Share This Page
Suppliers and packagers for triesence
✉ Email this page to a colleague
triesence
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Harrow Eye | TRIESENCE | triamcinolone acetonide | INJECTABLE;INTRAVITREAL | 022048 | NDA | Novartis Pharmaceuticals Corporation | 0078-0897-78 | 1 BLISTER PACK in 1 CARTON (0078-0897-78) / 1 VIAL, GLASS in 1 BLISTER PACK / 1 mL in 1 VIAL, GLASS | 2024-10-01 |
| Harrow Eye | TRIESENCE | triamcinolone acetonide | INJECTABLE;INTRAVITREAL | 022048 | NDA | Harrow Eye, LLC | 82667-800-01 | 1 BLISTER PACK in 1 CARTON (82667-800-01) / 1 VIAL, GLASS in 1 BLISTER PACK / 1 mL in 1 VIAL, GLASS | 2024-10-01 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: Triesence
Introduction
The pharmaceutical landscape encompasses a diverse array of medications, each underpinned by intricate manufacturing, regulatory pathways, and distribution channels. Triesence, a crucial intravitreal corticosteroid used primarily to treat a variety of retinal conditions, exemplifies this complexity. Understanding its supply chain, including authorized manufacturers, regional distributors, and market dynamics, is vital for stakeholders involved in procurement, healthcare delivery, and market analysis.
Overview of Triesence
Triesence (triamcinolone acetonide injectable suspension) is a sterile, preservative-free corticosteroid used in ophthalmology to manage macular edema, uveitis, and diabetic retinopathy. Approved by the U.S. Food and Drug Administration (FDA) in 2013, Triesence is considered a branded formulation of triamcinolone acetonide that emphasizes safety and efficacy through its preservative-free presentation ([1]).
Given its specific therapeutic niche, Triesence's supply chain depends on strict manufacturing standards, regulatory approvals, and controlled distribution to ensure product integrity and patient safety.
Manufacturers of Triesence
Triesence originates from Alcon Laboratories, a global leader in ophthalmic pharmaceuticals. Alcon developed Triesence as part of its portfolio of eye treatments, emphasizing high-quality manufacturing processes aligned with FDA and international regulations.
Alcon Laboratories: The primary and most recognized manufacturer of Triesence. Their manufacturing facilities operate under Good Manufacturing Practices (GMP) to maintain product quality, and they oversee the global distribution to meet demand across North America, Europe, and other markets ([2]).
Regulatory Status and Market Exclusivity: Being a branded product, Triesence's patent protections and regulatory approvals from agencies like the FDA underpin its market exclusivity. However, subsequent biosimilar or generic formulations may emerge, impacting the competitive landscape.
Supply Chain Dynamics and Distribution Partners
Following manufacturing approval, distribution plays a pivotal role in ensuring timely and safe delivery to healthcare providers.
Authorized Distributors:
Alcon partners with a network of authorized wholesale distributors and specialty pharmacies to supply Triesence across regions. These wholesalers ensure compliance with regulations, proper storage conditions, and traceability.
Geographical Accessibility:
- United States: Distribution is predominantly handled via Alcon’s own distribution centers and select authorized wholesalers.
- Europe and Other Markets: Licensing agreements often extend through regional subsidiaries or authorized partners to navigate local regulatory pathways.
Supply Chain Challenges:
- Regulatory Variability: Differing approval procedures can delay supply.
- Production Scalability: Maintaining steady inventory levels amid fluctuating demand is crucial, especially given the medication’s specialized use.
- Cold Chain Management: As a sterile injectable, Triesence requires strict cold chain logistics, increasing distribution complexity.
Emerging Market Suppliers and Biosimilars
The introduction of biosimilars or generic equivalents can influence supplier dynamics. While no biosimilar currently rivals Triesence directly, the landscape for corticosteroid injectables is evolving, with manufacturers seeking to develop comparable products under biosimilar pathways ([3]).
Potential Future Suppliers:
- Companies specializing in ophthalmic injectables, such as Sandoz (Novartis) or Teva Pharmaceuticals, might develop biosimilar corticosteroid injectables in response to patent expirations and market demand.
- Regional Generic Manufacturers: In emerging markets, local generics companies might seek approval for alternative formulations, potentially impacting the original supplier’s market share.
Regulatory and Quality Considerations
Ensuring supplier reliability for Triesence entails strict adherence to regulatory standards. The FDA’s approval process demands rigorous scrutiny of manufacturing practices, product stability, and sterility.
Quality Assurance:
Suppliers must demonstrate consistent compliance with standards, which is monitored through regular inspections, batch testing, and post-market surveillance.
International Certification:
Licensed suppliers often hold certifications such as ISO 13485 for medical devices and pharmaceuticals, reinforcing their credibility and capacity to produce high-quality ophthalmic injectables.
Market and Competitive Dynamics
The supply perspective is also influenced by competitive pressures, patent landscapes, and innovations in drug delivery systems. The increasing interest in sustained-release ocular implants and alternative corticosteroid formulations could alter supplier priorities and market access.
Impact of Biosimilars and Generics:
While no biosimilar of Triesence exists to date, pending patent expirations, competitors may emerge, increasing the number of suppliers and potentially reducing prices.
Pricing and Contractual Agreements:
Volume-based purchasing, long-term contracts, and formulary placements affect the procurement dynamics for healthcare providers and governmental agencies seeking reliable Triesence supplies.
Conclusion
The primary supplier for Triesence remains Alcon Laboratories, whose manufacturing and distribution network supports its global availability. While no biosimilars currently pose direct competition, evolving pharmaceutical innovations and patent landscapes suggest potential shifts. Ensuring pharmaceutical quality, regulatory compliance, and supply chain robustness remains paramount for stakeholders seeking consistent access to this ophthalmic corticosteroid.
Key Takeaways
- Alcon Laboratories is the sole manufacturer of the branded drug Triesence, maintaining strict quality and regulatory standards.
- Distribution channels include authorized wholesalers and specialty pharmacies, emphasizing cold chain logistics and regional compliance.
- The landscape may shift with industry developments in biosimilars or generics, potentially affecting supply and pricing.
- Regulatory adherence and quality assurance are critical for reliable supply chain management.
- Stakeholders should monitor patent expirations, biosimilar developments, and international regulatory changes for strategic procurement decisions.
FAQs
Q1: Are there any biosimilars available for Triesence?
A: Currently, no approved biosimilars directly compete with Triesence. Patent protections and manufacturing complexities have limited biosimilar entry, though industry interest persists.
Q2: How does Alcon ensure the quality of Triesence during distribution?
A: Through strict adherence to GMP standards, cold chain logistics, verified authorized distributors, and regular quality audits.
Q3: Can Triesence be purchased from regional generic suppliers?
A: No, Triesence is a branded product solely produced by Alcon; however, regional markets may have generic corticosteroid intravitreal injectables lacking the Triesence brand.
Q4: What challenges exist in the supply chain of Triesence?
A: Challenges include regulatory approval delays, production capacity constraints, cold chain logistics, and regional import/export regulations.
Q5: How might market dynamics affect future Triesence supplies?
A: Patent expirations and the development of biosimilars or alternative formulations could increase competition and influence supply stability and pricing.
References
[1] FDA. (2013). Triesence (triamcinolone acetonide injectable suspension) Approval Letter. Retrieved from FDA's official website.
[2] Alcon. (2022). About Alcon Pharmaceuticals. Corporate website.
[3] IMS Health. (2021). Global biosimilar market report.
More… ↓
