Suppliers and packagers for PREZISTA

PREZISTA

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Janssen Prods	PREZISTA	darunavir	SUSPENSION;ORAL	202895	NDA	Janssen Products LP	59676-565-01	1 BOTTLE, GLASS in 1 CARTON (59676-565-01) / 200 mL in 1 BOTTLE, GLASS	2011-12-16
Janssen Prods	PREZISTA	darunavir	TABLET;ORAL	021976	NDA	Janssen Products LP	59676-562-01	60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (59676-562-01)	2008-03-08
Janssen Prods	PREZISTA	darunavir	TABLET;ORAL	021976	NDA	Janssen Products LP	59676-563-01	480 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (59676-563-01)	2009-01-14
Janssen Prods	PREZISTA	darunavir	TABLET;ORAL	021976	NDA	Janssen Products LP	59676-564-01	240 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (59676-564-01)	2009-04-27
Janssen Prods	PREZISTA	darunavir	TABLET;ORAL	021976	NDA	Janssen Products LP	59676-566-30	30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (59676-566-30)	2012-11-09

PREZISTA (Darunavir) Supply Chain Analysis

Last updated: February 19, 2026

Executive Summary

This report analyzes the supply chain for PREZISTA (darunavir), an HIV-1 protease inhibitor. Key suppliers involved in the manufacturing of the active pharmaceutical ingredient (API) and finished drug product are identified, along with their geographical locations and known production capabilities. The analysis also examines patent expirations and regulatory filings that may impact future supply dynamics.

Who Are the Primary API Manufacturers for PREZISTA?

The primary active pharmaceutical ingredient (API) for PREZISTA is darunavir. Manufacturing of darunavir is complex and often involves multiple specialized chemical synthesis steps. Identifying specific API manufacturers for proprietary drugs can be challenging due to confidentiality agreements between the brand manufacturer and its suppliers. However, based on publicly available information, including regulatory filings and industry reports, certain entities are known to be involved in the production of darunavir or related intermediates.

• Johnson & Johnson (Janssen Pharmaceutical Companies): As the originator and brand holder of PREZISTA, Janssen has direct involvement in its manufacturing and supply chain. While Janssen may not directly synthesize every component of the API, it oversees and manages the entire production process, often through contract manufacturing organizations (CMOs) or dedicated internal facilities.
• Key Intermediates and Raw Material Suppliers: The synthesis of darunavir involves several complex chemical intermediates. Sourcing these intermediates often involves a global network of chemical manufacturers. Companies specializing in chiral synthesis and advanced organic chemistry are crucial. Specific names of these intermediate suppliers are typically not publicly disclosed due to competitive reasons and the confidential nature of supply agreements.
• Potential CMOs: The pharmaceutical industry frequently utilizes Contract Manufacturing Organizations (CMOs) for API production. These CMOs possess specialized expertise and manufacturing capacity. While specific CMOs for darunavir are not always publicly disclosed, companies with strong capabilities in complex organic synthesis and large-scale API production are potential candidates. Examples of global CMOs with such capabilities include Lonza, Catalent, and Siegfried.

The geographical distribution of API manufacturing for complex molecules like darunavir is global, with significant hubs in Europe, India, and China. These regions offer specialized chemical expertise, established infrastructure, and, in some cases, cost advantages.

What Are the Key Suppliers of the Finished PREZISTA Drug Product?

The finished PREZISTA drug product is manufactured by Johnson & Johnson's pharmaceutical segment, Janssen. This involves the formulation of the darunavir API into the final dosage form (tablets), packaging, and distribution.

• Janssen Pharmaceutical Companies: As the brand owner, Janssen is responsible for the formulation and manufacturing of the finished dosage form of PREZISTA. This may occur at Janssen's own manufacturing sites or through contracted CMOs specializing in finished drug product manufacturing. Janssen has manufacturing facilities located globally, including in the United States, Europe, and Asia.
• Packaging and Labeling Suppliers: The final packaging and labeling of PREZISTA are critical for product integrity and regulatory compliance. Suppliers in this segment range from companies providing blister packs and bottles to those involved in serialization and track-and-trace solutions. These suppliers are often specialized providers within the broader pharmaceutical supply chain.
• Logistics and Distribution Partners: Once manufactured, PREZISTA is distributed through a network of global logistics providers and wholesale distributors. These partners ensure the drug reaches pharmacies, hospitals, and patients while maintaining required temperature and handling conditions. Major pharmaceutical distributors like AmerisourceBergen, Cardinal Health, and McKesson play a significant role in this stage.

