Miglustat Patent Expiration
Miglustat was first introduced by Actelion Pharmaceuticals Us Inc
Miglustat Patents
Given below is the list of patents protecting Miglustat, along with the drug name that holds that patent and the company name owning that drug.
| Drug Used in | Drug Patent Number | Drug Patent Title | Drug Patent Expiry | Drug Owner |
|---|---|---|---|---|
| Opfolda | US12246062 | Recombinant human acid alpha-glucosidase | Sep 16, 2038 | Amicus Therap Us |
| Opfolda | US10857212 | Augmented acid alpha-glucosidase for the treatment of Pompe disease | Aug 12, 2037 | Amicus Therap Us |
| Opfolda | US11278601 | Augmented acid alpha-glucosidase for the treatment of Pompe disease | Dec 29, 2036 | Amicus Therap Us |
| Opfolda | US10208299 | Highly potent acid alpha-glucosidase with enhanced carbohydrates | Sep 30, 2035 | Amicus Therap Us |
| Opfolda | US10961522 | Highly potent acid alpha-glucosidase with enhanced carbohydrates | Sep 30, 2035 | Amicus Therap Us |
| Opfolda | US11753632 | Highly potent acid alpha-glucosidase with enhanced carbohydrates | Sep 30, 2035 | Amicus Therap Us |
| Opfolda | US10512677 | High concentration alpha-glucosidase compositions for the treatment of pompe disease | Mar 07, 2033 | Amicus Therap Us |
| Opfolda | US11278599 | High concentration alpha-glucosidase compositions for the treatment of Pompe disease | Mar 07, 2033 | Amicus Therap Us |
| Zavesca | US5525616 | Method of inhibiting glycolipid synthesis |
Jun 11, 2013
(Expired) | Actelion |
| Zavesca | US5472969 | Method of inhibiting glycolipid synthesis |
May 13, 2013
(Expired) | Actelion |
Miglustat's Family Patents
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Miglustat Generic API Manufacturers
Several generic applications have been filed for Miglustat. The first generic version for Miglustat was by Ani Pharmaceuticals Inc and was approved on Apr 17, 2018. And the latest generic version is by Navinta Llc and was approved on Mar 14, 2025.
Given below is the list of companies who have filed for Miglustat generic, along with the locations of their manufacturing plants worldwide.
1. ANI PHARMS
Ani Pharmaceuticals Inc has filed for 1 generic for Miglustat. Given below are the details of the strengths of this generic introduced by Ani Pharms.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 100MG | capsule | Prescription | ORAL | AB | Apr 17, 2018 |
2. CHARTWELL RX
Chartwell Rx Sciences Llc has filed for 1 generic for Miglustat. Given below are the details of the strengths of this generic introduced by Chartwell Rx.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 100MG | capsule | Discontinued | ORAL | N/A | Feb 3, 2022 |
3. EDENBRIDGE PHARMS
Edenbridge Pharmaceuticals Llc has filed for 1 generic for Miglustat. This 100mg version comes by the name YARGESA. Given below are the details of the strengths of this generic introduced by Edenbridge Pharms.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 100MG | capsule | Prescription | ORAL | AB | Aug 6, 2020 |
4. NAVINTA LLC
Navinta Llc has filed for 1 generic for Miglustat. Given below are the details of the strengths of this generic introduced by Navinta Llc.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 100MG | capsule | Prescription | ORAL | AB | Mar 14, 2025 |