Details for New Drug Application (NDA): 022334
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NDA 022334 describes AFINITOR, which is a drug marketed by Novartis and Novartis Pharm and is included in two NDAs. It is available from one supplier. There are three patents protecting this drug and three Paragraph IV challenges. Additional details are available on the AFINITOR profile page.
The generic ingredient in AFINITOR is everolimus. There are twelve drug master file entries for this compound. Nine suppliers are listed for this compound. Additional details are available on the everolimus profile page.
The generic ingredient in AFINITOR is everolimus. There are twelve drug master file entries for this compound. Nine suppliers are listed for this compound. Additional details are available on the everolimus profile page.
Summary for 022334
| Tradename: | AFINITOR |
| Applicant: | Novartis |
| Ingredient: | everolimus |
| Patents: | 2 |
| Formulation / Manufacturing: | see details |
Pharmacology for NDA: 022334
| Mechanism of Action | Cytochrome P450 2D6 Inhibitors Cytochrome P450 3A4 Inhibitors Protein Kinase Inhibitors mTOR Inhibitors |
| Physiological Effect | Decreased Immunologic Activity |
Medical Subject Heading (MeSH) Categories for 022334
Suppliers and Packaging for NDA: 022334
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| AFINITOR | everolimus | TABLET;ORAL | 022334 | NDA | Novartis Pharmaceuticals Corporation | 0078-0566 | 0078-0566-51 | 28 BLISTER PACK in 1 CARTON (0078-0566-51) / 1 TABLET in 1 BLISTER PACK (0078-0566-61) |
| AFINITOR | everolimus | TABLET;ORAL | 022334 | NDA | Novartis Pharmaceuticals Corporation | 0078-0567 | 0078-0567-51 | 28 BLISTER PACK in 1 CARTON (0078-0567-51) / 1 TABLET in 1 BLISTER PACK (0078-0567-61) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 5MG | ||||
| Approval Date: | Mar 30, 2009 | TE: | AB | RLD: | Yes | ||||
| Regulatory Exclusivity Expiration: | Feb 26, 2023 | ||||||||
| Regulatory Exclusivity Use: | TREATMENT OF ADULT PATIENTS WITH PROGRESSIVE, WELL-DIFFERENTIATED, NON-FUNCTIONAL, NEUROENDOCRINE TUMORS (NET) OF GASTROINTESTINAL (GI) OR LUNG ORIGIN, (EXCLUDING PANCREATIC) WITH UNRESECTABLE, LOCALLY ADVANCED OR METASTATIC DISEASE | ||||||||
| Patent: | ⤷ Try a Trial | Patent Expiration: | May 1, 2026 | Product Flag? | Substance Flag? | Delist Request? | Y | ||
| Patent: | ⤷ Try a Trial | Patent Expiration: | Jul 1, 2028 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | TREATMENT OF PATIENTS WITH PROGRESSIVE NEUROENDOCRINE TUMORS OF PANCREATIC ORIGIN (PNET) THAT ARE UNRESECTABLE, LOCALLY ADVANCED OR METASTATIC | ||||||||
Expired US Patents for NDA 022334
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Novartis | AFINITOR | everolimus | TABLET;ORAL | 022334-004 | Mar 30, 2012 | ⤷ Try a Trial | ⤷ Try a Trial |
| Novartis | AFINITOR | everolimus | TABLET;ORAL | 022334-002 | Mar 30, 2009 | ⤷ Try a Trial | ⤷ Try a Trial |
| Novartis | AFINITOR | everolimus | TABLET;ORAL | 022334-003 | Jul 9, 2010 | ⤷ Try a Trial | ⤷ Try a Trial |
| Novartis | AFINITOR | everolimus | TABLET;ORAL | 022334-004 | Mar 30, 2012 | ⤷ Try a Trial | ⤷ Try a Trial |
| Novartis | AFINITOR | everolimus | TABLET;ORAL | 022334-004 | Mar 30, 2012 | ⤷ Try a Trial | ⤷ Try a Trial |
| Novartis | AFINITOR | everolimus | TABLET;ORAL | 022334-001 | Mar 30, 2009 | ⤷ Try a Trial | ⤷ Try a Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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