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Last Updated: March 22, 2025

MECLOMEN Drug Patent Profile


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When do Meclomen patents expire, and what generic alternatives are available?

Meclomen is a drug marketed by Parke Davis and is included in one NDA.

The generic ingredient in MECLOMEN is meclofenamate sodium. There are eight drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the meclofenamate sodium profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Meclomen

A generic version of MECLOMEN was approved as meclofenamate sodium by MYLAN on September 3rd, 1986.

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Summary for MECLOMEN
Drug patent expirations by year for MECLOMEN
Recent Clinical Trials for MECLOMEN

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SponsorPhase
The University of Texas Health Science Center, HoustonPhase 2

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US Patents and Regulatory Information for MECLOMEN

ApplicantTradenameGeneric NameDosageNDAApproval DateTETypeRLDRSPatent No.Patent ExpirationProductSubstanceDelist Req.Exclusivity Expiration
Parke Davis MECLOMEN meclofenamate sodium CAPSULE;ORAL 018006-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Parke Davis MECLOMEN meclofenamate sodium CAPSULE;ORAL 018006-002 Approved Prior to Jan 1, 1982 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 2 of 2 entries

Market Dynamics and Financial Trajectory for Meclomen

Introduction

Meclomen, also known as Sodium Meclofenamate, is a non-steroidal anti-inflammatory drug (NSAID) that inhibits both cyclooxygenases and lipooxygenases of the arachidonic acid pathway. To understand the market dynamics and financial trajectory of Meclomen, we need to delve into various aspects of the pharmaceutical industry, including market trends, financial performance, and regulatory environments.

Market Trends in NSAIDs

Global Demand for NSAIDs

The demand for NSAIDs, including Meclomen, is influenced by several factors such as the prevalence of inflammatory conditions, pain management needs, and the availability of alternative treatments. The global market for NSAIDs has seen steady growth due to an increasing incidence of chronic pain and inflammatory diseases[4].

Competitive Landscape

The NSAID market is highly competitive, with numerous branded and generic options available. Meclomen competes with other NSAIDs such as ibuprofen, naproxen, and diclofenac. The competitive landscape is further complicated by the presence of compounded topical drugs, which offer customized treatment options and are gaining popularity due to their personalized nature[3].

Financial Performance of Pharmaceutical Companies

Revenue and Sales

Pharmaceutical companies that produce NSAIDs like Meclomen often report revenue based on sales of their products. For instance, Medexus Pharmaceuticals, which might not specifically produce Meclomen but operates in a similar market, reported significant revenue growth driven by acquisitions and increased sales of their products. In 2019, Medexus saw total revenues of $32.5 million, a substantial increase from $6.7 million in the same period the previous year[2].

Operating Expenses and Profitability

Operating expenses and profitability are crucial for pharmaceutical companies. Companies like Medincell, which are involved in the development and commercialization of various pharmaceutical products, often face significant operating expenses. Medincell reported an operating loss but anticipated a significant improvement in operating profit for the 2024-2025 fiscal year, highlighting the potential for long-term profitability in the pharmaceutical sector[5].

Prescription Drug Spending Trends

Overall Prescription Drug Spending

The overall trend in prescription drug spending is relevant to understanding the financial trajectory of specific drugs like Meclomen. Between 2016 and 2021, prescription drug spending in the U.S. increased from $520 billion to $603 billion, a 16% increase. This growth was driven more by increases in spending per prescription rather than the number of prescriptions filled[1].

Retail vs. Non-Retail Spending

The distinction between retail and non-retail drug expenditures is important. Retail drug expenditures, which include prescriptions filled at pharmacies, represented about 70% of prescription drug spending, while non-retail expenditures, such as those in hospitals and clinics, accounted for about 30%. Non-retail drug spending saw a higher rate of growth, increasing by 25% between 2016 and 2021[1].

