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Suppliers and packagers for kaletra
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kaletra
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Abbvie | KALETRA | lopinavir; ritonavir | SOLUTION;ORAL | 021251 | NDA | AbbVie Inc. | 0074-3956-46 | 1 BOTTLE in 1 CARTON (0074-3956-46) / 160 mL in 1 BOTTLE | 2010-06-18 |
| Abbvie | KALETRA | lopinavir; ritonavir | TABLET;ORAL | 021906 | NDA | AbbVie Inc. | 0074-0522-60 | 60 TABLET, FILM COATED in 1 BOTTLE (0074-0522-60) | 2010-06-18 |
| Abbvie | KALETRA | lopinavir; ritonavir | TABLET;ORAL | 021906 | NDA | AbbVie Inc. | 0074-3008-60 | 60 TABLET, FILM COATED in 1 BOTTLE (0074-3008-60) | 2020-04-08 |
| Abbvie | KALETRA | lopinavir; ritonavir | TABLET;ORAL | 021906 | NDA | AbbVie Inc. | 0074-4014-12 | 120 TABLET, FILM COATED in 1 BOTTLE (0074-4014-12) | 2020-04-08 |
| Abbvie | KALETRA | lopinavir; ritonavir | TABLET;ORAL | 021906 | NDA | AbbVie Inc. | 0074-6799-22 | 120 TABLET, FILM COATED in 1 BOTTLE (0074-6799-22) | 2010-06-18 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: Kaletra
Introduction
Kaletra, a combination antiretroviral therapy comprising lopinavir and ritonavir, is a widely prescribed medication for treating HIV/AIDS. Since its approval by the U.S. Food and Drug Administration (FDA) in 2000, Kaletra has been pivotal in managing HIV infections, especially in regions with high prevalence rates. The global supply chain for Kaletra involves a mixture of original patent-holders, generic manufacturers, and regional suppliers. Understanding these sources is essential for stakeholders involved in procurement, distribution, and healthcare delivery.
Original Patent and Initial Supply Chain
Abbott Laboratories (now part of AbbVie) originally developed Kaletra, securing patent rights and regulatory approvals in multiple markets. Their manufacturing facilities in the United States and international locations initially supplied Kaletra globally (1). Abbott's proprietary formulation and manufacturing processes ensured high-quality standards, positioning the company as the primary supplier during the initial commercialization phase.
Global Manufacturing and Distribution Dynamics
Post-patent expiration in various jurisdictions, the supply landscape for Kaletra expanded significantly, driven by the entry of generic manufacturers. The following sections detail primary suppliers, including patented and generic sources.
Original Patent Holders and Proprietary Supply
AbbVie remains the key patent holder for Kaletra in several markets, overseeing high-standard manufacturing and maintaining control over exclusivity periods through patent protections and regulatory data exclusivity rights. The company supplies Kaletra through its network of manufacturing plants, primarily in the United States, Europe, and emerging markets (2).
AbbVie's robust quality assurance protocols ensure compliance with international pharmacopeial standards, facilitating global distribution via direct sales or authorized distributors. Their strategic partnerships extend to major healthcare providers and procurement agencies, especially in high-income countries and regions where patent protections are upheld.
Generic Manufacturers and Market Entry Post-Patent Expiry
Following patent expiry—typically after 10-12 years—generic drug manufacturers worldwide began producing Kaletra, significantly lowering costs and improving access. Key players include:
- Zhejiang Hisun Pharmaceutical (China)
- MingChem Healthcare (India)
- Hetero Labs (India)
- Aurobindo Pharma (India)
- Cipla (India)
These companies have obtained regulatory approvals in various countries through abbreviated new drug application (ANDA) processes, ensuring bioequivalence with the innovator product. They supply Kaletra either as branded generics or under international non-proprietary names (INNs) for local markets (3).
Indian manufacturers, notably Cipla and Aurobindo, dominate the generic supply chain due to their early market entry and extensive API (Active Pharmaceutical Ingredient) production capabilities. Their manufacturing facilities adhere to Good Manufacturing Practices (GMP), ensuring quality for both domestic and export markets.
Chinese firms such as Zhejiang Hisun have also entered the market, aligning with China's push into global pharmaceutical manufacturing. This diversification increases supply resilience and reduces dependency on a single source.
