Galafold is a drug owned by Amicus Therapeutics Us Llc. It is protected by 62 US drug patents filed from 2018 to 2024 out of which none have expired yet. Galafold's patents have been open to challenges since 10 August, 2022. Based on its patents and exclusivities, its generic launch date is estimated to be Jan 11, 2042. Details of Galafold's patents and their expiration are given in the table below.
| Drug Patent Number | Drug Patent Title | Drug Patent Expiry | Status |
|---|---|---|---|
| These drug patents protect the active ingredient(API) of the drug. Only drug patent owner can launch products that use this active ingredient until these patents expire. | |||
| US11622962 | Methods of treating Fabry patients having renal impairment |
Mar, 2039
(14 years from now) | Active |
| US11826360 | Methods of treating Fabry patients having renal impairment |
Feb, 2039
(14 years from now) | Active |
| US11903938 | Methods of treating Fabry patients having renal impairment |
Aug, 2038
(13 years from now) | Active |
| US12042489 | Methods of treating Fabry patients having renal impairment |
May, 2038
(13 years from now) | Active |
| US11633387 | Methods of treating Fabry patients having renal impairment |
May, 2038
(13 years from now) | Active |
| US12109205 | Methods of treating Fabry patients having renal impairment |
May, 2038
(13 years from now) | Active |
| US11426396 | Methods of treating Fabry patients having renal impairment |
May, 2038
(13 years from now) | Active |
| US11357765 | Methods of treating Fabry patients having renal impairment |
May, 2038
(13 years from now) | Active |
| US11304940 | Methods of treating Fabry patients having renal impairment |
May, 2038
(13 years from now) | Active |
| US11612594 | Methods of treating Fabry patients having renal impairment |
May, 2038
(13 years from now) | Active |
| US12042488 | Methods of treating Fabry patients having renal impairment |
May, 2038
(13 years from now) | Active |
| US11357764 | Methods of treating Fabry patients having renal impairment |
May, 2038
(13 years from now) | Active |
| US11376244 | Methods of treating Fabry patients having renal impairment |
May, 2038
(13 years from now) | Active |
| US11612593 | Methods of treating Fabry patients having renal impairment |
May, 2038
(13 years from now) | Active |
| US11786516 | Methods of treating Fabry patients having renal impairment |
May, 2038
(13 years from now) | Active |
| These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| US11833164 | Methods of treating Fabry disease in patients having a mutation in the GLA gene |
Jan, 2042
(17 years from now) | Active |
| US11633388 | Methods of treating Fabry patients having renal impairment |
Mar, 2039
(14 years from now) | Active |
| US11642334 | Methods of treating Fabry patients having renal impairment |
Feb, 2039
(14 years from now) | Active |
| US11357784 | Use of migalastat for treating Fabry disease in pregnant patients |
Feb, 2039
(14 years from now) | Active |
| US12042490 | Methods of treating Fabry patients having renal impairment |
May, 2038
(13 years from now) | Active |
| US11458128 | Methods of treating Fabry patients having renal impairment |
May, 2038
(13 years from now) | Active |
| US11666564 | Methods of treating Fabry patients having renal impairment |
May, 2038
(13 years from now) | Active |
| US10857141 | Methods of treating Fabry patients having renal impairment |
May, 2038
(13 years from now) | Active |
| US10849890 | Methods of treating Fabry patients having renal impairment |
May, 2038
(13 years from now) | Active |
| US10849889 | Methods of treating Fabry patients having renal impairment |
May, 2038
(13 years from now) | Active |
| US10857142 | Methods of treating Fabry patients having renal impairment |
May, 2038
(13 years from now) | Active |
| US10874657 | Methods of treating Fabry patients having renal impairment |
May, 2038
(13 years from now) | Active |
| US10874655 | Methods of treating fabry patients having renal impairment |
May, 2038
(13 years from now) | Active |
| US10874656 | Methods of treating Fabry patients having renal impairment |
May, 2038
(13 years from now) | Active |
| US11389437 | Methods of treating Fabry patients having renal impairment |
May, 2038
(13 years from now) | Active |
| US11389436 | Methods of treating fabry patients having renal impairment |
May, 2038
(13 years from now) | Active |
