Share This Page
Suppliers and packagers for generic pharmaceutical drug: nintedanib esylate
✉ Email this page to a colleague
nintedanib esylate
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Boehringer Ingelheim | OFEV | nintedanib esylate | CAPSULE;ORAL | 205832 | NDA | Boehringer Ingelheim Pharmaceuticals, Inc. | 0597-0143-60 | 1 BOTTLE in 1 CARTON (0597-0143-60) / 60 CAPSULE in 1 BOTTLE | 2014-10-15 |
| Boehringer Ingelheim | OFEV | nintedanib esylate | CAPSULE;ORAL | 205832 | NDA | Boehringer Ingelheim Pharmaceuticals, Inc. | 0597-0145-60 | 1 BOTTLE in 1 CARTON (0597-0145-60) / 60 CAPSULE in 1 BOTTLE | 2014-10-15 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: Nintedanib Esylate
Introduction
Nintedanib esylate is a critical antifibrotic and angiokinase inhibitor used primarily in the treatment of idiopathic pulmonary fibrosis (IPF), systemic sclerosis-associated interstitial lung disease (SSc-ILD), and certain types of non-small cell lung cancer (NSCLC). As a cornerstone in managing fibrotic and oncological diseases, the demand for Nintedanib esylate has surged globally, prompting pharmaceutical manufacturers and supply chain stakeholders to seek reliable suppliers.
This report consolidates current suppliers, explores their manufacturing capabilities, and evaluates implications for pharmaceutical industry procurement, ensuring a robust understanding for stakeholders aiming to secure a steady supply of Nintedanib esylate.
Overview of Nintedanib Esylate
Nintedanib esylate belongs to the class of kinase inhibitors targeting multiple receptors involved in fibrosis and tumor growth, notably vascular endothelial growth factor (VEGF), fibroblast growth factor (FGF), and platelet-derived growth factor (PDGF) receptors. Its synthesis involves complex process routes, demanding high-quality raw materials, stringent regulatory compliance, and advanced manufacturing facilities.
The molecule's patent protection status varies across regions, influencing the landscape of manufacturing licenses and commercial suppliers.
Global Suppliers of Nintedanib Esylate
1. Original Manufacturer: Boehringer Ingelheim
Boehringer Ingelheim holds the original patent and is the primary supplier of Nintedanib (marketed as Ofev® or Esbriet®). The company maintains an extensive global manufacturing network, ensuring supply security through multiple production sites located in Germany, the US, and Asia.
-
Manufacturing Capabilities:
Boehringer Ingelheim employs high-containment facilities with advanced synthesis techniques for Nintedanib Esylate, ensuring batch consistency and compliance with Good Manufacturing Practices (GMP). -
Licensing & Distribution:
The company licenses regional partners in certain territories, with supply agreements geared toward ensuring global access.
2. Contract Manufacturing Organizations (CMOs)
Due to the high demand and manufacturing complexities, several CMOs have obtained licenses or production rights through sublicensing agreements, including:
-
Tianjin Biochemical Pharmaceutical Co. Ltd. (China):
This company is recognized for manufacturing active pharmaceutical ingredients (APIs) and has received approval for Nintedanib esylate synthesis. Their GMP-certified facilities are expanding capacity to meet regional demand. -
Fertin Pharma Ltd. (India):
Fertin Pharma specializes in APIs and intermediates, with capabilities aligned with international quality standards for Nintedanib esylate; however, their production volume is limited compared to tier-one suppliers. -
Hetero Labs Ltd. (India):
A key player in generic APIs, Hetero has reportedly scaled up synthesis processes for Nintedanib esylate, aiming at regional and emerging markets.
3. Generics and Biosimilar Manufacturers
The patent expiration process in certain jurisdictions may open opportunities for generics producers, including:
-
Mylan (now part of Viatris):
Historically engaged in the development of Nintedanib-based generics, with pending regulatory filings in multiple regions. -
Sun Pharmaceutical Industries Ltd.:
Rumored to be exploring developing biosimilar or generic formulations, though API-level manufacturing remains limited or in development.
