When do the THEOPHYL-SR patents expire, and when will generic THEOPHYL-SR be available?

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Ortho Mcneil Pharm	THEOPHYL-SR	theophylline	CAPSULE, EXTENDED RELEASE;ORAL	086480-001	Feb 8, 1985		DISCN	No	No	⤷ Start Trial	⤷ Start Trial				⤷ Start Trial
Ortho Mcneil Pharm	THEOPHYL-SR	theophylline	CAPSULE, EXTENDED RELEASE;ORAL	086471-001	Feb 8, 1985		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

Last updated: February 19, 2026

This report analyzes the investment potential of THEOPHYL-SR, a sustained-release theophylline formulation, by examining its patent landscape, clinical efficacy, market positioning, and competitive threats. The analysis targets R&D and investment professionals evaluating pharmaceutical assets.

What is THEOPHYL-SR and its Therapeutic Application?

THEOPHYL-SR is a pharmaceutical product containing theophylline, a methylxanthine bronchodilator. It is formulated for sustained release, aiming to provide a more consistent therapeutic effect and reduce the frequency of dosing compared to immediate-release formulations. Theophylline primarily functions by relaxing the smooth muscles of the airways, leading to bronchodilation. This mechanism makes it effective in the management of respiratory conditions characterized by bronchoconstriction.

What are the Key Indications for THEOPHYL-SR?

The primary indication for THEOPHYL-SR is the management of chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema. It is also used in the treatment of asthma, particularly in cases where other bronchodilators and anti-inflammatory treatments have not achieved adequate symptom control. The sustained-release nature of THEOPHYL-SR is intended to maintain therapeutic blood levels of theophylline over extended periods, thereby reducing exacerbations and improving daily symptom management for patients with these chronic respiratory conditions.

What is the Patent Status and Exclusivity for THEOPHYL-SR?

The patent landscape for THEOPHYL-SR is critical for determining its market exclusivity and potential for returns on investment. As a sustained-release formulation of an established drug, its patent protection likely focuses on the specific formulation, manufacturing process, or novel delivery system that confers the sustained-release property.

A comprehensive review of patent databases (e.g., USPTO, EPO, WIPO) is necessary to identify all relevant patents. Key patent families to investigate include those covering:

Formulation Patents: These patents claim the specific composition of the sustained-release matrix, excipients used, and the method of creating the slow-release profile. For THEOPHYL-SR, this would detail the technology ensuring the controlled release of theophylline over 12 or 24 hours, depending on the product's specific design.
Process Patents: These patents protect novel or improved methods of manufacturing the sustained-release dosage form, which can be essential for achieving consistent product quality and therapeutic effect.
Method of Use Patents: While less common for established drugs, these patents could cover new indications or specific patient populations where the sustained-release formulation demonstrates superior benefit.

The expiry dates of these patents are paramount. For instance, if the primary formulation patents expire in 2025, generic manufacturers could launch bioequivalent products shortly thereafter, significantly impacting market share and pricing. Identifying the earliest patent expiry date within the THEOPHYL-SR patent portfolio provides the clearest indicator of the end of its period of market exclusivity.

Hypothetical Patent Scenario:

Core Formulation Patent (US Patent X,XXX,XXX): Filed 2008, granted 2010, expires 2030. Claims a specific polymer matrix system for controlled theophylline release.
Manufacturing Process Patent (US Patent Y,YYY,YYY): Filed 2012, granted 2014, expires 2032. Claims a novel granulation technique for improved drug uniformity.
Excipient Combination Patent (EP Z,ZZZ,ZZZ): Filed 2015, granted 2017, expires 2035. Claims the use of a specific blend of hydrophilic and hydrophobic polymers.

In this hypothetical scenario, the earliest patent expiry date that directly protects the sustained-release nature of THEOPHYL-SR is 2030. However, the effective market exclusivity may be influenced by any patent term extensions (PTE) granted by regulatory authorities, which compensate for patent term lost during regulatory review. PTEs can extend patent protection for up to five years.

What is the Clinical Efficacy and Safety Profile of THEOPHYL-SR?

Evaluating THEOPHYL-SR's clinical performance requires a deep dive into its efficacy and safety data, typically derived from pivotal clinical trials and post-marketing surveillance.

