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Last Updated: December 22, 2024

THEOPHYLLINE-SR Drug Patent Profile


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When do Theophylline-sr patents expire, and when can generic versions of Theophylline-sr launch?

Theophylline-sr is a drug marketed by Scherer Rp and is included in one NDA.

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

DrugPatentWatch® Litigation and Generic Entry Outlook for Theophylline-sr

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

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Summary for THEOPHYLLINE-SR
Drug patent expirations by year for THEOPHYLLINE-SR
Recent Clinical Trials for THEOPHYLLINE-SR

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Tanta UniversityN/A
LG ChemPhase 1
Medical College of WisconsinPhase 1/Phase 2

See all THEOPHYLLINE-SR clinical trials

US Patents and Regulatory Information for THEOPHYLLINE-SR

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Scherer Rp THEOPHYLLINE-SR theophylline CAPSULE, EXTENDED RELEASE;ORAL 088255-001 Jun 12, 1986 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

THEOPHYLLINE-SR Market Analysis and Financial Projection Experimental

Theophylline-SR Market Dynamics and Financial Trajectory

Market Overview

Theophylline, a bronchodilator used primarily in the treatment of respiratory disorders such as asthma and chronic obstructive pulmonary disease (COPD), is a significant player in the pharmaceutical market. Here’s a detailed look at the market dynamics and financial trajectory of theophylline, particularly focusing on the sustained-release (SR) formulations.

Current Market Valuation

As of 2022, the global theophylline and aminophylline market was valued at approximately $318 million. This valuation is expected to grow, albeit at a slow pace, with a projected Compound Annual Growth Rate (CAGR) of 2% from 2022 to 2032, reaching a market value of $387.64 million by 2032[2].

Growth Drivers

Increasing Incidence of Respiratory Diseases

The rising incidence of respiratory conditions such as asthma and COPD is a major driver of the theophylline market. These diseases are becoming more prevalent due to demographic factors like aging populations and environmental pollution, thereby increasing the demand for theophylline-based treatments[2][3].

Cost-Effectiveness

Theophylline is recognized for its cost-effectiveness. Studies have shown that theophylline can significantly reduce hospital admission costs associated with exacerbations of COPD, making it a financially viable option for healthcare systems[2].

Innovations in Pharmaceutical Research

Continuous research and development in pharmaceuticals are leading to novel formulations and delivery systems for theophylline. These innovations are improving the safety and efficacy profiles of theophylline-based drugs, which in turn is driving market growth. Sustained-release formulations, such as APO-THEO ER, offer gradual and measured release of theophylline, enhancing patient compliance and therapeutic efficacy[4].

Market Segmentation

By Application

The theophylline market is segmented primarily by application, with asthma being the most significant segment. Other applications include insomnia and various other respiratory conditions. The demand for theophylline in treating asthma and COPD is the main driver of market expansion[2][3].

By Product

The global theophylline market includes various product forms such as injections, tablets, and capsules. Sustained-release tablets, like PrAPO-THEO ER, are particularly popular due to their convenience and improved pharmacokinetic profiles[4].

Revenue Growth

The revenue growth of the theophylline market is anticipated to be steady, driven by the expanding demand for bronchodilator drugs. The market's financial trajectory is influenced by factors such as the rising prevalence of respiratory diseases, improved drug formulations, and strategic partnerships between pharmaceutical companies and healthcare providers[2][3].

Challenges and Opportunities

Declining Use in Some Regions

Despite its global significance, the use of theophylline in some regions, such as the United States, has been declining due to the advent of new and more effective treatments for asthma, including inhaled glucocorticoids and long-acting inhaled β-receptor agonists. The narrow therapeutic index and potential side effects of theophylline have also contributed to this decline[2].

Opportunities in Emerging Markets

However, there are significant opportunities in emerging markets where access to healthcare is improving, and the incidence of respiratory diseases is on the rise. Strategic partnerships and innovations in drug delivery systems can help tap into these markets and drive further growth[2][3].

Pharmacokinetics and Therapeutic Range

The generally accepted optimal therapeutic serum theophylline concentrations are between 5 to 15 mg/L. Levels above 20 mg/L are usually associated with significant adverse drug reactions. The pharmacokinetics of theophylline are influenced by variables such as age, body weight, diet, concomitant medications, disease state, and smoking. Therefore, each patient's optimal therapeutic maintenance dosage should be determined by individual titration[4].

Compliance and Dosage Regimens

Compliance with theophylline dosage regimens can be a challenge. Studies have shown that once-daily dosing with sustained-release formulations can improve compliance compared to multiple-dose regimens. For example, Theo-Dur, a sustained-release formulation, showed better compliance and lower wheezing scores compared to Theolair, which required more frequent dosing[1].

Food Effects on Bioavailability

Food intake can significantly affect the bioavailability of some theophylline products. For instance, food taken with Theo-Dur Sprinkle can delay absorption and reduce bioavailability, highlighting the need for careful clinical monitoring and dietary advice when prescribing these medications[1].

Competitive Landscape

The competitive landscape of the theophylline market is characterized by major players adopting various business strategies to expand their market presence. Companies like Apotex Inc. and Key Pharmaceuticals Inc. are key players in the market, offering a range of theophylline formulations including sustained-release tablets[2][4].

Market Projections

The theophylline market is projected to grow at a CAGR of 6% from 2024 to 2031, reaching a market value of $660.1 million by 2031. This growth trajectory indicates robust market dynamics driven by the increasing incidence of respiratory conditions and advancements in pharmaceutical research[3].

Key Takeaways

  • Market Valuation: The global theophylline and aminophylline market was valued at approximately $318 million in 2022 and is expected to reach $387.64 million by 2032.
  • Growth Drivers: The market is driven by the increasing incidence of respiratory diseases and the cost-effectiveness of theophylline.
  • Innovations: Continuous research and development are improving the safety and efficacy of theophylline-based drugs.
  • Market Segmentation: The market is segmented primarily by application, with asthma being the most significant segment.
  • Revenue Growth: The revenue growth is anticipated to be steady, driven by expanding demand and strategic partnerships.

FAQs

1. What is the current market valuation of the theophylline and aminophylline market?

The current market valuation of the theophylline and aminophylline market is approximately $318 million as of 2022[2].

2. What is the projected growth rate of the theophylline market from 2022 to 2032?

The theophylline market is projected to grow at a CAGR of 2% from 2022 to 2032[2].

3. What are the primary drivers of the theophylline market?

The primary drivers of the theophylline market include the increasing incidence of respiratory diseases and the cost-effectiveness of theophylline[2][3].

4. How do sustained-release formulations impact patient compliance?

Sustained-release formulations, such as APO-THEO ER, improve patient compliance by reducing the frequency of dosing and providing a more stable therapeutic serum concentration[1][4].

5. What are the potential side effects of theophylline levels above the therapeutic range?

Levels above 20 mg/L are usually associated with significant adverse drug reactions, including toxicity. Therefore, careful monitoring and individual titration are necessary to maintain optimal therapeutic levels[4].

Sources

  1. Advantages and Disadvantages of 24-Hour Theophylline: Journal of Allergy and Clinical Immunology, Volume 76, Issue 4, 1985[1].
  2. Generic THEOPHYLLINE INN Equivalents, Drug Patent Expiry and Market Dynamics: Drug Patent Watch[2].
  3. Theophylline Market Size, Trends and Projections: Market Research Intellect[3].
  4. Theophylline Sustained Release Tablets: Apotex Inc., Product Monograph[4].
  5. South African Healthcare Reforms Towards Universal Healthcare: South African Medical Journal[5].

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