Regional Suppliers and Public Sector Procurement
Developing countries—particularly in Africa, Latin America, and Asia—commonly rely on regional suppliers and generic manufacturers for Kaletra. WHO prequalified suppliers such as MingChem Healthcare and Hetero Labs supply bulk pharmaceuticals to programs like the Global Fund and UNITAID, ensuring access to affordable HIV treatments (4).
Various national procurement agencies—such as India's CDSCO, Brazil's ANVISA, and African regional procurement bodies—authorize specific manufacturers based on local regulatory standards. These agencies often negotiate directly with manufacturers to secure volume discounts and ensure consistent supply.
Contract Manufacturing and Licensing Agreements
AbbVie's licensing agreements with generic manufacturers have facilitated the expansion of access. For example, AbbVie's voluntary licensing program with Indian producers like Cipla, Hetero, and Aurobindo allows them to produce Kaletra for select low- and middle-income countries (5). This approach ensures quality control and supports supply stability.
Additionally, contract manufacturing organizations (CMOs) serve as intermediaries, producing Kaletra under license or contract for brand-name companies. These CMOs often operate in India, China, and other manufacturing hubs, offering scalable production capacity.
Supply Chain Challenges and Considerations
Although multiple suppliers exist, several factors affect the Kaletra supply chain:
- Regulatory compliance: Suppliers must meet WHO-GMP standards to access global markets.
- Patent and licensing status: Patent protections in certain markets limit generic manufacturing.
- Manufacturing capacity: The COVID-19 pandemic exposed vulnerabilities in supply chains; disruptions impacted production and distribution.
- Quality assurance: Ensuring bioequivalence and consistent API quality remains a priority, especially for generics.
Efforts by international organizations aim to improve supply chain resilience by encouraging diversified manufacturing sources and fostering technology transfer collaborations.
Future Outlook and Emerging Suppliers
The ongoing patent cliffs and increased emphasis on affordable HIV treatment are likely to sustain a competitive landscape for Kaletra supply. Emerging manufacturers in Latin America and Africa are increasingly seeking prequalification status from WHO. Moreover, biosimilar and fixed-dose combination innovations may influence Kaletra's role in future HIV management.
Research into alternative APIs and novel formulations may further diversify supply options, reducing reliance on a handful of primary manufacturers.
Key Takeaways
- Original supplier: Abbott/AbbVie has historically been the primary source of Kaletra, controlling proprietary production through patents and manufacturing quality standards.
- Generic expansion: Post-patent expiry, multiple Indian and Chinese manufacturers have become key suppliers, offering affordable alternatives globally.
- Procurement strategies: International agencies and national governments strategically procure Kaletra from WHO-prequalified manufacturers, ensuring quality and supply stability.
- Licensing agreements: AbbVie's voluntary licensing has facilitated broader production in low-income regions, improving access.
- Supply chain resilience: Diversification of suppliers, adherence to GMP standards, and international cooperation remain critical to ensuring uninterrupted access to Kaletra.
FAQs
1. Who are the primary current suppliers of Kaletra?
Major suppliers include AbbVie (patented formulations) and generic manufacturers like Cipla, Hetero Labs, Aurobindo Pharma, and Zhejiang Hisun, especially in markets post-patent expiry.
2. How does patent status influence Kaletra supply options?
Patent protections restrict generic manufacturing in certain regions, limiting supply options until patent expiry or licensing agreements enable production by licensed manufacturers.
3. What agencies verify the quality of generic Kaletra products?
The World Health Organization (WHO) prequalifies manufacturing facilities, and national regulators like India's CDSCO and Brazil's ANVISA conduct rigorous reviews and inspections.
4. Are there regional differences in Kaletra supply sources?
Yes. High-income countries tend to rely on brand-name supplies from AbbVie, while low- and middle-income countries depend more heavily on WHO-prequalified generics from India and China.
5. What future trends could impact Kaletra's supply chain?
Patent expirations, development of new HIV therapies, biosimilars, and international licensing initiatives are key factors shaping future supply dynamics.
References
- Abbott Laboratories. (2000). FDA approval documents for Kaletra.
- AbbVie. (2022). Corporate licensing and manufacturing disclosures.
- World Health Organization. (2021). List of prequalified medicinal products.
- Global Fund. (2022). Procurement reports for HIV medicines.
- Medicines Patent Pool. (2021). Licensing agreements for Kaletra.
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