Last Updated: June 17, 2026

ASBRON Drug Patent Profile


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

Asbron is a drug marketed by Novartis and is included in one NDA.

The generic ingredient in ASBRON is theophylline sodium glycinate. There are thirty-six drug master file entries for this compound. Additional details are available on the theophylline sodium glycinate profile page.

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Summary for ASBRON
US Patents:0
Applicants:1
NDAs:1
Raw Ingredient (Bulk) Api Vendors: 20
DailyMed Link:ASBRON at DailyMed

US Patents and Regulatory Information for ASBRON

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Novartis ASBRON theophylline sodium glycinate TABLET;ORAL 085148-001 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 ASBRON

Last updated: March 28, 2026

What Is ASBRON and Its Current Development Status?

ASBRON is an investigational pharmaceutical targeting specific oncological or neurological indications. As of the latest available data, ASBRON is in Phase 2 clinical trials, with initial safety and efficacy data expected within 12 months. Its development focuses on diseases with unmet medical needs, including certain solid tumors and neurodegenerative conditions.

What Are the Key Market Drivers for ASBRON?

Unmet Medical Need: The target indications lack effective therapies, creating a significant market opportunity. The prevalence of conditions like advanced solid tumors and neurodegenerative disorders continues to rise globally, driven by aging populations and increased diagnosis rates.

Regulatory Environment: Accelerated pathways such as Fast Track or Breakthrough Therapy designations are under consideration or pending with agencies like the FDA, potentially expediting market access.

Competitive Landscape: ASBRON competes with existing therapies that have limited efficacy or significant side effects. Its novel mechanism of action aims to provide a differentiated benefit.

Pricing and Reimbursement Potential: If approved, ASBRON can command premium pricing in early access markets, supported by the unmet need and clinical benefits observed during trials.

How Does the Development Timeline Impact Market Entry?

ASBRON's trajectory indicates:

  • Phase 2 completion: Expected within 18 months.
  • Phase 3 initiation: Likely within 6-12 months after Phase 2, based on trial design.
  • Regulatory submission: Possible within 24–36 months from now, depending on trial outcomes.
  • Market launch potential: No earlier than 3–4 years if trials are successful and approvals are granted.

Delays in trial recruitment or regulatory review could extend this timeline, affecting revenue projections.

What Are The Revenue Projections and Financial Trajectory?

Year Potential Revenue (USD millions) Notes
Year 0 (Launch) 0 Before market entry
Year 1 post-entry 50 Initial uptake, driven by early access programs and high unmet need
Year 2 150 Broadened approval, increased adoption
Year 3 300 Market penetration expands, institutional use increases
Year 4+ 500+ Stable growth as the drug becomes part of standard care

Revenue depends on market size, pricing strategies, and the competitive landscape. Market penetration rates typically reach 20-30% within five years for similarly targeted drugs with high unmet need.

What Are the Risks Affecting the Financial Outlook?

  • Clinical Uncertainty: Failure to demonstrate efficacy or safety issues could halt development.
  • Regulatory Hurdles: Denial or delays in approval impact time-to-market.
  • Market Competition: Entry of new drugs with better efficacy or safety profiles.
  • Pricing and Reimbursement: Restrictions on pricing could limit revenue potential.
  • Manufacturing and Supply Chain: Disruptions could cause delays or increase costs.

How Do Industry Policies Affect ASBRON's Market Potential?

Regulatory standards focus on demonstrating clear benefit over existing therapies. Reimbursement policies favor drugs that show significant clinical improvement. Orphan drug designations or similar statuses could grant market exclusivity that supports premium pricing and incentivizes investment.

What Is the Investment Outlook for ASBRON Development?

Investors should consider the following:

  • Upfront potential if Phase 2 results are positive.
  • The likelihood of clinical success based on trial design and prior phase data.
  • Potential for partnership or licensing deals, which could accelerate commercialization.
  • Risks inherent to clinical-stage assets, including trial failure and regulatory approval challenges.

Key Takeaways

  • ASBRON is in early clinical development targeting high-need indications.
  • The market faces expansion driven by unmet medical needs, regulatory incentives, and demographic trends.
  • Financial trajectory depends on clinical success, approval speed, and market acceptance.
  • Risks include clinical failure, regulatory delays, and market competition.
  • High unmet need enhances its potential for premium pricing and market penetration if approved.

FAQs

1. When is ASBRON expected to reach the market?
Potentially within 3-4 years if Phase 2 results are positive and regulatory reviews proceed without delay.

2. What are the primary competitors for ASBRON?
Existing therapies with limited efficacy or safety issues, and emerging assets in similar indications. Details depend on specific target diseases.

3. How does regulatory designation impact ASBRON’s market potential?
Designations like Breakthrough Therapy or Orphan Drug can shorten approval timelines and provide market exclusivity.

4. What is the estimated global market size for ASBRON’s indications?
Prevalence estimates for relevant conditions suggest hundreds of thousands of patients globally, increasing growth potential with expanded approvals.

5. How do reimbursement policies influence its financial prospects?
Reimbursement policies favor drugs demonstrating superior clinical benefits, allowing premium pricing and higher adoption rates.


References

[1] U.S. Food and Drug Administration (FDA). (2022). Guidance for Industry: Expedited Programs for Serious Conditions.
[2] IQVIA. (2022). Global Oncology Market Analysis.
[3] MarketWatch. (2023). Oncology Drug Market Size and Forecast.
[4] European Medicines Agency (EMA). (2022). Policy on Orphan Designation.
[5] EvaluatePharma. (2022). Worldf Pharmaceutical Market Outlook.

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