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Suppliers and packagers for generic pharmaceutical drug: VISMODEGIB
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VISMODEGIB
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Genentech | ERIVEDGE | vismodegib | CAPSULE;ORAL | 203388 | NDA | Genentech, Inc. | 50242-140-01 | 1 BOTTLE, PLASTIC in 1 CARTON (50242-140-01) / 28 CAPSULE in 1 BOTTLE, PLASTIC | 2012-01-30 |
| Genentech | ERIVEDGE | vismodegib | CAPSULE;ORAL | 203388 | NDA | Genentech, Inc. | 50242-140-86 | 1 BOTTLE, PLASTIC in 1 CARTON (50242-140-86) / 28 CAPSULE in 1 BOTTLE, PLASTIC | 2012-01-30 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: Vismodegib
Introduction
Vismodegib, marketed under brand names such as Erivedge, is an oral medication primarily used for the treatment of advanced basal cell carcinoma (BCC), including metastatic and locally advanced cases. As a Hedgehog pathway inhibitor, vismodegib gained approval from the U.S. Food and Drug Administration (FDA) in 2012, marking a significant advancement in targeted oncology therapy. Due to its specialized nature and market demand, the supply chain ecosystem for vismodegib involves a complex network of manufacturers, authorized distributors, and raw material suppliers. This comprehensive analysis explores the key suppliers, manufacturing landscape, and the critical factors shaping the supply of vismodegib in the pharmaceutical industry.
Manufacturers of Vismodegib
1. Genentech (A Roche Subsidiary)
Genentech developed and commercialized vismodegib following its clinical success, securing FDA approval. As the original patent holder and marketer, Genentech (part of Roche) remains the primary supplier of the drug in the United States and several other regions. Roche's extensive global distribution network ensures drug availability in major markets, though the supply chain's specifics are often proprietary.
2. Mylan (Now part of Viatris)
While Mylan was a key generic pharmaceutical manufacturer, it did not produce vismodegib initially due to patent protections. Post-patent expiry, generic manufacturers can enter the market, which often influences availability and pricing. As of 2023, no generic versions of vismodegib have been broadly approved or marketed, maintaining Genentech as the primary source.
3. Other Potential Manufacturers
Given the high cost of drug development and regulatory hurdles, few manufacturers have entered the vismodegib supply chain. However, as patent exclusivity nears expiration, several Chinese and Indian generic pharmaceutical companies could seek approval, pending regulatory pathways and economic viability. No widespread generic manufacturing exists currently, but market anticipation exists.
Raw Material and Active Pharmaceutical Ingredient (API) Suppliers
1. Synthetic Chemistry Suppliers
Vismodegib's chemical synthesis involves complex processes requiring high-purity intermediates and advanced organic chemistry capabilities. Most APIs are produced by specialized contract manufacturing organizations (CMOs) with expertise in complex small-molecule synthesis.
2. Asian API Manufacturers
India, China, and South Korea dominate the API manufacturing landscape due to cost efficiency and technological capacity. Companies such as Zhejiang Huahai Pharmaceutical (China) and Dr. Reddy’s Laboratories (India) have large-scale chemical synthesis facilities capable of producing compounds similar to vismodegib APIs. However, confirmation of direct API supply for vismodegib from these entities is limited by confidentiality and regulatory filings.
3. Quality and Regulatory Compliance
API suppliers must adhere to good manufacturing practices (GMP) and obtain regulatory approvals from agencies such as the FDA, EMA, or other national authorities. Limited data suggests that Roche sources APIs from qualified CMOs with experience in high-value oncology drugs, ensuring consistent quality and supply.
Distribution and Supply Chain Dynamics
1. Authorized Distributors
Genentech/Roche employs a network of authorized distributors to route vismodegib to hospitals, specialty pharmacies, and healthcare providers. These distributors are typically large logistics firms with specialty pharmaceuticals experience, ensuring cold chain and storage requirements are maintained.
