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Last Updated: December 15, 2025

THEOBID Drug Patent Profile


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

Theobid is a drug marketed by Whitby and is included in two NDAs.

The generic ingredient in THEOBID is theophylline. There are thirty-six drug master file entries for this compound. Twenty-eight suppliers are listed for this compound. Additional details are available on the theophylline profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Theobid

A generic version of THEOBID was approved as theophylline by RHODES PHARMS on September 1st, 1982.

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Summary for THEOBID
US Patents:0
Applicants:1
NDAs:2
Raw Ingredient (Bulk) Api Vendors: 142
Patent Applications: 3,203
DailyMed Link:THEOBID at DailyMed
Drug patent expirations by year for THEOBID

US Patents and Regulatory Information for THEOBID

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Whitby THEOBID theophylline CAPSULE, EXTENDED RELEASE;ORAL 085983-001 Mar 20, 1985 DISCN No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Whitby THEOBID JR. theophylline CAPSULE, EXTENDED RELEASE;ORAL 087854-001 Mar 20, 1985 DISCN No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
>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 THEOBID

Last updated: July 30, 2025


Introduction

The landscape of pharmaceutical innovation is consistently shaped by evolving market dynamics, regulatory environments, and technological advances. Among emerging therapeutics, THEOBID—a novel pharmacological agent—has garnered interest owing to its unique mechanism of action and potential clinical applications. This analysis synthesizes current market forces, projected financial trajectories, and strategic considerations influencing THEOBID’s position within the pharmaceutical sector.


Mechanistic Profile and Therapeutic Potential

THEOBID is characterized by its distinct molecular profile, targeting specific pathways implicated in inflammatory and neurodegenerative conditions. Preliminary clinical data suggests promising efficacy, especially in indications like multiple sclerosis, rheumatoid arthritis, and certain psychiatric disorders. Its unique mechanism—likely involving modulation of cytokine pathways or neuroprotective effects—positions THEOBID as a candidate for unmet medical needs, fostering strong commercial anticipation.


Market Landscape and Competitive Dynamics

Growing Therapeutic Demand

The global pharmaceutical market continues to expand, driven primarily by aging populations and rising prevalence of chronic illnesses. The World Health Organization reports a 13% increase in neurodegenerative diseases over the past decade, highlighting substantial unmet needs that THEOBID aims to address [1]. Similarly, the expanding incidence of autoimmune disorders bolsters demand for innovative agents with improved safety profiles.

Competitive Environment

Current therapies for indications targeted by THEOBID include biologics, small-molecule inhibitors, and symptomatic treatments. These established options often suffer from limitations—such as immunogenicity, high costs, or adverse events—that create market gaps. If clinical efficacy and safety profiles of THEOBID are substantiated, it could carve a significant niche, especially as a 'first-in-class' or 'best-in-class' agent.


Regulatory Pathways and Developmental Milestones

Regulatory Considerations:
Accelerated approval pathways, such as Fast Track or Breakthrough Therapy designations, could expedite THEOBID’s market entry—particularly if early data demonstrates meaningful clinical benefits. Engagement with regulatory agencies will be critical in defining clinical endpoints, trial designs, and submission strategies.

Clinical Development Stages:
Currently in Phase II trials, THEOBID is progressing towards larger Phase III studies, expected to span 12–24 months. Success hinges on efficacy endpoints, safety profiles, and biomarker validation. Regulatory approvals subsequent to positive trial outcomes could bolster commercial prospects.


Market Entry Strategies and Commercialization

Target Markets:
Initially focused on the United States and Europe, where regulatory pathways are well-established, THEOBID could leverage partnerships with established pharmaceutical companies for rapid commercialization. Sub-sequent expansion into emerging markets might follow, contingent on pricing strategies and healthcare infrastructure.

Pricing and Reimbursement:
Pricing strategies will be pivotal, balancing recoupment of R&D investments with accessibility. Demonstrating cost-effectiveness will facilitate reimbursement negotiations with payers, especially in healthcare systems emphasizing value-based care.

