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 |
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 |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | EQ 84MG BASE | ||||
| Approval Date: | Aug 19, 2014 | TE: | AB | RLD: | Yes | ||||
| Patent: | ⤷ Get Started Free | Patent Expiration: | Dec 13, 2038 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | LONG-TERM TREATMENT OF ADULTS WITH GAUCHER DISEASE TYPE 1 WHO ARE CYP2D6 EXTENSIVE METABOLIZERS WITH MILD HEPATIC IMPAIRMENT AND ARE CONCURRENTLY TAKING A STRONG OR MODERATE CYP3A INHIBITOR | ||||||||
| Patent: | ⤷ Get Started Free | Patent Expiration: | Dec 13, 2038 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | LONG-TERM TREATMENT OF ADULTS WITH GAUCHER DISEASE TYPE 1 WHO ARE CYP2D6 EXTENSIVE METABOLIZERS WITH MODERATE TO SEVERE RENAL IMPAIRMENT | ||||||||
| Patent: | ⤷ Get Started Free | Patent Expiration: | Jan 31, 2031 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | LONG-TERM TREATMENT OF ADULTS WITH GAUCHER DISEASE TYPE 1 WHO ARE CYP2D6 EXTENSIVE OR INTERMEDIATE METABOLIZERS WITH 84 MG TWICE PER DAY OF ELIGLUSTAT (EQUIVALENT TO 100 MG OF ELIGLUSTAT TARTRATE TWICE PER DAY) | ||||||||
Expired US Patents for NDA 205494
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Genzyme Corp | CERDELGA | eliglustat tartrate | CAPSULE;ORAL | 205494-001 | Aug 19, 2014 | ⤷ Get Started Free | ⤷ Get Started Free |
| Genzyme Corp | CERDELGA | eliglustat tartrate | CAPSULE;ORAL | 205494-001 | Aug 19, 2014 | ⤷ Get Started Free | ⤷ Get Started Free |
| Genzyme Corp | CERDELGA | eliglustat tartrate | CAPSULE;ORAL | 205494-001 | Aug 19, 2014 | ⤷ Get Started Free | ⤷ Get Started Free |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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