Efficacy:

Bronchodilatory Effect: Studies demonstrate THEOPHYL-SR's ability to improve pulmonary function, typically measured by Forced Expiratory Volume in 1 second (FEV1) and Peak Expiratory Flow (PEF). Sustained release aims to maintain these improvements over 12 or 24-hour dosing intervals, reducing diurnal symptom variability.
Symptom Reduction: Clinical trials should demonstrate a statistically significant reduction in COPD or asthma symptoms, such as dyspnea, cough, and wheezing, compared to placebo or immediate-release theophylline. Patient-reported outcome measures (PROMs) are crucial here.
Exacerbation Prevention: The ultimate measure of efficacy for chronic respiratory diseases is the reduction in the frequency and severity of exacerbations. Data showing a decreased rate of COPD exacerbations requiring hospitalization or antibiotic/corticosteroid treatment is a strong indicator of therapeutic value. For example, a hypothetical Phase III trial might show a 20% reduction in moderate to severe COPD exacerbations per patient-year compared to placebo.
Consistency of Effect: A key advantage of sustained-release formulations is the maintenance of therapeutic serum concentrations, avoiding the peaks and troughs associated with immediate-release drugs. This consistency is linked to better symptom control and potentially fewer side effects. Target therapeutic range for theophylline is generally 10-20 µg/mL.

Safety:

Theophylline has a narrow therapeutic index, meaning the difference between effective and toxic doses is small. This necessitates careful monitoring of serum theophylline levels. Key safety considerations for THEOPHYL-SR include:

Common Side Effects: Nausea, vomiting, headache, insomnia, irritability, and tremors are dose-related and often associated with serum concentrations at the higher end of the therapeutic range or above.
Serious Adverse Events: Seizures, cardiac arrhythmias (e.g., tachycardia, ventricular ectopy), and hypotension can occur at toxic levels. These events underscore the importance of appropriate dosing and therapeutic drug monitoring.
Drug Interactions: Theophylline is metabolized by cytochrome P450 enzymes, leading to numerous potential drug interactions. Common interacting drugs include CYP1A2 inhibitors (e.g., cimetidine, fluvoxamine, oral contraceptives) which can increase theophylline levels, and CYP1A2 inducers (e.g., rifampicin, phenytoin, St. John's Wort) which can decrease levels.
Patient Monitoring: Regulatory guidelines and prescribing information for sustained-release theophylline emphasize the need for regular monitoring of serum theophylline concentrations, especially when initiating therapy, changing dose, or in patients with conditions affecting drug metabolism (e.g., liver disease, heart failure, fever).

A robust safety profile, characterized by manageable side effects and a well-understood risk-benefit ratio when therapeutic drug monitoring is employed, enhances the value proposition of THEOPHYL-SR.

What is the Market Size and Growth Potential for THEOPHYL-SR?

The market for COPD and asthma therapeutics is substantial and projected to grow, driven by an aging global population, increasing prevalence of respiratory diseases, and improving diagnostic capabilities.

COPD Market: The global COPD market was valued at approximately USD 15.1 billion in 2022 and is forecast to grow at a compound annual growth rate (CAGR) of 3.8% from 2023 to 2030 (Source: Grand View Research [1]). Key drivers include smoking rates, air pollution, and occupational dust exposure.
Asthma Market: The global asthma market was valued at USD 27.3 billion in 2022 and is expected to expand at a CAGR of 4.2% over the forecast period (Source: Grand View Research [2]). Factors influencing this growth include increased awareness, technological advancements in inhaler devices, and the development of biologics.

THEOPHYL-SR competes within the broader bronchodilator segment, which includes beta-agonists (short-acting and long-acting), anticholinergics, and xanthines. While newer classes of drugs and inhaler technologies have gained prominence, theophylline remains a viable option for certain patient profiles, particularly those who do not achieve adequate control with standard therapies or for whom cost is a significant factor.

Factors influencing THEOPHYL-SR's specific market potential:

Penetration Rate: The percentage of COPD and asthma patients currently treated with sustained-release theophylline. This is likely to be lower than for inhaled therapies due to the oral route of administration and the need for monitoring.
Market Share within Xanthine Class: Theophylline is the dominant xanthine bronchodilator. Its market share depends on the availability and success of other methylxanthines.
Pricing and Reimbursement: The price of THEOPHYL-SR relative to other COPD and asthma medications, and its coverage by insurance providers and national health systems, will significantly influence its market adoption. As a more established drug, it may offer a cost-effective alternative.
Geographic Penetration: The sales performance of THEOPHYL-SR will vary by region, influenced by local treatment guidelines, physician prescribing habits, and the competitive landscape in specific markets.

Estimating THEOPHYL-SR's specific market share requires granular data on prescription volumes and sales figures for the drug across its key markets. Without this specific data, the market growth potential is derived from the overall respiratory disease market trends.

What is the Competitive Landscape for THEOPHYL-SR?

THEOPHYL-SR operates in a competitive environment with both established and emerging therapies for COPD and asthma. Its competitive positioning depends on its therapeutic advantages, cost-effectiveness, and the presence of newer treatment modalities.

Direct Competitors (Sustained-Release Theophylline):

Other Branded Sustained-Release Theophylline Products: Depending on the region and manufacturer, there may be other branded sustained-release theophylline formulations available. These would directly compete on price, formulation characteristics, and marketing efforts.
Generic Sustained-Release Theophylline: Once patents expire, numerous generic versions of sustained-release theophylline become available, significantly increasing price competition and eroding market share from branded products.

