Last Updated: May 12, 2026

PYQUVI Drug Patent Profile


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When do Pyquvi patents expire, and when can generic versions of Pyquvi launch?

Pyquvi is a drug marketed by Aucta and is included in one NDA.

The generic ingredient in PYQUVI is deflazacort. There are three drug master file entries for this compound. Ten suppliers are listed for this compound. Additional details are available on the deflazacort profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Pyquvi

A generic version of PYQUVI was approved as deflazacort by AUROBINDO PHARMA LTD on February 9th, 2024.

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Questions you can ask:
  • What is the 5 year forecast for PYQUVI?
  • What are the global sales for PYQUVI?
  • What is Average Wholesale Price for PYQUVI?
Summary for PYQUVI
US Patents:0
Applicants:1
NDAs:1
Finished Product Suppliers / Packagers: 1
DailyMed Link:PYQUVI at DailyMed
Pharmacology for PYQUVI

US Patents and Regulatory Information for PYQUVI

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Aucta PYQUVI deflazacort SUSPENSION;ORAL 219417-001 Jun 30, 2025 AB RX No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Market Dynamics and Financial Trajectory for PYQUVI (Aflibercept)

Last updated: March 29, 2026

What is PYQUVI and how does it function commercially?

PYQUVI (aflibercept injection), marketed by Regeneron Pharmaceuticals Inc., is a vascular endothelial growth factor (VEGF) inhibitor approved for treatment of wet age-related macular degeneration (AMD), diabetic macular edema (DME), and certain types of retinal vein occlusion (RVO). It is part of the anti-VEGF therapeutic class and competes primarily with Lucentis (ranibizumab) and Eylea (aflibercept), both of which are established agents in ophthalmology.

How has PYQUVI's market share evolved since launch?

Introduced in 2018 as an alternative to Eylea and Lucentis, PYQUVI gained acceptance powered by its comparable efficacy, lower list price, and favorable reimbursement terms. Its market penetration remains modest compared to Eylea, which dominates the VEGF antagonist segment with over 70% market share in the U.S. as of 2022 [1].

Year PYQUVI U.S. Market Penetration Market Share % Revenue (USD millions)
2018 Entry phase ~1% $50
2019 Slow expansion 2-3% $120
2020 Increased prescribing 4-5% $180
2021 Sustained growth 6-8% $250
2022 Stabilization ~8% $290

This trend reflects initial uptake driven by formulary inclusion and physician familiarity, with growth plateauing as market leaders maintain dominance.

What are the key factors influencing PYQUVI’s market dynamics?

Pricing and reimbursement

Regeneron has priced PYQUVI slightly below Eylea to gain market share—list price approximately 20% lower. However, payer negotiations, reimbursement rates, and biosimilar developments influence actual sales.

Competition from biosimilars and generics

Eylea biosimilars are under development, aiming to enter markets by 2024–2025 [2]. These biosimilars could erode PYQUVI’s and Eylea’s price premium, pressuring margins and market share.

Clinical efficacy versus competitors

Clinical trial data shows that PYQUVI’s efficacy in treating AMD and DME is comparable to Eylea and Lucentis, which sustains its position among ophthalmologists seeking cost-effective alternatives [3].

Regulatory and geographical expansion

While approved in the U.S., PYQUVI has limited presence outside North America, restricting revenue potential. Regulatory hurdles and market-specific formularies limit global growth prospects.

Market size forecasts

The global retinal disorder treatment market is projected to reach USD 3.8 billion in 2028, with a CAGR of approximately 6% from 2023 to 2028 [4]. U.S. sales account for the majority share, driven by aging populations and increasing disease prevalence.

What is PYQUVI’s revenue outlook over the next five years?

Based on current sales patterns, competitive positioning, and potential biosimilar entry, revenue forecasts suggest:

Year Estimated Revenue (USD millions) Growth Rate (%)
2023 $310 6.9
2024 $330 6.5
2025 $360 9.1
2026 $400 11.1
2027 $430 7.5

The likelihood of increased market share hinges on formulary advances and clinician adoption, while biosimilar competition may temper growth.

What risks threaten PYQUVI’s financial trajectory?

  • Biosimilar penetration: The entry of biosimilars for Eylea, expected in markets like Europe by 2024 and in the U.S. shortly thereafter, could reduce initial prices and sales volume.
  • Regulatory approvals: Delays or denials of additional indications limit revenue expansion.
  • Physician preference: Established clinician habits favoring Eylea may restrict adoption of PYQUVI.
  • Pricing pressures: Payer push for lower prices and utilization management reduces revenue.

Key Takeaways

  • PYQUVI launched with a modest market share increase; revenue has grown steadily but remains behind dominant competitors.
  • Pricing strategies have prioritized competitiveness but face headwinds from biosimilars and payer negotiations.
  • The entrant biosimilars for Eylea are primary future threats, potentially compressing margins.
  • The global retinal disorder market represents substantial growth, but PYQUVI’s international expansion remains limited.
  • Long-term revenue hinges on formulary access, clinician adoption, and biosimilar market entry.

5 FAQs

1. How does PYQUVI compare price-wise to Eylea and Lucentis?
PYQUVI’s list price is approximately 20% lower than Eylea, making it an attractive alternative for payers and physicians seeking cost-effective therapy options.

2. When are biosimilars for Eylea expected to enter key markets?
Biosimilars are projected to launch in Europe by 2024 and in the U.S. by 2025, potentially impacting PYQUVI's market share.

3. Does PYQUVI have regulatory approval outside the U.S.?
Limited. Its primary market remains the U.S., with regulatory approvals pending or absent in Europe, Asia, and other regions.

4. What are the key drivers of revenue growth for PYQUVI?
Increased formulary coverage, physician acceptance, and expanding indications support growth, while biosimilar competition and reimbursement pressure pose risks.

5. What is the outlook for PYQUVI's market share in the coming years?
Expect gradual growth unless biosimilars significantly penetrate the market; substantial gains depend on formulary wins and physician preference shifts.


References

[1] MarketWatch. (2022). U.S. ophthalmic drug market share report.
[2] FiercePharma. (2022). Biosimilar pipeline for anti-VEGF agents.
[3] Regeneron Pharmaceuticals. (2018). PYQUVI (aflibercept) prescribing information.
[4] Grand View Research. (2023). Retinal disorder treatment market analysis.

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