DrugPatentWatch Database Preview
Details for New Drug Application (NDA): 205494
The generic ingredient in CERDELGA is eliglustat tartrate. There are six drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the eliglustat tartrate profile page.
Summary for 205494
Tradename: | CERDELGA |
Applicant: | Genzyme Corp |
Ingredient: | eliglustat tartrate |
Patents: | 3 |
Suppliers and Packaging for NDA: 205494
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
CERDELGA | eliglustat tartrate | CAPSULE;ORAL | 205494 | NDA | Genzyme Corporation | 58468-0220 | N | 58468-0220-2 |
CERDELGA | eliglustat tartrate | CAPSULE;ORAL | 205494 | NDA | Genzyme Corporation | 58468-0220 | N | 58468-0220-1 |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | EQ 84MG BASE | ||||
Approval Date: | Aug 19, 2014 | TE: | RLD: | Yes | |||||
Regulatory Exclusivity Expiration: | Aug 19, 2021 | ||||||||
Regulatory Exclusivity Use: | LONG-TERM TREATMENT OF ADULT PATIENTS WITH GAUCHER DISEASE TYPE 1 WHO ARE CYP2D6 EXTENSIVE METABOLIZERS (EMS), INTERMEDIATE METABOLIZERS (IMS), OR POOR METABOLIZERS (PMS) AS DETECTED BY AN FDA-CLEARED TEST. | ||||||||
Regulatory Exclusivity Expiration: | Aug 19, 2019 | ||||||||
Regulatory Exclusivity Use: | NEW CHEMICAL ENTITY | ||||||||
Patent: | ➤ Try a Free Trial | Patent Expiration: | Apr 29, 2022 | Product Flag? | Substance Flag? | Delist Request? | |||
Patented Use: | TREATMENT OF GAUCHER DISEASE TYPE 1 |
Complete Access Available with Subscription