| US10792278 | Methods of treating Fabry patients having renal impairment |
May, 2038
(13 years from now) | Active |
| US10792279 | Methods of treating Fabry patients having renal impairment |
May, 2038
(13 years from now) | Active |
| US10799491 | Methods of treating Fabry patients having renal impairment |
May, 2038
(13 years from now) | Active |
| US10806727 | Methods of treating fabry patients having renal impairment |
May, 2038
(13 years from now) | Active |
| US11813255 | Methods of treating Fabry patients having renal impairment |
May, 2038
(13 years from now) | Active |
| US11278538 | Methods of treating Fabry patients having renal impairment |
May, 2038
(13 years from now) | Active |
| US11278537 | Methods of treating Fabry patients having renal impairment |
May, 2038
(13 years from now) | Active |
| US11278536 | Methods of treating Fabry patients having renal impairment |
May, 2038
(13 years from now) | Active |
| US11278539 | Methods of treating Fabry patients having renal impairment |
May, 2038
(13 years from now) | Active |
| US11278540 | Methods of treating Fabry patients having renal impairment |
May, 2038
(13 years from now) | Active |
| US11357763 | Methods of treating fabry patients having renal impairment |
May, 2038
(13 years from now) | Active |
| US11357762 | Methods of treating Fabry patients having renal impairment |
May, 2038
(13 years from now) | Active |
| US10471053 | Methods of treating Fabry patients having renal impairment |
May, 2038
(13 years from now) | Active |
| US11357761 | Methods of treating Fabry patients having renal impairment |
May, 2038
(13 years from now) | Active |
| US10251873 | Methods of treating fabry patients having renal impairment |
May, 2038
(13 years from now) | Active |
| US11234972 | Methods of treating fabry disease in patients having the G9331A mutation in the GLA gene |
Mar, 2037
(12 years from now) | Active |
| US10076514 | Methods of treating fabry disease in patients having the G9331A mutation in the GLA gene |
Mar, 2037
(12 years from now) | Active |
| USRE48608 | Method to predict response to pharmacological chaperone treatment of diseases |
Oct, 2031
(6 years from now) | Active |
| US9095584 | Method to predict response to pharmacological chaperone treatment of diseases |
Feb, 2029
(4 years from now) | Active |
| US10813921 | Method to predict response to pharmacological chaperone treatment of diseases |
Feb, 2029
(4 years from now) | Active |
| US8592362 | Method to predict response to pharmacological chaperone treatment of diseases |
Feb, 2029
(4 years from now) | Active |
| US10525045 | Dosing regimens for the treatment of lysosomal storage diseases using pharmacological chaperones |
Apr, 2028
(3 years from now) | Active |
| US10925866 | Dosing regimens for the treatment of lysosomal storage diseases using pharmacological chaperones |
Apr, 2028
(3 years from now) | Active |
| US11033538 | Dosing regimens for the treatment of lysosomal storage diseases using pharmacological chaperones |
Apr, 2028
(3 years from now) | Active |
| US9999618 | Dosing regimens for the treatment of lysosomal storage diseases using pharmacological chaperones |
Apr, 2028
(3 years from now) | Active |
| US9987263 | Methods for treatment of Fabry disease |
May, 2027
(2 years from now) | Active |
| US10406143 | Methods for treatment of fabry disease |
May, 2027
(2 years from now) | Active |
| US10383864 | Methods for treatment of Fabry disease |
May, 2027
(2 years from now) | Active |
| US11241422 | Methods for treatment of Fabry disease |
May, 2027
(2 years from now) | Active |
| US9000011 | Methods for treatment of Fabry disease |
May, 2027
(2 years from now) | Active |
| US9480682 | Methods for treatment of Fabry disease |
May, 2027
(2 years from now) | Active |
A patent's expiry date may change depending upon legal activities going on that patent. Critical activities like abandoning of a patent, term extension of a patent or amendment of its claims can increase or decrease the life of a patent hence affecting its expiry date and in turn affecting the generic launch date of that drug. Tracking these ongoing activities on a patent application helps to keep an eye on the latest developments in the patent process of the drug which can give an idea of how early a drug's generic could be available. The next section provides a list of recent legal activities on Galafold's patents.