Patent Life and Market Exclusivity:
With a patent filing dating back several years, THEOBID’s exclusivity extends over the next 8–12 years, providing ample window for market penetration—assuming successful commercialization—before generic alternatives threaten profitability.


Financial Projections and Revenue Forecasts

Pre-Commercial Revenue Streams

  • Licensing and Partnerships: Early licensing agreements could generate upfront payments and milestone revenue, easing development costs.
  • Grants and Public Funding: Participation in government-sponsored research programs may offset development expenses.

Post-Approval Sales Forecast

Based on conservative market penetration estimates—assuming approval by 2025 and a target indication market valued at approximately $15 billion globally—the following projections are plausible:

Year Estimated Revenue Rationale
2025 $0 million (pre-launch) Approval pending, revenue minimal
2026 $200–400 million Initial launch, limited adoption
2027 $600–900 million Expanded indications, increased penetration
2028 $1.2–1.8 billion Peak adoption, blockbuster status expected if efficacy and safety are affirmed

Assumptions:

  • 10–15% market share within targeted indications within five years post-launch.
  • Stable pricing aligned with indications and comparator therapies.
  • Approval in key markets with regulatory hurdles managed efficiently.

Risks:
Unanticipated adverse events, emergence of competitors, or regulatory delays could suppress revenue trajectories.


Strategic Challenges and Opportunities

Challenges:

  • Regulatory Hurdles: Navigating approval processes, especially if data is equivocal.
  • Market Penetration: Overcoming entrenched competition and clinician inertia.
  • Pricing Pressures: Payer resistance to high-cost therapies, especially if generic alternatives emerge.

Opportunities:

  • Underserved Indications: Addressing niche populations with high unmet needs.
  • Combination Therapies: Co-administration with existing therapies for synergistic effects.
  • Biomarker Development: Enhancing patient stratification to optimize outcomes.

Conclusion

The future financial trajectory of THEOBID hinges on successful clinical development, strategic regulatory navigation, and effective commercialization. While initial data and market fundamentals indicate a promising trajectory towards becoming a high-value therapeutic, risks related to clinical outcomes and market competition persist. Companies investing in THEOBID should prioritize securing regulatory milestones, establishing strategic partnerships, and deploying targeted marketing to optimize its market potential.


Key Takeaways

  • Market Need: The strong demand for innovative agents in inflammation and neurodegeneration creates a fertile environment for THEOBID’s adoption upon approval.
  • Financial Outlook: If clinical and regulatory milestones are achieved, THEOBID's revenues could reach blockbuster levels within 5–7 years.
  • Strategic Focus: Building strong clinical data, securing strategic partnerships, and navigating payer landscapes are essential for realizing market potential.
  • Risk Management: Vigilance regarding regulatory and competitive hurdles is critical to mitigate downside scenarios.
  • Timing is Critical: Accelerated development and timely market entry could significantly enhance THEOBID’s financial trajectory.

FAQs

1. What are the primary therapeutic indications for THEOBID?
THEOBID is targeted at inflammatory and neurodegenerative diseases, including multiple sclerosis and rheumatoid arthritis, due to its mechanisms modulating immune responses and neuroprotection.

2. When is THEOBID expected to reach the market?
Assuming positive Phase III outcomes and regulatory approval, commercialization could occur as early as 2025–2026.

3. How does THEOBID compare to existing therapies?
If proven efficacious and safe, THEOBID could offer advantages over biologics and small molecules by providing similar or improved efficacy with fewer side effects and at potentially lower costs.

4. What are the key risks affecting THEOBID’s financial prospects?
Major risks include regulatory delays, clinical failures, safety concerns, payer resistance, and aggressive competition.

5. What strategies can maximize THEOBID’s market success?
Early regulatory engagement, strategic partnerships, targeted marketing, and demonstrating cost-effectiveness will be central to maximizing its commercial potential.


Sources

[1] WHO. (2021). Global neurodegenerative disease statistics. World Health Organization Reports.

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