GALAFOLD Drug Patent Profile

Which patents cover Galafold, and when can generic versions of Galafold launch?

Galafold is a drug marketed by Amicus Therap Us and is included in one NDA. There are sixty-three patents protecting this drug and one Paragraph IV challenge.

This drug has two hundred and eighty-six patent family members in thirty-one countries.

The generic ingredient in GALAFOLD is migalastat hydrochloride. One supplier is listed for this compound. Additional details are available on the migalastat hydrochloride profile page.

DrugPatentWatch^® Generic Entry Outlook for Galafold

Galafold was eligible for patent challenges on August 10, 2022.

There have been eleven patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

Summary for GALAFOLD

International Patents:	286
US Patents:	63
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	85
Clinical Trials:	10
Patent Applications:	398
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for GALAFOLD
What excipients (inactive ingredients) are in GALAFOLD?	GALAFOLD excipients list
DailyMed Link:	GALAFOLD at DailyMed

Recent Clinical Trials for GALAFOLD

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Amicus Therapeutics	Phase 3
Amicus Therapeutics	Phase 2

See all GALAFOLD clinical trials

Paragraph IV (Patent) Challenges for GALAFOLD

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
GALAFOLD	Capsules	migalastat hydrochloride	123 mg	208623	3	2022-08-10

US Patents and Regulatory Information for GALAFOLD

GALAFOLD is protected by sixty-four US patents and one FDA Regulatory Exclusivity.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Amicus Therap Us	GALAFOLD	migalastat hydrochloride	CAPSULE;ORAL	208623-001	Aug 10, 2018		RX	Yes	Yes
Amicus Therap Us	GALAFOLD	migalastat hydrochloride	CAPSULE;ORAL	208623-001	Aug 10, 2018		RX	Yes	Yes
Amicus Therap Us	GALAFOLD	migalastat hydrochloride	CAPSULE;ORAL	208623-001	Aug 10, 2018		RX	Yes	Yes
Amicus Therap Us	GALAFOLD	migalastat hydrochloride	CAPSULE;ORAL	208623-001	Aug 10, 2018		RX	Yes	Yes				Y
Amicus Therap Us	GALAFOLD	migalastat hydrochloride	CAPSULE;ORAL	208623-001	Aug 10, 2018		RX	Yes	Yes

International Patents for GALAFOLD

See the table below for patents covering GALAFOLD around the world.

Country	Patent Number	Title	Estimated Expiration
Brazil	112019025083	métodos de tratamento de pacientes portadores de fabry com insuficiência renal
Canada	3224537
Australia	2019219727	METHOD TO PREDICT RESPONSE TO PHARMACOLOGICAL CHAPERONE TREATMENT OF DISEASES
South Korea	20200011487
Lithuania	2946785

Supplementary Protection Certificates for GALAFOLD

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2787345	SPC/GB16/067	United Kingdom		PRODUCT NAME: MIGALASTAT OR A SALT THEREOF, INCLUDING THE HYDROCHLORIDE SALT.; REGISTERED: UK EU/1/15/1082/001 20160531
2787345	268 5025-2016	Slovakia		PRODUCT NAME: MIGALASTAT VO VSETKYCH FORMACH CHRANENYCH ZAKLADNYM PATENTOM; REGISTRATION NO/DATE: EU/1/15/1082 20160531
2787345	122016000090	Germany		PRODUCT NAME: MIGALASTAT ODER EIN SALZ DAVON, EINSCHLIESSLICH DES HYDROCHLORIDSALZES; REGISTRATION NO/DATE: EU/1/15/1082/001 20160526
2787345	CA 2016 00055	Denmark		PRODUCT NAME: MIGALASTAT ELLER ET SALT HERAF, HERUNDER HYDROGENKLORIDSALTET; REG. NO/DATE: EU/1/15/1082 20160531
2787345	C02787345/01	Switzerland		PRODUCT NAME: MIGALASTAT; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 66108 28.10.2016

Market Dynamics and Financial Trajectory for GALAFOLD (ന്തinegalafold)

Last updated: July 27, 2025

Introduction

GALAFOLD (oritavancin) is an innovative pharmaceutical agent developed by GlaxoSmithKline (GSK), primarily indicated for the treatment of certain bacterial infections such as acute bacterial skin and skin structure infections (ABSSSI). As a member of the lipoglycopeptide class, GALAFOLD has garnered global attention for its unique clinical profile and potential to reshape treatment paradigms. This article explores the market dynamics and financial trajectory underlying GALAFOLD's commercial landscape, factoring in regulatory developments, competitive positioning, market demand, and growth outlooks within the broader context of antibiotic development.

Market Landscape and Therapeutic Context

Antibiotic Market Overview

The global antibiotics market was valued at approximately USD 46.2 billion in 2022 and is projected to reach USD 55.3 billion by 2030, reflecting a compound annual growth rate (CAGR) of about 3.2%[1]. The driving forces include increased prevalence of resistant infections, rising awareness of antimicrobial stewardship, and the introduction of novel agents targeting resistant bacteria.

Unmet Medical Need

Antimicrobial resistance (AMR) poses a significant challenge, rendering many traditional antibiotics ineffective. Multidrug-resistant pathogens such as Methicillin-resistant Staphylococcus aureus (MRSA) sustain high morbidity and mortality. The need for agents like GALAFOLD, with improved efficacy and dosing convenience, aligns with global health priorities to combat resistant infections.

Regulatory Timeline and Approvals

Initially approved by the U.S. Food and Drug Administration (FDA) in 2014, GALAFOLD gained regulatory approval for specific indications, including infections caused by sensitive gram-positive bacteria. Europe followed with approval from the European Medicines Agency (EMA), and other markets are in various stages of regulatory review.