Specialty and High-Cost Drugs

Impact on Market Dynamics

Specialty and high-cost drugs, including some NSAIDs, have seen significant growth. Specialty drug spending increased by 43% between 2016 and 2021, despite a minimal increase in the number of specialty prescriptions. This trend is driven by higher spending per prescription and the increasing use of specialty drugs in non-retail settings[1].

Compounded Topical Drugs Market

Relevance to Meclomen

While Meclomen is not a compounded topical drug, the growth in this market segment can influence the broader pharmaceutical landscape. The global compounded topical drugs market is projected to grow at a CAGR of 4.25% from 2024 to 2034, driven by demand for personalized treatments and advancements in compounding technologies. This trend indicates a shift towards more customized and effective treatment options, which could impact the market dynamics of traditional NSAIDs like Meclomen[3].

Regulatory Environment

FDA and State Regulations

The regulatory environment plays a critical role in the pharmaceutical industry. Meclomen, as an FDA-approved drug, is subject to stringent regulations. However, compounded drugs, which are not FDA-approved but regulated by State Pharmacy Boards, offer a different regulatory landscape. This distinction can affect the market trajectory of Meclomen and similar drugs[3].

Financial Projections and Challenges

Revenue Growth and Operating Profit

For a drug like Meclomen, revenue growth would depend on factors such as market demand, competition, and pricing strategies. Companies operating in this space often anticipate significant revenue growth and improvements in operating profit, as seen in the case of Medincell, which expects a 2- to 3-fold increase in revenue and a significant improvement in operating profit[5].

Challenges

High costs and low insurance reimbursement are significant barriers to the adoption of certain pharmaceuticals. For Meclomen, managing these costs and ensuring adequate reimbursement would be crucial for maintaining market share and financial viability[3].

Key Takeaways

  • Market Growth: The market for NSAIDs, including Meclomen, is influenced by trends in prescription drug spending and the demand for pain management and inflammatory treatments.
  • Financial Performance: Pharmaceutical companies producing NSAIDs can experience significant revenue growth and improvements in operating profit, but face challenges related to operating expenses and regulatory compliance.
  • Regulatory Environment: The regulatory landscape, including FDA approvals and state regulations, affects the market dynamics and financial trajectory of pharmaceutical products.
  • Specialty and High-Cost Drugs: The increasing use of specialty and high-cost drugs impacts the broader pharmaceutical market and can influence the sales and profitability of traditional NSAIDs.

FAQs

  1. What is Meclomen used for? Meclomen, or Sodium Meclofenamate, is used as a non-steroidal anti-inflammatory drug (NSAID) to treat inflammatory conditions and manage pain.

  2. How does the market for NSAIDs impact Meclomen? The market for NSAIDs is highly competitive, and Meclomen competes with other branded and generic NSAIDs. Market trends, such as the demand for pain management and inflammatory treatments, influence its sales and profitability.

  3. What are the key financial challenges for pharmaceutical companies producing NSAIDs? Key financial challenges include managing operating expenses, ensuring adequate reimbursement from insurance, and navigating the competitive landscape.

  4. How does the regulatory environment affect Meclomen? Meclomen, as an FDA-approved drug, is subject to federal regulations. However, the presence of compounded drugs regulated by state boards can affect market dynamics and competition.

  5. What are the projections for the compounded topical drugs market, and how might it impact Meclomen? The compounded topical drugs market is projected to grow at a CAGR of 4.25% from 2024 to 2034. This growth in customized treatment options could influence the market share of traditional NSAIDs like Meclomen by offering alternative treatment choices.

Sources

  1. Trends in Prescription Drug Spending, 2016-2021 - ASPE analysis of IQVIA National Sales Perspective (NSP) Data[1].
  2. Medexus Pharmaceuticals Reports Operating and Financial Results - Medexus Pharmaceuticals press release[2].
  3. Compounded Topical Drugs Market Sees Significant Growth - Future Market Insights report[3].
  4. Hemorheologic effects of Meclomen - PubMed article[4].
  5. Medincell Publishes Its Consolidated Half-year Financial Results - Medincell press release[5].

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