You're using a free limited version of DrugPatentWatch: Upgrade for Complete Access

Last Updated: December 25, 2024

PRE-PEN Drug Profile


✉ Email this page to a colleague

« Back to Dashboard


Summary for Tradename: PRE-PEN
Recent Litigation for PRE-PEN

Identify key patents and potential future biosimilar entrants

District Court Litigation
Case NameDate
JAZZ PHARMACEUTICALS IRELAND LIMITED v. LUPIN LTD.2023-01-19
JAZZ PHARMACEUTICALS IRELAND LIMITED v. LUPIN INC.2021-07-28

See all PRE-PEN litigation

Note on Biologic Patents

Matching patents to biologic drugs is far more complicated than for small-molecule drugs.

DrugPatentWatch employs three methods to identify biologic patents:

  1. Brand-side disclosures in response to biosimilar applications
  2. These patents were identified from disclosures by the brand-side company, in response to a potential biosimilar seeking to launch. They have a high certainty of blocking biosimilar entry. The expiration dates listed are not estimates — they're expiration dates as indicated by the brand-side company.

  3. General brand-side disclosures
  4. These patents were identified from searching drug labels and other general disclosures from the brand-side company. This list may exclude some of the patents which block biosimilar launch, and some of these patents listed may not actually block biosimilar launch. The expiration dates listed for these patents are estimates, based on the grant date of the patent.

  5. Patents from broad patent text search
  6. For completeness, these patents were identified by searching the patent literature for mentions of the branded or ingredient name of the drug. Some of these patents protect the original drug, whereas others may protect follow-on inventions or even inventions casually mentioning the drug. The expiration dates listed for these patents are estimates, based on the grant date of the patent.

1) High Certainty: US Patents for PRE-PEN Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for PRE-PEN Derived from Company Disclosures

No patents found based on company disclosures

3) Low Certainty: US Patents for PRE-PEN Derived from Patent Text Search

These patents were obtained by searching patent claims

PRE-PEN Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Biologic Drugs: A Focus on PRE-PEN

Introduction to Biologic Drugs

Biologic drugs, including products like PRE-PEN, are large molecule compounds designed to treat complex and often rare diseases. These drugs have become a significant segment of the pharmaceutical industry, driving innovation and growth.

Global Biologics Market Overview

The global biologics market is projected to exceed $600 billion by 2032, driven by increasing demand for personalized treatments for chronic diseases[1].

  • Chronic Diseases: The rise in chronic diseases such as autoimmune disorders, cancer, and genetic diseases is a major driver for the biologics market.
  • Regional Growth: North America is the largest market for biologics, with the Asian Pacific region also experiencing substantial growth.

Market Drivers for Biologics

Several factors are driving the growth of the biologics market:

Demand for Personalized Treatments

The medical industry's emphasis on novel drugs and treatments, particularly for chronic or age-related diseases, is a significant driver. Biologics offer targeted and often more effective treatments compared to traditional small molecule drugs[1].

Technological Advancements

Advancements in diagnostics and treatment medications, including the development of oral medications for conditions like Crohn’s disease and rheumatoid arthritis, are expected to drive a new wave of branded therapies[1].

Self-Administered Biologics

The rise in self-administered biologics, facilitated by devices such as prefilled syringes, autoinjectors, and wearable injectors, has increased patient convenience and reduced healthcare costs. This segment is projected to grow at a CAGR of 4.5% from 2024 to 2034[4].

PRE-PEN and ALK's Financial Outlook

Acquisition and Integration

ALK, the company behind PRE-PEN, has recently acquired the PRE-PEN operation in the USA. This acquisition is part of ALK's broader strategy to enhance its product portfolio and market presence[5].

Revenue Growth

ALK's financial outlook for 2024 indicates robust revenue growth, particularly driven by European tablet sales. The company expects revenue to grow by 14-16% organically in local currencies, with European tablet sales being a key driver[2].

