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Last Updated: December 22, 2024

THEOCHRON Drug Patent Profile


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Which patents cover Theochron, and what generic alternatives are available?

Theochron is a drug marketed by Nostrum Pharms Llc and is included in one NDA.

The generic ingredient in THEOCHRON 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 Theochron

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

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Drug patent expirations by year for THEOCHRON

US Patents and Regulatory Information for THEOCHRON

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Nostrum Pharms Llc THEOCHRON theophylline TABLET, EXTENDED RELEASE;ORAL 087400-003 Feb 21, 1985 RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Nostrum Pharms Llc THEOCHRON theophylline TABLET, EXTENDED RELEASE;ORAL 087400-005 Aug 9, 2023 AB RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Nostrum Pharms Llc THEOCHRON theophylline TABLET, EXTENDED RELEASE;ORAL 087400-004 Feb 21, 1985 RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Nostrum Pharms Llc THEOCHRON theophylline TABLET, EXTENDED RELEASE;ORAL 087400-002 Jan 11, 1983 AB RX 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

THEOCHRON Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Theophylline (Theochron)

Introduction

Theophylline, marketed under various brand names including Theochron, is a methylxanthine derivative used primarily to manage symptoms of asthma, chronic obstructive pulmonary disease (COPD), and other lung conditions. Despite its long history and established use, the market dynamics and financial trajectory of theophylline have undergone significant changes.

Historical Context and Medical Uses

Theophylline was first introduced as a clinical treatment for asthma in 1922, leveraging its bronchodilator effects. It has been used for various respiratory conditions, including asthma, COPD, and infant apnea. The drug exhibits multiple mechanisms of action, including phosphodiesterase inhibition, adenosine receptor blockade, and histone deacetylase activation, which contribute to its therapeutic efficacy[2][4].

Decline in Usage

The use of theophylline in the treatment of asthma and COPD has diminished over the years due to the advent of newer, more effective medications such as inhaled glucocorticoids and long-acting inhaled β-receptor agonists. The narrow therapeutic index of theophylline, which requires careful monitoring to avoid toxicity, has also contributed to its declining popularity. Despite this, theophylline remains beneficial, especially in patients with difficult-to-manage symptoms[1][2].

Market Competition

The market for respiratory medications is highly competitive, with newer drugs offering better safety profiles and efficacy. Theophylline's side effect profile, which includes nausea, vomiting, headache, and potential for severe adverse effects like seizures and cardiac arrhythmias at high serum concentrations, has made it less favorable compared to newer alternatives[2].

Financial Performance

The financial performance of pharmaceutical companies producing theophylline is influenced by several factors, including market demand, competition, and regulatory environments. High drug prices, which have been a contentious issue, can impact the financial performance of pharmaceutical companies. Media coverage of drug prices can significantly affect a company's stock value and market capitalization, as seen in studies examining the relationship between drug price news and financial outcomes of pharmaceutical companies[3].

Impact of Media Coverage

Media coverage of drug prices can lead to public and regulatory scrutiny, potentially affecting the stock prices of pharmaceutical companies. Companies that face criticism for high drug prices may experience a reduction in their stock value, which can have long-term implications for their financial performance and capitalization[3].

Cost and Pricing

The cost of developing and maintaining theophylline as a treatment option is relatively lower compared to newer medications. However, the pricing strategy for theophylline must balance profitability with patient accessibility. Pharmaceutical companies often argue that high drug prices are necessary to cover the costs of research and development, although this claim has been questioned by several studies[3].

Regulatory and Clinical Considerations

Theophylline's use is heavily regulated due to its narrow therapeutic index and potential for adverse effects. Healthcare providers must closely monitor patients' serum concentrations to avoid toxicity. This requirement for careful monitoring can increase healthcare costs and may influence the financial trajectory of the drug[2].

Patient Compliance and Administration

Theophylline is available in various formulations, including sustained-release preparations, which can enhance patient compliance. However, the need for frequent monitoring and potential side effects can still impact patient adherence and overall treatment outcomes[1][2].

Interprofessional Healthcare Team Involvement

The management of theophylline involves an interprofessional healthcare team, including nurse practitioners, primary care providers, pulmonologists, and pharmacists. This team must be aware of the drug's adverse effect profile and ensure close monitoring of patients. This collaborative approach can improve patient outcomes but also adds to the overall cost of care[2].

Future Outlook

Despite the decline in its use, theophylline still holds value in specific clinical scenarios, particularly for patients with refractory symptoms who do not respond well to newer treatments. Ongoing research into its immunomodulatory and anti-inflammatory properties may renew interest in its use, potentially stabilizing or even improving its market position[1].

Key Takeaways

  • Declining Usage: Theophylline's use has decreased due to the advent of newer medications.
  • Market Competition: The market for respiratory medications is highly competitive, favoring newer drugs with better safety profiles.
  • Financial Performance: Media coverage of drug prices and regulatory scrutiny can impact the financial performance of pharmaceutical companies.
  • Regulatory Considerations: Theophylline's narrow therapeutic index requires careful monitoring, affecting its cost and patient compliance.
  • Interprofessional Care: An interprofessional healthcare team is essential for managing theophylline, improving patient outcomes but adding to care costs.

FAQs

What are the primary medical uses of theophylline?

Theophylline is primarily used to treat asthma, chronic obstructive pulmonary disease (COPD), and other lung conditions caused by reversible airflow obstruction. It is also used for infant apnea and is under investigation for anosmia[2].

Why has the use of theophylline declined?

The use of theophylline has declined due to the advent of newer medications such as inhaled glucocorticoids and long-acting inhaled β-receptor agonists, which offer better efficacy and safety profiles. Additionally, theophylline's narrow therapeutic index and potential for serious side effects have contributed to its declining popularity[1][2].

What are the common side effects of theophylline?

Common side effects include nausea, vomiting, headache, increased stomach acid secretion, and gastroesophageal reflux. Central nervous system symptoms such as irritability, lightheadedness, and dizziness can also occur. Severe side effects include seizures and cardiac arrhythmias at high serum concentrations[2].

How does media coverage of drug prices affect pharmaceutical companies?

Media coverage of drug prices can significantly impact the financial performance and capitalization of pharmaceutical companies. Negative coverage can lead to a reduction in stock value and market capitalization, while positive coverage can have the opposite effect[3].

What is the role of the interprofessional healthcare team in managing theophylline?

The interprofessional healthcare team, including nurse practitioners, primary care providers, pulmonologists, and pharmacists, plays a crucial role in managing theophylline. They must be aware of the drug's adverse effect profile, ensure close monitoring of patients, and collaborate to improve patient outcomes[2].

Sources

  1. Theophylline: Recent Advances in the Understanding of Its Mode of Action and Use in Disease Management. Mayo Clinic Proceedings.
  2. Theophylline - StatPearls - NCBI Bookshelf. NCBI.
  3. Relationship Over Time Between Drug Price News and U.S. Pharmaceutical Companies’ Financial Results. ScholarWorks.
  4. Theophylline: Uses, Interactions, Mechanism of Action - DrugBank. DrugBank.
  5. Theochron Advanced Patient Information - Drugs.com. Drugs.com.

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