Supply Chain Considerations
Manufacturing Complexity
The synthesis of Nintedanib esylate involves intricate multi-step processes sensitive to impurities, requiring proprietary expertise and specialized equipment. This complexity constrains the number of capable suppliers and elevates barriers for new entrants.
Regulatory Approvals
Suppliers must comply with regional regulatory agencies’ standards (e.g., FDA, EMA, PMDA). Variations in regulatory recognition can influence supply timelines and market access.
Intellectual Property and Licensing
Patent protections restrict manufacturing rights in most jurisdictions. However, patent expiry in some regions (e.g., Japan, Europe, US) is gradually allowing generic manufacturers to enter the market, increasing supply diversification.
Supply Risks and Mitigation
Dependence on regional suppliers introduces risks related to geopolitical issues, supply chain disruptions, and quality concerns. Strategic inventory management and diversification of suppliers are essential for uninterrupted supply.
Emerging and Future Suppliers
As patent protections expire and biosimilar development accelerates, a broader supplier base appears inevitable. Chinese and Indian manufacturers are investing heavily in API synthesis capacity, with several announcing plans to produce Nintedanib esylate at scale.
Advancements in process chemistry and licensing agreements are expected to enhance supply security and reduce costs, making Nintedanib more accessible worldwide.
Conclusion
The supply landscape for Nintedanib esylate comprises original innovators, licensed CMOs, and emerging generic producers. While Boehringer Ingelheim remains the primary supplier, the increasing involvement of regional manufacturers—especially those in China and India—is shaping a more competitive, diversified supply environment. Stakeholders should prioritize establishing supply agreements with multiple reputable sources, monitor patent status, and stay agile in response to manufacturing and regulatory developments.
Key Takeaways
- Boehringer Ingelheim remains the dominant supplier, leveraging multiple manufacturing sites globally.
- Regional CMOs in China, India, and other emerging markets have scaled or are scaling production, expanding supply options.
- Patent expirations are opening pathways for generic manufacturers, potentially increasing supply and reducing costs.
- Supply chain resilience hinges on diversifying sources, ensuring regulatory compliance, and managing intellectual property considerations.
- Continued investment in process chemistry and licensing agreements will shape future supply dynamics, impacting pricing and access.
Frequently Asked Questions (FAQs)
1. Who currently manufactures the active pharmaceutical ingredient (API) for Nintedanib esylate?
Primary manufacturing rights are held by Boehringer Ingelheim, with licensed production by CMOs such as Tianjin Biochemical Pharmaceutical Co. Ltd., Fertin Pharma, and Hetero Labs. Generic manufacturers are emerging, especially in India and China.
2. Are there approved generic versions of Nintedanib esylate?
In some regions where patents have expired, generic versions are under development or have received regulatory approval. However, widespread availability depends on patent status and regional regulatory processes.
3. How stable is the supply of Nintedanib esylate globally?
Supply stability depends on patent protections, manufacturing capacity, geopolitical factors, and regulatory approval. Diversification of suppliers is essential to mitigate risks.
4. What are the primary challenges in manufacturing Nintedanib esylate?
The complex synthesis route requires specialized chemistry, high-quality raw materials, and strict quality controls, restricting the number of capable manufacturers.
5. How does patent expiry impact the supply landscape?
Patent expiry enables generic manufacturers to produce the API, increasing competition, supply, and potentially reducing prices. It also attracts new suppliers into the market.
References:
- Boehringer Ingelheim. Nintedanib (Ofev®) Product Information. [Online]. Available at: https://www.boehringer-ingelheim.com
- U.S. Food and Drug Administration (FDA). Patent and exclusivity data for Nintedanib. [Online].
- European Medicines Agency (EMA). Nintedanib approvals and licensing details. [Online]
- Industry reports on API manufacturing in China and India.
- Clinical trial registries and patent databases for biosimilar and generic development updates.
More… ↓
