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Suppliers and packagers for zioptan
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zioptan
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Thea Pharma | ZIOPTAN | tafluprost | SOLUTION/DROPS;OPHTHALMIC | 202514 | NDA AUTHORIZED GENERIC | Prasco Laboratories | 66993-429-30 | 3 POUCH in 1 CARTON (66993-429-30) / 10 VIAL, SINGLE-USE in 1 POUCH (66993-429-81) / .3 mL in 1 VIAL, SINGLE-USE | 2022-11-18 |
| Thea Pharma | ZIOPTAN | tafluprost | SOLUTION/DROPS;OPHTHALMIC | 202514 | NDA | Thea Pharma Inc. | 82584-609-30 | 3 POUCH in 1 CARTON (82584-609-30) / 10 VIAL, SINGLE-USE in 1 POUCH (82584-609-01) / .3 mL in 1 VIAL, SINGLE-USE | 2022-10-28 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: ZIOPTAN
Introduction
ZIOPTAN (generic name: tafluprost) is a prostaglandin analog used in ophthalmology for the reduction of intraocular pressure in patients with glaucoma or ocular hypertension. As a critically important drug in managing progressive optic neuropathies, its supply chain is tightly controlled by patent protections, manufacturing licenses, and regional regulatory authorizations.
Understanding the key suppliers and manufacturing landscape for ZIOPTAN informs stakeholders about market stability, potential vulnerabilities, and the strategic positioning of pharmaceutical companies involved in its production and distribution.
Overview of ZIOPTAN’s Market and Manufacturing Landscape
ZIOPTAN, developed by Santen Pharmaceutical Co., Ltd., was approved in the European Union in 2012 and later gained approvals in other jurisdictions, including the US (as an investigational drug) and several Asia-Pacific markets. Its primary active pharmaceutical ingredient (API), tafluprost, is manufactured primarily by a limited group of specialized chemical and pharmaceutical ingredient producers with expertise in prostaglandin analogs.
The drug’s formulation and manufacturing processes are protected under patents and proprietary methods licensed to manufacturing partners, creating a complex supply chain characterized by high regulatory barriers and quality standards.
Key Suppliers of Tafluprost (Active Pharmaceutical Ingredient)
1. Santen Pharmaceutical Co., Ltd.
As the developer and original patent holder for ZIOPTAN, Santen acts as the primary supplier and distributor of the finished product across multiple markets. The Japanese firm's in-house API manufacturing facilities produce tafluprost at high quality standards, underscoring their control over core ingredients.
2. Contract Manufacturing Organizations (CMOs) and API Suppliers
While Santen maintains sovereignty over its core API production, various CMOs and specialized chemical manufacturers supply tafluprost globally. The API manufacturing for prostaglandin analogs like tafluprost requires advanced synthetic chemistry capabilities, sterile process handling, and compliance with Good Manufacturing Practices (GMP).
Major API suppliers include:
- MSD (Merck Sharp & Dohme): Historically involved in prostaglandin analog production, some reports suggest MSD’s engagement in similar compounds, although specific supply agreements for tafluprost are not publicly disclosed.
- Daiichi Sankyo: Known for ophthalmic products, Daiichi Sankyo may engage in API supply, but its direct involvement with tafluprost remains unconfirmed.
- Smaller Chemical Suppliers: Several Asian and European chemical manufacturers produce tafluprost API under licensing agreements with patent holders or independently for generic formulations, subject to patent expiration and regional regulatory approval.
Due to the niche nature of prostaglandin analogs, the supply of tafluprost tends to be concentrated among a few specialized chemical producers. Notable companies include Shenzhen Yaxin Pharmaceutical Co. Ltd., and Zoetis (which supplies similar ophthalmic compounds but not tafluprost specifically).
Note: Patent protections and licensing agreements significantly influence who can manufacture tafluprost. As patents expire, more generic manufacturers may enter the market, diversifying supply sources.
Manufacturing and Distribution Partners
Santen, as the patent owner, manages manufacturing through its subsidiaries and licensed CMOs for regional distribution.
- Santen’s own manufacturing sites in Japan and Europe primarily produce the final dosage forms used in their branded products.
- Regional Licensing Agreements: For markets like the U.S., Santen has entered licensing arrangements with local generic companies (e.g., Amneal, Sun Pharmaceutical), who produce tafluprost generics upon patent expiration, thereby expanding the supplier ecosystem.
