Rho(d) immune globulin intravenous (human) - Biologic Drug Details

Summary for rho(d) immune globulin intravenous (human)

Tradenames:	2
High Confidence Patents:	0
Applicants:	2
BLAs:	2
Suppliers: see list	2

Pharmacology for rho(d) immune globulin intravenous (human)

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 brand-side disclosures

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.

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 rho(d) immune globulin intravenous (human) Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for rho(d) immune globulin intravenous (human) Derived from DrugPatentWatch Analysis and Company Disclosures

These patents were obtained from company disclosures

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Patent No.	Estimated Patent Expiration	Source
Csl Behring Ag	RHOPHYLAC	rho(d) immune globulin intravenous (human)	Injection	125070	11,419,936	2039-08-27	DrugPatentWatch analysis and company disclosures
Csl Behring Ag	RHOPHYLAC	rho(d) immune globulin intravenous (human)	Injection	125070	12,144,861	2035-12-03	DrugPatentWatch analysis and company disclosures
Csl Behring Ag	RHOPHYLAC	rho(d) immune globulin intravenous (human)	Injection	125070	12,194,101	2041-10-29	DrugPatentWatch analysis and company disclosures
Csl Behring Ag	RHOPHYLAC	rho(d) immune globulin intravenous (human)	Injection	125070	9,241,897	2031-02-03	DrugPatentWatch analysis and company disclosures
Csl Behring Ag	RHOPHYLAC	rho(d) immune globulin intravenous (human)	Injection	125070	9,422,364	2031-02-24	DrugPatentWatch analysis and company disclosures

3) Low Certainty: US Patents for rho(d) immune globulin intravenous (human) 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
Kamada Ltd.	WINRHO SD, WINRHO SDF LIQUID, WINRHO SDF LYOPHILIZED	rho(d) immune globulin intravenous (human)	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)	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)	Injection	103649	7,304,033	2022-05-23	Patent claims search

International Patents for rho(d) immune globulin intravenous (human)

Country	Patent Number	Estimated Expiration
Poland	3763384
Turkey	201903403
Spain	2755760
Brazil	112017010442
Canada	2968915
World Intellectual Property Organization (WIPO)	2011095543
Japan	6078344

Rho(d) immune globulin intravenous (human) Market Analysis and Financial Projection

Last updated: February 14, 2026

What Are the Key Market Dynamics for Rho(D) Immune Globulin Intravenous (Human)?

Rho(D) immune globulin intravenous (human), marketed under brands like RhoGAM IV and WinRho SDF, primarily serves the prevention of hemolytic disease of the fetus and newborn (HDFN). Its market hinges on several factors:

• Regulatory Status: Approved by the FDA for prevention of HDFN in Rh-negative pregnant women. Other agencies, such as EMA, maintain similar approvals.
• Clinical Demand: driven by the incidence of Rh-negative pregnancies; approximately 15% of pregnant women are Rh-negative globally, indicating a sizeable at-risk population. Birth rates in developed countries for Rh-negative women range from 8 to 15 per 1,000 pregnancies.
• Competing Therapies: Limited. Rh immunoglobulin remains the only prophylactic option for Rh incompatibility, providing little competition.
• Market Penetration: High in North America and Europe, but less in regions with limited healthcare infrastructure.
• Supply Chain & Manufacturing: Dependent on plasma collection and fractionation facilities. There are limited manufacturers—numbers range from 2 to 4 globally.

How Do Market Forces Drive the Revenue and Growth of Rho(D) Immune Globulin Intravenous (Human)?

• Demand Stability: Steady, contingent upon birth rates of Rh-negative women. Global birth rates affect total addressable markets.
• Pricing Strategies: List prices in the US generally range from $300 to $400 per dose, with variations based on dosage and manufacturer. Payer reimbursement policies influence net revenue.
• Pricing and Access: Insurance coverage is widespread in developed markets; however, out-of-pocket costs may influence administration rates in underinsured populations.
• Patent Status and Generic Competition: The original patent expired decades ago; recent market entries are generics or biosimilars, enhancing competition and pressuring prices.
• Regulatory Developments: Potential approvals of biosimilars or alternative prophylactic strategies could influence revenue.

What Are the Financial Trends and Future Outlook?

• Historical Revenue Figures: Estimated global sales exceeded $1 billion annually as of 2021, concentrated primarily in North America (~60%) and Europe (~25%) [1].
• Growth Drivers: Steady demand driven by Rh-negative birth rates, enhanced awareness, and expanded indications like immune thrombocytopenic purpura (ITP) off-label uses.
• Market Challenges: Supply constraints due to dependence on plasma collection, high production costs, and limited number of manufacturers.
• Biosimilar Impact: Several biosimilar candidates are under development or approved in multiple regions. Their market penetration could depress prices.
• Emerging Markets: Growth potential exists; however, affordability and healthcare infrastructure limit penetration in regions like Africa and parts of Asia.

How Do External Factors Influence Market Trajectory?

• Regulatory Policies: Changes in approval pathways or reimbursement policies can impact supply and pricing.
• Technological Innovation: Advances in monoclonal antibodies or alternative prophylactics for Rh incompatibility may reduce reliance on plasma-derived products.
• Public Health Trends: Decreasing birth rates in some regions could suppress demand, while rising awareness may bolster prophylactic use.
• Supply Chain Risks: Plasma donation shortages, especially during events like pandemics, affect production capacity.

Summary Data Table

Metric	Details
Global sales (2021)	>$1 billion
Number of manufacturers	2–4 globally
US price per dose	$300–$400
Rh-negative birth prevalence	8–15 per 1,000 pregnancies in developed regions
Patent status	Patents expired; market dominated by generics/biosimilars

Key Takeaways

• Rho(D) immune globulin intravenous (human) maintains a stable market because of its essential prophylactic role.
• Revenue growth depends on birth rates of Rh-negative women, with limited influence from new product launches.
• Patent expirations and biosimilar entries are pressuring prices but also expanding access.
• Supply chain and manufacturing constraints pose risks to consistent availability.
• Emerging markets offer growth opportunities, contingent on healthcare infrastructure development and affordability.

Frequently Asked Questions

1. How reliant is the Rho(D) immune globulin market on specific geographic regions? The U.S. and Europe generate the majority of sales; growth in emerging markets remains limited due to healthcare access issues.

2. What factors could disrupt the current market for Rho(D) immune globulin? Development of alternative prophylactic treatments, regulatory changes easing biosimilar approvals, or plasma donation shortages.

3. Are biosimilars affecting the market? Yes. Several biosimilars are approved or under development, leading to price competition.

4. What is the outlook for demand in the next five years? Demand is expected to remain stable or slightly decline, aligned with birth rate trends, unless new indications or markets emerge.

5. How do manufacturing challenges impact supply? Plasma collection constraints and high production costs risk shortages and price fluctuations.

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Sources:

[1] IQVIA. "Global Immunoglobulin Market Review," 2022.