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Last Updated: December 22, 2024

OMECLAMOX-PAK Drug Patent Profile


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When do Omeclamox-pak patents expire, and when can generic versions of Omeclamox-pak launch?

Omeclamox-pak is a drug marketed by Cumberland and is included in one NDA.

The generic ingredient in OMECLAMOX-PAK is amoxicillin; clarithromycin; omeprazole. There are forty-six drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the amoxicillin; clarithromycin; omeprazole profile page.

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Summary for OMECLAMOX-PAK
US Patents:0
Applicants:1
NDAs:1
Finished Product Suppliers / Packagers: 1
What excipients (inactive ingredients) are in OMECLAMOX-PAK?OMECLAMOX-PAK excipients list
DailyMed Link:OMECLAMOX-PAK at DailyMed
Drug patent expirations by year for OMECLAMOX-PAK

US Patents and Regulatory Information for OMECLAMOX-PAK

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Cumberland OMECLAMOX-PAK amoxicillin; clarithromycin; omeprazole CAPSULE, TABLET, CAPSULE, DELAYED RELEASE;ORAL 050824-001 Feb 8, 2011 DISCN Yes 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

OMECLAMOX-PAK Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Omeclamox-Pak

Overview of Omeclamox-Pak

Omeclamox-Pak is a branded prescription product that combines omeprazole, amoxicillin, and clarithromycin, specifically designed for the treatment of Helicobacter pylori (H. pylori) infections and related duodenal ulcer disease. This combination therapy is notable for its comprehensive approach to eradicating H. pylori bacteria, which is a common cause of stomach ulcers and other gastrointestinal issues[1][2][5].

Market Dynamics

Treatment Paradigm

The treatment landscape for H. pylori infections is evolving, with recent approvals of combination therapies like Omeclamox-Pak, Phathom Pharmaceuticals' VOQUEZNA TRIPLE and DUAL PAK, and TALICIA. These advancements have significantly altered the market scenario, offering patients and healthcare providers more effective and convenient treatment options[5].

Market Size and Growth

The global H. pylori infection market, which includes Omeclamox-Pak, is anticipated to grow at a CAGR of 1.9% from 2022 to 2032. As of 2021, the market size was estimated at USD 3.41 billion. This growth is driven by the increasing prevalence of H. pylori infections and the adoption of new combination therapies[5].

Competitive Landscape

Omeclamox-Pak competes in a market with other combination therapies such as PYLERA and newer entrants like VOQUEZNA TRIPLE and DUAL PAK. The competitive landscape is influenced by factors such as efficacy, patient compliance, and marketing strategies. Cumberland Pharmaceuticals' partnership with Pernix Therapeutics to promote Omeclamox-Pak to gastroenterologists is a strategic move to enhance its market presence[1][4][5].

Financial Trajectory

Revenue Contribution

Omeclamox-Pak contributes to the revenue streams of Cumberland Pharmaceuticals, although it is one of the smaller contributors compared to other products like Kristalose and Vibativ. For the second quarter of 2020, Omeclamox-Pak generated $0.01 million in revenue, which is a minor fraction of the total net revenues from continuing operations of $9.6 million during the same period[3].

Operating Expenses

The promotion and distribution of Omeclamox-Pak are part of Cumberland Pharmaceuticals' overall operating expenses. Total operating expenses for the second quarter of 2020 were $11.2 million, which includes costs associated with selling and marketing, research and development, and general and administrative activities[3].

Financial Performance

Cumberland Pharmaceuticals' financial performance has been mixed, with net revenues from continuing operations showing stability but operating expenses impacting profitability. For the second quarter of 2020, the company reported a net loss of $(0.9) million or $(0.06) per share. The financial trajectory of Omeclamox-Pak is closely tied to the overall financial health and strategic decisions of Cumberland Pharmaceuticals[3].

Marketing and Promotion

Partnership with Pernix Therapeutics

The exclusive agreement between Cumberland Pharmaceuticals and Pernix Therapeutics to promote Omeclamox-Pak is a key strategy to increase its market reach. This partnership focuses on targeting gastroenterologists, who are the primary prescribers for H. pylori treatments. This targeted approach aims to enhance the product's visibility and adoption among the medical community[1][4].

Clinical Significance

Efficacy and Compliance

Omeclamox-Pak's combination of omeprazole, amoxicillin, and clarithromycin is clinically significant because it addresses the complex nature of H. pylori infections. This regimen is designed to improve patient compliance by simplifying the treatment process into a single pack, which can lead to better treatment outcomes[1][2].

Future Outlook

Market Growth and New Therapies

The H. pylori infection market is expected to grow, driven by the approval of new combination therapies and changing treatment paradigms. Omeclamox-Pak, along with other novel therapies, is poised to capture a significant share of this growing market. However, the competitive landscape and evolving treatment guidelines will continue to shape the market dynamics[5].

Key Takeaways

  • Market Growth: The H. pylori infection market is anticipated to grow at a CAGR of 1.9% from 2022 to 2032.
  • Combination Therapies: Omeclamox-Pak is part of a new wave of combination therapies that are changing the treatment landscape for H. pylori infections.
  • Financial Performance: The financial trajectory of Omeclamox-Pak is influenced by Cumberland Pharmaceuticals' overall financial health and strategic marketing efforts.
  • Clinical Significance: Omeclamox-Pak's combination therapy improves patient compliance and treatment outcomes for H. pylori infections.
  • Competitive Landscape: The market is competitive, with multiple combination therapies vying for market share.

FAQs

1. What is Omeclamox-Pak used for? Omeclamox-Pak is used for the treatment of Helicobacter pylori (H. pylori) infections and related duodenal ulcer disease.

2. Who are the key partners in promoting Omeclamox-Pak? Cumberland Pharmaceuticals and Pernix Therapeutics have an exclusive agreement to promote Omeclamox-Pak to gastroenterologists in the United States.

3. How does Omeclamox-Pak contribute to Cumberland Pharmaceuticals' revenue? Omeclamox-Pak is a minor contributor to Cumberland Pharmaceuticals' revenue, with $0.01 million generated in the second quarter of 2020.

4. What is the expected growth rate of the H. pylori infection market? The H. pylori infection market is anticipated to grow at a CAGR of 1.9% from 2022 to 2032.

5. What are the key components of Omeclamox-Pak? Omeclamox-Pak combines omeprazole, amoxicillin, and clarithromycin.

Sources

  1. Cumberland Pharmaceuticals And Pernix Therapeutics Enter Into Exclusive Agreement To Promote Omeclamox-PakĀ®
    • Cumberland Pharmaceuticals Investor Relations
  2. Cumberland Pharmaceuticals Reports Third Quarter 2021 Financial Results
    • Cumberland Pharmaceuticals Investor Relations
  3. Cumberland Pharmaceuticals Reports Second Quarter 2020 Financial Results and Company Update
    • Biospace
  4. FORM 10-K Pernix Therapeutics Holdings, Inc.
    • Pernix Therapeutics Holdings, Inc.
  5. Helicobacter pylori Infection Market to Exhibit Growth at a Paltry CAGR of 1.9% During the Forecast Period 2022-2032
    • PR Newswire

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