Mechanism of Action: Glucosylceramide Synthase Inhibitors
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Drugs with Mechanism of Action: Glucosylceramide Synthase Inhibitors
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Actelion | ZAVESCA | miglustat | CAPSULE;ORAL | 021348-001 | Jul 31, 2003 | AB | RX | Yes | Yes | ⤷ Subscribe | ⤷ Subscribe | ⤷ Subscribe | |||
| Edenbridge Pharms | YARGESA | miglustat | CAPSULE;ORAL | 209821-001 | Aug 6, 2020 | AB | RX | No | No | ⤷ Subscribe | ⤷ Subscribe | ⤷ Subscribe | |||
| Amicus Therap Us | OPFOLDA | miglustat | CAPSULE;ORAL | 215211-001 | Sep 28, 2023 | RX | Yes | Yes | 10,857,212 | ⤷ Subscribe | ⤷ Subscribe | ||||
| Amicus Therap Us | OPFOLDA | miglustat | CAPSULE;ORAL | 215211-001 | Sep 28, 2023 | RX | Yes | Yes | 10,512,677 | ⤷ Subscribe | ⤷ Subscribe | ||||
| Amicus Therap Us | OPFOLDA | miglustat | CAPSULE;ORAL | 215211-001 | Sep 28, 2023 | RX | Yes | Yes | 10,208,299 | ⤷ Subscribe | Y | Y | ⤷ Subscribe | ||
| Amicus Therap Us | OPFOLDA | miglustat | CAPSULE;ORAL | 215211-001 | Sep 28, 2023 | RX | Yes | Yes | ⤷ Subscribe | ⤷ Subscribe | ⤷ Subscribe | ||||
| Amicus Therap Us | OPFOLDA | miglustat | CAPSULE;ORAL | 215211-001 | Sep 28, 2023 | RX | Yes | Yes | 11,753,632 | ⤷ Subscribe | ⤷ Subscribe | ||||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
