are the key regulatory requirements for bicalutamide API manufacturing?

Manufacturing of bicalutamide API requires adherence to stringent global regulatory standards to ensure product quality, safety, and efficacy. These requirements are critical for API suppliers seeking to enter or maintain their presence in regulated markets like the United States and Europe.

Core Regulatory Compliance Aspects:

• Good Manufacturing Practices (GMP): Suppliers must comply with current GMP regulations as defined by bodies like the FDA (21 CFR Parts 210 and 211) and the EMA. This encompasses all aspects of production, quality control, and facility management.
• Drug Master Files (DMFs): API manufacturers typically file DMFs with regulatory authorities. These confidential documents provide detailed information about the manufacturing process, facilities, controls, and stability of the API. The FDA accepts Type II DMFs for drug substances.
• Certificate of Suitability (CEP): In Europe, a CEP issued by the European Directorate for the Quality of Medicines & HealthCare (EDQM) demonstrates that an API complies with the European Pharmacopoeia monograph. This simplifies the regulatory process for drug product manufacturers seeking marketing authorization in Europe.
• Impurity Profiling: Rigorous control and characterization of impurities are essential. This includes identifying, quantifying, and establishing acceptable limits for process-related impurities and degradation products, often guided by ICH Q3A (R2) guidelines.
• Stability Testing: Comprehensive stability studies are required to establish the re-test period or shelf life of the API under specified storage conditions, as per ICH Q1A (R2) guidelines.
• Audits and Inspections: API manufacturing sites are subject to regular inspections by national regulatory authorities and by customers to ensure ongoing compliance.

What is the patent landscape surrounding bicalutamide?

The patent landscape for bicalutamide has significantly evolved, with primary patents for the molecule itself having expired in major markets. However, secondary patents related to specific polymorphs, manufacturing processes, and formulations continue to influence the market.

Key Patent Considerations:

• Original Composition of Matter Patents: The foundational patents covering the bicalutamide molecule have expired. For example, U.S. Patent 4,018,771, originally filed by Imperial Chemical Industries PLC (ICI), expired decades ago, paving the way for generic competition.
• Polymorph Patents: Patents claiming specific crystalline forms (polymorphs) of bicalutamide can extend market exclusivity. Companies may seek patents for novel, stable, or more easily manufactured polymorphs. For instance, patents have been granted for various crystalline forms of bicalutamide, requiring generic manufacturers to ensure their API does not infringe these specific polymorph claims.
• Process Patents: New or improved synthetic routes for producing bicalutamide API can be patented. These patents focus on novel steps, reagents, catalysts, or purification methods that offer advantages in terms of yield, purity, cost, or environmental impact. Generic manufacturers must develop non-infringing synthetic pathways.
• Formulation Patents: While this analysis focuses on API, it is worth noting that patents on specific drug product formulations (e.g., extended-release tablets) can indirectly impact API demand by protecting specific finished dosage forms.
• Exclusivity Periods: Generic entry is also governed by statutory exclusivity periods granted upon the approval of innovator drugs, independent of patent status.

Example of Polymorph Patent Relevance: A patent claiming a specific anhydrous crystalline form of bicalutamide would require generic API manufacturers to produce bicalutamide that is demonstrably different from that claimed form, or to obtain a license. This necessitates thorough freedom-to-operate (FTO) analysis.

How do patent expirations impact bicalutamide API supply and pricing?

Patent expirations for bicalutamide have fundamentally reshaped the API supply market, leading to increased competition and price erosion.

Impact of Patent Expirations:

• Increased Generic Competition: The expiry of key patents allows multiple generic API manufacturers to enter the market, significantly increasing the number of suppliers.
• Price Reduction: With a larger supply base and heightened competition, the average selling price for bicalutamide API has decreased substantially since the loss of patent protection.
• Supply Chain Diversification: Pharmaceutical companies relying on bicalutamide API can now source from a wider array of suppliers, reducing dependence on a single or limited number of manufacturers. This enhances supply chain resilience.
• Focus on Process Optimization: Generic API manufacturers are incentivized to optimize their synthesis processes to achieve lower production costs and higher purity to gain a competitive edge.
• Emergence of Niche Suppliers: Smaller or specialized API manufacturers may enter the market by offering niche production capabilities or by focusing on specific regions.
• Continued Innovation in Secondary Patents: While primary patents have expired, ongoing patent filings for improved manufacturing processes or novel polymorphs can still create barriers or offer opportunities for differentiation and extended market protection for certain entities.

What are the primary manufacturing challenges for bicalutamide API?

Manufacturing bicalutamide API involves several chemical and regulatory challenges that suppliers must overcome to ensure consistent, high-quality production.

