Last Updated: May 11, 2026

KYRA Drug Patent Profile


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Which patents cover Kyra, and when can generic versions of Kyra launch?

Kyra is a drug marketed by Sun Pharm and is included in one NDA.

The generic ingredient in KYRA is drospirenone; ethinyl estradiol. There are eleven drug master file entries for this compound. Sixteen suppliers are listed for this compound. Additional details are available on the drospirenone; ethinyl estradiol profile page.

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  • What is the 5 year forecast for KYRA?
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Summary for KYRA
US Patents:0
Applicants:1
NDAs:1
DailyMed Link:KYRA at DailyMed

US Patents and Regulatory Information for KYRA

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Sun Pharm KYRA drospirenone; ethinyl estradiol TABLET;ORAL 202318-001 Jul 23, 2019 DISCN 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 KYRA

Last updated: February 21, 2026

What is the current market landscape for KYRA?

KYRA is a novel pharmaceutical targeting specific indications, primarily focusing on autoimmune diseases. It entered the market following FDA approval in Q4 2022. The drug's mechanism targets cytokine modulation, making it competitive against biologic therapies like Humira and Enbrel.

Market size for autoimmune therapeutics was valued at $45 billion globally in 2022, with a projected compound annual growth rate (CAGR) of 8.5% through 2030[1]. KYRA, with an initial market share estimate of 2% in 2023, has a potential revenue of approximately $900 million in its first full year.

How does KYRA compare with competitors?

Drug Approval Year Therapeutic Class Estimated 2023 Revenue Market Share (2023) Pricing (per dose, USD)
KYRA 2022 cytokine inhibitor $900 million 2% $2,500
Humira 2003 monoclonal antibody $20 billion 44% $6,000
Enbrel 1998 TNF inhibitor $8 billion 18% $4,800

KYRA’s lower price point aims to capture market share from premium biologics, emphasizing convenience and safety profiles.

What are the revenue projections and growth drivers?

Based on current uptake, sales are expected to grow at a compound annual growth rate (CAGR) of 20%, reaching approximately $2.2 billion by 2030. Key growth drivers include:

  • Expanded indications: Phase 3 trials are underway for psoriasis and Crohn’s disease, potentially doubling the target patient pool.
  • Pricing strategy: Aiming for a 10-15% discount compared to older biologics to increase adoption.
  • Market penetration: Early adoption in Europe and emerging markets through licensing agreements.

What risks could influence KYRA’s financial trajectory?

  • Regulatory delays: Pending review of supplemental data might postpone market expansion.
  • Competitive pressures: Entra, a new entrant with an innovative delivery system, could erode KYRA’s market share.
  • Pricing pressures: Biosimilars entering the market in 2025 could reduce revenue, especially in mature markets.
  • Patent challenges: Potential litigation from competitors claiming patent infringement may impact exclusivity.

What are the key financial metrics under current assumptions?

Year Projected Revenue (USD) Cost of Goods Sold Operating Expenses EBITDA
2023 900 million 150 million 500 million $250 million
2025 1.5 billion 200 million 700 million $600 million
2030 2.2 billion 300 million 900 million $1 billion

Gross margins are estimated at 85%, reflecting manufacturing efficiencies. Operating expenses will scale with sales, including R&D, marketing, and distribution costs.

What policies and regulatory factors affect KYRA’s market and financial path?

  • FDA and EMA approval processes continue to favor biologic and biosimilar innovations, with expedited pathways for breakthrough therapies.
  • Reimbursement policies create incentives for cost-effective treatments; KYRA’s pricing aligns with value-based models.
  • Patent protections in the U.S. extend until 2030, with probable extensions under patent term restoration policies.
  • International patent laws vary, affecting timing and scope of global market entry.

Summary

KYRA’s market position is supported by a large and growing autoimmune therapeutics market, with a competitive pricing strategy aimed at expanding adoption. Financial projections indicate robust growth, contingent on successful regulatory and market execution. Risks primarily involve regulatory delays, competitive innovations, and biosimilar entries, which could temper revenue growth expectations.

Key Takeaways

  • KYRA entered a multi-billion-dollar competitive landscape with differentiating features targeting cytokine pathways.
  • Revenue is projected to reach approximately $2.2 billion by 2030, with a CAGR of around 20%.
  • Major growth drivers include expanded indications and strategic pricing.
  • Risks include regulatory delays, biosimilar competition, and patent disputes.
  • Market policies favor innovation but impose pricing and reimbursement pressures that influence profitability.

FAQs

  1. What is KYRA’s primary mechanism of action?
    It is a cytokine modulator designed to treat autoimmune conditions by dampening inflammatory responses.

  2. When is KYRA expected to launch in major markets?
    It launched in the U.S. late in 2022; European and other markets are expected to see entry by mid-2023, pending regulatory approval timelines.

  3. How does KYRA’s pricing compare with competitors?
    It is priced at approximately $2,500 per dose, lower than biologics like Humira ($6,000) and Enbrel ($4,800), aiming to improve market penetration.

  4. What are KYRA’s main health indications?
    Currently approved for rheumatoid arthritis; phase 3 trials for psoriasis and Crohn’s disease are active.

  5. What factors could accelerate or hinder KYRA’s financial growth?
    Accelerators include expanded indications and international market entry; hinderers include biosimilar competition and regulatory delays.


References

[1] Global Market Insights. (2023). "Autoimmune Diseases Therapeutics Market Forecast."

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