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Last Updated: December 22, 2024

SLO-PHYLLIN Drug Patent Profile


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When do Slo-phyllin patents expire, and when can generic versions of Slo-phyllin launch?

Slo-phyllin is a drug marketed by Sanofi Aventis Us and is included in six NDAs.

The generic ingredient in SLO-PHYLLIN 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 Slo-phyllin

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

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Summary for SLO-PHYLLIN
Drug patent expirations by year for SLO-PHYLLIN

US Patents and Regulatory Information for SLO-PHYLLIN

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Sanofi Aventis Us SLO-PHYLLIN theophylline CAPSULE, EXTENDED RELEASE;ORAL 085206-001 May 24, 1982 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Sanofi Aventis Us SLO-PHYLLIN theophylline SYRUP;ORAL 085187-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Sanofi Aventis Us SLO-PHYLLIN theophylline CAPSULE, EXTENDED RELEASE;ORAL 085203-001 May 24, 1982 DISCN Yes No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Sanofi Aventis Us SLO-PHYLLIN theophylline CAPSULE, EXTENDED RELEASE;ORAL 085205-001 May 24, 1982 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

SLO-PHYLLIN Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Theophylline (Slo-Phyllin)

Introduction to Theophylline (Slo-Phyllin)

Theophylline, marketed under various brand names including Slo-Phyllin, is a bronchodilator used primarily for the relief and prevention of symptoms associated with asthma and reversible bronchospasm. Understanding the market dynamics and financial trajectory of this drug is crucial for pharmaceutical companies, investors, and healthcare providers.

Market Size and Growth Projections

The global theophylline market has been experiencing steady growth, driven by several key factors. As of 2023, the market size was valued at USD 421.2 million and is projected to reach USD 660.1 million by 2031, growing at a Compound Annual Growth Rate (CAGR) of 6% from 2024 to 2031[3].

Drivers of Market Growth

Increasing Incidence of Respiratory Conditions

The rising incidence of respiratory conditions such as asthma and Chronic Obstructive Pulmonary Disease (COPD) is a significant driver of the theophylline market. These conditions are becoming more prevalent due to demographic factors like aging populations and environmental pollution[3].

Advances in Pharmaceutical Research and Development

Continuous research and development in pharmaceuticals are leading to the introduction of novel formulations and delivery systems for theophylline. These advancements are improving the safety and efficacy profiles of theophylline-based drugs, which in turn is increasing their demand[3].

Strategic Partnerships and Market Reach

Strategic partnerships between pharmaceutical companies and healthcare providers are expanding the market reach of theophylline. These collaborations ensure greater access to theophylline pharmaceuticals, contributing to the overall growth of the market[3].

Market Segmentation

The theophylline market is segmented based on several criteria:

Application

The primary applications of theophylline include the treatment of asthma, insomnia, and other conditions. Asthma is the most significant segment, given the widespread use of theophylline as a bronchodilator in managing asthma symptoms[3].

Product Form

Theophylline is available in various forms, including injections, tablets, and capsules. Each form has its own market share and growth trajectory, with tablets being one of the most commonly prescribed forms[3].

Geography

The market is geographically segmented into regions such as North America, Europe, Asia-Pacific, South America, and the Middle East and Africa. Each region has its own growth rate and market dynamics, influenced by local healthcare systems and regulatory environments[3].

Competitive Landscape

The theophylline market is characterized by a competitive landscape involving several major players. Companies such as Aarti Drugs, AdvaCarePharma, Aldo-Union, Astellas Pharma, Biotechnica Pharma Global, Mylan, Pfizer, and Teva Pharmaceuticals are key participants in this market. These companies engage in various strategies to maintain market share, including innovation in drug formulations and strategic partnerships[3].

Porter’s Five Forces Analysis

Buyers' Bargaining Power

The bargaining power of buyers in the theophylline market is moderate. Patients, particularly those not exempt from prescription levies, have some leverage in choosing between different brands and formulations based on price and efficacy. However, the necessity of the drug for managing chronic conditions limits their bargaining power[3].

