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Last Updated: December 22, 2024

PHOTREXA Drug Patent Profile


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Which patents cover Photrexa, and what generic alternatives are available?

Photrexa is a drug marketed by Glaukos and is included in one NDA.

The generic ingredient in PHOTREXA is riboflavin 5'-phosphate. There are ten drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the riboflavin 5'-phosphate profile page.

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Drug patent expirations by year for PHOTREXA
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Recent Clinical Trials for PHOTREXA

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Comprehensive EyeCare of Central OhioPhase 4
Glaukos CorporationPhase 4
Avedro, Inc.Phase 4

See all PHOTREXA clinical trials

US Patents and Regulatory Information for PHOTREXA

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Glaukos PHOTREXA riboflavin 5'-phosphate SOLUTION/DROPS;OPHTHALMIC 203324-001 Apr 15, 2016 RX Yes Yes ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Glaukos PHOTREXA VISCOUS IN DEXTRAN 20% riboflavin 5'-phosphate SOLUTION/DROPS;OPHTHALMIC 203324-002 Apr 15, 2016 RX Yes Yes ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

PHOTREXA Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Photrexa

Introduction

Photrexa, a key product in Glaukos Corporation's Corneal Health franchise, has been a significant contributor to the company's financial performance and market growth. Here, we will delve into the market dynamics and financial trajectory of Photrexa, highlighting its sales performance, market expansion, and the challenges it has faced.

Sales Performance

U.S. Market

Photrexa has consistently shown strong sales growth in the U.S. market. In 2022, U.S. Photrexa sales reached $56.3 million, representing a 12% increase compared to 2021[1]. In the fourth quarter of 2022, Photrexa sales hit a quarterly record of $15.3 million, with a year-over-year growth of 13%[1]. This trend continued into 2023, with Photrexa achieving record sales of $19.2 million in the fourth quarter[5].

International Market

While the primary focus has been on the U.S. market, Glaukos has also been expanding its international presence. The company has seen broad-based growth internationally, although this has been somewhat offset by unfavorable foreign exchange headwinds[1].

Market Expansion and Adoption

Increasing Adoption

The strong sales performance of Photrexa is attributed to increasing adoption and deeper penetration in both existing and new markets. Glaukos has been successful in driving new account starts and expanding access for keratoconus patients, a rare disease that Photrexa treats[1][3].

Regulatory Approvals and Agreements

Glaukos has secured several regulatory approvals and agreements that have facilitated the expansion of Photrexa. For instance, the company finalized a new French CEPS agreement, which adjusted rebate tiers and expanded the addressable patient population, positively impacting revenues[2].

Challenges and Headwinds

Reimbursement Issues

Despite the strong performance, Photrexa has faced reimbursement issues. In 2022, Glaukos encountered sporadic reimbursement challenges, which the company addressed through investments to improve the reimbursement process. These efforts have shown signs of improvement[1].

MDRP Impact

The company has also navigated the impact of the Medicare Drug Price Negotiation Program (MDRP) on its Corneal Health franchise, including Photrexa. This has presented a headwind, particularly in the fourth quarter of 2024, as the most significant impact of MDRP is expected during this period[2].

Foreign Exchange Headwinds

International growth has been affected by significant and unfavorable foreign exchange headwinds, which have offset some of the gains in international markets[1].

Financial Impact and Guidance

Revenue Contribution

Photrexa has been a substantial contributor to Glaukos's revenue. In the second quarter of 2024, Corneal Health franchise sales, including Photrexa, reached $19.8 million, representing a 7% year-over-year growth[2].

Full-Year Guidance

Glaukos has provided full-year revenue guidance, which includes modest contributions from Photrexa. For 2023, the company expected global consolidated net sales to be between $290 million and $295 million, taking into account various factors including the impact of MDRP and foreign currency exchange rates[1].

Investment and Pipeline Development

Glaukos continues to invest in its pipeline, including novel technologies that complement Photrexa. These investments are aimed at expanding the company's addressable markets and driving long-term sustainable growth. For example, the company is progressing with its next-generation corneal cross-linking therapy, Epioxa, and other clinical and preclinical programs[2].

Key Takeaways

  • Strong Sales Growth: Photrexa has shown consistent year-over-year sales growth in the U.S. market.
  • Market Expansion: The product has seen increasing adoption and deeper penetration in both U.S. and international markets.
  • Regulatory Approvals: Securing new regulatory approvals and agreements has been crucial for market expansion.
  • Challenges: Reimbursement issues and foreign exchange headwinds have presented challenges.
  • Financial Impact: Photrexa remains a significant contributor to Glaukos's revenue, with ongoing investments aimed at long-term growth.

FAQs

What were the U.S. Photrexa sales in 2022?

U.S. Photrexa sales in 2022 were $56.3 million, representing a 12% increase compared to 2021[1].

How has Photrexa performed internationally?

Photrexa has seen broad-based growth internationally, although this has been somewhat offset by unfavorable foreign exchange headwinds[1].

What challenges has Photrexa faced in terms of reimbursement?

Photrexa faced sporadic reimbursement challenges in 2022, which Glaukos addressed through investments to improve the reimbursement process[1].

How does MDRP impact Photrexa sales?

The Medicare Drug Price Negotiation Program (MDRP) has presented a headwind to the Corneal Health franchise, including Photrexa, with the most significant impact expected in the fourth quarter of 2024[2].

What is Glaukos's full-year revenue guidance for 2023?

Glaukos expects full-year 2023 global consolidated net sales to be between $290 million and $295 million[1].

Sources

  1. Glaukos-4Q-2022-Quarterly-Summary-Document_vF.pdf
  2. Glaukos Corp. (GKOS) Q2 2024 Earnings Call Corrected Transcript
  3. Glaukos Corp. (GKOS) Q3 2020 Earnings Call Corrected Transcript
  4. Prescription Drug Price Growth Report Data
  5. Glaukos Corp. (GKOS) 4Q23 Earnings Call Transcript

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