EBIT Margin Improvement

The EBIT margin is expected to improve to 19-21% in 2024, up from 14% in the previous year. This improvement is mainly driven by high sales growth, efficiencies, and lower R&D costs[2].

Operational Efficiencies

ALK is focusing on operational efficiencies, including the optimization of existing platforms and the reduction of R&D expenses. These measures are expected to further improve the capacity cost-to-revenue ratio and contribute to higher profitability[2].

Market Dynamics Affecting PRE-PEN

Competitive Landscape

The biologics market, including products like PRE-PEN, is highly competitive. Companies such as Novo Nordisk, Eli Lilly, Johnson & Johnson, and Pfizer are key players in this space. The competitive dynamics, including pricing and rebate adjustments, play a significant role in market growth[4].

Regulatory Environment

Regulatory approvals and the introduction of biosimilars can significantly impact the market dynamics. Biosimilars, which are biologic products that are highly similar to an already approved biologic, are expected to reduce drug costs and increase market competition[3].

Patient Preferences

Patients increasingly prefer self-administered biologics due to their flexibility and lower healthcare costs. This preference is driving the adoption of self-administered formulations, which is a key segment for products like PRE-PEN[4].

Economic Implications

Cost Impact

Biologic drugs, including PRE-PEN, are often expensive, with annual costs approaching or exceeding $100,000. The introduction of biosimilars is expected to reduce these costs, although to a lesser degree than seen with small-molecule generic drugs[3].

Public Payer Impact

Public payers are experiencing significant increases in spending on biologic drugs. For example, spending on biologic drugs under Medicare Part D grew substantially between 2009 and 2012 due to increases in prescription volume and prices[3].

Regional Growth and Market Share

Europe

European tablet sales are a significant growth driver for ALK, with sales expected to grow at a rate significantly above the growth in 2023. This is driven by a high number of new patients starting treatment and improved pricing and rebate adjustments[2].

North America and International Markets

While North America and international markets are also expected to see growth, the rates are lower compared to Europe. The USA self-administered biologics market is forecast to grow at a CAGR of 3.4% from 2024 to 2034[4].

Key Takeaways

  • Market Growth: The global biologics market is expected to exceed $600 billion by 2032, driven by demand for personalized treatments.
  • Revenue Growth: ALK expects revenue to grow by 14-16% organically in local currencies, driven by European tablet sales.
  • Operational Efficiencies: ALK is focusing on operational efficiencies to improve profitability.
  • Competitive Landscape: The market is highly competitive, with key players including Novo Nordisk, Eli Lilly, and Johnson & Johnson.
  • Regulatory Environment: The introduction of biosimilars will impact market dynamics and reduce drug costs.

FAQs

Q: What is the projected growth of the global biologics market by 2032? A: The global biologics market is anticipated to exceed $600 billion by 2032[1].

Q: What are the key drivers for the growth of the biologics market? A: The key drivers include demand for personalized treatments for chronic diseases, technological advancements, and the rise in self-administered biologics[1][4].

Q: How is ALK's financial outlook for 2024? A: ALK expects revenue to grow by 14-16% organically in local currencies, with an EBIT margin improvement to 19-21%[2].

Q: What is the impact of biosimilars on the biologics market? A: Biosimilars are expected to reduce drug costs and increase market competition, although to a lesser degree than seen with small-molecule generic drugs[3].

Q: Why are self-administered biologics gaining popularity? A: Self-administered biologics are preferred due to their flexibility, lower healthcare costs, and the convenience of subcutaneous delivery over IV formulations[4].

Sources

  1. Oxford Global: Biologics Market Trends and Predictions: New Horizons Beckon.
  2. ALK Investors: Financial reporting - Investors | ALK.
  3. The American Journal of Managed Care: The Economic Implications of Biosimilars.
  4. Future Market Insights: Self-administered Biologics Market Size & Demand, 2034.
  5. GlobeNewswire: Nine-month interim report (Q3) 2024 (unaudited).

More… ↓

⤷  Subscribe

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.