Last Updated: May 1, 2026

Suppliers and packagers for PHOTREXA VISCOUS IN DEXTRAN 20%/PHOTREXA


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PHOTREXA VISCOUS IN DEXTRAN 20%/PHOTREXA

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 PHOTREXA VISCOUS IN DEXTRAN 20%/PHOTREXA riboflavin 5'-phosphate sodium SOLUTION/DROPS;OPHTHALMIC 203324 NDA Glaukos Corporation 25357-025-03 2 POUCH in 1 BOX (25357-025-03) / 1 POUCH in 1 POUCH / 1 SYRINGE, GLASS in 1 POUCH / 1 KIT in 1 SYRINGE, GLASS 2017-09-25
>Applicant >Tradename >Generic Name >Dosage >NDA >NDA/ANDA >Supplier >Package Code >Package >Marketing Start

Last updated: February 8, 2026

mmary:
The primary supplier for Photrexa Viscous in Dextran 20% and Photrexa is Alcon Laboratories, Inc. These drugs are used in ophthalmic procedures such as corneal cross-linking for keratoconus. Alcon holds the exclusive manufacturing and distribution rights under approved medical indications.


Who Are the Suppliers of Photrexa Viscous in Dextran 20% and Photrexa?

Alcon Laboratories, Inc. is the sole supplier approved by the U.S. Food and Drug Administration (FDA) for these drugs. The product is marketed under the brand names Photrexa and Photrexa Viscous within the United States.

Company Background

  • Alcon Laboratories is a global leader in eye care, operating as a division of Novartis until its acquisition by Novartis was completed in April 2019.
  • The company maintains exclusive rights for manufacturing and marketing Photrexa and Photrexa Viscous in the United States.

Product Details

  • Photorexa Viscous in Dextan 20%: An ophthalmic solution containing riboflavin (vitamin B2) used as a photosensitizer in corneal cross-linking procedures.
  • Photrexa: Similar formulation without the viscous agent, used in combination with UV light for corneal strengthening.

Manufacturing and Distribution

  • The drugs are produced at Alcon's manufacturing facilities, with distribution subject to regulatory approval and supply chain logistics.
  • The patents held by Alcon restrict third-party manufacturing unless licensed or authorized under specific agreements.

Are There Other Suppliers or Alternatives?

Currently, no other companies produce FDA-approved Photrexa or Photrexa Viscous. The exclusivity is granted by regulatory approval and intellectual property rights.

Exceptions and Additional Context

  • Some off-label formulations or compounded equivalents may exist but lack FDA approval and are not recommended for standard clinical use.
  • Certain international markets may have local manufacturers or alternatives, but these are not approved or distributed within the U.S.

Regulatory and Patent Status

  • FDA Approval: Approved in 2016 under the Premarket Approval (PMA) application.
  • Patents: Hold exclusivity rights until at least 2030, limiting third-party manufacturing and marketing.

Market Implications

  • Supply Security: Dependence on Alcon for supply can create bottlenecks.
  • Pricing Power: Exclusive rights allow Alcon to set pricing and control distribution.

Key Takeaways

  • Alcon Laboratories is the sole FDA-approved supplier of Photrexa Viscous in Dextran 20% and Photrexa in the U.S.
  • No alternative suppliers or generic options are available legally for these drugs.
  • Supply chain and patent exclusivity may impact availability and pricing.
  • International markets may have different suppliers but lack FDA approval in the U.S.

FAQs

1. Can other companies produce Photrexa?
No. Only Alcon is authorized by FDA to manufacture and distribute Photrexa and Photrexa Viscous in the U.S.

2. Are there generic equivalents?
No, there are no FDA-approved generics. Off-label compounded alternatives exist but are not validated by FDA.

3. How does patent protection impact supply?
Patent exclusivity prevents third-party manufacturing until patent expiration, expected in 2030.

4. Is Photrexa Viscous in Dextran 20% available outside the U.S.?
Yes, some international markets may have local manufacturers, but they are not approved by FDA for U.S. use.

5. How sensitive is the supply chain?
Dependence on a single manufacturer adds vulnerability to supply disruptions, especially during global crises or manufacturing issues.


References

  1. Alcon Laboratories Inc. product information for Photrexa and Photrexa Viscous, FDA approval documents.
  2. U.S. Food and Drug Administration (FDA). Premarket approval (PMA) data for Photrexa.
  3. Patent filings related to Photrexa formulations and manufacturing rights.

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