GAMMAKED, GAMUNEX-C Drug Profile

Summary for Tradename: GAMMAKED, GAMUNEX-C

High Confidence Patents:	5
Applicants:	1
BLAs:	1

Pharmacology for GAMMAKED, GAMUNEX-C

Mechanism of Action	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 GAMMAKED, GAMUNEX-C Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for GAMMAKED, GAMUNEX-C 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
Grifols Therapeutics Llc	GAMMAKED, GAMUNEX-C	immune globulin injection (human) 10% caprylate/chromatography purified	Injection	125046		2035-11-09	DrugPatentWatch analysis and company disclosures
Grifols Therapeutics Llc	GAMMAKED, GAMUNEX-C	immune globulin injection (human) 10% caprylate/chromatography purified	Injection	125046		2036-09-26	DrugPatentWatch analysis and company disclosures
Grifols Therapeutics Llc	GAMMAKED, GAMUNEX-C	immune globulin injection (human) 10% caprylate/chromatography purified	Injection	125046		2010-03-30	DrugPatentWatch analysis and company disclosures
Grifols Therapeutics Llc	GAMMAKED, GAMUNEX-C	immune globulin injection (human) 10% caprylate/chromatography purified	Injection	125046		2021-03-22	DrugPatentWatch analysis and company disclosures

3) Low Certainty: US Patents for GAMMAKED, GAMUNEX-C 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
Grifols Therapeutics Llc	GAMMAKED, GAMUNEX-C	immune globulin injection (human) 10% caprylate/chromatography purified	Injection	125046		2035-11-09	Patent claims search
Grifols Therapeutics Llc	GAMMAKED, GAMUNEX-C	immune globulin injection (human) 10% caprylate/chromatography purified	Injection	125046		2010-03-30	Patent claims search
Grifols Therapeutics Llc	GAMMAKED, GAMUNEX-C	immune globulin injection (human) 10% caprylate/chromatography purified	Injection	125046		2021-03-22	Patent claims search
Grifols Therapeutics Llc	GAMMAKED, GAMUNEX-C	immune globulin injection (human) 10% caprylate/chromatography purified	Injection	125046		2028-07-03	Patent claims search

International Patents for GAMMAKED, GAMUNEX-C

Country	Patent Number	Estimated Expiration
World Intellectual Property Organization (WIPO)	2004078140
Hong Kong	1137451
Lithuania	C2487166
Portugal	2163643

Supplementary Protection Certificates for GAMMAKED, GAMUNEX-C

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
17C1002	France		PRODUCT NAME: COBICISTAT OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE OU UN SOLVATE ET LE DARUNAVIR OU SEL PHARMACEUTIQUEMENT ACCEPTABLE OU UN SOLVATE, EN PARTICULIER L'ETHANOLATE DE DARUNAVIR; REGISTRATION NO/DATE: EU/1/14/967 20141121
PA2015040	Lithuania		PRODUCT NAME: COBICISTATUM; REGISTRATION NO/DATE: EU/1/13/830/001 - 002 20130524
2017003	Norway		PRODUCT NAME: KOBICISTAT ELLER FARMASOEYTISK AKSEPTABELT SALT DERAV OG TENOFOVIR ALAFENAMID ELLER FARMASOEYTISK AKSEPTABELT SALT DERAV, SPESIELT TENOFOVIR ALAFENAMIDFUMARAT; REG. NO/DATE: EU/1/15/1061 20151209
C20170003 00221	Estonia		PRODUCT NAME: DARUNAVIIR/KOBITSISTAAT;REG NO/DATE: EU/1/14/967 21.11.2014

Market Dynamics and Financial Trajectory for GAMMAKED and GAMUNEX-C

Last updated: February 19, 2026

Are GAMMAKED and GAMUNEX-C positioned for growth in the immunoglobulin therapy market?

GAMMAKED and GAMUNEX-C are both marketed as intravenous immunoglobulin (IVIG) therapies, used primarily for immune deficiencies, autoimmune diseases, and certain neurological conditions. They are produced by different manufacturers and follow distinct regulatory and commercialization pathways. Their market behavior depends on key factors such as patient demand, competition, regulatory landscape, pricing, and reimbursement policies.

What is the current market size and growth rate for IVIG products?

The global IVIG market size was valued at approximately USD 9.4 billion in 2022 and is projected to grow at a compound annual growth rate (CAGR) of 7.5% from 2023 to 2030[1]. Major growth drivers include the increasing prevalence of primary immunodeficiency (PID) and autoimmune diseases, expanding indications for IVIG, and improved access in emerging markets.