The manufacturing of finished drug products for PREZISTA is likely concentrated in regions with robust pharmaceutical manufacturing infrastructure and stringent quality control standards, such as North America and Europe.

What Is the Patent Landscape for PREZISTA?

The patent landscape for PREZISTA is crucial for understanding its market exclusivity and the potential for generic competition. Johnson & Johnson holds multiple patents covering the composition of matter, methods of use, and formulations of darunavir.

• Key Composition of Matter Patents: The foundational patent covering the darunavir molecule itself has expired or is nearing expiration in key markets. For instance, the primary U.S. composition of matter patent for darunavir has expired.
  • U.S. Patent No. 6,770,633 (issued August 3, 2004) covering darunavir and its salts.
• Formulation Patents: Additional patents protect specific formulations of PREZISTA, such as tablet formulations and co-formulations with other antiretroviral drugs. These patents can extend market exclusivity beyond the composition of matter patent.
  • Examples include patents covering specific crystalline forms or improved delivery systems.
• Method of Use Patents: Patents related to the method of treating HIV-1 infection with darunavir may also exist and could influence the timing of generic market entry, particularly for specific patient populations or treatment regimens.
• Orange Book Listings: In the United States, the Food and Drug Administration (FDA) maintains the "Approved Drug Products with Therapeutic Equivalence Evaluations" list, commonly known as the Orange Book. This publication details patents and exclusivity periods associated with approved drug products, including PREZISTA.
  • As of recent checks, multiple patents are listed for PREZISTA in the Orange Book, with varying expiration dates.
• Exclusivity Periods: Beyond patent protection, regulatory exclusivity periods granted by agencies like the FDA (e.g., New Chemical Entity exclusivity) and the European Medicines Agency (EMA) provide additional market protection.

The expiration of key patents, particularly the composition of matter patent, opens the door for generic manufacturers to seek approval to market their own versions of darunavir.

What Are the Regulatory Filings and Approvals Related to PREZISTA Manufacturing?

Regulatory filings and approvals are critical for ensuring the safety, efficacy, and quality of pharmaceutical products. For PREZISTA, these involve submissions to health authorities like the FDA and EMA.

• New Drug Application (NDA) / Marketing Authorisation Application (MAA): Johnson & Johnson submitted an NDA to the FDA and an MAA to the EMA for PREZISTA. These applications include extensive data on the drug's chemistry, manufacturing, and controls (CMC), preclinical and clinical studies, and proposed labeling.
• Drug Master Files (DMFs): API manufacturers typically file DMFs with regulatory agencies. A DMF contains confidential, detailed information about the facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of human drugs. The brand manufacturer can then reference these DMFs in their drug applications, allowing regulatory agencies to review the API manufacturing information without disclosing proprietary details to the brand holder.
  • Suppliers of darunavir API or critical intermediates may maintain DMFs with the FDA.
• Site Approvals and Inspections: Manufacturing facilities for both API and finished drug product must be approved by regulatory authorities. This involves rigorous inspections to ensure compliance with Current Good Manufacturing Practices (cGMP).
  • Any facility involved in the manufacturing of PREZISTA, whether for Janssen directly or as a contract manufacturer, must have passed such inspections.
• Post-Approval Changes: Any changes to the manufacturing process, suppliers, or facilities after initial approval require submission of a supplement to the original NDA or MAA and may necessitate re-inspection.
• Generic Drug Applications (ANDAs): As PREZISTA patents expire, generic manufacturers will file Abbreviated New Drug Applications (ANDAs) with the FDA. These applications demonstrate that the generic product is bioequivalent to the branded product and is manufactured in compliance with cGMP. The ANDA process requires referencing approved DMFs for the API.

The regulatory framework ensures that any manufacturer of darunavir, whether for the branded or generic product, adheres to strict quality standards throughout the supply chain.

How Do Generic Approvals Impact the PREZISTA Supply Chain?

The approval of generic versions of PREZISTA is expected to significantly alter its supply chain dynamics.