Indirect Competitors (Alternative Bronchodilators and Therapies):

Long-Acting Beta-Agonists (LABAs): Drugs like salmeterol, formoterol, olodaterol, and vilanterol are widely used as first-line bronchodilators in COPD and add-on therapy in asthma. They offer convenient once- or twice-daily dosing via inhalation.
Long-Acting Muscarinic Antagonists (LAMAs): Tiotropium, aclidinium, glycopyrronium, and umeclidinium are primary bronchodilators for COPD and often used in combination with LABAs. They also provide once-daily inhaled dosing.
Combination Inhalers (LABA/LAMA, LABA/ICS): The current standard of care in many COPD and severe asthma guidelines involves combination inhalers, offering enhanced efficacy and adherence. Examples include Symbicort (budesonide/formoterol), Advair (salmeterol/fluticasone), and Trelegy Ellipta (fluticasone furoate/umeclidinium/vilanterol).
Inhaled Corticosteroids (ICS): Essential for asthma management and increasingly used in moderate-to-severe COPD.
Other Xanthines: While less common, other methylxanthines might exist or emerge in specific markets.
Newer Therapies: For severe asthma, biologics like anti-IgE (omalizumab), anti-IL5 (mepolizumab, reslizumab, benralizumab), and anti-IL4Rα (dupilumab) offer targeted treatments.

Competitive Advantages of THEOPHYL-SR:

Oral Administration: Avoids the need for inhaler devices and the technique required for effective inhalation, which can be challenging for some patients.
Cost-Effectiveness: Compared to many newer biologics and advanced combination inhalers, THEOPHYL-SR may offer a lower cost of treatment, particularly for patients with limited insurance coverage or in resource-constrained healthcare systems.
Established Efficacy: Theophylline has a long history of use, and its efficacy profile is well-understood for managing chronic airflow obstruction.

Competitive Disadvantages of THEOPHYL-SR:

Narrow Therapeutic Index & Monitoring Requirements: The need for regular blood tests to monitor serum theophylline levels adds complexity and cost for both patients and healthcare systems, and increases the risk of toxicity if not managed properly.
Side Effect Profile: Potential for significant side effects, especially at supra-therapeutic levels.
Drug Interactions: Extensive potential for interactions with other medications.
Less Convenient Dosing: While sustained-release improves convenience over immediate-release, it still requires daily oral intake, which can be less convenient than once-daily inhaled therapies.
Perceived as a "Second-Line" or "Older" Therapy: In many guidelines, theophylline is relegated to later lines of therapy after inhaled bronchodilators and ICS have been optimized, especially for asthma.

What is the Regulatory Landscape and Approvals for THEOPHYL-SR?

The regulatory pathway for THEOPHYL-SR, like any pharmaceutical product, involves rigorous review by health authorities in each target market. Key considerations include:

Initial Marketing Authorizations: Approval from agencies like the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA), and other national regulatory bodies. These approvals are based on comprehensive data packages demonstrating safety and efficacy.
Formulation-Specific Approvals: Regulatory approval for a sustained-release formulation of theophylline is distinct from that of immediate-release forms. The focus is on demonstrating the bioequivalence and clinical performance of the sustained-release profile.
Labeling Requirements: Prescribing information will include details on indications, contraindications, warnings (especially regarding narrow therapeutic index and toxicity), precautions (e.g., drug interactions, monitoring requirements), adverse reactions, and dosing guidelines.
Post-Marketing Surveillance: Ongoing monitoring of the drug's safety in the real-world setting is mandatory. This includes reporting of adverse events and potentially conducting further studies if new safety signals emerge.
Generic Approvals: For generic versions, the primary regulatory hurdle is demonstrating bioequivalence to the reference listed drug (RLD), which would be the innovator THEOPHYL-SR product. This typically involves pharmacokinetic studies.
Therapeutic Drug Monitoring (TDM) Guidelines: Regulatory bodies often emphasize or mandate the importance of TDM for xanthines due to their narrow therapeutic index. This is reflected in product labeling and physician education.

Specific approvals for THEOPHYL-SR would be documented by the FDA (e.g., on the Orange Book for approved drug products with therapeutic equivalence evaluations) and the EMA (e.g., through EudraCT or the European Public Assessment Report - EPAR). The existence and maintenance of these approvals are critical for ongoing market access.

What are the Financial Projections and Valuation Considerations for THEOPHYL-SR?

Financial projections for THEOPHYL-SR are contingent upon a number of factors, including market penetration, pricing strategies, patent exclusivity duration, and the cost of goods sold (COGS).

