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Last Updated: December 23, 2024

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GALAFOLD Drug Patent Profile


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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 forty-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

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Summary for GALAFOLD
Drug patent expirations by year for GALAFOLD
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for GALAFOLD
Generic Entry 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:
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

SponsorPhase
Amicus TherapeuticsPhase 3
Amicus TherapeuticsPhase 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.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of GALAFOLD is ⤷  Subscribe.

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 ⤷  Subscribe ⤷  Subscribe
Amicus Therap Us GALAFOLD migalastat hydrochloride CAPSULE;ORAL 208623-001 Aug 10, 2018 RX Yes Yes 10,857,142 ⤷  Subscribe ⤷  Subscribe
Amicus Therap Us GALAFOLD migalastat hydrochloride CAPSULE;ORAL 208623-001 Aug 10, 2018 RX Yes Yes 11,278,536 ⤷  Subscribe ⤷  Subscribe
Amicus Therap Us GALAFOLD migalastat hydrochloride CAPSULE;ORAL 208623-001 Aug 10, 2018 RX Yes Yes 11,426,396 ⤷  Subscribe Y ⤷  Subscribe
Amicus Therap Us GALAFOLD migalastat hydrochloride CAPSULE;ORAL 208623-001 Aug 10, 2018 RX Yes Yes 11,241,422 ⤷  Subscribe ⤷  Subscribe
Amicus Therap Us GALAFOLD migalastat hydrochloride CAPSULE;ORAL 208623-001 Aug 10, 2018 RX Yes Yes 11,278,539 ⤷  Subscribe ⤷  Subscribe
Amicus Therap Us GALAFOLD migalastat hydrochloride CAPSULE;ORAL 208623-001 Aug 10, 2018 RX Yes Yes 11,357,764 ⤷  Subscribe Y ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

International Patents for GALAFOLD

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

Country Patent Number Title Estimated Expiration
Canada 3224546 ⤷  Subscribe
Hungary E065615 ⤷  Subscribe
Japan 2021097673 疾病の薬理シャペロン治療に対する応答性を予測する方法 (METHODS TO PREDICT RESPONSE TO PHARMACOLOGICAL CHAPERONE TREATMENT OF DISEASES) ⤷  Subscribe
Eurasian Patent Organization 201992869 ⤷  Subscribe
Taiwan 201919623 Methods of treating Fabry disease in patients having the G933LA mutation in the GLA gene ⤷  Subscribe
Japan 2022130589 ⤷  Subscribe
Hungary S1600048 ⤷  Subscribe
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for GALAFOLD

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2787345 C20160037 00206 Estonia ⤷  Subscribe PRODUCT NAME: MIGALASTAAT;REG NO/DATE: EU/1/15/1082 31.05.2016
2787345 53/2016 Austria ⤷  Subscribe PRODUCT NAME: MIGALASTAT ODER EIN SALZ DAVON, EINSCHLIESSLICH DES HYDROCHLORIDSALZES; REGISTRATION NO/DATE: EU/1/15/1082 (MITTEILUNG) 20160531
2787345 C 2016 042 Romania ⤷  Subscribe PRODUCT NAME: MIGALASTAT SAU O SARE A ACESTUIA, INCLUSIV SAREACLORHIDRAT; NATIONAL AUTHORISATION NUMBER: EU/1/15/1082; DATE OF NATIONAL AUTHORISATION: 20160526; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/15/1082; DATE OF FIRST AUTHORISATION IN EEA: 20160526
2787345 PA2016033 Lithuania ⤷  Subscribe PRODUCT NAME: MIGALASTATAS ARBA JO DRUSKA, ISKAITANT IR HIDROCHLORIDO DRUSKA; REGISTRATION NO/DATE: EU/1/15/1082 20160526
2787345 122016000090 Germany ⤷  Subscribe PRODUCT NAME: MIGALASTAT ODER EIN SALZ DAVON, EINSCHLIESSLICH DES HYDROCHLORIDSALZES; REGISTRATION NO/DATE: EU/1/15/1082/001 20160526
2787345 CR 2016 00055 Denmark ⤷  Subscribe PRODUCT NAME: MIGALASTAT ELLER ET SALT HERAF, HERUNDER HYDROGENKLORIDSALTET; REG. NO/DATE: EU/1/15/1082 20160531
2787345 268 5025-2016 Slovakia ⤷  Subscribe PRODUCT NAME: MIGALASTAT VO VSETKYCH FORMACH CHRANENYCH ZAKLADNYM PATENTOM; REGISTRATION NO/DATE: EU/1/15/1082 20160531
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

GALAFOLD Market Analysis and Financial Projection Experimental

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

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