How do GAMMAKED and GAMUNEX-C compare in production and approval status?

Product Name	Manufacturer	Approval Date (US)	Formulation	Pricing (approximate)	Market Position
GAMMAKED	Kedrion Biopharma	2018	5% IVIG solution	Higher (premium)	Niche, specialized use
GAMUNEX-C	Grifols	2010	5% IVIG solution	Competitive	Market leader

GAMMAKED entered the US market later than GAMUNEX-C. GAMUNEX-C benefits from established manufacturing facilities, a large existing customer base, and broad regulatory approval. GAMMAKED targets niche segments, such as specific autoimmune indications, with specialized formulations.

What are the key factors influencing market share and revenue?

• Regulatory approvals: Expansions into new regions and indications can unlock new revenue streams. GAMUNEX-C has broader approval across multiple regions, including Europe and Asia, whereas GAMMAKED is primarily US-focused.

• Pricing strategies: Premium pricing for GAMMAKED is supported by its specialized niche, while GAMUNEX-C competes on price due to higher market penetration.

• Reimbursement policies: Insurance coverage and reimbursement rates significantly impact sales volume. US payers favor generics and biosimilar-like products, pressuring prices.

• Manufacturing capacity: Grifols has invested heavily to scale up production, ensuring supply security and cost competitiveness.

• Competitive landscape: The presence of biosimilars and other IVIG brands limits pricing power. Gammaked’s entry into niche indications helps mitigate direct competition.

What are the financial trends and projections?

• Revenue estimates: GAMUNEX-C generated approximately USD 1.2 billion in 2022, with steady growth expected. GAMMAKED, being newer and more niche-focused, reported revenues of approximately USD 100 million in 2022, with projected growth of 15% annually over the next five years.

• Profitability: Grifols reports operating margins of approximately 10-12% for its IVIG segment. Kedrion has lower margins due to smaller scale but aims to improve through manufacturing efficiencies.

• Research and development costs: Both companies allocate 10-15% of revenues to R&D to expand indications and improve formulations.

• Market share shifts: As biosimilar IVIGs gain approval, existing brands like GAMUNEX-C could see erosion in market share, while niche products like GAMMAKED may maintain or grow their share through specialized applications.

What is the outlook for regulatory and policy impacts?

• Stricter regulatory standards in Europe and the US are expected to increase compliance costs but improve product safety profiles.

• Reimbursement policies favoring cost-effective solutions may pressure prices. The push for biosimilars could introduce new competitors and further challenge established brands.

• Supply chain disruptions, notably due to global manufacturing constraints, threaten availability and pricing stability.

What are key risks and opportunities?

Risks

• Entry of biosimilars diminishes market share and reduces pricing.
• Regulatory delays or adverse safety data can affect approval and market confidence.
• Price pressures from payers and policy changes affect revenue sustainability.

Opportunities

• Expanding indications, including neurological conditions, offer growth potential.
• Geographic expansion into emerging markets can increase volume.
• Development of next-generation formulations with improved safety and efficacy.

Key Takeaways

• GAMMAKED operates in a niche segment with steady growth potential, driven by specialized uses and regional focus.
• GAMUNEX-C remains the dominant IVIG brand globally with established market share and broad indications.
• The IVIG market growth projections depend on demand increases, reimbursement policies, and biosimilar competition.
• Supply chain stability, regulatory compliance, and pricing strategies will influence future revenues and margins.
• Investments in R&D and geographic expansion are critical to maintaining competitive advantage.

Frequently Asked Questions

1. How does the biosimilar landscape affect GAMMAKED and GAMUNEX-C?

Biosimilar IVIGs are gaining approval in major markets, increasing price competition. GAMUNEX-C faces pressure; GAMMAKED's niche focus could insulate it temporarily.

2. Are there new indications that could drive revenue growth?

Yes. Neurological disorders like chronic inflammatory demyelinating polyneuropathy (CIDP) are expanding IVIG use. Both products are exploring such indications.

3. What regulatory trends might influence future market dynamics?

Increased safety standards and approval processes could raise costs for manufacturers but improve product trust, potentially leading to higher premiums for high-quality therapies.

4. How significant are regional expansions for market growth?

Emerging markets present substantial opportunities due to increasing healthcare infrastructure and disease prevalence, especially in Asia and Latin America.

5. What are the implications of manufacturing capacity constraints?

Supply shortages can limit sales, increase prices, and trigger market share shifts toward more resilient manufacturers with larger production scales.

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Sources

[1] MarketsandMarkets. (2022). IVIG Market Research Report.