2. Supply Chain Challenges
Limited manufacturing capacity, complex synthesis pathways, and strict regulatory controls limit rapid scaling of vismodegib production. Supply disruptions may arise from API shortages, manufacturing issues, or regulatory delays in expanding manufacturing capacity.
3. Global Market Access
While approved in major markets (United States, European Union, Japan), geographic access depends on licensing agreements, import/export regulations, and local approval processes. Limited regional manufacturing facilities can create supply bottlenecks, especially in emerging markets.
Patent and Regulatory Impact on Supply
Vismodegib's initial patent protection and exclusivity granted Roche delayed generic entry. Once patents expire, multiple manufacturers can apply for approval, increasing supply options. Patent litigations and regulatory hurdles often determine how quickly generics dominate the market, affecting overall supply stability and pricing.
Future Outlook
1. Market Penetration of Generics
As patent exclusivity diminishes (expected around 2024-2025), generic manufacturers from India and China could significantly enhance supply capacity, reducing costs and increasing accessibility.
2. Contract Manufacturing Expansion
Existing pharmaceutical firms may expand or diversify their manufacturing capacities via third-party CMOs, ensuring supply resilience amidst rising demand, especially considering the therapy's relevance in hereditary syndromes and research settings.
3. Supply Chain Optimization
Improved global regulatory harmonization, supply chain transparency, and advanced manufacturing techniques will likely mitigate current bottlenecks and ensure broader availability.
Key Considerations for Stakeholders
- Pharmaceutical companies should closely monitor patent timelines and licensing opportunities to secure or expand supply channels.
- Investors in biotechnology should evaluate manufacturing capacity expansion plans of both original patent holders and emerging generics.
- Healthcare providers must be aware of supply chain limitations impacting drug availability, especially in urgent treatment scenarios.
- Regulators should facilitate streamlined approval processes for generics to improve supply stability.
Key Takeaways
- Primary Manufacturer: Roche's Genentech remains the main supplier of vismodegib, with limited competition due to patent protections.
- Potential for Generics: Patent expiration (anticipated circa 2024) opens avenues for multiple manufacturers—primarily in India and China—to enter the market.
- Supply Chain Factors: API sourcing from Asian CMOs and sophisticated distribution networks underpin product availability but face challenges related to capacity and quality assurance.
- Regulatory Landscape: Approval pathways for generics and biosimilars will influence future supply stability and pricing.
- Strategic Implications: Stakeholders must anticipate market shifts, patent expiries, and manufacturing capacity expansions to make informed supply and investment decisions.
FAQs
1. When will generic versions of vismodegib become available?
Generic versions are expected to enter the market around the patent expiry date, anticipated circa 2024–2025, subject to regulatory approvals and patent litigation outcomes.
2. Which companies are likely to manufacture generic vismodegib?
Indian pharmaceutical firms such as Dr. Reddy’s Laboratories and Cipla, and Chinese manufacturers with API production capacity, are primary candidates for generic production upon patent expiry.
3. Are there regional differences in vismodegib supply?
Yes. While Roche supplies the drug in many markets, developing regions may experience delays due to regulatory hurdles, limited local manufacturing, or import restrictions.
4. How does API sourcing impact the supply of vismodegib?
API sourcing from Asian CMOs influences supply stability and cost. High-quality manufacturing and regulatory compliance are critical to prevent shortages and quality issues.
5. What should healthcare providers consider regarding vismodegib availability?
Providers should monitor supply chains, especially during patent transitions, to ensure uninterrupted patient access and consider alternative treatments if shortages occur.
References
[1] U.S. Food and Drug Administration. (2012). FDA approves Erivedge for advanced basal cell carcinoma.
[2] Roche. (2012). Roche announces approval of Vismodegib for advanced basal cell carcinoma.
[3] Indian Pharma News. (2023). Potential generics enter the pipeline as patent approaches expiry.
[4] European Medicines Agency. (2012). Summary of Product Characteristics for Vismodegib.
[5] MarketWatch. (2023). Oncology drug manufacturing and supply chain analysis.
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