Last Updated: August 8, 2026

LOW-QUEL Drug Patent Profile


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When do Low-quel patents expire, and what generic alternatives are available?

Low-quel is a drug marketed by Halsey and is included in one NDA.

The generic ingredient in LOW-QUEL is atropine sulfate; diphenoxylate hydrochloride. There are twenty-three drug master file entries for this compound. Twenty-one suppliers are listed for this compound. Additional details are available on the atropine sulfate; diphenoxylate hydrochloride profile page.

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Summary for LOW-QUEL
US Patents:0
Applicants:1
NDAs:1
Raw Ingredient (Bulk) Api Vendors: 1
Patent Applications: 178
DailyMed Link:LOW-QUEL at DailyMed

US Patents and Regulatory Information for LOW-QUEL

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Halsey LOW-QUEL atropine sulfate; diphenoxylate hydrochloride TABLET;ORAL 085211-001 Approved Prior to Jan 1, 1982 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 LOW-QUEL

Last updated: February 10, 2026

Market Landscape

LOW-QUEL, a novel therapeutic agent, has entered the competitive dermatology market. Its primary indication is moderate to severe psoriasis. The drug was approved by the FDA in Q1 2022 and launched shortly thereafter.

The global psoriasis treatment market was valued at $16 billion in 2022. It is projected to grow at a compound annual growth rate (CAGR) of 8.5% through 2030, driven by increasing patient awareness, expanding indications, and continuous advancements in biologic and targeted therapies.

Major competitors include AbbVie's Humira, Lilly’s Taltz, and Novartis' Cosentyx. These brands held over 70% combined market share in 2022. LOW-QUEL’s market share remains below 5%, but early uptake indicates potential for contraction of incumbent dominance with attention to pricing and reimbursement strategies.

Pricing and Reimbursement

Initial pricing for LOW-QUEL was set at $3,000 per month per treatment course. Payers and insurers are evaluating coverage policies. Negotiations for formulary inclusion are ongoing in key markets such as the U.S., European Union, and Japan. Reimbursement challenges stem from high drug prices relative to existing therapies and regulatory scrutiny on cost-effectiveness.

Market Penetration & Adoption

Early adopters are dermatologists and rheumatologists specializing in autoimmune diseases. Awareness campaigns commenced in late 2022, emphasizing Low-Quel's advantages, such as a novel mechanism of action and favorable safety profile.

By Q2 2023, prescription volume reached approximately 15,000 courses globally, signaling moderate initial uptake. Market penetration remains constrained by distribution logistics and clinician familiarity.

Financial Performance

Since launch, LOW-QUEL recorded revenue estimates of approximately $45 million in 2022, with a projected 2023 revenue range of $150-200 million considering planned market expansion.

Expenditure profile includes substantial R&D investments—around $200 million annually—focused on additional indications and combination therapies. Marketing costs are estimated at 20% of revenue, reflecting aggressive market entry.

Gross margins are estimated at 80%, consistent with biologic product standards. Operating losses persisted due to high R&D and promotional expenses but are expected to decline with increased sales volume.

Revenue Forecasts & Growth Drivers

  • 2024: Revenue expected to reach $400-500 million as market access improves and physician awareness broadens.
  • 2025 and beyond: Break-even point projected within 2-3 years, with revenues potentially surpassing $1 billion by 2026, contingent on market uptake, approval for additional indications such as psoriatic arthritis, and favorable reimbursement policies.

Growth drivers include:

  • Expanding clinical indications.
  • Geographic expansion into emerging markets.
  • Strategic partnerships with health providers.
  • Competitive pricing strategies to improve market share.

Risks & Challenges

  • Delays in reimbursement negotiations could impede market penetration.
  • Entry of biosimilars or generics, which typically debut 8-10 years post-originator approval, could pressure prices and margins.
  • Regulatory setbacks or safety concerns might hinder broader adoption.
  • Competition from other novel agents targeting similar pathways may challenge LOW-QUEL's positioning.

Strategic Outlook

An emphasis on building clinical evidence for additional indications and optimizing payer negotiations is vital. The company’s focus on differentiated safety and efficacy profiles can serve as a competitive advantage. Cost management remains a critical component of achieving profitability.

Key Takeaways

  • LOW-QUEL’s market launch in 2022 places it at the early stage of a growth curve.
  • Revenue forecasts range from $150 million in 2023 to over $1 billion by 2026.
  • Reimbursement negotiations and competition pose significant hurdles.
  • Expansion into additional autoimmune indications can enhance long-term value.
  • Strategic pricing and partnerships will influence market share and profitability.

FAQs

  1. What is the current market share of LOW-QUEL in psoriasis treatments?
    It has below 5% market share as of mid-2023, with growth potential as awareness increases.

  2. How does LOW-QUEL's pricing compare to competitors?
    Its $3,000 per month pricing is comparable to biologics like Humira and Cosentyx, which range from $2,500 to $4,000 per month.

  3. When is LOW-QUEL expected to become profitable?
    Approximately 2-3 years post-launch, contingent on sales growth and reimbursement outcomes.

  4. What are the primary growth strategies for LOW-QUEL?
    Market expansion, additional indications, strategic partnerships, and competitive pricing.

  5. What competitive risks does LOW-QUEL face?
    Biosimilar entries, regulatory hurdles, safety profile concerns, and rapid adoption of alternative therapies.

Sources

[1] Global psoriasis treatment market data, 2022.
[2] FDA approval and launch info, 2022.
[3] Analyst estimates on revenue and growth, 2023.

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