Latest Legal Activities on Galafold's Patents
Given below is the list of recent legal activities going on the following patents of Galafold.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Entity Status Set To Undiscounted (Initial Default Setting or Status Change) | 17 Jun, 2024 | US10925866 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 12 Jun, 2024 | US10874657 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 12 Jun, 2024 | US10874655 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 12 Jun, 2024 | US10874656 |
| Entity Status Set To Undiscounted (Initial Default Setting or Status Change) | 05 Jun, 2024 | US10874655 |
| Entity Status Set To Undiscounted (Initial Default Setting or Status Change) | 05 Jun, 2024 | US10874656 |
| Entity Status Set To Undiscounted (Initial Default Setting or Status Change) | 05 Jun, 2024 | US10874657 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 22 May, 2024 | US10857141 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 22 May, 2024 | US10857142 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 15 May, 2024 | US10849890 |
FDA has granted several exclusivities to Galafold. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Galafold, regardless of the status of it's patents. These exclusivities hence play a crucial role in delaying the generic launch. Given below are details of the exclusivities granted to Galafold.
Exclusivity Information
Galafold holds 2 exclusivities out of which 1 have expired. Its last outstanding exclusivity is set to expire in 2025. Details of Galafold's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | Aug 10, 2023 |
| Orphan Drug Exclusivity(ODE-205) | Aug 10, 2025 |
Several oppositions have been filed on Galafold's European patents. EP oppositions can significantly impact the timeline for the generic launch of drugs. If an opposition results in the revocation or amendment of a patent, it can shorten the exclusivity period of the original drug. This can lead to an earlier entry of generic versions into the market. To help you estimate the potential early arrival of Galafold's generic, the next section provides detailed information on ongoing and past EP oppositions related to Galafold patents.
Galafold's Oppositions Filed in EPO
Galafold has faced multiple oppositions in the European Patent Office. The earliest opposition was filed on May 31, 2022, by Gill Jennings & Every Llp. This opposition was filed on patent number EP17714100A. Click below to reveal the latest opposition data.
| Application | Filing Date | Opposition Party | Legal Status |
|---|---|---|---|
 | |||
| EP17714100A | May, 2022 | Teva Pharmaceutical Industries Ltd | Granted and Under Opposition |
| EP17714100A | May, 2022 | Gill Jennings & Every LLP | Granted and Under Opposition |
US patents provide insights into the exclusivity only within the United States, but Galafold is protected by patents in multiple countries. Understanding the full scope of patent protection is crucial in strategizing market entry. By looking at the broader patent landscape, you can identify markets with weaker patent protection which could be ideal generic entry points. The following section offers details on Galafold's family patents as well as insights into ongoing legal events on those patents.
Galafold's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Galafold's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Jan 11, 2042 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Galafold Generics:
There are no approved generic versions for Galafold as of now.
How can I launch a generic of Galafold before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Galafold's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Galafold's sponsor is invalid, unenforceable, or will not be infringed by your generic product.
Given below are the details of the already filed Para IV certificates on Galafold -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 123 mg | 10 Aug, 2022 | 3 | 06 Feb, 2039 |
About Galafold
Galafold is a drug owned by Amicus Therapeutics Us Llc. It is used for managing left ventricular mass index in Fabry disease patients. Galafold uses Migalastat Hydrochloride as an active ingredient. Galafold was launched by Amicus Therap Us in 2018.
Can you believe Galafold received compensation for the extended wait time during the regulatory approval process?
A supplementary protection certificate (SPC) is a type of intellectual property right granted in the European Union. It provides an extension of the term of protection for a medicinal product that has been authorized for sale in the EU, beyond the 20-year term provided by the basic patent. The aim of SPCs is to compensate for the time taken to get regulatory approval for a new drug, and to provide an incentive for companies to invest in research and development in the field of medicinal products.
Approval Date:
Galafold was approved by FDA for market use on 10 August, 2018.
NCE-1 date:
NCE-1 date also known as the four year date occurs four years after the original drug approval and marks the first opportunity for a generic manufacturer to file an ANDA with a Paragraph IV certification. This is the earliest point when generic competition might begin, provided the challenge is successful. Since the approval date for Galafold is 10 August, 2018, its NCE-1 date is estimated to be 10 August, 2022.
Active Ingredient:
Galafold uses Migalastat Hydrochloride as the active ingredient. Check out other Drugs and Companies using Migalastat Hydrochloride ingredient
Treatment:
Galafold is used for managing left ventricular mass index in Fabry disease patients.
Dosage:
Galafold is available in capsule form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| EQ 123MG BASE | CAPSULE | Prescription | ORAL |