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Last Updated: December 23, 2024

OVIDREL Drug Profile


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Summary for Tradename: OVIDREL
Recent Clinical Trials for OVIDREL

Identify potential brand extensions & biosimilar entrants

SponsorPhase
Sports Medicine Research and Testing LaboratoryEarly Phase 1
Nanjing UniversityN/A
University of VirginiaEarly Phase 1

See all OVIDREL clinical trials

Pharmacology for OVIDREL
Established Pharmacologic ClassGonadotropin
Chemical StructureGonadotropins
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 OVIDREL Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for OVIDREL Derived from Company Disclosures

No patents found based on company disclosures

3) Low Certainty: US Patents for OVIDREL Derived from Patent Text Search

These patents were obtained by searching patent claims

OVIDREL Market Analysis and Financial Projection Experimental

Biologics Market Dynamics and Financial Trajectory: Focus on OVIDREL

Introduction to Biologics and OVIDREL

Biologics, including drugs like OVIDREL, are a class of drugs that are derived from living organisms and are used to treat a variety of medical conditions. OVIDREL, specifically, is a recombinant human chorionic gonadotropin (hCG) used in assisted reproductive technologies (ART) such as in vitro fertilization (IVF) and ovulation induction.

Global Biologics Market Outlook

The global biologics market is experiencing significant growth, driven by several key factors. As of 2023, the biologics market size was valued at USD 349.6 billion and is projected to reach USD 699.5 billion by 2032, with a compound annual growth rate (CAGR) of 7.8% during the forecast period of 2024-2032[1].

Key Drivers of the Biologics Market

  • Increasing Burden of Chronic Diseases: The rising prevalence of chronic diseases is a major driver, as biologics offer targeted and often more effective treatments compared to traditional drugs.
  • Technological Advancements: Continuous advancements in drug delivery systems and the development of novel biologic therapies, such as gene therapy, antisense, and RNAi therapies, are driving market expansion.
  • Growing Adoption of Biosimilars: The increasing acceptance and approval of biosimilars are contributing to the market's growth.
  • Improved Healthcare Infrastructure: Better healthcare infrastructure and favorable reimbursement policies are also significant factors[1].

OVIDREL: A Specific Biologic Drug

OVIDREL is a recombinant human chorionic gonadotropin (hCG) used to trigger ovulation in women undergoing ART. Here are some key points about OVIDREL:

Pharmacokinetics and Pharmacodynamics

  • OVIDREL has a mean terminal half-life of about 26.5 ± 2.5 hours when administered intravenously and 29 ± 6 hours when administered subcutaneously[5].
  • The drug induces a clear increase in androstenedione serum levels by 24 hours after dosing, with pharmacologic effects that are not always proportional to exposure[5].

Efficacy in ART

  • Clinical studies have shown that OVIDREL is clinically and statistically equivalent to urinary-derived hCG products in terms of efficacy in IVF and embryo transfer. For example, in Study 7648, the mean number of oocytes retrieved per patient was 10.6, and the clinical pregnancy rate per initiated treatment cycle was 33%[5].

Market Position and Financial Trajectory

While specific financial data for OVIDREL alone is not readily available, its performance can be inferred from the broader biologics market trends.

Segmental Growth

The segment of biologic drugs used in reproductive health, including OVIDREL, benefits from the overall growth in the biologics market. The increasing demand for ART and the expanding use of biologic drugs in fertility treatments contribute to the segment's growth.

Competitive Environment

The biologics market is highly competitive, with several major players. Companies like Merck KGaA, Darmstadt, Germany, are investing heavily in life science and biopharmaceutical research, including novel modalities such as mRNA and ADCs, which can impact the competitive landscape for drugs like OVIDREL[3].

Revenue Projections

While specific revenue projections for OVIDREL are not available, the overall biologics market is expected to grow significantly. For instance, the global market for biological therapeutic drugs is projected to increase from $452.9 billion in 2023 to $823.4 billion by the end of 2028, with a CAGR of 12.7% during the forecast period[4].

Challenges and Opportunities

Regulatory Approvals

The approval of biologic drugs by regulatory agencies is a critical factor. The escalating approvals of biologics, including novel therapies, are expected to drive market expansion[1].

Technological Advancements

Continuous technological advancements in drug delivery systems and the development of new biologic therapies present opportunities for growth. However, these advancements also pose challenges in terms of competition and the need for continuous innovation[1].

Market Expansion

The biopharmaceutical industry's rapid expansion, particularly in regions with growing healthcare needs, offers significant opportunities for biologic drugs like OVIDREL. The increasing awareness about biologic therapies and favorable reimbursement policies further support market growth[1].

Conclusion

OVIDREL, as a part of the broader biologics market, is poised to benefit from the significant growth trends in this sector. Driven by technological advancements, increasing chronic disease prevalence, and growing adoption of biosimilars, the biologics market is expected to continue its robust growth trajectory.

Key Takeaways

  • The global biologics market is projected to reach USD 699.5 billion by 2032.
  • OVIDREL's efficacy in ART is well-documented, with clinical and statistical equivalence to traditional hCG products.
  • Technological advancements and regulatory approvals are key drivers of the biologics market.
  • The competitive environment is highly dynamic, with major players investing in novel modalities.
  • The biopharmaceutical industry's expansion and favorable reimbursement policies support market growth.

Frequently Asked Questions

1. What is OVIDREL used for?

OVIDREL is used to trigger ovulation in women undergoing assisted reproductive technologies (ART) such as in vitro fertilization (IVF) and ovulation induction.

2. How does OVIDREL compare to traditional hCG products?

OVIDREL has been shown to be clinically and statistically equivalent to urinary-derived hCG products in terms of efficacy in IVF and embryo transfer[5].

3. What are the key drivers of the biologics market?

Key drivers include the increasing burden of chronic diseases, technological advancements, growing adoption of biosimilars, improved healthcare infrastructure, and favorable reimbursement policies[1].

4. What is the projected growth rate of the biologics market?

The biologics market is expected to grow at a CAGR of 7.8% from 2024 to 2032[1].

5. How does OVIDREL's pharmacokinetics impact its efficacy?

OVIDREL's pharmacokinetics show a mean terminal half-life of about 26.5 ± 2.5 hours when administered intravenously and 29 ± 6 hours when administered subcutaneously, with pharmacologic effects that are not always proportional to exposure[5].

Cited Sources:

  1. Biologics Market Size to Reach USD 699.5 Billion by 2032, Impelled by Emergence of Advanced Drug Delivery Systems - Biospace
  2. Ovidrel® (choriogonadotropin alfa) - accessdata.fda.gov
  3. Merck KGaA, Darmstadt, Germany - Q3 24 Roadshow - EMD Group
  4. Biologic Therapeutic Drugs: Technologies and Global Markets - BCC Research
  5. Ovidrel Prescribing Information English - EMD Serono

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