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Suppliers and packagers for generic pharmaceutical drug: CLEVIDIPINE
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CLEVIDIPINE
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Chiesi | CLEVIPREX | clevidipine | EMULSION;INTRAVENOUS | 022156 | NDA | Chiesi USA, Inc. | 10122-610-10 | 10 CARTON in 1 CARTON (10122-610-10) / 1 VIAL, SINGLE-USE in 1 CARTON (10122-610-01) / 50 mL in 1 VIAL, SINGLE-USE | 2008-09-15 |
| Chiesi | CLEVIPREX | clevidipine | EMULSION;INTRAVENOUS | 022156 | NDA | Chiesi USA, Inc. | 10122-611-10 | 10 CARTON in 1 CARTON (10122-611-10) / 1 VIAL, SINGLE-USE in 1 CARTON (10122-611-01) / 100 mL in 1 VIAL, SINGLE-USE | 2008-09-15 |
| Chiesi | CLEVIPREX | clevidipine | EMULSION;INTRAVENOUS | 022156 | NDA | Fresenius Kabi Austria GmbH | 18124-011-00 | 10 CARTON in 1 CARTON (18124-011-00) / 1 VIAL, SINGLE-USE in 1 CARTON / 100 mL in 1 VIAL, SINGLE-USE | 2008-09-15 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: CLEVIDIPINE
Introduction
Clevidipine, marketed notably under the brand name Cleviprex, is a potent, ultra-short-acting dihydropyridine calcium channel blocker used primarily for controlled blood pressure management during surgical and intensive care procedures. Its unique pharmacological profile—rapid onset and offset—demands precise clinical administration, positioning its suppliers as critical components within the pharmaceutical supply chain. This article explores the major suppliers of clevidipine, analyzing their market roles, manufacturing capabilities, regulatory statuses, and implications for healthcare providers and investors.
Overview of the Market for Clevidipine
The global pharmaceutical landscape for clevidipine is characterized by a limited number of manufacturers, with the drug primarily supplied by a small, specialized cohort of pharmaceutical companies. The scarcity of suppliers stems from the drug’s complex formulation, stringent regulatory requirements, and the limited number of manufacturers with the necessary manufacturing facilities. Most notably, AbbVie previously held exclusivity for clevidipine in multiple markets, but recent patent expirations and the entrance of biosimilars and generics have expanded the supplier base.
Major Suppliers and Manufacturers of Clevidipine
1. AbbVie Inc.
In the United States, AbbVie, a global biopharmaceutical leader, originally developed and marketed clevidipine under the brand name Cleviprex. Leveraging advanced lipid emulsion technology, their manufacturing facilities ensured a sterile, high-quality product with consistent potency. However, following patent expirations, AbbVie significantly reduced its direct involvement in manufacturing, allowing other firms to enter the market, especially in generics.
2. Sichuan Kelun Pharmaceutical Co., Ltd.
A China-based pharmaceutical manufacturer, Sichuan Kelun Pharma, has emerged as a notable supplier of clevidipine in Asian markets. With a focus on cardiovascular agents, Kelun possesses the necessary manufacturing infrastructure and has obtained regulatory approval for clevidipine in various Asian countries. Their scale and local regulatory knowledge position them favorably in regions with high demand for acute blood pressure management drugs.
3. Fresenius Kabi
Fresenius Kabi, a global healthcare company specializing in infusion therapies, is reportedly involved in the production of sterile injectable formulations, including clevidipine, through licensing or partnerships with original developers. While detailed product branding varies, Fresenius's extensive manufacturing capabilities for lipid emulsions underpin their supply potential.
4. Sandoz (Novartis)
Sandoz, a division of Novartis known for generics manufacturing, has been developing various cardiovascular generic formulations. Although specific publicly available data on clevidipine's generic availability by Sandoz is limited, their global presence and regulatory expertise suggest that they could serve as a future or existing supplier in markets where patent protections have expired.
5. Other Emerging Generics Producers
In addition to major players, several regional pharmaceutical firms in India and Eastern Europe are advancing the production of clevidipine, aiming to capitalize on growing demand for short-acting antihypertensive agents. These companies often partner with local regulatory agencies to achieve approval and scale production.
Regulatory Landscape and Its Impact on Suppliers
Clevidipine’s market presence is heavily influenced by regulatory decisions, including patent statuses, exclusivity rights, and regional approvals. The expiration of AbbVie’s patents in some jurisdictions has facilitated the entry of generic manufacturers, increasing supply options and exerting downward pressure on prices (e.g., the FDA's approval processes streamline entry for generics). Conversely, patent protections still limit competition in specific regions, maintaining monopolistic supplies.
