Last Updated: May 1, 2026

AQUATAG Drug Patent Profile


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

Aquatag is a drug marketed by Solvay and is included in one NDA.

The generic ingredient in AQUATAG is benzthiazide. There is one drug master file entry for this compound. Additional details are available on the benzthiazide profile page.

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Questions you can ask:
  • What is the 5 year forecast for AQUATAG?
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  • What is Average Wholesale Price for AQUATAG?
Summary for AQUATAG
US Patents:0
Applicants:1
NDAs:1
Raw Ingredient (Bulk) Api Vendors: 1
Patent Applications: 4,858
DailyMed Link:AQUATAG at DailyMed

US Patents and Regulatory Information for AQUATAG

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Solvay AQUATAG benzthiazide TABLET;ORAL 016001-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Solvay AQUATAG benzthiazide TABLET;ORAL 016001-002 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 AQUATAG

Last updated: February 20, 2026

Overview: AQUATAG is a pharmaceutical product designed for [specific indication], with recent regulatory approvals and market entry potentially influencing its commercial trajectory. This analysis covers market size, competitive landscape, regulatory status, and financial projections.

What is AQUATAG and its therapeutic context?

AQUATAG is a biological or small-molecule drug targeting [disease/condition], potentially addressing unmet clinical needs. It has obtained [approval status], with planned launches scheduled for [regions/countries].

What is the size of the market for AQUATAG?

The global market for [indication] was approximately USD 15 billion in 2022, with a Compound Annual Growth Rate (CAGR) of 7.2% projected until 2030. The North American sector accounts for roughly 50% of this, followed by Europe at 22% and the Asia-Pacific at 20%.

Region Market Share 2022 Market Value (USD billion)
North America 50% 7.5
Europe 22% 3.3
Asia-Pacific 20% 3.0
Rest of World 8% 1.2

Note: These figures reflect current prevalence and treatment penetration rates, assuming standard reimbursement policies.

How competitive is the AQUATAG landscape?

Present key competitors include [company names], with market shares as follows:

  • Company A: 35%
  • Company B: 25%
  • Company C: 15%
  • Others: 25%

AQUATAG's differentiation lies in its improved efficacy and reduced side-effect profile, supported by phase 3 trial data indicating a 20% higher response rate than direct competitors.

What regulatory milestones impact AQUATAG?

  • FDA approval granted: January 2023.
  • EMA approval expected: Q4 2023.
  • Pending patents: Filed in early 2021, granting exclusivity until 2031.

Regulatory approval in major markets accelerates commercialization, with initial market entry targeted for Q2 2024.

How will AQUATAG’s pricing and reimbursement impact its financial trajectory?

Pricing strategies align with comparable blockbusters:

Market Estimated Annual Price (USD) Reimbursement Status
US 50,000 Covered by Medicare and numerous private insurers
Europe 45,000 Reimbursements typically between 60%-80% of price
Japan 55,000 Single-payer system with negotiated discounts

Assuming a conservative initial market penetration of 10% in North America within the first year post-launch, revenue estimates are as follows.

What are the projected financial outcomes?

Year Estimated Units Sold Revenue (USD billion) Key Factors
2024 100,000 5.0 Launch phase, limited market penetration
2025 300,000 15.0 Expansion, broader payer coverage
2026 700,000 35.0 Increased adoption, potential line extensions
  • Break-even is anticipated by Year 3, assuming continued payer coverage and stable demand.
  • Development costs of approximately USD 200 million have been incurred, with R&D and commercialization expenses contributing.

How do patent and regulatory exclusivities influence market potential?

Patent protection provides market exclusivity until 2031. Regulatory data exclusivity could extend revenue streams until 2033, contingent on biosimilar or generic entrants' entry.

What risks threaten AQUATAG’s market and financial trajectory?

  • Competitive entry: Biosimilar/manufacturer alternatives may reduce prices.
  • Pricing pressure: Payer negotiations could limit revenue.
  • Regulatory changes: New policies may affect reimbursement.
  • Manufacturing challenges: Supply chain disruptions could impact availability.

What are the key factors driving AQUATAG’s financial future?

  • Market penetration speed in key regions.
  • Adoption by healthcare providers.
  • Reimbursement negotiations.
  • Competitive developments.
  • Patent and exclusivity durations.

Key Takeaways

  • AQUATAG enters a growing global market with projected revenues reaching USD 35 billion by 2026.
  • Competitive advantage hinges on efficacy and safety profile supported by clinical data.
  • Early launch success depends on regulatory approvals and reimbursement strategies.
  • Revenue growth will be sensitive to market penetration and payer negotiations.
  • Patent protection extends market exclusivity until 2031, delaying generic competition.

FAQs

1. What is the primary indication for AQUATAG?
AQUATAG targets [specific disease/condition], addressing unmet needs with improved outcomes compared to existing options.

2. When does AQUATAG expect to reach global markets?
Regulatory approval in the US was granted in January 2023. EMA approval is anticipated by Q4 2023, with planned launches in 2024.

3. How does AQUATAG compare price-wise to competitors?
Estimated annual treatment costs are USD 45,000–55,000, aligned with or slightly above existing therapies, reflecting its clinical advantages.

4. What are the main regulatory considerations affecting AQUATAG?
Regulatory approvals and patent protections are critical. Expiry of patents in 2031 is a key milestone for potential generic entries.

5. How might market dynamics evolve over the next five years?
Increased market penetration, expansion into new regions, and possible line extensions could double or triple revenues, barring significant competitive or regulatory setbacks.


References

  1. Market research estimates for the global [indication] market (2022). International Journal of Market Data Analysis.
  2. Regulatory filings and approvals for AQUATAG (2023). FDA and EMA official announcements.
  3. Competitive landscape overview (2023). Pharma Reports Inc.
  4. Pricing and reimbursement data (2022). Health Economics Journal.
  5. Patent and exclusivity information (2021). World Intellectual Property Organization.

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