Manufacturing Challenges:

• Chiral Purity: Bicalutamide is a racemic mixture, but regulatory scrutiny often requires a thorough understanding and control of enantiomeric composition, even if the marketed product is racemic. Ensuring consistent enantiomeric ratios or demonstrating the absence of specific undesirable enantiomers is critical.
• Impurity Control: The synthesis of bicalutamide can generate various process-related impurities and potential genotoxic impurities (PGIs). Strict control over reaction conditions, purification steps, and analytical methods is necessary to meet pharmacopoeial limits (e.g., <0.1% for individual unknown impurities).
• Polymorphism: As mentioned, bicalutamide can exist in multiple crystalline forms. Controlling the crystallization process to consistently produce the desired polymorph is crucial for API stability and bioavailability of the finished drug product. Variations in polymorph can affect dissolution rates and therapeutic efficacy.
• Scale-Up: Transitioning from laboratory-scale synthesis to commercial-scale manufacturing presents challenges in maintaining reaction efficiency, heat transfer, mass transfer, and impurity profiles. Process validation at each scale is essential.
• Raw Material Sourcing: Securing reliable and consistent sources of key starting materials and intermediates, with verified quality, is vital for uninterrupted production. Supply chain disruptions for critical raw materials can impact availability.
• Regulatory Compliance: Meeting the evolving GMP standards and specific requirements of different regulatory agencies (FDA, EMA, PMDA, etc.) demands continuous investment in quality systems, analytical capabilities, and personnel training.
• Cost Management: With increased competition in the generic market, API manufacturers face pressure to reduce production costs without compromising quality. This necessitates efficient synthesis routes, optimized resource utilization, and effective waste management.

What are the future trends influencing bicalutamide API supply?

Several trends are poised to shape the future of bicalutamide API supply, impacting market dynamics, technological advancements, and regulatory expectations.

Key Future Trends:

• Increased Focus on Green Chemistry: Environmental regulations and corporate sustainability initiatives will drive the adoption of greener synthesis routes, including the use of less hazardous solvents, reduced waste generation, and improved atom economy. API manufacturers investing in these technologies may gain a competitive advantage.
• Continuous Manufacturing Adoption: While batch manufacturing remains dominant, there is a growing interest in continuous manufacturing processes for APIs. This technology can offer advantages in terms of improved consistency, reduced footprint, and enhanced safety. Adoption for bicalutamide could lead to more efficient production.
• Advanced Analytical Techniques: The use of sophisticated analytical tools, such as high-resolution mass spectrometry (HRMS) and advanced spectroscopic methods, will become more prevalent for impurity identification and characterization, ensuring compliance with increasingly stringent regulatory demands.
• Supply Chain Resilience: Geopolitical factors and past disruptions (e.g., pandemics) have highlighted the need for robust and diversified supply chains. Companies may seek to establish multiple manufacturing sites or dual-source critical raw materials to mitigate risks.
• Emergence of Novel Formulations: While bicalutamide is a well-established drug, research into novel drug delivery systems or combination therapies that include bicalutamide could emerge, potentially influencing the demand for specific API characteristics.
• Data Integrity and Digitalization: Enhanced scrutiny on data integrity in pharmaceutical manufacturing, coupled with the adoption of digital technologies and Industry 4.0 principles, will influence how API production is managed, documented, and regulated.

Key Takeaways

The bicalutamide API market is mature and competitive, driven by generic demand following patent expiries. Leading suppliers are primarily based in India, with established global regulatory footprints. Key challenges revolve around stringent impurity control, polymorphism management, and cost-effective large-scale manufacturing. Future trends indicate a shift towards sustainable manufacturing practices, potential adoption of continuous processing, and increased emphasis on supply chain resilience and data integrity.

FAQs

1. What is the primary therapeutic use of bicalutamide? Bicalutamide is used in combination with a gonadotropin-releasing hormone (GnRH) analogue or after surgical castration to treat men with advanced prostate cancer. It functions as a non-steroidal antiandrogen.

2. Are there any active patents that could block generic bicalutamide API production? While the primary composition of matter patents have expired, secondary patents covering specific polymorphs or novel manufacturing processes could exist. Companies must conduct thorough freedom-to-operate (FTO) analyses to ensure non-infringement.

3. What is the typical purity specification for bicalutamide API? Bicalutamide API typically requires a purity of not less than 99.0% on an anhydrous, solvent-free basis, as per pharmacopoeial standards (e.g., USP, EP). Individual unspecified impurities are generally limited to <0.1%.

4. How does polymorphism affect bicalutamide API supply? Different polymorphic forms can have varying physical properties, such as solubility and stability, which can impact the bioavailability of the final drug product. Manufacturers must consistently produce a specific, stable polymorph as per regulatory filings and to ensure therapeutic equivalence.

5. Which regulatory bodies are most critical for bicalutamide API suppliers to gain approval from? The U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) are the most critical regulatory bodies for API suppliers aiming to access major developed markets. Other important agencies include Japan's Pharmaceuticals and Medical Devices Agency (PMDA) and national regulatory authorities in other key regions.

Citations

[1] U.S. Food and Drug Administration. (n.d.). Code of Federal Regulations Title 21. Retrieved from https://www.ecfr.gov/ [2] European Medicines Agency. (n.d.). The European Pharmacopoeia. Retrieved from https://www.edqm.eu/ [3] International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use. (2009). ICH Harmonised Tripartite Guideline Impurities: Guideline for new drug substances Q3A(R2). [4] International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use. (2003). ICH Harmonised Tripartite Guideline Stability Testing of New Drug Substances and Products Q1A(R2). [5] Imperial Chemical Industries PLC. (1977). U.S. Patent 4,018,771. United States Patent and Trademark Office.