Key Financial Metrics to Consider:

Revenue Projections: Based on estimated market share within its target indications, patient populations, and average selling price (ASP). Revenue growth will be influenced by market expansion, price adjustments, and the threat of genericization.
Cost of Goods Sold (COGS): Manufacturing costs, raw material sourcing, and supply chain efficiency. For an established drug like theophylline, COGS is generally stable, but optimization can enhance margins.
Operating Expenses: Marketing, sales, regulatory affairs, research and development (for line extensions or new indications), and general administrative costs.
Profitability Margins: Gross margin, operating margin, and net profit margin. These will be impacted by pricing pressures, particularly post-patent expiry.
Discounted Cash Flow (DCF) Analysis: A primary valuation method projecting future cash flows and discounting them back to the present value using an appropriate discount rate, which reflects the risk associated with the investment.
Comparable Company Analysis (CCA): Benchmarking THEOPHYL-SR's financial metrics (e.g., revenue multiples, EBITDA multiples) against similar pharmaceutical products or companies.

Valuation Considerations:

Patent Cliff: The most significant factor impacting valuation is the impending expiry of key patents. A product nearing its patent cliff will experience a sharp decline in revenue and profitability as generics enter the market.
Market Exclusivity Period: The duration of uninterrupted market exclusivity is a primary driver of peak sales and overall return on investment.
Genericization Impact: Post-patent expiry, revenue from THEOPHYL-SR will likely decline by 70-90% within the first few years due to generic competition.
Pipeline and Life Cycle Management: Potential for THEOPHYL-SR to be formulated into new delivery systems, combined with other agents, or approved for new indications could extend its commercial life and value.
Therapeutic Niche Dominance: If THEOPHYL-SR holds a dominant position within a specific, underserved niche within COPD or asthma management, it can command higher valuations, even with generic competition.
Geographic Performance: Performance in high-revenue markets (e.g., U.S., Western Europe) versus emerging markets will dictate overall financial success.

A robust financial model incorporating realistic assumptions about market dynamics, patent expiry, and competitive entry is essential for an accurate valuation.

Key Takeaways

THEOPHYL-SR is a sustained-release theophylline formulation for COPD and asthma, offering oral bronchodilation.
Its market exclusivity is dictated by patent expiry dates, with potential generic entry posing a significant risk to revenue post-expiry.
Clinical efficacy focuses on bronchodilation and symptom reduction, while safety necessitates careful monitoring due to theophylline's narrow therapeutic index and potential for toxicity.
The COPD and asthma markets are substantial, but THEOPHYL-SR faces intense competition from inhaled therapies and combination products.
Regulatory approval hinges on demonstrating sustained-release performance, safety, and ongoing pharmacovigilance.
Valuation is heavily influenced by the timing of patent expiry and the anticipated impact of generic competition.

Frequently Asked Questions

What is the primary mechanism of action for THEOPHYL-SR?

THEOPHYL-SR's primary mechanism of action is bronchodilation, achieved through the inhibition of phosphodiesterase enzymes, leading to increased intracellular cyclic adenosine monophosphate (cAMP) levels in airway smooth muscle cells.

What are the key risks associated with THEOPHYL-SR therapy?

Key risks include its narrow therapeutic index, which requires regular blood monitoring to avoid toxicity, potential for serious adverse events like seizures and cardiac arrhythmias, and numerous drug interactions.

How does THEOPHYL-SR compare to inhaled bronchodilators?

THEOPHYL-SR is administered orally, offering an alternative to inhaled medications which require proper device technique and can be challenging for some patients. However, inhaled therapies are generally considered first-line due to better targeted delivery and often fewer systemic side effects when used appropriately.

When is the projected expiry of the key patents protecting THEOPHYL-SR?

The projected expiry of key patents varies by specific patent family. An investor must consult detailed patent filings and legal opinions to determine the earliest expiry date for patents covering the core formulation and manufacturing processes essential for the sustained-release property.

What is the typical therapeutic drug monitoring range for theophylline?

The generally accepted therapeutic serum theophylline concentration range is 10-20 µg/mL. Concentrations above 20 µg/mL increase the risk of toxicity, while concentrations below 10 µg/mL may not provide optimal therapeutic benefit.

Citations

[1] Grand View Research. (2023). COPD Market Size, Share & Trends Analysis Report By Drug Class, By Route Of Administration, By Distribution Channel, By Region, And Segment Forecasts, 2023 - 2030. Retrieved from https://www.grandviewresearch.com/industry-analysis/copd-market

[2] Grand View Research. (2023). Asthma Market Size, Share & Trends Analysis Report By Drug Class, By Treatment Strategy, By Route Of Administration, By Distribution Channel, By Region, And Segment Forecasts, 2023 - 2030. Retrieved from https://www.grandviewresearch.com/industry-analysis/asthma-market

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