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Suppliers and packagers for aricept
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aricept
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Eisai Inc | ARICEPT | donepezil hydrochloride | TABLET;ORAL | 020690 | NDA | Eisai Inc. | 62856-245-30 | 30 TABLET, FILM COATED in 1 BOTTLE (62856-245-30) | 1996-11-25 |
| Eisai Inc | ARICEPT | donepezil hydrochloride | TABLET;ORAL | 020690 | NDA | Eisai Inc. | 62856-246-30 | 30 TABLET, FILM COATED in 1 BOTTLE (62856-246-30) | 1996-11-25 |
| Eisai Inc | ARICEPT | donepezil hydrochloride | TABLET;ORAL | 022568 | NDA | Eisai Inc. | 62856-247-30 | 30 TABLET, FILM COATED in 1 BOTTLE (62856-247-30) | 2010-07-23 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: Aricept
Introduction
Aricept (donepezil hydrochloride) is a widely prescribed medication used primarily for the treatment of Alzheimer's disease. Its significance in neurodegenerative disorder management has made it a high-demand pharmaceutical compound. As the market for cognitive enhancers expands, understanding the supplier landscape for Aricept is critical for stakeholders, including healthcare providers, pharmaceutical companies, and investors. This report offers a comprehensive overview of current suppliers, manufacturing sources, and the strategic considerations shaping the supply chain of Aricept.
Manufacturers of Aricept
Original Patent and Early Production
Aricept was developed by Eisai Co., Ltd., in collaboration with Pfizer Inc., who held the original patent. The drug received FDA approval in 1996, marking it as one of the earliest approved acetylcholinesterase inhibitors for Alzheimer's disease. Initially, Eisai was the sole producer of Aricept, controlling patent rights and manufacturing processes. Their global distribution network ensured widespread availability.
Generic Manufacturers Post-Patent Expiry
The patent for Aricept expired in 2010 in the United States, prompting multiple pharmaceutical firms to enter the market with generic versions. Key generic suppliers include:
- Teva Pharmaceutical Industries Ltd.: One of the largest producers of generic donepezil, Teva maintains an extensive manufacturing footprint and supplies to numerous global markets.
- Mylan N.V. (now part of Viatris): Offers generic donepezil tablets, adhering to strict quality and regulatory standards.
- Actavis (now part of Allergan, acquired by AbbVie): Supplies various formulations of donepezil, emphasizing cost-effective generics.
- Dr. Reddy's Laboratories: Provides quality-assured generic donepezil, with a significant presence in emerging markets.
- Sun Pharmaceutical Industries: Produces and distributes donepezil generics across multiple regions.
Manufacturing Locations
Generic manufacturers typically produce donepezil in facilities certified by regulatory agencies such as the FDA, EMA, or the WHO. Manufacturing sites are predominantly situated in:
- India (e.g., Dr. Reddy's, Sun Pharma)
- Israel (e.g., Teva)
- United States and European countries for certain formulations
Establishing manufacturing locations in these regions allows companies to reduce costs while maintaining compliance with regulatory standards.
Supply Chain Dynamics and Key Suppliers
Active Pharmaceutical Ingredient (API) Suppliers
The core of donepezil production hinges on the supply of high-purity API. Major suppliers include:
- Hikal Ltd. (India): Provides pharmaceutical-grade APIs, including donepezil.
- Jubilant Life Sciences: Supplies intermediates and active pharmaceutical ingredients.
- LKT Laboratories: Specializes in research chemicals and APIs, including donepezil.
Emerging suppliers from India and China continue to expand their role, driven by competitive pricing and high-quality standards.
Excipients and Formulation Components
Formulating Aricept tablets involves maritime excipients such as microcrystalline cellulose, starch, and magnesium Stearate. Leading excipient suppliers include:
- DuPont Nutrition & Health
- Avicenna Pharma
- Colorcon Inc.
Consistent supply and quality of excipients are vital for maintaining drug stability and bioavailability.
