Miglustat Patent Expiration

Miglustat was first introduced by Actelion Pharmaceuticals Us Inc in its drug Zavesca on Jul 31, 2003. Another drug containing Miglustat is Opfolda. 5 different companies have introduced drugs containing Miglustat.


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 US10208299 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 US10857212 Augmented acid alpha-glucosidase for the treatment of Pompe disease Aug 12, 2037 Amicus Therap Us
Opfolda US10961522 Highly potent acid alpha-glucosidase with enhanced carbohydrates Sep 30, 2035 Amicus Therap Us
Opfolda US11278599 High concentration alpha-glucosidase compositions for the treatment of Pompe disease Mar 07, 2033 Amicus Therap Us
Opfolda US11278601 Augmented acid alpha-glucosidase for the treatment of Pompe disease Dec 29, 2036 Amicus Therap Us
Opfolda US11753632 Highly potent acid alpha-glucosidase with enhanced carbohydrates Sep 30, 2035 Amicus Therap Us
Zavesca US5472969 Method of inhibiting glycolipid synthesis May 13, 2013

(Expired)

Actelion
Zavesca US5525616 Method of inhibiting glycolipid synthesis Jun 11, 2013

(Expired)

Actelion



Miglustat Generics

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 Breckenridge Pharmaceutical Inc and was approved on Feb 3, 2022.

Given below is the list of companies who have filed for Miglustat generic.


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. BRECKENRIDGE

Breckenridge Pharmaceutical Inc has filed for 1 generic for Miglustat. Given below are the details of the strengths of this generic introduced by Breckenridge.

Strength Dosage Form Availability Application Pathway TE code Launch Date
100MG capsule Prescription ORAL AB 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