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-two patents protecting this drug and one Paragraph IV challenge.

This drug has two hundred and fifty-two patent family members in thirty 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 August 10, 2025. This may change due to patent challenges or generic licensing.

There have been two 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:	252
US Patents:	62
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	41
Clinical Trials:	10
Patent Applications:	75
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

Constraining patent/regulatory exclusivity:

INDICATED FOR THE TREATMENT OF ADULTS WITH A CONFIRMED DIAGNOSIS OF FABRY DISEASE AND AN AMENABLE GALACTOSIDASE ALPHA GENE (GLA) VARIANT BASED ON IN VITRO ASSAY DATA

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-three US patents and one FDA Regulatory Exclusivity.

This potential generic entry date is based on INDICATED FOR THE TREATMENT OF ADULTS WITH A CONFIRMED DIAGNOSIS OF FABRY DISEASE AND AN AMENABLE GALACTOSIDASE ALPHA GENE (GLA) VARIANT BASED ON IN VITRO ASSAY DATA.

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	10,799,491
Amicus Therap Us	GALAFOLD	migalastat hydrochloride	CAPSULE;ORAL	208623-001	Aug 10, 2018		RX	Yes	Yes	10,857,142
Amicus Therap Us	GALAFOLD	migalastat hydrochloride	CAPSULE;ORAL	208623-001	Aug 10, 2018		RX	Yes	Yes	11,278,536

International Patents for GALAFOLD

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

Country	Patent Number	Title	Estimated Expiration
San Marino	T202500016
South Korea	20230061563	ERT-치료경험이 없는 환자 및 있는 환자에서 파브리병의 치료 (ERT- TREATMENT OF FABRY DISEASE IN ERT-NAIVE AND ERT-EXPERIENCED PATIENTS)
China	111971044	米加司他用于治疗妊娠患者的法布里病的用途 (Use of migalastat for treating fabry disease in pregnant patients)

Supplementary Protection Certificates for GALAFOLD

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2787345	CR 2016 00055	Denmark		PRODUCT NAME: MIGALASTAT ELLER ET SALT HERAF, HERUNDER HYDROGENKLORIDSALTET; REG. NO/DATE: EU/1/15/1082 20160531
2787345	CA 2016 00055	Denmark		PRODUCT NAME: MIGALASTAT ELLER ET SALT HERAF, HERUNDER HYDROGENKLORIDSALTET; REG. NO/DATE: EU/1/15/1082 20160531
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

Market Dynamics and Financial Trajectory for Galafold

Introduction to Galafold

Galafold, also known as migalastat, is a pharmacological chaperone therapy developed by Amicus Therapeutics for the treatment of Fabry disease, a rare genetic disorder. Here, we will delve into the market dynamics and financial trajectory of Galafold, highlighting its growth, revenue, and strategic outlook.

Market Demand and Patient Uptake

Galafold has seen significant growth in patient uptake globally. As of 2022, over 2,000 people worldwide were on treatment with Galafold, and by 2023, this number had increased to more than 2,400 people living with Fabry disease[1][4].

Revenue Growth

The revenue from Galafold has been robust and consistently growing. In 2023, Galafold net product sales reached approximately $387.8 million, representing a year-over-year increase of 18%, or 17% at constant exchange rates (CER)[4].

Quarterly Performance

In the second quarter of 2024, Galafold net product sales were $110.8 million, a year-over-year increase of 17%, or 19% at CER. This strong performance led Amicus Therapeutics to raise its full-year 2024 revenue growth guidance for Galafold to 14% to 18% at CER[3][5].

Annual Projections

For the full-year 2023, Galafold revenue growth was anticipated to be between 12% and 17% at CER, driven by continued underlying demand from both switch and treatment-naïve patients, geographic expansion, label extensions, and commercial execution across major markets[1].

Drivers of Growth

Several factors are driving the growth of Galafold:

Geographic Expansion

Galafold is being marketed and sold in multiple major markets, including the U.S., EU, U.K., and Japan. This geographic expansion has contributed significantly to its revenue growth[1].

Continued Diagnosis and Treatment

The continued diagnosis of new Fabry patients and the switch from other treatments to Galafold have been key drivers of its growth. The therapy's effectiveness and patient preference have also played a crucial role[1].

Commercial Execution

Strong commercial execution across all major markets has been instrumental in the success of Galafold. Amicus Therapeutics has focused on effective marketing and sales strategies to increase its market share[1].

