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Last Updated: December 22, 2024

THEOLAIR-SR Drug Patent Profile


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When do Theolair-sr patents expire, and what generic alternatives are available?

Theolair-sr is a drug marketed by 3M and is included in four NDAs.

The generic ingredient in THEOLAIR-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 Theolair-sr

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

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Summary for THEOLAIR-SR
Drug patent expirations by year for THEOLAIR-SR

US Patents and Regulatory Information for THEOLAIR-SR

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
3m THEOLAIR-SR theophylline TABLET, EXTENDED RELEASE;ORAL 088369-001 Jul 16, 1987 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
3m THEOLAIR-SR theophylline TABLET, EXTENDED RELEASE;ORAL 089132-001 Jul 16, 1987 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
3m THEOLAIR-SR theophylline TABLET, EXTENDED RELEASE;ORAL 086363-002 Jul 16, 1987 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
3m THEOLAIR-SR theophylline TABLET, EXTENDED RELEASE;ORAL 088364-001 Jul 16, 1987 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

THEOLAIR-SR Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Theolair-SR (Theophylline)

Introduction

Theolair-SR, a brand name for theophylline, is a xanthine drug used to treat symptoms and reversible airflow obstruction associated with chronic asthma and other chronic lung diseases. Understanding the market dynamics and financial trajectory of this drug involves examining several key factors, including its usage, side effects, interactions, generic competition, and healthcare cost implications.

Usage and Clinical Significance

Theophylline is a well-established medication in the management of respiratory diseases. It is particularly useful for patients who do not respond adequately to other treatments or as part of a combination therapy regimen. The drug must be individualized based on peak serum theophylline concentration measurements to ensure maximum benefit with minimal risk of adverse effects[1].

Side Effects and Safety Profile

The side effects of theophylline are generally mild when peak serum concentrations are below 20 mcg/mL, consisting of transient caffeine-like effects such as nausea, vomiting, headache, and insomnia. However, at higher concentrations, more severe adverse reactions can occur, including persistent vomiting, cardiac arrhythmias, and intractable seizures, which can be fatal[1][4].

Dosage and Administration

The dosage of theophylline must be carefully adjusted based on serum concentration measurements. Dose increases should only be made if the previous dosage is well tolerated and at intervals of no less than 3 days to allow serum concentrations to reach the new steady state. This careful management is crucial to avoid adverse effects and ensure therapeutic efficacy[1].

Generic Competition

The generic drug industry plays a significant role in the market dynamics of theophylline. Generic versions of theophylline are widely available, and their prices decline with the number of competitors. Studies have shown that generic drug prices approach long-run marginal costs when there are 8 or more competitors in the market. This competition can significantly impact the financial trajectory of brand-name drugs like Theolair-SR, as generic alternatives become more affordable and attractive to consumers and healthcare providers[3].

Interactions with Other Medications

Theophylline interacts with several other medications, which can affect its clearance and efficacy. For example, drugs like rifampin and sulfinpyrazone can decrease theophylline levels, while others like troleandomycin and ticlopidine can increase them. These interactions must be carefully managed to maintain therapeutic levels and avoid adverse effects[1].

Healthcare Cost Implications

The cost of theophylline and its impact on healthcare expenditures are important considerations. School-based health centers (SBHCs) and other healthcare programs have shown that managing chronic conditions like asthma can reduce overall healthcare costs, including hospitalizations and emergency department visits. The use of theophylline as part of a comprehensive treatment plan can contribute to these cost savings by improving patient outcomes and reducing the need for more expensive interventions[2].

Market Trends and Financial Projections

The financial trajectory of Theolair-SR is influenced by broader market trends in the pharmaceutical industry. The shift towards generic and specialty drugs has impacted the profitability of retail pharmacies and prescription benefit managers (PBMs). Generic drugs, including those of theophylline, can no longer offset losses due to government price caps and decreased generic market profits. This trend suggests that the financial performance of Theolair-SR may be affected by the increasing competition from generic versions and the changing business strategies of pharmacies and PBMs[5].

Impact of Regulatory Environment

Regulatory changes and institutional features of the generic drug industry also affect the market dynamics of theophylline. Early approval for generic versions can provide a competitive advantage, leading to higher profits for the first entrants. However, as more generic competitors enter the market, prices decline, and profits are reduced. This regulatory environment influences the financial trajectory of brand-name drugs like Theolair-SR by creating a competitive landscape where generic alternatives become increasingly attractive[3].

Patient and Provider Preferences

Patient and provider preferences play a crucial role in the market dynamics of theophylline. The choice between brand-name and generic versions is often influenced by factors such as cost, efficacy, and side effect profiles. As healthcare systems aim to reduce costs while maintaining quality care, the preference for generic theophylline may increase, impacting the financial performance of Theolair-SR[5].

Conclusion

The market dynamics and financial trajectory of Theolair-SR are complex and influenced by multiple factors. These include the drug's clinical significance, side effect profile, generic competition, interactions with other medications, healthcare cost implications, market trends, regulatory environment, and patient and provider preferences. As the pharmaceutical landscape continues to evolve, understanding these factors is essential for predicting the future financial performance of Theolair-SR.

Key Takeaways

  • Individualized Dosage: Theophylline dosages must be tailored based on serum concentration measurements to ensure efficacy and safety.
  • Generic Competition: The presence of generic theophylline significantly impacts the market dynamics and financial trajectory of Theolair-SR.
  • Healthcare Costs: Effective management of chronic conditions using theophylline can reduce overall healthcare costs.
  • Market Trends: Shifts in the pharmaceutical industry, such as the rise of generic and specialty drugs, affect the profitability of Theolair-SR.
  • Regulatory Environment: Early approval for generic versions and regulatory changes influence the competitive landscape.

FAQs

Q: What is the primary use of Theolair-SR? A: Theolair-SR (theophylline) is used to treat the symptoms and reversible airflow obstruction associated with chronic asthma and other chronic lung diseases.

Q: How is the dosage of Theolair-SR adjusted? A: The dosage of Theolair-SR must be individualized based on peak serum theophylline concentration measurements to ensure maximum benefit with minimal risk of adverse effects.

Q: What are the common side effects of Theolair-SR? A: Common side effects include caffeine-like adverse effects such as nausea, vomiting, headache, and insomnia. More severe side effects can occur at higher serum concentrations.

Q: How does generic competition affect Theolair-SR? A: Generic competition significantly reduces the prices and profitability of Theolair-SR as more generic competitors enter the market.

Q: What is the impact of Theolair-SR on healthcare costs? A: Effective use of Theolair-SR as part of a comprehensive treatment plan can reduce overall healthcare costs by improving patient outcomes and reducing the need for more expensive interventions.

Sources

  1. RxList: Theolair (Theophylline): Side Effects, Uses, Dosage, Interactions...
  2. Interact for Health: FINAL REPORT Evaluation of Healthcare Costs and Utilization...
  3. Federal Trade Commission: Generic Drug Industry Dynamics...
  4. Drugs.com: Theolair-SR Side Effects: Common, Severe, Long Term...
  5. ASHP: Strategic Directions in System Formulary, Drug Policy, and High-Cost Drugs...

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