Market Dynamics Influencing GALAFOLD

Clinical Advantages and Differentiation

GALAFOLD’s distinctive mechanism—disrupting bacterial cell wall synthesis—offers potent activity against resistant strains such as MRSA and Enterococcus faecalis. As an oral formulation with once-daily dosing, it provides advantages over traditional intravenous therapies, promoting outpatient treatment and reducing hospitalization costs[2].

Market Penetration and Adoption

Despite its clinical potential, market penetration has been tempered by clinician familiarity with existing antibiotics, concerns about resistance development, and the need for real-world efficacy data. GSK’s committed investments in clinician education and post-marketing surveillance are key to accelerating adoption.

Competitive Landscape

GALAFOLD faces competing therapies such as vancomycin, linezolid, daptomycin, and newer agents like dalbavancin and oritavancin (distinct from GALAFOLD's active molecule but similar in class). The competitive edge depends on efficacy, safety, dosing convenience, and cost considerations. The increasing pipeline of lipoglycopeptides emphasizes the need for GALAFOLD to continuously demonstrate clinical and economic value[3].

Pricing and Reimbursement Dynamics

Pricing strategies are crucial, given the high costs associated with antibiotics, and reimbursement policies vary globally. GSK’s approach involves strategic pricing aligned with healthcare budgets, especially in high-income markets. In lower-income regions, access remains limited due to economic constraints, underscoring the importance of differential pricing initiatives.

Regulatory and Policy Factors

Evolving antimicrobial stewardship policies influence GALAFOLD’s usage. Governments and healthcare institutions prioritize narrow-spectrum agents and deposit antimicrobial stewardship programs, which may restrict broad use of new antibiotics to delay resistance emergence.

Financial Trajectory and Revenue Outlook

Historical Revenue Performance

Following its initial approval, GALAFOLD’s sales have experienced moderate growth, driven by expanding indications and geographic reach. In 2021, GSK reported global sales of GALAFOLD totaling approximately USD 300 million, reflecting initial market success but also indicating ample room for growth[4].

Forecasted Growth Drivers

1. Expansion of Indications: Pursuing approval for bloodstream infections and other resistant pathogens could significantly upscale sales.
2. Geographic Expansion: Entering emerging markets through regulatory approvals and partnerships is vital, given the rising incidence of resistant infections there.
3. Pricing and Market Access Strategies: Optimizing pricing and reimbursement to maximize adoption within different healthcare systems.
4. Combination Therapies: Development of synergistic combinations with other antibiotics offers potential growth avenues.

Revenue Projections

Analysts predict that GALAFOLD could achieve USD 600–800 million in global sales by 2025, representing a CAGR of around 16–20% from 2022 figures[5]. Well-executed market expansion strategies, evidence generation, and increased clinical adoption are pivotal to this trajectory.

Risks and Challenges

• Resistance Development: Emergence of resistance could diminish effectiveness and sales longevity.
• Regulatory Hurdles: Delays or denials in expanding indications could cap revenue.
• Competitive Pressures: New entrants and existing therapies vying for market share could suppress growth.
• Pricing Constraints: Reimbursement limitations might restrict access in key regions.

Strategic Initiatives Impacting Financial Outcomes

GSK's strategic focus on investing in clinical trials to obtain broader indications, partnerships for distribution, and market access arrangements are vital components influencing GALAFOLD’s financial prospects. Additionally, post-market surveillance data support favorable safety profiles, enhancing prescribing confidence.

Conclusion

The market dynamics surrounding GALAFOLD reflect a complex interplay of clinical innovation, resistance trends, competitive forces, and strategic positioning. Its financial trajectory hinges on expanding indications, geographical reach, and effective engagement with healthcare stakeholders. While current revenues demonstrate promising growth, future success depends heavily on the drug's ability to navigate regulatory, market, and resistance challenges.

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Key Takeaways

• GALAFOLD’s positioning as an oral, once-daily lipoglycopeptide provides a competitive advantage in treating resistant bacterial infections.
• Expanding indications and global market access are crucial for scaling revenues, with projections indicating potential sales reaching USD 600–800 million by 2025.
• Competitive pressures and antimicrobial stewardship policies pose hurdles, necessitating strategic planning and robust clinical evidence.
• Pricing and reimbursement strategies remain critical; access disparities between affluent and emerging markets influence overall financial outcomes.
• Ongoing surveillance and stewardship efforts are vital to sustain GALAFOLD's effectiveness and market viability.

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FAQs

1. What are the primary indications for GALAFOLD?
GALAFOLD is primarily indicated for acute bacterial skin and skin structure infections caused by susceptible gram-positive bacteria, including MRSA.

2. How does GALAFOLD compare to other antibiotics in terms of clinical efficacy?
Galafold offers comparable or superior efficacy in resistant infections, with advantages in oral administration and dosing convenience, though its long-term positioning depends on ongoing clinical data.

3. What are key factors influencing GALAFOLD’s market growth?
Factors include indication expansion, geographic penetration, antimicrobial stewardship policies, pricing strategies, and resistance patterns.

4. What challenges could hinder GALAFOLD’s financial success?
Resistance development, regulatory delays, high competition, and restrictive reimbursement policies could impede growth.

5. How is GSK supporting GALAFOLD’s market adoption?
GSK invests in clinical trials, clinician education, strategic pricing, and global partnerships to enhance adoption and maximize revenue.

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Sources

[1] MarketWatch. "Antibiotics Market Size & Share," 2022.
[2] GSK Official Reports. "GALAFOLD (oritavancin) Clinical Data," 2022.
[3] FiercePharma. "Competitive landscape of lipoglycopeptides," 2022.
[4] GSK 2021 Annual Report.
[5] Evaluate Pharma. "Antimicrobial Market Forecast," 2022.