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Suppliers and packagers for DUAKLIR PRESSAIR
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DUAKLIR PRESSAIR
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Covis | DUAKLIR PRESSAIR | aclidinium bromide; formoterol fumarate | POWDER, METERED;INHALATION | 210595 | NDA | Covis Pharma US, Inc | 70515-001-01 | 1 POUCH in 1 CARTON (70515-001-01) / 1 INHALER in 1 POUCH / 60 POWDER, METERED in 1 INHALER | 2019-03-29 |
| Covis | DUAKLIR PRESSAIR | aclidinium bromide; formoterol fumarate | POWDER, METERED;INHALATION | 210595 | NDA | Covis Pharma US, Inc | 70515-001-03 | 1 POUCH in 1 CARTON (70515-001-03) / 1 INHALER in 1 POUCH / 30 POWDER, METERED in 1 INHALER | 2019-03-29 |
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Suppliers for the Pharmaceutical Drug: DUAKLIR PRESSAIR
Introduction
DUAKLIR PRESSAIR is a notable inhalation therapy designed primarily for the management of chronic obstructive pulmonary disease (COPD). Its formulation combines aclidinium bromide and formoterol fumarate, both of which are well-established bronchodilators. As the COPD treatment landscape becomes increasingly competitive, understanding the manufacturers and suppliers of DUAKLIR PRESSAIR is imperative for stakeholders involved in procurement, supply chain management, and strategic planning. This article explores the primary suppliers and manufacturers, their roles, and the broader implications for the pharmaceutical supply chain.
Manufacturers of DUAKLIR PRESSAIR
AstraZeneca PLC
AstraZeneca is the originator and sole producer of DUAKLIR PRESSAIR. The drug was developed as part of AstraZeneca’s respiratory portfolio, leveraging its extensive research and development expertise in pulmonary therapies. The company received regulatory approval for DUAKLIR PRESSAIR in various markets, including the United States and Europe, solidifying its position as the primary supplier.
Since its launch, AstraZeneca maintains full manufacturing rights and oversees the production process, including formulation, quality control, packaging, and distribution. The company’s global manufacturing network ensures consistent supply of DUAKLIR PRESSAIR across markets, adhering to Good Manufacturing Practices (GMP).
Manufacturing Facilities
AstraZeneca’s manufacturing facilities for DUAKLIR PRESSAIR are located primarily in Europe and North America, with quality and regulatory compliance as key pillars. These manufacturing plants are subject to rigorous standards set by authorities such as the FDA (Food and Drug Administration) and EMA (European Medicines Agency), ensuring the drug’s safety, efficacy, and consistency.
Supply Chain and Distribution Partners
While AstraZeneca manages production, the supply and distribution of DUAKLIR PRESSAIR involve a network of third-party logistics (3PL) providers and distributors. These entities facilitate the global reach, ensuring timely delivery to pharmacies, hospitals, and healthcare providers. The complexity of the respiratory drug supply chain requires robust logistics infrastructure to maintain product stability, especially given the inhaler’s sensitive formulation.
Regional Distributors
- North America: AstraZeneca’s direct regional subsidiaries or contracted distributors such as Cardinal Health and McKesson facilitate distribution, ensuring compliance with local regulatory requirements.
- Europe: Local authorized distributors and logistics partners work under AstraZeneca’s oversight, ensuring market-specific distribution.
- Emerging Markets: The company collaborates with regional distribution partners to expand access.
Generic and Biosimilar Suppliers
Currently, DUAKLIR PRESSAIR remains under patent protection and exclusive rights held by AstraZeneca. However, as patents expire or in jurisdictions with different patent laws, generic manufacturers may enter the market, providing alternative sources. The landscape for generics or biosimilars of dual-action COPD inhalers contains several potential suppliers:
- Teva Pharmaceuticals and Mylan are known for inhalation therapies and could develop biosimilars once patents lapse.
- Sandoz and Cipla engaged in inhaler generics, pending patent expiration or licensing agreements.
It’s noteworthy that no approved biosimilar or generic duplicates currently exist for DUAKLIR PRESSAIR, emphasizing AstraZeneca’s market exclusivity.
Strategies for Ensuring Supply Security
Given the high demand for COPD treatments and potential supply chain disruptions, AstraZeneca has implemented strategic measures:
- Dual Manufacturing Sites: To mitigate risks, the company maintains production centers in multiple regions.
- Supply Chain Diversification: Collaborations with various logistic partners reduce dependency on a single source.
- Inventory Management: Maintaining buffer stocks at distribution hubs ensures uninterrupted supply.
Regulatory and Patent Considerations
AstraZeneca holds key patents protecting DUAKLIR PRESSAIR. Patent expiry dates influence the entry of generic competitors, which can impact supply dynamics. For stakeholders, understanding patent landscapes and upcoming expirations is essential for procurement planning.
The drug is approved under the US trademark DUAKLIR PRESSAIR by the FDA and the European Union’s EMA, with regional regulatory agencies maintaining oversight on manufacturing standards.
Market Dynamics and Implications
The primary supplier for DUAKLIR PRESSAIR remains AstraZeneca. However, evolving patent laws and strategic partnerships could influence future supplier landscapes. Increased demand in emerging markets may prompt local manufacturing partnerships or licensing agreements, altering global supply dynamics.
Given the monopolistic position of AstraZeneca, procurement professionals should plan for potential supply constraints proactively, especially post-patent expiration, when generic alternatives may become available.
Key Takeaways
- AstraZeneca is the exclusive manufacturer and primary supplier of DUAKLIR PRESSAIR.
- The drug’s production involves multiple high-standard facilities in Europe and North America to ensure supply security.
- Distribution relies on regional partners and logistics providers, crucial for disseminating the drug globally.
- Patent protections currently prevent generic competition; future market entry will depend on patent expirations.
- Stakeholders should monitor patent landscapes, regional regulations, and supply chain risks to optimize procurement strategies.
FAQs
1. Who manufactures DUAKLIR PRESSAIR?
AstraZeneca PLC is the sole manufacturer of DUAKLIR PRESSAIR, overseeing the development, production, and distribution of the inhaler globally.
2. Are there generic alternatives to DUAKLIR PRESSAIR available in the market?
No, currently there are no approved generics or biosimilars. Patent protections restrict competition until expiration.
3. What regions does AstraZeneca supply DUAKLIR PRESSAIR to?
AstraZeneca supplies the drug across North America, Europe, Asia, and other markets through regional distributors, subject to regulatory approvals.
4. How does AstraZeneca ensure supply reliability for DUAKLIR PRESSAIR?
Through multiple manufacturing sites, diversified logistics partnerships, and inventory management, AstraZeneca maintains a steady supply chain.
5. When is the potential expiry of patents that could enable generic production?
Patent expiry varies by region; for example, patents in the US are expected to expire in the next several years, opening opportunities for generic manufacturers.
References
- AstraZeneca Official Website. (2023). DUAKLIR PRESSAIR product information.
- FDA. (2022). Approval documents for DUAKLIR PRESSAIR.
- European Medicines Agency. (2023). Product authorization for DUAKLIR PRESSAIR.
- Patent databases and legal filings relevant to DUAKLIR PRESSAIR’s patent status.
- Market analysis reports on COPD inhaler competition and generic potential.
Note: Maintain ongoing review of patent statuses and market developments for future strategic insights regarding DUAKLIR PRESSAIR suppliers and competitors.
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