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Details for New Drug Application (NDA): 205494
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NDA 205494 describes CERDELGA, which is a drug marketed by Genzyme Corp and is included in one NDA. It is available from one supplier. There are four patents protecting this drug and one Paragraph IV challenge. Additional details are available on the CERDELGA profile page.
The generic ingredient in CERDELGA is eliglustat tartrate. There are eight drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the eliglustat tartrate profile page.
The generic ingredient in CERDELGA is eliglustat tartrate. There are eight 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: | 4 |
Generic Entry Opportunity Date for 205494
Generic Entry Date for 205494*:
Constraining patent/regulatory exclusivity:
Dosage:
CAPSULE;ORAL |
*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.
Pharmacology for NDA: 205494
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 | 58468-0220-1 | 4 BLISTER PACK in 1 CARTON (58468-0220-1) > 14 CAPSULE in 1 BLISTER PACK |
| CERDELGA | eliglustat tartrate | CAPSULE;ORAL | 205494 | NDA | Genzyme Corporation | 58468-0220 | 58468-0220-2 | 1 BLISTER PACK in 1 CARTON (58468-0220-2) > 14 CAPSULE in 1 BLISTER PACK |
Paragraph IV (Patent) Challenges for 205494
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| CERDELGA | CAPSULE;ORAL | eliglustat tartrate | 205494 | 2018-08-20 |
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: | Start Trial | Patent Expiration: | Apr 29, 2022 | Product Flag? | Substance Flag? | Y | Delist Request? | ||
| Patented Use: | TREATMENT OF GAUCHER DISEASE TYPE 1 | ||||||||
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