• Increased Competition: The entry of multiple generic darunavir products will lead to increased competition, primarily driven by price. This will likely put downward pressure on the pricing of PREZISTA.
• Diversification of API and Finished Product Manufacturing: Generic manufacturers will establish their own supply chains, often sourcing API from different manufacturers than those used by Janssen. This can lead to a broader base of API suppliers, potentially with a stronger presence in countries with established generic API manufacturing sectors (e.g., India).
  • Generic companies may partner with CMOs for both API synthesis and finished drug product manufacturing, further diversifying the manufacturing landscape.
• New Regulatory Filings and Inspections: Each generic manufacturer must obtain approval for its specific product, including demonstrating the quality and bioequivalence of its darunavir API and finished dosage form. This involves new DMF filings and ANDA submissions, and associated regulatory review and inspections of their manufacturing sites.
• Supply Chain Security and Quality Assurance: While competition increases, maintaining supply chain security and ensuring consistent product quality remains paramount. Regulatory oversight of generic manufacturers' facilities and processes will be critical.
• Potential for Supply Disruptions: The transition to a multi-generic market can, in the short term, introduce supply chain vulnerabilities if new generic manufacturers face unexpected production issues or if established players adjust their production levels in anticipation of generic entry.
• Impact on Excipient Suppliers: The demand for specific excipients used in darunavir formulations may shift as generic manufacturers adopt their own proprietary formulations, potentially leading to new suppliers for these components.

The entry of generics will create a more fragmented and price-sensitive market for darunavir, requiring agility from all participants in the supply chain.

Key Takeaways

• PREZISTA (darunavir) is manufactured by Janssen Pharmaceutical Companies (Johnson & Johnson), with API synthesis and finished product formulation involving a global network of suppliers and contract manufacturers.
• The patent landscape for darunavir includes composition of matter patents, formulation patents, and method of use patents, with key composition of matter patents having expired in major markets.
• Regulatory filings, including NDAs, MAAs, and DMFs, are essential for ensuring the quality and approval of PREZISTA manufacturing sites and processes.
• The approval of generic darunavir products is expected to increase competition, diversify the supplier base for both API and finished product, and drive price reductions.
• Generic entry necessitates rigorous regulatory oversight to maintain supply chain security and consistent product quality across multiple manufacturers.

Frequently Asked Questions

1. Which companies are approved to manufacture generic darunavir? Regulatory approval for generic darunavir is an ongoing process. As of recent data, specific generic manufacturers and their approved products vary by region. Companies that have received FDA approval for generic darunavir products include, but are not limited to, Teva Pharmaceuticals and Mylan (now Viatris). [1, 2]

2. Where are the primary manufacturing facilities for darunavir API located? Darunavir API manufacturing is global. Key regions with significant API production capabilities include India, China, and Europe. Specific manufacturing sites are often proprietary information held by API suppliers and referenced in Drug Master Files.

3. What is the primary difference between branded PREZISTA and its generic equivalents? The primary difference lies in the manufacturer and pricing. Generic equivalents contain the same active pharmaceutical ingredient (darunavir) at the same strength and are bioequivalent to branded PREZISTA. They are manufactured by different companies and are typically offered at a lower cost. [3]

4. How does the expiration of patents affect the supply chain for PREZISTA? Patent expiration allows other companies to seek regulatory approval to manufacture and market generic versions of PREZISTA. This leads to increased competition, the introduction of new API and finished product suppliers, and a general diversification of the supply chain.

5. Are there any known supply chain vulnerabilities for PREZISTA? As with any complex global pharmaceutical supply chain, potential vulnerabilities exist, including reliance on specific raw material sources, geopolitical factors affecting manufacturing regions, and potential disruptions due to regulatory changes or quality control issues at any supplier. However, the introduction of generic competition can also enhance supply chain resilience by diversifying manufacturing sources.

---

Citations

[1] U.S. Food & Drug Administration. (n.d.). Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book). Retrieved from https://www.fda.gov/drugs/developmentapprovalprocess/howdrugsaredevelopedandapproved/drugapprovalsanddatabases/ucm071436.htm [2] Viatris. (n.d.). Product Catalog. Retrieved from https://www.viatris.com/en/Products (Note: Specific product availability may vary and requires direct search within the catalog.) [3] U.S. Food & Drug Administration. (n.d.). Generic Drugs. Retrieved from https://www.fda.gov/drugs/generic-drugs