GALAFOLD Drug Patent Profile

When do Galafold patents expire, 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 ninety 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.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be May 16, 2027. This may change due to patent challenges or generic licensing.

There have been twelve 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:	290
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

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for GALAFOLD

NDA:

208623

Dosage:

CAPSULE;ORAL

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

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.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

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

International Patents for GALAFOLD

When does loss-of-exclusivity occur for GALAFOLD?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Australia

Canada

Cyprus

Denmark

European Patent Office

Hong Kong

Hungary

Japan

Lithuania

Luxembourg

Mexico

Netherlands

Poland

Portugal

Slovenia

Spain

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

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

Country	Patent Number	Title	Estimated Expiration
Canada	2715407
South Korea	20240017111
South Korea	20240017112
Mexico	2022001623

Supplementary Protection Certificates for GALAFOLD

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2787345	634	Finland
2787345	1690052-4	Sweden		PRODUCT NAME: MIGALASTAT OR A SALT THEREOF, INCLUDING THE HYDROCHLORIDE SALT.; REG. NO/DATE: EU/1/15/1082 20160531
2787345	300843	Netherlands		PRODUCT NAME: MIGALASTAT OF EEN ZOUT DAARVAN, WAARONDER HET HYDROCHLORIDEZOUT; REGISTRATION NO/DATE: EU/1/15/1082 20160531
2787345	53/2016	Austria		PRODUCT NAME: MIGALASTAT ODER EIN SALZ DAVON, EINSCHLIESSLICH DES HYDROCHLORIDSALZES; REGISTRATION NO/DATE: EU/1/15/1082 (MITTEILUNG) 20160531

GALAFOLD Market Dynamics and Financial Trajectory

Last updated: February 20, 2026

GALAFOLD (aka migalastat) is a pharmacologic chaperone for Fabry disease, a rare genetic disorder caused by alpha-galactosidase A deficiency. Its market penetration and financial outlook depend on approval status, competitive landscape, pricing strategies, and reimbursement environments.

Regulatory Status and Market Penetration

GALAFOLD received FDA approval in August 2018 and EMA approval in September 2016 for the treatment of adults with Fabry disease who have amenable mutations. It is marketed primarily in North America, Europe, and select Asia-Pacific regions.

As of 2022, GALAFOLD reported net sales of approximately $200 million, representing a 20% annual increase. Adoption remains limited relative to enzyme replacement therapies (ERTs) like agalsidase beta (Fabrazyme) and agalsidase alfa (Replagal), which have been on the market longer.

Competitive Landscape

Therapy Type	Market Share (2022)	Notes
Enzyme Replacement Therapy	60%	Mature, established treatments
GALAFOLD	10%	Growing, limited by mutation eligibility
Other options (e.g., off-label, experimental)	30%	Smaller, variable efficacy

GALAFOLD's niche is in patients with amenable mutations, approximately 35-50% of the Fabry patient population.

Market Drivers

• Mutation-specific genomic testing: Advances enable better identification of suitable candidates.
• Patient preference: Oral administration contrasts with ERT infusions.
• Regulatory approvals: Expand access in key markets.

Market Challenges

• Mutation eligibility constraints: Limits patient pool.
• Pricing pressures: Reimbursement negotiations in the US and Europe impact revenue.
• Limited long-term data: Question of sustained efficacy over multiple years.

Financial Trajectory Projections

Year	Estimated Global Sales (USD)	CAGR	Key Assumptions
2023	$250 million	25%	Continued uptake, new markets open
2024	$312 million	25%	FDA approvals in additional territories
2025	$390 million	25%	Expanded mutation testing, price stability

Growth is primarily driven by expanding mutation testing, increased physician familiarity, and approval in additional markets.

Analysts project GALAFOLD could reach $500-$600 million in annual sales by 2027 if market share increases to 15-20% of the Fabry disease treatment market. The actual trajectory hinges on mutation screening adoption, competitive activity, and pricing pressures.

Pricing and Reimbursement

GALAFOLD's average annual wholesale acquisition cost (WAC) is approximately $360,000. Insurance coverage varies by country:

• United States: Coverage depends on patient-specific mutation testing and prior authorization.
• Europe: Pricing negotiations with health authorities influence access.
• Asia-Pacific: Market expansion relies on local reimbursement and approval processes.

Key Takeaways

• GALAFOLD's revenue growth is limited by mutation-specific eligibility, but increasing mutation testing and market access can accelerate the trajectory.
• The drug faces competition from well-established enzyme replacement therapies.
• Pricing pressures and reimbursement negotiations impact profit margins.
• The global market potential in Fabry disease treatment could approach $600 million by 2027 if adoption rates and mutation screening improve.
• Expansion into pediatric populations and combination therapies present future opportunities.

FAQs

1. What mutations are compatible with GALAFOLD?
Mutations classified as "amenable" based on in vitro assays determine eligibility. Approximately 35-50% of Fabry mutations are amenable, varying by genetic testing methods.

2. How does GALAFOLD compare with enzyme replacement therapies?
GALAFOLD offers oral administration and fewer infusion-related adverse events. ERT remains standard but requires regular infusions, making GALAFOLD an alternative for eligible patients.

3. What are the main factors influencing GALAFOLD’s sales growth?
Expansion of mutation testing, greater physician awareness, regulatory approvals in new territories, and payer reimbursement policies.

4. Are there any upcoming regulatory decisions?
Additional approvals are anticipated in South Korea, Japan, and other Asia-Pacific countries. Ongoing clinical trials explore efficacy in pediatric populations.

5. What strategic considerations should investors monitor?
Market expansion, mutation testing adoption rates, competitive launches, patent developments, and pricing negotiations.

References

1. U.S. Food and Drug Administration. (2018). FDA approves treatment for rare genetic disorder.
2. European Medicines Agency. (2016). EMA approval for migalastat.
3. Evaluate Pharma. (2022). Fabry disease therapeutics pipeline and sales data.
4. IQVIA. (2023). Global drug sales report.
5. National Organization for Rare Disorders. (2022). Fabry Disease: Therapeutic Outlook.