Distributor Networks
Major pharmaceutical distributors like McKesson, Cardinal Health, and AmerisourceBergen facilitate the distribution of Aricept and its generics across healthcare institutions globally. Their logistics frameworks ensure steady availability amidst fluctuating demand.
Market Trends and Strategic Implications
Patent Expiry and Market Competition
The loss of patent protection in 2010 dramatically increased the number of suppliers, intensifying price competition. Generic manufacturers now exert considerable influence over global availability and pricing, which benefits healthcare payers but challenges original patent holders.
Supply Security Concerns
Recent years have seen disruptions in supply chains due to manufacturing issues, regulatory interventions, or geopolitical factors affecting regions like India and China. Companies are increasingly seeking diversified sourcing strategies and establishing backup manufacturing facilities.
Regulatory Frameworks
Suppliers must comply with stringent regulatory standards. The quality assurance and GMP (Good Manufacturing Practice) compliance of suppliers like Teva and Mylan reinforce their market dominance. Conversely, regulatory actions against certain manufacturers can disrupt supply.
Future Outlook
Emerging Suppliers and Innovations
Biotech companies exploring cholinesterase inhibitors with improved efficacy may impact the competitive landscape. Additionally, continuous advancements in process engineering may enable existing suppliers to reduce costs or enhance supply reliability.
Supply Chain Resilience Strategies
Manufacturers and distributors are increasingly investing in supply chain resilience by:
- Collaborating with multiple API and excipient suppliers
- Establishing regional manufacturing hubs
- Implementing digital supply chain monitoring systems
Such strategies aim to mitigate risks and ensure continuous supply, especially amidst global disruptions like pandemics.
Conclusion
The supplier landscape for Aricept encompasses both original developers and a broad network of generic manufacturers. Leading suppliers like Teva, Mylan, and Dr. Reddy's dominate the market, with API sourcing primarily from India and China. The post-patent environment has fostered a competitive but complex supply chain landscape that demands strategic risk management. As demand persists and generic competition intensifies, supply chain agility and regulatory compliance will be critical to maintaining consistent availability of this vital Alzheimer's therapy.
Key Takeaways
- The original patent holder, Eisai, initially controlled Aricept supply, but generics dominate post-patent expiration.
- Major generic suppliers include Teva, Mylan/Viatris, Dr. Reddy's, Sun Pharma, and Allergan (AbbVie).
- API sourcing primarily occurs in India and China, with quality and regulatory compliance being essential.
- Supply chain risks are mitigated through diversified sourcing and regional manufacturing hubs.
- Ongoing market competition and regulatory dynamics shape the future supply of Aricept.
FAQs
Q1: Who are the main generic manufacturers of Aricept?
Main generic producers include Teva Pharmaceutical Industries, Mylan (Viatris), Dr. Reddy's Laboratories, Sun Pharmaceutical Industries, and Allergan (AbbVie).
Q2: Where is the active pharmaceutical ingredient (API) for Aricept sourced?
Primarily from manufacturers in India and China, with some suppliers in Israel and the United States, all adhering to international quality standards.
Q3: How has patent expiration affected the supply landscape of Aricept?
Patent expiry in 2010 led to a surge in generic manufacturers, increasing supply options but also intensifying price competition and supply chain complexity.
Q4: What regulatory standards do suppliers for Aricept need to meet?
Suppliers must comply with GMP standards set by authorities such as the FDA, EMA, or WHO, ensuring product safety, quality, and efficacy.
Q5: What strategic measures are companies adopting to ensure a stable supply of Aricept?
Companies are diversifying API sources, establishing regional manufacturing facilities, and implementing monitoring systems to prevent supply disruptions.
Sources
[1] U.S. Food and Drug Administration (FDA). Aricept (donepezil hydrochloride) Tablets.
[2] GlobalData. Market Report on Alzheimer’s Disease Drugs.
[3] Statista. Global Sales of Donepezil and Generics.
[4] Pharmaceutical Technology. Supply Chain Strategies in Pharma Industry.
[5] India Brand Equity Foundation (IBEF). Indian Pharmaceutical Industry Overview.
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