Suppliers and packagers for simbrinza

simbrinza

Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Alcon Labs Inc	SIMBRINZA	brimonidine tartrate; brinzolamide	SUSPENSION/DROPS;OPHTHALMIC	204251	NDA	Alcon Laboratories, Inc.	0065-4147-25	1 BOTTLE, DROPPER in 1 CARTON (0065-4147-25) / 2.5 mL in 1 BOTTLE, DROPPER	2013-05-06
Alcon Labs Inc	SIMBRINZA	brimonidine tartrate; brinzolamide	SUSPENSION/DROPS;OPHTHALMIC	204251	NDA	Alcon Laboratories, Inc.	0065-4147-27	1 BOTTLE, DROPPER in 1 CARTON (0065-4147-27) / 8 mL in 1 BOTTLE, DROPPER	2013-05-06

Suppliers for the Pharmaceutical Drug: SIMBRINZA

Last updated: August 1, 2025

Introduction

Simbrinza is a combination medication used primarily for the management of glaucoma and elevated intraocular pressure (IOP). Comprising brinzolamide and brimonidine tartrate, it functions to reduce fluid production within the eye, thus lowering IOP [1]. As a specialized ophthalmic formulation, the supply chain for Simbrinza involves multiple pharmaceutical manufacturers, distributors, and regulatory bodies. Understanding who supplies Simbrinza, the competitive landscape, and the dynamics driving availability is crucial for stakeholders across health services, procurement, and distribution channels.

Manufacturers of Simbrinza

1. Alcon Laboratories, Inc.

Alcon remains the principal and exclusive manufacturer of Simbrinza. The drug was developed and launched by Alcon, a leading global ophthalmic pharmaceutical company, under their Vision Care division. Since its FDA approval in 2013, Alcon has maintained exclusive rights to produce and distribute the medication in the United States and other major markets.

Alcon invests substantially in research, production, and marketing, ensuring supply chain stability for Simbrinza in key regions. The company's manufacturing facilities are located across the United States, Switzerland, and other countries, conforming to stringent Good Manufacturing Practices (GMP) [2].

2. Contract Manufacturers

While Alcon oversees primary production, some pharmaceutical assets involve contract manufacturing organizations (CMOs). These third-party entities assist in the formulation, quality testing, and packaging processes to meet regulatory standards. Details of specific CMOs remain proprietary; however, Alcon's reliance on CMOs aligns with industry standards for maintaining high-quality production and scalable supply.

Distribution and Supply Chain

1. Global Distribution Networks

Alcon maintains a vast distribution network to ensure the widespread availability of Simbrinza in developed markets. The distribution channels involve wholesalers, specialty pharmacies, and hospital procurement systems. These entities manage the inventory, logistics, and downstream distribution to retail outlets and healthcare providers.

2. Regional Variations and Generic Availability

Although Alcon is the sole manufacturer of Simbrinza, the landscape varies by country:

• United States: Simbrinza is directly supplied by Alcon through licensed distributors and pharmacies.
• Europe and Asia: Regulatory approvals and market authorizations influence availability; some regions may see delays or limited supply based on local regulatory processes [3].

3. Generics and Biosimilars

To date, no generic versions of Simbrinza have been approved or marketed, primarily due to patent protections and exclusivity rights held by Alcon. However, patent expirations and legal challenges may influence future generic competition, possibly altering the supply dynamics.

Regulatory and Patent Landscape

1. Patent Protections

Alcon's patent for Simbrinza, covering the formulation and specific delivery mechanisms, generally provides exclusivity for 20 years from filing. This patent protection restricts other manufacturers from producing identical or similar formulations until expiry, which impacts supply competition and pricing.

2. Regulatory Approvals

In addition to FDA approval, regulatory authorities such as the European Medicines Agency (EMA) and Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) have approved Simbrinza, influencing supply avenues in respective markets. Approvals facilitate licensing agreements with local distributors, ensuring supply continuity.

Challenges and Considerations

• Supply Chain Disruptions: Manufacturing disruptions, raw material shortages, or regulatory delays impact availability.
• Limited Competition: As a patented product with no generics, supply remains monopolized by Alcon, posing risks of price inflation and procurement constraints.
• Emerging Biosimilars: Future development of biosimilars or alternative combination therapies might influence market dynamics.

Conclusion

The supply landscape for Simbrinza is predominantly controlled by Alcon Laboratories, Inc., which maintains exclusive manufacturing rights and global distribution channels. Although current supply chains are robust, factors such as patent protections, regulatory approvals, and manufacturing capacity influence ongoing availability. Stakeholders should monitor patent timelines, regulatory developments, and potential market entrants that could reshape the supply environment.

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Key Takeaways

• Alcon Labs is the exclusive supplier of Simbrinza, ensuring control over manufacturing and distribution.
• No generics are currently available, maintaining high barriers to market entry and exclusive supply.
• Regulatory approvals influence supplier networks, with Alcon leveraging its global footprint for distribution.
• Supply chain resilience depends on manufacturing capacity, raw material availability, and regulatory stability.
• Future market entrants and patent expirations could increase competition, diversify supply sources, and impact pricing.

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FAQs

1. Are there any generic alternatives to Simbrinza available on the market?
No, as of now, generic versions of Simbrinza have not been approved or marketed due to patent protections held by Alcon. Future patent expirations could enable generics.

2. How does Alcon ensure supply stability for Simbrinza?
Alcon maintains multiple manufacturing facilities and employs contract manufacturing organizations, adhering to GMP standards, coupled with global distribution networks to meet demand.

3. What regions primarily receive Simbrinza from Alcon?
Simbrinza is widely available in the United States, Europe, and Asia, with regional regulatory approvals dictating its accessibility.

4. Are there alternative medications for glaucoma treatment with similar supply chain control?
Yes, other branded combination medications exist, but each has different manufacturers and supply chains, which may impact availability and pricing.

5. How might patent expirations influence future suppliers for Simbrinza?
Patent expirations could permit other manufacturers to develop and market generic versions, broadening the supply base and increasing market competition.

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References

[1] Alcon, "Simbrinza prescribing information," 2013.
[2] U.S. Food and Drug Administration, "Alcon Receives FDA Approval for Simbrinza," 2013.
[3] European Medicines Agency, "Approval status of Simbrinza," 2014.