Details for New Drug Application (NDA): 022405
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NDA 022405 describes CAPRELSA, which is a drug marketed by Genzyme Corp and is included in one NDA. It is available from one supplier. There is one patent protecting this drug. Additional details are available on the CAPRELSA profile page.
The generic ingredient in CAPRELSA is vandetanib. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the vandetanib profile page.
The generic ingredient in CAPRELSA is vandetanib. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the vandetanib profile page.
Summary for 022405
| Tradename: | CAPRELSA |
| Applicant: | Genzyme Corp |
| Ingredient: | vandetanib |
| Patents: | 1 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 022405
Generic Entry Date for 022405*:
Constraining patent/regulatory exclusivity:
Dosage:
TABLET;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: 022405
Suppliers and Packaging for NDA: 022405
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| CAPRELSA | vandetanib | TABLET;ORAL | 022405 | NDA | Genzyme Corporation | 58468-7820 | 58468-7820-3 | 1 BOTTLE, PLASTIC in 1 CARTON (58468-7820-3) / 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC |
| CAPRELSA | vandetanib | TABLET;ORAL | 022405 | NDA | Genzyme Corporation | 58468-7840 | 58468-7840-3 | 1 BOTTLE, PLASTIC in 1 CARTON (58468-7840-3) / 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 100MG | ||||
| Approval Date: | Apr 6, 2011 | TE: | RLD: | Yes | |||||
| Patent: | ⤷ Start Trial | Patent Expiration: | Aug 8, 2028 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 300MG | ||||
| Approval Date: | Apr 6, 2011 | TE: | RLD: | Yes | |||||
| Patent: | ⤷ Start Trial | Patent Expiration: | Aug 8, 2028 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
Expired US Patents for NDA 022405
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Genzyme Corp | CAPRELSA | vandetanib | TABLET;ORAL | 022405-002 | Apr 6, 2011 | ⤷ Start Trial | ⤷ Start Trial |
| Genzyme Corp | CAPRELSA | vandetanib | TABLET;ORAL | 022405-001 | Apr 6, 2011 | ⤷ Start Trial | ⤷ Start Trial |
| Genzyme Corp | CAPRELSA | vandetanib | TABLET;ORAL | 022405-001 | Apr 6, 2011 | ⤷ Start Trial | ⤷ Start Trial |
| Genzyme Corp | CAPRELSA | vandetanib | TABLET;ORAL | 022405-001 | Apr 6, 2011 | ⤷ Start Trial | ⤷ Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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