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Last Updated: April 9, 2025

SOMOPHYLLIN-CRT Drug Patent Profile


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When do Somophyllin-crt patents expire, and what generic alternatives are available?

Somophyllin-crt is a drug marketed by Graham Dm and is included in five NDAs.

The generic ingredient in SOMOPHYLLIN-CRT 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-crt

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

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Summary for SOMOPHYLLIN-CRT
Drug patent expirations by year for SOMOPHYLLIN-CRT

US Patents and Regulatory Information for SOMOPHYLLIN-CRT

ApplicantTradenameGeneric NameDosageNDAApproval DateTETypeRLDRSPatent No.Patent ExpirationProductSubstanceDelist Req.Exclusivity Expiration
Graham Dm SOMOPHYLLIN-CRT theophylline CAPSULE, EXTENDED RELEASE;ORAL 087193-001 Approved Prior to Jan 1, 1982 DISCN Yes 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 087763-001 Feb 27, 1985 DISCN No No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Graham Dm SOMOPHYLLIN-CRT theophylline CAPSULE, EXTENDED RELEASE;ORAL 088382-001 Feb 27, 1985 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 5 of 5 entries

Market Dynamics and Financial Trajectory of Theophylline: A Comprehensive Analysis

Introduction

Theophylline, a methylxanthine derivative, is a widely used bronchodilator in the treatment of respiratory disorders such as asthma and chronic obstructive pulmonary disease (COPD). This article delves into the market dynamics and financial trajectory of theophylline, providing insights into its current market valuation, growth drivers, competitive landscape, and future projections.

Market Overview

Theophylline is an essential medication in the management of respiratory diseases. Here is a snapshot of its market:

  • 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[1].

Growth Drivers

Increasing Incidence of Respiratory Diseases

The rising incidence of respiratory conditions such as asthma and COPD is a significant 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[1].

Cost-Effectiveness

The cost-effectiveness of theophylline is another key driver. The drug is available in various forms, including injections, tablets, and capsules, offering convenience and flexibility to patients. This versatility contributes to the market's growth[1].

Innovations in Pharmaceutical Research

Innovations in pharmaceutical research and development are improving the safety and efficacy of theophylline-based drugs. These advancements are crucial in maintaining and expanding the market share of theophylline[1].

Geographical Distribution

North American Region

The North American region is expected to hold a significant market share due to its well-established healthcare infrastructure and the increasing incidence of lung diseases in the aging population. Other regions such as Europe, Asia-Pacific, and the Middle East are also contributing to the market's growth[1].

Competitive Landscape

The theophylline market is highly competitive, with numerous international and regional companies vying for market share. Key players such as GlaxoSmithKline plc, Altor BioScience Corporation, Ono Pharmaceutical Corporation Ltd., and Octapharma AG are implementing various strategies including product portfolio expansion, regional development, mergers, and acquisitions to strengthen their market positions[1].

Financial Projections

Global Market Size

The global theophylline market was valued at $421.2 million in 2023 and is projected to reach $660.1 million by 2031, growing at a CAGR of 6% from 2024 to 2031. This growth trajectory indicates robust market dynamics driven by the increasing incidence of respiratory conditions and advancements in pharmaceutical research[1].

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[1].

Challenges and Opportunities

Declining Use in Some Regions

Despite its global growth, theophylline faces challenges in some regions, particularly in the United States, where its use is declining due to the advent of new treatments and its narrow therapeutic index. This decline poses a challenge to the overall market growth[1].

Innovations and Strategic Partnerships

Innovations in pharmaceutical research and strategic partnerships between companies offer significant opportunities for growth. These collaborations can lead to improved drug formulations and expanded market reach[1].

Impact of Regulatory and Economic Factors

Patent Expiration and Generic Competition

The expiration of patents for branded drugs typically leads to the entry of generic competitors, which can significantly reduce drug prices. However, for drugs targeting small patient populations, the lack of generic competition can result in higher prices and longer periods of market exclusivity[2].

Economic Incentives for Innovation

The economics of drug development often involve a trade-off between current welfare and future innovation. High prices for branded drugs provide incentives for firms to invest in research and development, which is crucial for the development of new treatments, including those targeting small patient populations[2].

Regional Market Dynamics

North America

The well-established healthcare infrastructure in North America, combined with the increasing incidence of respiratory diseases, makes this region a significant market for theophylline[1].

Europe and Asia-Pacific

These regions are also experiencing growth due to similar factors, including aging populations and environmental pollution. The Asia-Pacific region, in particular, is expected to see substantial growth due to its large and growing population[1].

Key Players and Their Strategies

Product Portfolio Expansion

Companies like GlaxoSmithKline plc and Ono Pharmaceutical Corporation Ltd. are expanding their product portfolios to include various forms of theophylline, enhancing their market presence[1].

Regional Development and Partnerships

Regional development and strategic partnerships are key strategies adopted by these companies to penetrate new markets and strengthen their positions in existing ones[1].

Future Outlook

Projected Growth

The theophylline market is expected to grow steadily, driven by the increasing incidence of respiratory diseases and advancements in pharmaceutical research. The market is projected to reach $660.1 million by 2031, growing at a CAGR of 6% from 2024 to 2031[1].

Challenges and Opportunities

While the market faces challenges such as declining use in some regions, innovations and strategic partnerships offer significant opportunities for growth. The ability to target small patient populations with precision medicines could also change the market dynamics and pricing strategies of pharmaceutical firms[2].

Key Takeaways

  • The global theophylline market is valued at approximately $318 million as of 2022 and is expected to grow at a CAGR of 2% from 2022 to 2032.
  • The increasing incidence of respiratory diseases and cost-effectiveness are primary drivers of the market.
  • The North American region holds a significant market share due to its well-established healthcare infrastructure.
  • Innovations in pharmaceutical research and strategic partnerships are crucial for market growth.
  • The market faces challenges such as declining use in some regions but offers opportunities through precision medicines and regional development.

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[1].

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[1].

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

The primary drivers include the increasing incidence of respiratory diseases, cost-effectiveness, and innovations in pharmaceutical research[1].

4. Which region is expected to hold a significant market share in the theophylline market?

The North American region is expected to hold a significant market share due to its well-established healthcare infrastructure and the rising incidence of lung diseases[1].

5. What are the challenges facing the theophylline market in some regions?

The challenges include the declining use of theophylline in regions like the United States due to the advent of new treatments and the narrow therapeutic index of theophylline[1].

Cited Sources:

  1. Drug Patent Watch. Generic THEOPHYLLINE INN equivalents, drug patent expiry and ... [Online]. Available: https://www.drugpatentwatch.com/p/generic/theophylline
  2. National Bureau of Economic Research. The Economics of Drug Development: Pricing and Innovation in a ... [Online]. Available: https://www.nber.org/reporter/2018number3/economics-drug-development-pricing-and-innovation-changing-market
  3. PubChem. Theophylline | C7H8N4O2 | CID 2153 - PubChem. [Online]. Available: https://pubchem.ncbi.nlm.nih.gov/compound/Theophylline
  4. ASPE. Competition in Prescription Drug Markets, 2017-2022. [Online]. Available: https://aspe.hhs.gov/reports/competition-prescription-drug-markets
"The cornerstone of a well-functioning market is competition. President Biden’s Executive Order 14036, “Promoting Competition in the American Economy” identified a lack of competition as a key driver for problems across economic sectors." - ASPE, *Competition in Prescription Drug Markets, 2017-2022*[4].

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