Suppliers' Bargaining Power

Suppliers in the theophylline market, including raw material providers and manufacturers, have significant bargaining power. The quality and availability of raw materials can impact the production and pricing of theophylline, giving suppliers considerable influence over the market[3].

Threat of New Entrants

The threat of new entrants in the theophylline market is relatively low due to high barriers to entry, such as regulatory approvals, research and development costs, and the need for established distribution networks[3].

Threat of Substitutes

The threat of substitutes is moderate, as other bronchodilators and asthma medications are available. However, theophylline's established efficacy and patient compliance reduce the likelihood of significant substitution[3].

Degree of Competition

The degree of competition within the theophylline market is high, with multiple players competing for market share. This competition drives innovation and pricing strategies, benefiting consumers through better products and potentially lower prices[3].

Financial Trajectory

Revenue Growth

The revenue growth of the theophylline market is expected to be robust, driven by the increasing demand for the drug due to rising respiratory conditions and advancements in pharmaceutical research. The market is projected to grow from USD 421.2 million in 2023 to USD 660.1 million by 2031[3].

Profit Margins

Pharmaceutical companies involved in the theophylline market can expect higher profit margins due to the drug's high demand and the competitive pricing strategies employed. However, profit margins can be influenced by factors such as raw material costs, regulatory changes, and competition from generic versions[1].

Regulatory Environment

The regulatory environment plays a crucial role in the theophylline market. Laws and regulations regarding generic substitution, such as Drug Product Selection (DPS) laws, can significantly impact the market dynamics. DPS laws allow pharmacists to substitute brand-name drugs with generic versions, which can increase the market share of generic theophylline and reduce prices for consumers[1].

Consumer Impact

Cost and Accessibility

The cost of theophylline can disproportionately affect younger, working-age patients who are not exempt from prescription levies. However, the introduction of generic versions and competitive pricing can make the drug more accessible to a wider range of consumers[5].

Efficacy and Safety

The efficacy and safety of theophylline are critical for consumer satisfaction. The drug's therapeutic window, where the concentration in the serum is between 10 to 20 μg/mL, is crucial for optimal benefit and minimal risk of toxicity. Continuous research and development aim to improve these aspects, enhancing patient compliance and overall market growth[4].

Key Takeaways

  • The global theophylline market is expected to grow from USD 421.2 million in 2023 to USD 660.1 million by 2031, driven by increasing respiratory conditions and advancements in pharmaceutical research.
  • The market is segmented by application, product form, and geography, with asthma treatment being the primary application.
  • The competitive landscape is characterized by high competition among major pharmaceutical companies.
  • Regulatory environments, such as DPS laws, can significantly impact market dynamics and consumer prices.
  • The drug's efficacy and safety are critical for consumer satisfaction and market growth.

FAQs

What are the primary drivers of the theophylline market growth?

The primary drivers include the rising incidence of respiratory conditions like asthma and COPD, advancements in pharmaceutical research and development, and strategic partnerships between pharmaceutical companies and healthcare providers.

How is the theophylline market segmented?

The market is segmented by application (asthma, insomnia, other), product form (injection, tablet, capsule), and geography (North America, Europe, Asia-Pacific, etc.).

What is the projected market size of theophylline by 2031?

The market is projected to reach USD 660.1 million by 2031, growing at a CAGR of 6% from 2024 to 2031.

Who are the key players in the theophylline market?

Key players include Aarti Drugs, AdvaCarePharma, Aldo-Union, Astellas Pharma, Biotechnica Pharma Global, Mylan, Pfizer, and Teva Pharmaceuticals.

How does the regulatory environment impact the theophylline market?

Regulatory laws such as DPS laws can increase the market share of generic theophylline, reduce prices for consumers, and influence profit margins for pharmaceutical companies.

What are the critical factors for consumer satisfaction with theophylline?

The efficacy and safety of theophylline, particularly maintaining the therapeutic window of 10 to 20 μg/mL, are crucial for optimal benefit and minimal risk of toxicity.

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