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Last Updated: April 3, 2025

SOMOPHYLLIN Drug Patent Profile


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

Somophyllin is a drug marketed by Fisons and Graham Dm and is included in nine NDAs.

The generic ingredient in SOMOPHYLLIN 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 Somophyllin

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

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Summary for SOMOPHYLLIN
Drug patent expirations by year for SOMOPHYLLIN

US Patents and Regulatory Information for SOMOPHYLLIN

ApplicantTradenameGeneric NameDosageNDAApproval DateTETypeRLDRSPatent No.Patent ExpirationProductSubstanceDelist Req.Exclusivity Expiration
Fisons SOMOPHYLLIN aminophylline ENEMA;RECTAL 018232-001 Apr 2, 1982 DISCN No No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Fisons SOMOPHYLLIN-DF aminophylline SOLUTION;ORAL 087045-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Graham Dm SOMOPHYLLIN-CRT theophylline CAPSULE, EXTENDED RELEASE;ORAL 087194-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Graham Dm SOMOPHYLLIN-CRT theophylline CAPSULE, EXTENDED RELEASE;ORAL 088383-001 Feb 27, 1985 DISCN No No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
>Applicant>Tradename>Generic Name>Dosage>NDA>Approval Date>TE>Type>RLD>RS>Patent No.>Patent Expiration>Product>Substance>Delist Req.>Exclusivity Expiration
Showing 1 to 4 of 4 entries

Theophylline and Aminophylline Market Dynamics: A Deep Dive into SOMOPHYLLIN

Introduction to Theophylline and Aminophylline

Theophylline and aminophylline are crucial medications in the treatment of respiratory disorders, particularly asthma and chronic obstructive pulmonary disease (COPD). These drugs act as muscle relaxants, improving diaphragmatic contraction and reducing airway responses to irritants, along with some anti-inflammatory effects.

Market Size and Growth Projections

The global theophylline and aminophylline market is valued at US$ 318 million as of 2022 and is anticipated to reach US$ 387.64 million by 2032, growing at a slow-paced Compound Annual Growth Rate (CAGR) of 2% during the forecast period[1].

Key Drivers of Market Growth

Increasing Incidence of Respiratory Diseases

The rising number of patients with COPD and other respiratory diseases is a significant driver of the market. These conditions necessitate the use of theophylline and aminophylline, making them essential in the medical sector[1].

Cost-Effectiveness and Convenience

These drugs are cost-effective and can be administered orally or intravenously, which is convenient for patients. This convenience and affordability contribute to their widespread adoption[1].

Innovations in Personalized Medicine

Rapid innovations in personalized medicine are creating lucrative opportunities for manufacturers. Tailored treatment approaches are enhancing the efficacy and appeal of theophylline and aminophylline[1].

Regional Market Dynamics

North American Market

The North American region, particularly the U.S., is expected to hold a significant market share due to the increasing aging population and rising healthcare expenditures. The well-established healthcare infrastructure in this region further supports the growth of the theophylline and aminophylline market[1].

Competitive Landscape

The market for theophylline and aminophylline is highly competitive, with numerous international and regional companies vying for market share. Major players are adopting strategies such as product portfolio expansion, regional development, mergers, and acquisitions to strengthen their positions[1].

Business Strategies and Market Expansion

To expand their geographic presence and consumer base, key players are implementing various business strategies. These include:

Product Portfolio Growth

Companies are focusing on expanding their product portfolios to offer a wider range of theophylline and aminophylline formulations, catering to different patient needs[1].

Regional Development

Regional expansion is another key strategy, with companies targeting emerging economies where the demand for these drugs is increasing due to growing healthcare needs[1].

Mergers and Acquisitions

Mergers and acquisitions are common tactics used by major players to enhance their market presence and access new markets[1].

Impact of Healthcare Infrastructure

The well-established healthcare infrastructure in regions like North America plays a crucial role in the adoption and growth of theophylline and aminophylline. Access to advanced healthcare facilities and a strong regulatory framework support the market's expansion[1].

Economic Considerations

Cost-Benefit Analysis

The cost-effectiveness of theophylline and aminophylline is a significant economic factor. These drugs offer a balance between cost and therapeutic benefit, making them a preferred choice for treating respiratory disorders[1].

Healthcare Expenditures

Rising healthcare expenditures, particularly in regions like North America, are driving the demand for these drugs. Increased spending on healthcare translates to higher adoption rates of theophylline and aminophylline[1].

Regulatory and Policy Influences

Regulatory bodies play a critical role in the approval and adoption of new drugs. The approval of innovative formulations of theophylline and aminophylline can accelerate their market penetration and acceptance in clinical practice[3].

Patient Advocacy and Awareness

Patient advocacy networks are essential in promoting awareness, education, and access to new treatments. These networks help ensure that patients benefit from the latest advances in respiratory care, including the use of theophylline and aminophylline[3].

Diagnostic Technologies

Improvements in diagnostic technologies aid in the earlier detection and treatment of respiratory diseases. This early detection is critical for the optimal management of conditions like asthma and COPD, further driving the demand for theophylline and aminophylline[3].

Challenges and Opportunities

Challenges

Despite the growth, the market faces challenges such as the slow-paced CAGR and intense competition. Manufacturers must navigate these challenges through innovative strategies and product development.

Opportunities

The increasing incidence of respiratory diseases and advancements in personalized medicine present significant opportunities for growth. Companies that can innovate and expand their product offerings are likely to benefit from these trends.

Key Takeaways

  • The global theophylline and aminophylline market is projected to grow at a CAGR of 2% from 2022 to 2032.
  • The market is driven by the increasing incidence of respiratory diseases and the cost-effectiveness of these drugs.
  • North America is expected to hold a significant market share due to its well-established healthcare infrastructure.
  • Companies are adopting various strategies, including product portfolio growth and regional development, to strengthen their market positions.
  • Regulatory approvals and patient advocacy networks are crucial for the market's growth.

FAQs

1. What is the current market value of theophylline and aminophylline? The current market value of theophylline and aminophylline is US$ 318 million as of 2022[1].

2. What is the projected growth rate of the theophylline and aminophylline market? The market is projected to grow at a CAGR of 2% from 2022 to 2032[1].

3. Which region is expected to hold a significant market share? The North American region, particularly the U.S., is expected to hold a significant market share due to the increasing aging population and rising healthcare expenditures[1].

4. What are the key drivers of the theophylline and aminophylline market? The key drivers include the increasing incidence of respiratory diseases, cost-effectiveness, convenience of administration, and innovations in personalized medicine[1].

5. How do regulatory bodies influence the market? Regulatory bodies influence the market through the approval of new and innovative drugs, which accelerates their adoption in clinical practice[3].

Cited Sources

  1. Future Market Insights, "Theophylline And Aminophylline Market Size, Demand & Trends – FMI"
  2. Interact for Health, "FINAL REPORT Evaluation of Healthcare Costs and Utilization"
  3. GlobeNewswire, "Multiple Sclerosis Drugs Market Outlook and Strategic Business Report 2024-2030"

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