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Last Updated: January 20, 2025

BIVIGAM Drug Profile


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Summary for Tradename: BIVIGAM
High Confidence Patents:0
Applicants:1
BLAs:1
Recent Clinical Trials: See clinical trials for BIVIGAM
Recent Clinical Trials for BIVIGAM

Identify potential brand extensions & biosimilar entrants

SponsorPhase
Northwestern UniversityPhase 2/Phase 3

See all BIVIGAM clinical trials

Pharmacology for BIVIGAM
Mechanism of ActionAntigen Neutralization
Physiological EffectPassively Acquired Immunity
Established Pharmacologic ClassHuman Immunoglobulin G
Chemical StructureImmunoglobulins
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 BIVIGAM Derived from Brand-Side Litigation

No patents found based on brand-side litigation

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

No patents found based on company disclosures

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

These patents were obtained by searching patent claims
Showing 1 to 6 of 6 entries

BIVIGAM Market Analysis and Financial Projection

Market Dynamics and Financial Trajectory for BIVIGAM

Introduction BIVIGAM, an immunoglobulin product developed by ADMA Biologics, has been a cornerstone in the company's financial trajectory. Despite its lower margin profile compared to the flagship product ASCENIV, BIVIGAM has played a crucial role in ADMA's revenue growth and strategic evolution.

Revenue Growth and Market Position

  • Historical Context: In the first quarter of 2023, ADMA Biologics reported a significant increase in total revenues, with BIVIGAM contributing to this growth. The product mix continued to favorably evolve, driven by the expanding customer base and physician, payer, and patient acceptance of BIVIGAM[1].
  • ASCENIV Dominance: While ASCENIV has become the primary driver of revenue, BIVIGAM's sales have been substantial. The accelerated monetization of lower-margin BIVIGAM inventory in the first quarter of 2023 was a key factor in the company's financial performance[1].

Financial Performance

  • Gross Margin Expansion: The depletion of lower-margin BIVIGAM inventory is anticipated to lead to material gross margin expansion over the coming quarters. This shift towards higher-margin products, along with ASCENIV, is expected to improve overall profitability[1].
  • Production Scale: The successful ramp-up of BIVIGAM production to the 4,400-liter scale has provided a solid foundation for future growth. This expansion has improved the product's margin profile and increased plant production capacity, enabling fewer batches to support revenue goals[1][4].

Strategic Initiatives

  • Label Expansion Opportunities: Post-marketing clinical studies have progressed as planned, potentially leading to label expansion opportunities for both BIVIGAM and ASCENIV to include pediatric-aged primary humoral immunodeficiency (PI) patients. This expansion could significantly increase the market reach and revenue potential for both products[1][4].

Yield Enhancement Opportunities

  • Plasma Supply Self-Sufficiency: ADMA’s BioCenters segment has been expanding, with eight FDA-licensed collection centers operational and two additional centers pending licensure. The company anticipates achieving raw material plasma supply self-sufficiency by the end of 2023, which will support its upwardly revised production and revenue forecasts[1].

Future Outlook

  • Revenue Projections: While ASCENIV continues to dominate the revenue landscape, BIVIGAM’s strategic importance lies in its role as a foundational product that has driven initial market acceptance and customer base expansion. As ADMA Biologics continues to scale up production and improve manufacturing efficiency, BIVIGAM’s contribution to overall revenue is expected to stabilize and potentially increase as the company shifts towards higher-margin products[1][3].

Key Takeaways

  1. Revenue Contribution: BIVIGAM has been a significant contributor to ADMA Biologics' revenue growth, particularly in the first quarter of 2023.
  2. Gross Margin Improvement: The depletion of lower-margin BIVIGAM inventory is expected to lead to material gross margin expansion.
  3. Production Scale Expansion: The successful ramp-up of BIVIGAM production to the 4,400-liter scale has improved the product’s margin profile and increased plant production capacity.
  4. Strategic Importance: BIVIGAM has played a crucial role in driving initial market acceptance and expanding the customer base for ADMA Biologics.
  5. Future Outlook: As ADMA Biologics continues to scale up production and improve manufacturing efficiency, BIVIGAM’s contribution to overall revenue is expected to stabilize and potentially increase.

FAQs

  1. What is the current market position of BIVIGAM?

    • BIVIGAM continues to be a significant product in ADMA Biologics' portfolio, contributing substantially to the company's revenue growth.
  2. How has BIVIGAM’s production scale impacted its financial performance?

    • The expansion of BIVIGAM production to the 4,400-liter scale has improved the product’s margin profile and increased plant production capacity, leading to fewer batches needed to support revenue goals.
  3. What are the label expansion opportunities for BIVIGAM?

    • Post-marketing clinical studies may provide label expansion opportunities for BIVIGAM to include pediatric-aged primary humoral immunodeficiency (PI) patients, potentially increasing market reach and revenue potential.
  4. How does ADMA Biologics plan to enhance plasma supply self-sufficiency?

    • ADMA’s BioCenters segment is expanding, with eight FDA-licensed collection centers operational and two additional centers pending licensure. The company anticipates achieving raw material plasma supply self-sufficiency by the end of 2023.
  5. What is the future outlook for BIVIGAM’s contribution to ADMA Biologics’ revenue?

    • As ADMA Biologics continues to scale up production and improve manufacturing efficiency, BIVIGAM’s contribution to overall revenue is expected to stabilize and potentially increase as the company shifts towards higher-margin products.

Sources

  1. ADMA Biologics Announces First Quarter 2023 Financial Results
  2. ADMA Biologics Announces Fourth Quarter and Full Year 2023 Financial Results
  3. ADMA Q2-2024 Earnings Call
  4. ADMA Biologics Announces Fourth Quarter and Full Year 2022 Financial Results
  5. ADMA Biologics Announces Second Quarter 2023 Financial Results

More… ↓

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