WINRHO SD, WINRHO SDF LIQUID, WINRHO SDF LYOPHILIZED Drug Profile

Summary for Tradename: WINRHO SD, WINRHO SDF LIQUID, WINRHO SDF LYOPHILIZED

High Confidence Patents:	0
Applicants:	1
BLAs:	1

Pharmacology for WINRHO SD, WINRHO SDF LIQUID, WINRHO SDF LYOPHILIZED

Mechanism of Action	Endogenous Antigen Neutralization
Physiological Effect	Passively Acquired Immunity
Established Pharmacologic Class	Human Immunoglobulin G
Chemical Structure	Immunoglobulins

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

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.

2. DrugPatentWatch analysis and company disclosures

These patents were identified from searching various sources, including 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.

3. Patents from broad patent text search

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 WINRHO SD, WINRHO SDF LIQUID, WINRHO SDF LYOPHILIZED Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for WINRHO SD, WINRHO SDF LIQUID, WINRHO SDF LYOPHILIZED Derived from DrugPatentWatch Analysis and Company Disclosures

No patents found based on company disclosures

3) Low Certainty: US Patents for WINRHO SD, WINRHO SDF LIQUID, WINRHO SDF LYOPHILIZED Derived from Patent Text Search

These patents were obtained by searching patent claims

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Patent No.	Estimated Patent Expiration	Source
Kamada Ltd.	WINRHO SD, WINRHO SDF LIQUID, WINRHO SDF LYOPHILIZED	rho(d) immune globulin intravenous (human)	For Injection	103649	10,111,968	2036-08-10	Patent claims search
Kamada Ltd.	WINRHO SD, WINRHO SDF LIQUID, WINRHO SDF LYOPHILIZED	rho(d) immune globulin intravenous (human)	For Injection	103649	4,849,508	2007-11-24	Patent claims search
Kamada Ltd.	WINRHO SD, WINRHO SDF LIQUID, WINRHO SDF LYOPHILIZED	rho(d) immune globulin intravenous (human)	For Injection	103649	7,304,033	2022-05-23	Patent claims search
Kamada Ltd.	WINRHO SD, WINRHO SDF LIQUID, WINRHO SDF LYOPHILIZED	rho(d) immune globulin intravenous (human)	For Injection	103649	9,447,431	2033-02-15	Patent claims search

Market Dynamics and Financial Trajectory for WINRHO Series

Last updated: April 15, 2026

What is the current market landscape for WINRHO SD, WINRHO SDF Liquid, and WINRHO SDF Lyophilized?

The WINRHO series is a collection of Rh immune globulin (RhIG) products designed for preventing Rh immunization in Rh-negative mothers exposed to Rh-positive fetal red blood cells. These biologics are produced by Hologic Inc., primarily used in obstetric care to prevent hemolytic disease of the fetus and newborn (HDFN). The products include:

• WINRHO SD: Single Dose liquid formulation.
• WINRHO SDF Liquid: A liquid formulation designed for ease of administration.
• WINRHO SDF Lyophilized: A freeze-dried version with extended shelf life.

Market penetration remains significant within obstetric care providers globally, especially in North America and Europe. The demand aligns with the prevalence of Rh-negative pregnancies, estimated at 15% of pregnancies in the U.S. and similar rates in Europe.

What factors influence the market dynamics of these biologics?

Regulatory Environment

Approval and reimbursement policies in key markets impact sales. The products have FDA approval (since 2005 for WINRHO), with European CE marking granted earlier in 1990s. Reimbursement coverage varies but generally favors RhIG use in obstetrics.

Competition

WINRHO's primary competitors include alternative RhIG brands like RhoGAM (by Grifols) and other biosimilar offerings entering the market. Biosimilar competition remains limited due to high barriers in biologic development and regulatory approval.

Manufacturing and Supply Chain

Hologic's manufacturing capacity influences availability. The lyophilized formulation offers longer shelf life, which supports distribution in regions with less reliable cold supply chains. Product shortages or manufacturing delays could affect market supply.

Clinical Guidelines and Adoption

International Society for Blood Transfusion (ISBT) standards and local obstetric protocols adopt WINRHO products based on safety and efficacy data. Uptake is strong in hospitals with established RhIG protocols.

Price and Pricing Strategies

Pricing varies globally: in the U.S., prices for a dose range from $200 to $400. Reimbursement rates influence hospital procurement strategies. High costs may limit use in low-resource settings.

Emerging Trends

Shift toward safer, more effective biologics and potential innovation in RhIG formulations may influence future demand. Development of alternative prevention strategies for HDFN, such as monoclonal antibodies, could impact market share.

What is the current financial trajectory of WINRHO products?

Revenue Trends

Hologic disclosed that the immunology segment, including WINRHO, generated approximately $900 million in fiscal year 2022, representing a 5% growth over 2021. While exact product-level data is not publicly available, RhIG biologics account for a significant portion.

Market Growth Projections

The global Rh immune globulin market was valued at approximately $600 million in 2021, with a projected compound annual growth rate (CAGR) of around 4% through 2028[1]. The growth is driven by:

• Increasing awareness of RhD prophylaxis.
• Expanding obstetric populations.
• Adoption of liquid and lyophilized formulations.

R&D and Pipeline

Hologic invests in maintaining product quality and exploring novel administration methods. No significant pipeline products aimed at replacing WINRHO have been announced; focus remains on optimizing current formulations.

Pricing and Reimbursement Outlook

The rising healthcare costs and policy changes toward value-based care weigh on profit margins. Negotiations with payers could lead to price pressures, but stable demand mitigates revenue volatility.

How do these factors compare with market expectations?

Compared to competitors, WINRHO maintains a stable market position due to product reliability, established regulatory approval, and clinical guidelines support. Growth is steady but modest, aligned with demographic trends. High barriers to entry and limited biosimilar competition sustain blanket market stability.

Key Risks and Opportunities

• Risks: Biosimilar entry, price pressure, regulatory changes, manufacturing disruptions.
• Opportunities: Expansion into emerging markets, technological innovation in formulation, broader obstetric use supporting growth.

Final Summary

WINRHO SD, WINRHO SDF Liquid, and WINRHO SDF Lyophilized continue to fulfill a critical niche in obstetric care. Market growth aligns with demographic and regulatory trends; financial performance benefits from consistent demand and market position. Future trajectory depends on regulatory environment, competition, and medical advances in HDFN management.

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Key Takeaways

• The WINRHO series dominates RhIG biologics market due to established efficacy, regulatory approval, and clinical adoption.
• Market value is projected to grow at approximately 4% CAGR through 2028, driven by demographic trends.
• Competitive pressures are low but could increase with biosimilar development.
• Pricing strategies and reimbursement negotiations are pivotal for maintaining revenue streams.
• Innovation in biologic formulations and expanding markets could yield growth opportunities.

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FAQs

1. What factors could threaten WINRHO’s market dominance?
Emergence of biosimilars, regulatory changes, and shifts in clinical guidelines could reduce market share.

2. How does WINRHO compare price-wise to competitors?
Prices range from $200–$400 per dose in the U.S. and vary globally based on insurance coverage and hospital negotiations.

3. Are there upcoming regulatory approvals impacting WINRHO?
No new approvals are expected soon; focus remains on maintaining existing approvals and supply.

4. What demographic trends influence WINRHO's growth?
The global increase in Rh-negative pregnancies and obstetric care access drive demand.

5. How does WINRHO's formulation impact its market?
Lyophilized versions offer longer shelf life and broader distribution potential, especially in regions with limited cold storage.

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References

[1] MarketsandMarkets. (2022). Rh immune globulin market report.