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Details for New Drug Application (NDA): 021560
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The generic ingredient in ZORTRESS is everolimus. There are twelve drug master file entries for this compound. One supplier is 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 | 021560-003 | 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 | 021560-002 | Apr 20, 2010 | Start Trial | Start Trial |
Novartis | ZORTRESS | everolimus | TABLET;ORAL | 021560-003 | Apr 20, 2010 | Start Trial | Start Trial |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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