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Details for New Drug Application (NDA): 021560
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NDA 021560 describes ZORTRESS, which is a drug marketed by Novartis and is included in one NDA. It is available from one supplier. There is one patent protecting this drug and one Paragraph IV challenge. Additional details are available on the ZORTRESS profile page.
The generic ingredient in ZORTRESS is everolimus. There are twelve drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the everolimus profile page.
The generic ingredient in ZORTRESS is everolimus. There are twelve drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the everolimus profile page.
Summary for 021560
| Tradename: | ZORTRESS |
| Applicant: | Novartis |
| Ingredient: | everolimus |
| Patents: | 1 |
| Formulation / Manufacturing: | see details |
Pharmacology for NDA: 021560
| Mechanism of Action | Protein Kinase Inhibitors Cytochrome P450 3A4 Inhibitors P-Glycoprotein Inhibitors Cytochrome P450 2D6 Inhibitors mTOR Inhibitors |
| Physiological Effect | Decreased Immunologic Activity |
Medical Subject Heading (MeSH) Categories for 021560
Suppliers and Packaging for NDA: 021560
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ZORTRESS | everolimus | TABLET;ORAL | 021560 | NDA | Novartis Pharmaceuticals Corporation | 0078-0414 | 0078-0414-20 | 60 BLISTER PACK in 1 BOX (0078-0414-20) > 1 TABLET in 1 BLISTER PACK (0078-0414-61) |
| ZORTRESS | everolimus | TABLET;ORAL | 021560 | NDA | Novartis Pharmaceuticals Corporation | 0078-0415 | 0078-0415-20 | 60 BLISTER PACK in 1 BOX (0078-0415-20) > 1 TABLET in 1 BLISTER PACK (0078-0415-61) |
Paragraph IV (Patent) Challenges for 021560
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| ZORTRESS | TABLET;ORAL | everolimus | 021560 | 2013-09-30 |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 0.25MG | ||||
| Approval Date: | Apr 20, 2010 | TE: | AB | RLD: | Yes | ||||
| Patent: | Start Trial | Patent Expiration: | Mar 9, 2020 | Product Flag? | Substance Flag? | Delist Request? | Y | ||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 0.5MG | ||||
| Approval Date: | Apr 20, 2010 | TE: | AB | RLD: | Yes | ||||
| Patent: | Start Trial | Patent Expiration: | Mar 9, 2020 | Product Flag? | Substance Flag? | Delist Request? | Y | ||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 0.75MG | ||||
| Approval Date: | Apr 20, 2010 | TE: | AB | RLD: | Yes | ||||
| Patent: | Start Trial | Patent Expiration: | Mar 9, 2020 | Product Flag? | Substance Flag? | Delist Request? | Y | ||
Expired US Patents for NDA 021560
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Novartis | ZORTRESS | everolimus | TABLET;ORAL | 021560-002 | Apr 20, 2010 | Start Trial | Start Trial |
| Novartis | ZORTRESS | everolimus | TABLET;ORAL | 021560-001 | Apr 20, 2010 | Start Trial | Start Trial |
| Novartis | ZORTRESS | everolimus | TABLET;ORAL | 021560-001 | Apr 20, 2010 | Start Trial | Start Trial |
| Novartis | ZORTRESS | everolimus | TABLET;ORAL | 021560-003 | Apr 20, 2010 | Start Trial | Start Trial |
| Novartis | ZORTRESS | everolimus | TABLET;ORAL | 021560-002 | Apr 20, 2010 | Start Trial | Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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