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Last Updated: December 25, 2024

ACTHIB,OMNIHIB Drug Profile


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Summary for Tradename: ACTHIB,OMNIHIB
High Confidence Patents:0
Applicants:1
BLAs:1
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 ACTHIB,OMNIHIB Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for ACTHIB,OMNIHIB Derived from Company Disclosures

No patents found based on company disclosures

3) Low Certainty: US Patents for ACTHIB,OMNIHIB Derived from Patent Text Search

No patents found based on company disclosures

ACTHIB,OMNIHIB Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for ActHIB and OmniHIB

Introduction

ActHIB and OmniHIB are haemophilus b conjugate vaccines, crucial in preventing invasive diseases caused by Haemophilus influenzae type b (Hib) in infants and children. These vaccines are part of the broader biological drugs market, which is experiencing significant growth driven by various factors.

Market Context

The global biological drugs market is expanding rapidly, driven by an increase in research and development activities, the rising prevalence of chronic diseases, and a growing demand for personalized medicine. In 2023, the biological drugs market was valued at USD 296.2 billion and is projected to grow to USD 326.12 billion by 2030[3].

Product Overview

ActHIB and OmniHIB are identical products manufactured by Sanofi Pasteur Inc. and distributed by different entities. These vaccines are indicated for the prevention of invasive Hib diseases, such as meningitis, epiglottitis, pericarditis, pneumonia, and septic arthritis, in children from 2 months to 5 years of age[1][2][4].

Target Market

The primary target market for ActHIB and OmniHIB is infants and children up to the age of 5. These vaccines are recommended for all children in this age group to protect against serious and potentially life-threatening Hib infections[2].

Administration and Dosage

ActHIB and OmniHIB are administered intramuscularly, typically as part of a four-dose series. The vaccines can be reconstituted using diphtheria and tetanus toxoids and pertussis vaccine (DTP) and must be used within 24 hours after reconstitution[1][4].

Safety and Efficacy

Studies have shown that ActHIB and OmniHIB are safe and effective in children from 2 months to 5 years of age. There are no significant pediatric-specific problems that limit their usefulness in this age group. However, safety and efficacy have not been established in children younger than 2 months or older than 5 years[2].

Side Effects

While generally well-tolerated, these vaccines can cause side effects such as diarrhea, loss of appetite, vomiting, fever, and redness or swelling at the injection site. More severe but rare side effects include seizures, chest pain, and allergic reactions[2].

Market Drivers

Several factors drive the demand for ActHIB and OmniHIB:

Increasing Prevalence of Chronic Diseases

The rising incidence of chronic diseases, including infections that can be prevented by vaccines, contributes to the growing demand for biological drugs like ActHIB and OmniHIB[3].

Advances in Biotechnology

Advancements in genetic engineering and biotechnology have improved the development and efficacy of biological drugs, including conjugate vaccines[3].

Regulatory Support

Streamlined regulatory frameworks, particularly in North America, facilitate faster approvals and market entry for new biological drugs, including vaccines. The Inflation Reduction Act, for example, provides extended patent protection for biologics, incentivizing further investment[3].

Growing Aging Population

The increasing aging population and the subsequent rise in autoimmune diseases and other chronic conditions also fuel the demand for effective treatments, including vaccines[3].

Financial Trajectory

The financial performance of ActHIB and OmniHIB is closely tied to the overall biological drugs market. Here are some key financial insights:

Market Size and Growth

The biological drugs market, which includes vaccines, is expected to grow from USD 296.2 billion in 2023 to USD 326.12 billion by 2030. This growth is driven by the increasing demand for advanced therapeutic interventions, including vaccines[3].

Revenue Contribution

Vaccines, including conjugate vaccines like ActHIB and OmniHIB, contribute significantly to the revenue of the biological drugs market. While specific revenue figures for these vaccines are not publicly disclosed, they are part of the broader vaccine segment that is experiencing robust growth[3].

Competitive Landscape

The market for biological drugs is highly competitive, with major players like Sanofi Pasteur Inc., Pfizer, and Biohaven Pharmaceutical Holding Company Ltd. investing heavily in research and development. Strategic collaborations and the introduction of novel biologics further drive market growth[3].

Regional Insights

North America holds a dominant position in the biological drugs market, including vaccines, due to a well-developed pharmaceutical industry, access to advanced healthcare facilities, and widespread insurance coverage. This region is expected to continue driving the growth of the market for vaccines like ActHIB and OmniHIB[3].

Key Takeaways

  • Market Growth: The biological drugs market, including vaccines like ActHIB and OmniHIB, is expected to grow significantly by 2030.
  • Target Market: These vaccines are primarily targeted at infants and children from 2 months to 5 years of age.
  • Safety and Efficacy: ActHIB and OmniHIB have been shown to be safe and effective in preventing invasive Hib diseases.
  • Market Drivers: Increasing prevalence of chronic diseases, advances in biotechnology, and regulatory support drive the demand for these vaccines.
  • Financial Trajectory: The financial performance of these vaccines is tied to the overall growth of the biological drugs market.

FAQs

Q: What is the primary indication for ActHIB and OmniHIB vaccines? A: ActHIB and OmniHIB vaccines are indicated for the prevention of invasive diseases caused by Haemophilus influenzae type b in infants and children from 2 months to 5 years of age[1][2].

Q: How are ActHIB and OmniHIB vaccines administered? A: These vaccines are administered intramuscularly, typically as part of a four-dose series, and can be reconstituted using DTP vaccine[1][4].

Q: What are the common side effects of ActHIB and OmniHIB vaccines? A: Common side effects include diarrhea, loss of appetite, vomiting, fever, and redness or swelling at the injection site[2].

Q: Why is the demand for ActHIB and OmniHIB vaccines increasing? A: The demand is driven by the increasing prevalence of chronic diseases, advances in biotechnology, and regulatory support[3].

Q: What is the expected growth of the biological drugs market, including vaccines like ActHIB and OmniHIB? A: The biological drugs market is expected to grow from USD 296.2 billion in 2023 to USD 326.12 billion by 2030[3].

Sources

  1. FDA: ActHIB.
  2. Mayo Clinic: Haemophilus b conjugate vaccine (intramuscular route).
  3. Maximize Market Research: Biological Drugs Market: Global Industry Analysis.
  4. RxList: DTP (Diphtheria and Tetanus Toxoids and Pertussis Vaccine).

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