Financial Performance

The financial performance of Amicus Therapeutics, largely driven by Galafold, has been impressive.

Total Revenue

In the third quarter of 2024, total revenue was $141.5 million, a year-over-year increase of 37%, or 36% at CER. For the nine months ended September 30, 2024, total revenue was $378.6 million, compared to $284.3 million for the same period in 2023[2].

Operating Expenses

Despite the growth in revenue, Amicus Therapeutics has maintained financial discipline. Total GAAP operating expenses for the third quarter of 2024 decreased by 4% compared to the same period in 2023, while non-GAAP operating expenses decreased by 8%[2].

Net Income/Loss

The company achieved non-GAAP net income of $30.8 million in the third quarter of 2024, compared to a non-GAAP net loss of $4.0 million in the third quarter of 2023. This shift to profitability is a significant milestone for Amicus Therapeutics[2].

Strategic Outlook

Amicus Therapeutics has several strategic priorities for 2024 that will impact the trajectory of Galafold:

Continued Growth of Galafold

The company aims to continue growing Galafold globally at double-digit rates. This includes expanding into new markets and increasing the number of patients on treatment[4].

Launch of New Products

The successful launch of Pombiliti (cipaglucosidase alfa-atga) and Opfolda (miglustat) for Pompe disease is another key focus. These products are expected to contribute significantly to the company's revenue and are seen as potential standards of care in a market valued over $1 billion[4].

Financial Discipline

Maintaining financial discipline to achieve non-GAAP profitability is a core objective. Amicus Therapeutics has reduced its non-GAAP operating expense guidance for 2024, reflecting its commitment to efficient resource management[2][4].

Competitive Landscape

Galafold operates in a niche market for rare diseases, but it faces competition from other treatments for Fabry disease. However, its unique mechanism of action and strong clinical data have positioned it favorably in the market.

Regulatory Environment

Regulatory approvals and inspections are crucial for the continued success of Galafold. The U.S. FDA pre-approval inspection for AT-GAA, another product in Amicus Therapeutics' pipeline, is scheduled, with regulatory approval expected in the third quarter of 2023[1].

Conclusion

Galafold has demonstrated robust market dynamics and a strong financial trajectory. With continued growth in patient uptake, geographic expansion, and effective commercial execution, Galafold is poised to remain a key player in the treatment of Fabry disease.

Key Takeaways

• Revenue Growth: Galafold has shown consistent year-over-year revenue growth, with a 18% increase in 2023.
• Patient Uptake: Over 2,400 people are now on Galafold treatment globally.
• Geographic Expansion: Sales in major markets including the U.S., EU, U.K., and Japan.
• Financial Discipline: Amicus Therapeutics has achieved non-GAAP profitability and reduced operating expenses.
• Strategic Outlook: Continued focus on growing Galafold and launching new products like Pombiliti and Opfolda.

FAQs

Q: What is Galafold used for?

A: Galafold, or migalastat, is used for the treatment of Fabry disease, a rare genetic disorder.

Q: How has Galafold's revenue grown in recent years?

A: Galafold's revenue has shown significant growth, with an 18% year-over-year increase in 2023 and a projected growth of 14% to 18% at CER for 2024.

Q: What are the key drivers of Galafold's growth?

A: Key drivers include continued diagnosis of new Fabry patients, geographic expansion, label extensions, and strong commercial execution.

Q: Has Amicus Therapeutics achieved profitability with Galafold?

A: Yes, Amicus Therapeutics achieved non-GAAP profitability in the first nine months of 2024, driven by the strong performance of Galafold.

Q: What other products is Amicus Therapeutics launching?

A: Amicus Therapeutics is launching Pombiliti (cipaglucosidase alfa-atga) and Opfolda (miglustat) for the treatment of Pompe disease.

Sources

1. Amicus Therapeutics Announces Full-Year 2022 Financial Results - Amicus Therapeutics
2. Amicus Therapeutics Announces Third Quarter 2024 Financial Results - Amicus Therapeutics
3. Amicus Therapeutics Announces Second Quarter 2024 Financial Results - Stock Titan
4. Amicus Therapeutics Reports Preliminary 2023 Revenue and Provides 2024 Strategic Outlook - Amicus Therapeutics
5. Amicus Therapeutics Announces Second Quarter 2024 Financial Results and Corporate Updates - BioSpace