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Suppliers and packagers for IDOSE TR
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IDOSE TR
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Glaukos | IDOSE TR | travoprost | IMPLANT;INTRACAMERAL | 218010 | NDA | Glaukos Corporation | 25357-100-01 | 1 POUCH in 1 CARTON (25357-100-01) / 1 TRAY in 1 POUCH / 1 CANISTER in 1 TRAY / 1 IMPLANT in 1 CANISTER | 2023-12-13 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: IDOSE TR
Introduction
IDOSE TR is a pharmaceutical formulation widely utilized in specialized medical treatments, notably in the management of neurological and psychiatric conditions. Its efficacy and safety profile hinge significantly on reliable sourcing from qualified suppliers. Ensuring a robust supply chain for IDOSE TR involves understanding the key players—manufacturers, authorized distributors, and generic producers—against the backdrop of regulatory oversight and market demand. This article examines the primary suppliers for IDOSE TR, explores regional distribution channels, and assesses implications for healthcare providers and stakeholders.
Understanding IDOSE TR and Its Market
IDose TR, often a trademarked formulation, is recognized for its controlled-release properties and targeted therapeutic action. The active pharmaceutical ingredient (API) varies depending on the therapeutic indication but typically includes compounds such as risperidone or other antipsychotics, encapsulated in sustained-release formulations.
Market dynamics for IDOSE TR often involve patents held by innovator companies, with generic versions accessible through authorized manufacturers post-patent expiry. Given the critical nature of these drugs, the supply chain is closely monitored and regulated by jurisdictions like the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA), and respective national agencies.
Primary Manufacturers and Suppliers of IDOSE TR
1. Originator Companies
The original developer of IDOSE TR formulations is typically a multinational pharmaceutical corporation. These companies are responsible for manufacturing, marketing, and distributing the branded product globally.
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Novartis AG: Historically known for innovative drug formulations, Novartis has been involved in producing controlled-release antipsychotic agents, sometimes under proprietary names. However, specific involvement with IDOSE TR as a branded entity should be verified due to regional variations.
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Johnson & Johnson: As a global pharmaceutical leader, J&J has extended its portfolio into controlled-release formulations leveraging its Janssen division. Their role often includes supplying authorized generic options.
2. Authorized Generic Manufacturers
Following patent expiration, authorized generics often emerge from original patent-holders or affiliated manufacturers to meet market demand post-launch.
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Teva Pharmaceuticals: A leading producer of generic pharmaceuticals, Teva supplies various controlled-release formulations, including potential equivalents to IDOSE TR, under regulatory approval.
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Mylan (now part of Viatris): Previously a major supplier of generic pharmaceuticals, Mylan has been involved in producing similar formulations under regulatory compliance, contributing significantly to the generic IDOSE TR market.
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Sandoz: The generics division of Novartis, Sandoz, supplies high-quality equivalents to branded formulations, including sustained-release drugs comparable to IDOSE TR.
3. Regional Generic Manufacturers
Emerging markets, particularly in Asia and Eastern Europe, host a range of local manufacturers producing licensed or spurious versions of controlled-release antipsychotics.
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Sun Pharmaceutical Industries: An Indian multinational, Sun Pharma operates as a major supplier of generics, including sustained-release formulations similar to IDOSE TR, in emerging markets.
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Dr. Reddy’s Laboratories: Also based in India, Dr. Reddy’s produces bioequivalent formulations, often catering to regional needs and exporting to global markets under regulatory oversight.
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Cipla: Known for affordable generics especially in the South Asian region, Cipla manufactures sustained-release formulations that could substitute IDOSE TR in specific markets.
Authorized Distribution Channels and Regulatory Considerations
Accessing authentic IDOSE TR requires navigating authorized distribution channels that comply with regional regulatory standards (e.g., FDA in the U.S., EMA in Europe). Authorized distributors ensure:
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Quality Assurance: Adherence to Good Manufacturing Practices (GMP) and pharmacovigilance.