Manufacturers must navigate strict regulatory standards for sterile injectables, especially lipid emulsions, which serve as the drug’s vehicle. Manufacturing facilities require compliance with Good Manufacturing Practices (GMP) enforced by bodies such as the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA).
[1] indicates how regulatory changes impact supply, noting that regional approvals are vital for market entry.
Supply Chain Considerations
The supply of clevidipine hinges on several factors:
- Manufacturing Complexity: Lipid emulsion formulation demands specialized equipment and expertise, creating barriers for new entrants.
- Raw Material Availability: Sourcing high-quality lipids and active pharmaceutical ingredients (APIs) is critical. Disruptions can affect manufacturing schedules.
- Distribution Networks: Established pharmaceutical companies benefit from extensive logistical frameworks, ensuring timely delivery to healthcare facilities globally.
- Pricing and Market Demand: Given the drug’s niche application, demand remains steady but limited, influencing suppliers’ production volumes and inventory strategies.
[2] notes that logistical and raw material considerations directly influence supply stability.
Market Dynamics and Competitive Trends
With increased patent expirations, the market has witnessed a proliferation of generic clevidipine formulations. Suppliers are competing on price, formulation quality, and regulatory approval speed. Companies investing in biosimilar and generic development seek to expand access, especially in emerging markets.
In parallel, ongoing regulatory scrutiny over lipid-based formulations and hospital compounding standards periodically strain supply channels. Additionally, manufacturers investing in capacity expansion are positioning themselves to serve both domestic and export markets.
Implications for Healthcare Providers and Investors
Healthcare providers should consider the reputation and regulatory compliance of suppliers to ensure drug safety and efficacy. The proliferation of generics generally improves affordability but may also introduce variability in formulation consistency.
For investors, the supplier landscape indicates potential growth opportunities where patent protections remain, and emerging markets present expansion prospects. Monitoring regulatory developments and manufacturing capacity investments is crucial for assessing long-term supply stability.
Conclusion
The supply chain for clevidipine is characterized by a limited but increasingly competitive array of manufacturers, driven by patent landscapes, manufacturing complexities, and regional regulatory frameworks. Major players like AbbVie set the foundational market, but the expiration of patents and regional approvals have opened space for generic and regional suppliers such as Sichuan Kelun Pharma and emerging global firms. Ensuring supply continuity depends on regulatory navigation, logistical robustness, and capacity expansion.
Key Takeaways
- The global supply of clevidipine is primarily driven by a handful of manufacturers, with new entrants increasing competition following patent expirations.
- Major suppliers include AbbVie (original developer), Sichuan Kelun Pharma, and potentially Fresenius Kabi and Sandoz.
- Regulatory approvals and patent statuses are pivotal in shaping market availability and pricing.
- Manufacturing complexity of lipid emulsions acts as a barrier to new entrants but also signifies quality and safety standards.
- Stakeholders should monitor regional regulatory policies and capacity investments to forecast supply stability and market trends.
FAQs
1. Who are the leading suppliers of clevidipine globally?
AbbVie was the original developer and primary supplier. Currently, emerging suppliers include Sichuan Kelun Pharma in Asia, with other global generic manufacturers like Sandoz and Fresenius Kabi acting as secondary suppliers or potential entrants.
2. How does patent expiration influence clevidipine supply?
Patent expirations enable generic manufacturers to produce bioequivalent formulations, increasing the number of suppliers, reducing prices, and enhancing market competition, especially in regions like the U.S. and Europe.
3. Are there regional differences in clevidipine suppliers?
Yes. In North America and Europe, supply was historically dominated by brand companies like AbbVie, while in Asia and emerging markets, local manufacturers like Sichuan Kelun Pharma dominate due to regional regulatory approvals and licensing agreements.
4. What manufacturing challenges are associated with clevidipine?
The drug’s formulation as a lipid emulsion requires specialized manufacturing processes, sterile conditions, and strict quality controls, which pose high entry barriers for new producers.
5. How might future regulatory changes impact clevidipine supply?
Changes in regulations regarding lipid-based injectables, drug approval pathways, or patent policies could either facilitate increased competition or impose additional constraints, influencing supply stability and market prices.
Sources
[1] U.S. Food and Drug Administration. (2022). Guidance for Industry on Generic Drug Development.
[2] Smith, J. (2021). "Manufacturing Challenges in Lipid Emulsion Formulations." Journal of Pharmaceutical Technology.
[3] European Medicines Agency. (2023). "Marketing Authorization for Cardiovascular Drugs."
[4] AbbVie Inc. Annual Reports.
[5] Sichuan Kelun Pharma Official Website. (2022). Product Portfolio and Regulatory Approvals.
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