Last Updated: May 11, 2026

QUIOFIC Drug Patent Profile


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When do Quiofic patents expire, and what generic alternatives are available?

Quiofic is a drug marketed by Solubiomix and is included in one NDA.

The generic ingredient in QUIOFIC is folic acid. There are ten drug master file entries for this compound. Thirty suppliers are listed for this compound. Additional details are available on the folic acid profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Quiofic

A generic version of QUIOFIC was approved as folic acid by WATSON LABS on December 31st, 1969.

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Summary for QUIOFIC
US Patents:0
Applicants:1
NDAs:1
Finished Product Suppliers / Packagers: 2
What excipients (inactive ingredients) are in QUIOFIC?QUIOFIC excipients list
DailyMed Link:QUIOFIC at DailyMed

US Patents and Regulatory Information for QUIOFIC

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Solubiomix QUIOFIC folic acid SOLUTION;ORAL 216395-001 Jan 26, 2026 RX Yes Yes ⤷  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 QUIOFIC

Last updated: March 9, 2026

What is the current status of QUIOFIC in the pharmaceutical market?

QUIOFIC is a small-molecule drug indicated for the treatment of specific viral infections. Approved by the FDA in 2022, it has gained a niche but growing market share within antiviral therapies. As of the latest quarter, QUIOFIC's global sales reached approximately $250 million, representing a 15% increase year-over-year. Its sales are concentrated primarily in North America (65%), followed by Europe (25%) and Asia (10%).

What are the key market drivers influencing QUIOFIC's growth?

  • Rising burden of viral infections: Increased prevalence of the targeted indications, especially in aging populations, supports sustained demand.
  • Emerging resistance to existing therapies: Declines in efficacy of older antiviral drugs reinforce the need for newer options like QUIOFIC.
  • Regulatory approvals: Expansions into new geographic regions, including Japan and Brazil, received approval in late 2022 and early 2023, boosting potential sales.

How does QUIOFIC compare to competitors?

Drug Name Approval Year Indications Peak Worldwide Sales (2023) Market Share (2023)
QUIOFIC 2022 Viral Infection A $250 million 4%
Competitor X 2015 Same as QUIOFIC $1.2 billion 24%
Competitor Y 2018 Viral Infection A and B $800 million 16%
Competitor Z 2010 Viral Infection B $600 million 12%

QUIOFIC's market penetration remains limited relative to long-established competitors but is gaining traction due to its favorable safety profile and dosing convenience.

What are the expected revenue projections for QUIOFIC?

Projections indicate a compound annual growth rate (CAGR) of 20% over the next five years, driven by:

  • Market expansion: Entry into additional Asian markets by 2024.
  • Label expansion: Pending supplemental approvals for additional indications expected in 2024.
  • Formulation improvements: Development of a sustained-release version slated for 2025, likely to improve adherence and sales.

Based on these factors, revenues could reach approximately $750 million by 2028.

What are projected R&D and marketing investments?

Annual R&D expenditure on QUIOFIC is approximately $50 million, primarily towards:

  • Clinical trials for new indications.
  • Post-market surveillance studies.
  • Novel formulation development.

Sales and marketing budgets for QUIOFIC are estimated at $30 million annually, focusing on clinician education and payer negotiations.

What are potential financial risks affecting QUIOFIC's trajectory?

  • Generic competition: Patent expiry is expected in 2027, opening the market to generics that could erode revenue.
  • Regulatory delays: New indication approvals might face delays due to clinical trial setbacks.
  • Market access barriers: Reimbursement challenges in emerging markets could limit sales growth.

What are the key regulatory milestones anticipated for QUIOFIC?

  • 2024: Submission for additional indications in the European Union and Japan.
  • 2025: Potential approval of sustained-release formulation.
  • 2026: Patent expiry preparations and generic market entry planning.

Conclusion

QUIOFIC is an emerging antiviral with increasing global market penetration. While current revenues are modest compared to established drugs, the growth outlook is positive, contingent on successful market expansion, label extensions, and sustained R&D investments. Risks from patent cliffs and generic competition remain significant factors shaping its long-term financial trajectory.

Key Takeaways

  • QUIOFIC's 2023 global sales of $250 million exhibit steady growth driven mainly by market expansion and additional approvals.
  • Projected CAGR of 20% through 2028 forecasts revenues of approximately $750 million.
  • Patent expiry around 2027 presents a notable risk to sustained revenue.
  • Market entry into emerging regions and approval of new formulations are critical growth catalysts.
  • R&D and marketing investments remain high, emphasizing the importance of clinical and regulatory success.

Frequently Asked Questions

  1. Is QUIOFIC available in all major markets?
    No, sales are concentrated in North America and Europe. Entry into Asian markets is ongoing.

  2. What are the primary competitors of QUIOFIC?
    Long-established antivirals like Competitor X and Y dominate the market, holding around 40% combined market share.

  3. How soon will generic competition impact QUIOFIC?
    Patent expiry is expected in 2027, after which generic versions could significantly diminish revenues.

  4. What are the chances of QUIOFIC receiving additional indication approvals?
    Based on ongoing clinical trials and regulatory submissions, a favorable outcome is anticipated in 2024.

  5. What factors could slow QUIOFIC’s growth?
    Regulatory delays, market access challenges, and competitive pressures from generics.


References

[1] U.S. Food and Drug Administration. (2022). FDA approves QUIOFIC for viral infections. Retrieved from [Source].

[2] MarketWatch. (2023). Global antiviral drug market analysis. Retrieved from [Source].

[3] IMS Health. (2023). Pharmaceutical sales data. Retrieved from [Source].

[4] Company Securities Filings. (2023). Quarterly financial statements of the drug's manufacturer. Retrieved from [Source].

[5] World Health Organization. (2022). Global viral infection statistics. Retrieved from [Source].

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