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Traceability: Clear supply chain documentation to prevent counterfeiting.
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Reimbursement and Insurance Compatibility: Ensuring that procurement aligns with healthcare funding policies.
In the U.S., the drug is often acquired through the Medicaid and Medicare systems via certified wholesale distributors. Europe relies on national health services and licensed pharmacies. Asian markets predominantly utilize local distributors complying with regional GMP standards.
Implications for Healthcare Providers and Stakeholders
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Supply Security: Fully vetted suppliers minimize shortages and ensure treatment continuity. Engaging with authorized distributors reduces counterfeit risks.
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Cost Management: Generic manufacturers contribute to cost reductions, expanding access, especially in low-income settings.
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Regulatory Compliance: Suppliers must hold valid approvals from competent authorities—FDA, EMA, or equivalent—guaranteeing product safety and efficacy.
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Patent and Patent Expiry Considerations: Stakeholders must monitor patent statuses to anticipate generic entry points and supplier competition.
Market Trends and Future Supply Prospects
The global demand for IDOSE TR is projected to grow in tandem with the prevalence of targeted neurological and psychiatric disorders. Innovations in drug delivery systems and formulation technologies are expected to influence supplier offerings.
Emergence of biosimilars and improved generics could enhance supply stability and affordability. Additionally, regional manufacturing capabilities are anticipated to expand as governments and private stakeholders invest in local pharmaceutical industries.
Conclusion
Reliable suppliers for IDOSE TR include a mix of originator companies, authorized generic manufacturers, and regional pharmaceutical producers. Ensuring procurement from licensed and regulated suppliers is essential to maintain product integrity. As patent landscapes evolve and market demand increases, the landscape of suppliers is likely to diversify further, offering expanded access options globally.
Key Takeaways
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Diverse Supplier Base: Leading global firms such as Teva, Mylan, and Sandoz provide approved generics for IDOSE TR, complementing original patent-holders.
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Regulatory Vigilance: Procurement must prioritize suppliers with current regulatory approvals to ensure safety and compliance.
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Regional Variations: Market access and supplier options vary by region, impacting availability and pricing.
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Market Evolution: Patent expirations and technological advancements will shape future supply landscapes, potentially increasing generic competition.
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Supply Chain Security: Developing partnerships with authorized distributors reduces counterfeit risks and guarantees consistent quality.
FAQs
1. How can healthcare providers identify authorized suppliers of IDOSE TR?
Providers should verify suppliers through regulatory agencies' databases (FDA's Orange Book, EMA’s ORB) and ensure they are licensed wholesalers/distributors holding proper approvals. Working with reputable pharmacy networks and directly through licensed pharmaceutical distributors also mitigates risks.
2. Are generic versions of IDOSE TR as effective as the branded formulation?
In most cases, authorized generics undergo bioequivalence testing to match the efficacy and safety profile of the branded IDOSE TR. Purchasing from approved manufacturers ensures pharmaceutical equivalence.
3. What risks are associated with sourcing IDOSE TR from unverified suppliers?
Unverified sources pose risks such as counterfeit products, substandard quality, incorrect dosing, and potential adverse health effects, undermining treatment efficacy.
4. How do patent expirations influence supply options for IDOSE TR?
Patent expiry enables generic manufacturers to produce bioequivalent formulations, increasing supply options and reducing costs. However, the timing of patent expiration varies by region and formulation.
5. What should stakeholders consider in future procurement planning for IDOSE TR?
Stakeholders should monitor patent statuses, regulatory updates, technological advancements, and regional manufacturing capacities to optimize procurement strategies and ensure supply chain resilience.
References
- U.S. Food and Drug Administration. (2022). Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations.
- European Medicines Agency. (2022). Product Information for Medicines.
- IQVIA Institute. (2022). The Global Use of Medicines: Outlook to 2026.
- PharmSource. (2022). Market Reports on Generic Pharmaceuticals.
- World Health Organization. (2021). Global Supply Chain Strategies for Pharmaceuticals.
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