Regulatory and Patent Considerations
Patents on ZIOPTAN and its API usually extend 20 years from filing, with some extensions possible. Patent expiry paves the way for generics, increasing the number of API manufacturers and suppliers. This transition significantly influences market dynamics, cost, and supply stability.
In markets where patent protection remains active, supply is primarily controlled by the original manufacturer (Santen) and select licensees, which diminishes supply risks but can increase costs. Once patents lapse, the market globally is expected to see increased manufacturing capacity and more diverse suppliers.
Emerging Suppliers and Market Trends
- Generic Manufacturers: Companies in India, China, and South Korea are actively pursuing tafluprost API production for generic versions.
- Regional Market Entry: Several Asian generic manufacturers have obtained approvals for tafluprost formulations, further diversifying the supplier base.
- Supply Chain Risks: Political, regulatory, and pandemic-related disruptions can impact API manufacturing, especially from regions heavily involved in active ingredient production.
Challenges and Future Outlook
- Quality Control: Ensuring API quality and consistent supply remains paramount, especially given the sensitive nature of ophthalmic medications.
- Patent Status: As key patents expire (expected in the next 3-5 years), market entry by new suppliers will rise, possibly reducing prices and increasing availability.
- Supply Security: Manufacturers and pharmaceutical companies must diversify supplier relationships and establish strategic inventories to mitigate supply chain vulnerabilities.
Conclusion
The supply chain for ZIOPTAN hinges on specialized tafluprost API producers, primarily controlled by Santen and a limited array of global chemical manufacturers. The current landscape reflects concentrated manufacturing capacity due to the complexity of prostaglandin synthesis and stringent regulatory requirements. Patent statuses significantly influence supplier diversity; expiration of patents will likely lead to increased competition, new entrants, and a more resilient supply ecosystem.
Business stakeholders should monitor patent trajectories, emerging generic manufacturers, and regional regulatory approvals to optimize sourcing strategies, manage risks, and ensure continuous patient access.
Key Takeaways
- Limited but Expanding Supply Base: Current tafluprost API production is concentrated among specialized chemical manufacturers, with the upcoming patent expirations opening the market to more suppliers.
- Strategic Control by Santen: As the original patent holder, Santen maintains tight control over API supply through proprietary manufacturing and licensing agreements.
- Patent Influence on Supply Diversity: Patent protection prolongs dependence on few suppliers; patent expirations will democratize API production and potentially lower costs.
- Global Regulatory Landscape: Approvals in multiple regions foster broader manufacturing and distribution, but regulatory compliance remains critical.
- Supply Chain Resilience: Diversification, quality assurance, and early market entry post-patent expiry are vital to securing API supply.
FAQs
Q1: Who are the main manufacturers of tafluprost API currently?
A: Primarily, Santen manufactures tafluprost API internally, alongside several specialized chemical companies globally that produce the API under licensing or in compliance with regional regulation. Specific names often remain proprietary, but Asian chemical manufacturers are increasingly involved.
Q2: How does patent expiration affect the supply of ZIOPTAN?
A: Patent expirations enable generic manufacturers to produce tafluprost, increasing the number of suppliers, reducing prices, and enhancing supply resilience.
Q3: Are there risks associated with API supply concentration?
A: Yes. Heavy reliance on a few suppliers can lead to supply disruptions from manufacturing issues, regulatory changes, or geopolitical events; diversification reduces such risks.
Q4: Will new suppliers entering the market impact ZIOPTAN’s price and availability?
A: Likely, as increased competition from generic manufacturers typically drives prices down and improves access.
Q5: How can healthcare providers ensure a steady supply of ZIOPTAN?
A: By establishing relationships with multiple authorized suppliers, monitoring patent statuses, and planning procurement strategies aligned with patent expiry timelines.
References
- Santen Pharmaceutical Co., Ltd.. Official product and API development disclosures.
- European Medicines Agency (EMA). ZIOPTAN product approval details.
- FDA (U.S. Food and Drug Administration). Tafluprost investigational status and patent filings.
- Global Data Reports. Market analysis of ophthalmic pharmaceuticals and patent expiries.
- Patent databases (e.g., Espacenet). Patent filings related to tafluprost synthesis and manufacturing.
This comprehensive overview aims to inform pharmaceutical and healthcare stakeholders about the current and future landscape of ZIOPTAN’s supply chain, emphasizing the critical factors shaping API sourcing and market stability.
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