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. General 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 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 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		2032-02-15	Patent claims search
Kamada Ltd.	WINRHO SD, WINRHO SDF LIQUID, WINRHO SDF LYOPHILIZED	rho(d) immune globulin intravenous (human)	For Injection	103649		2006-11-25	Patent claims search
Kamada Ltd.	WINRHO SD, WINRHO SDF LIQUID, WINRHO SDF LYOPHILIZED	rho(d) immune globulin intravenous (human)	For Injection	103649		2021-05-23	Patent claims search
Kamada Ltd.	WINRHO SD, WINRHO SDF LIQUID, WINRHO SDF LYOPHILIZED	rho(d) immune globulin intravenous (human)	For Injection	103649		2032-02-15	Patent claims search

WINRHO SD, WINRHO SDF LIQUID, WINRHO SDF LYOPHILIZED Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory of WinRho SDF

Introduction

WinRho SDF, a Rho(D) Immune Globulin Intravenous (Human) product, is a biologic drug indicated for the treatment of immune thrombocytopenic purpura (ITP) and the suppression of Rh isoimmunization. Here, we delve into the market dynamics and financial trajectory of this critical biologic drug.

Market Indications and Patient Population

WinRho SDF is specifically approved for use in Rho(D)-positive patients with ITP, including children and adults with chronic or acute ITP, and those with ITP secondary to HIV infection[1][4][5].

Competitive Landscape

The market for ITP treatments is competitive, with various therapeutic options available, including other immunoglobulins, thrombopoietin receptor agonists, and corticosteroids. However, WinRho SDF holds a unique position due to its specific mechanism of action and patient population focus.

Mechanism of Action and Clinical Efficacy

The drug works by binding anti-D antibodies to Rho(D)-positive red blood cells, leading to their preferential destruction and sparing the platelets. This results in a transient increase in platelet counts, typically peaking around seven days after treatment[2][4].

Safety and Adverse Reactions

Despite its efficacy, WinRho SDF is associated with significant safety concerns, including intravascular hemolysis (IVH), which can lead to severe anemia, acute renal insufficiency, renal failure, and disseminated intravascular coagulation (DIC). These complications necessitate close monitoring of patients post-administration[1][4][5].

Regulatory Environment

WinRho SDF has been approved by regulatory bodies such as the FDA since 1996 for the treatment of ITP and suppression of Rh isoimmunization. The drug's safety and efficacy have not been evaluated in patients with non-ITP causes of thrombocytopenia or in previously splenectomized patients[3][5].

Market Size and Growth

The global ITP treatment market is growing, driven by increasing awareness, better diagnostic tools, and an expanding patient population. WinRho SDF, being a niche product, captures a significant share within this market segment. The market size for ITP treatments is projected to grow due to the rising prevalence of autoimmune diseases and the need for effective treatments.

Financial Performance

The financial performance of WinRho SDF is influenced by several factors, including sales volume, pricing strategies, and competition. Given its specific indications and the critical nature of the conditions it treats, WinRho SDF commands a premium price. However, the high cost can be a barrier to access in some markets.

Revenue Streams

Revenue for WinRho SDF is generated primarily through hospital and clinical settings where the drug is administered. Additional revenue streams come from its use in suppressing Rh isoimmunization in pregnant women.

Challenges and Opportunities

• Challenges:
  • Safety concerns and the need for close patient monitoring post-administration.
  • High cost and potential barriers to access.
  • Competition from other ITP treatments.
• Opportunities:
  • Growing demand for effective ITP treatments.
  • Expansion into new markets, particularly in regions with limited access to current therapies.
  • Potential for use in other clinical situations requiring an increase in platelet count.

Key Players and Partnerships

WinRho SDF is manufactured by Cangene Corp and distributed by various partners, including Kamada Pharmaceuticals and Accuristix in different regions. Strategic partnerships and collaborations are crucial for expanding market reach and improving patient access[2][4].

Pricing and Reimbursement

The pricing of WinRho SDF varies by region and is influenced by local healthcare policies and reimbursement structures. In many countries, the drug is covered under national health insurance programs, which helps in making it more accessible to patients.

Future Outlook

The future outlook for WinRho SDF is promising, given the ongoing need for effective treatments for ITP and Rh isoimmunization. Continuous monitoring and improvement of safety profiles, along with strategic marketing and distribution, will be key to maintaining and growing its market share.

Threats and Mitigation Strategies

• Threats:
  • Emergence of new treatments with better safety profiles.
  • Regulatory changes affecting approval or reimbursement.
  • Economic factors impacting healthcare spending.
• Mitigation Strategies:
  • Continuous clinical research to enhance safety and efficacy.
  • Diversification of product lines to reduce dependence on a single drug.
  • Strong regulatory and market surveillance.

Key Takeaways

• WinRho SDF is a critical biologic drug for treating ITP and suppressing Rh isoimmunization.
• It operates in a competitive market with unique challenges and opportunities.
• Safety concerns and high costs are significant factors influencing its market dynamics.
• The drug's financial trajectory is driven by its niche market position, regulatory approvals, and strategic partnerships.

Frequently Asked Questions (FAQs)

Q1: What is the primary indication for WinRho SDF?

• WinRho SDF is primarily indicated for the treatment of immune thrombocytopenic purpura (ITP) in Rho(D)-positive patients and for the suppression of Rh isoimmunization in non-sensitized Rho(D)-negative patients[1][4][5].

Q2: What are the significant safety concerns associated with WinRho SDF?

• The significant safety concerns include intravascular hemolysis (IVH), severe anemia, acute renal insufficiency, renal failure, and disseminated intravascular coagulation (DIC)[1][4][5].

Q3: How does WinRho SDF work?

• WinRho SDF works by binding anti-D antibodies to Rho(D)-positive red blood cells, leading to their preferential destruction and sparing the platelets, thus increasing platelet counts[2][4].

Q4: What is the typical duration of the therapeutic effect of WinRho SDF?

• The therapeutic effect of WinRho SDF is transient, with platelet counts usually elevated from several days to several weeks after administration[2].

Q5: Are there any specific patient populations that should be closely monitored when treated with WinRho SDF?

• Yes, patients at risk of renal insufficiency or failure, those with pre-existing risk factors for thrombotic events, and those with predisposing conditions for IVH should be closely monitored[4].

Cited Sources:

1. WinRho SDF for the treatment of immune thrombocytopenic purpura - WinRho.
2. WinRho® SDF, Rho(D) Immunoglobulin (Human), for Injection - Product Monograph.
3. Rho(D) Immune Globulin Intravenous (Human)(Cangene Corp) - Synapse.
4. WinRho - Kamada Pharmaceuticals - Kamada Pharmaceuticals.
5. WinRho SDF Liquid - FDA - FDA.