Details for New Drug Application (NDA): 214487
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NDA 214487 describes TAVNEOS, which is a drug marketed by Chemocentryx and is included in one NDA. It is available from one supplier. There are four patents protecting this drug. Additional details are available on the TAVNEOS profile page.
The generic ingredient in TAVNEOS is avacopan. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the avacopan profile page.
The generic ingredient in TAVNEOS is avacopan. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the avacopan profile page.
Summary for 214487
| Tradename: | TAVNEOS |
| Applicant: | Chemocentryx |
| Ingredient: | avacopan |
| Patents: | 4 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 214487
Generic Entry Date for 214487*:
Constraining patent/regulatory exclusivity:
Dosage:
CAPSULE;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: 214487
| Mechanism of Action | Complement 5a Receptor Antagonists Cytochrome P450 3A4 Inhibitors |
Suppliers and Packaging for NDA: 214487
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| TAVNEOS | avacopan | CAPSULE;ORAL | 214487 | NDA | ChemoCentryx, Inc. | 73556-168 | 73556-168-01 | 1 BOTTLE, PLASTIC in 1 CARTON (73556-168-01) / 180 CAPSULE in 1 BOTTLE, PLASTIC |
| TAVNEOS | avacopan | CAPSULE;ORAL | 214487 | NDA | ChemoCentryx, Inc. | 73556-168 | 73556-168-02 | 1 BOTTLE, PLASTIC in 1 CARTON (73556-168-02) / 30 CAPSULE in 1 BOTTLE, PLASTIC |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 10MG | ||||
| Approval Date: | Oct 7, 2021 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Oct 7, 2028 | ||||||||
| Regulatory Exclusivity Use: | AS AN ADJUNCTIVE TREATMENT OF ADULT PATIENTS WITH SEVERE ACTIVE ANTI-NEUTROPHIL CYTOPLASMIC AUTOANTIBODY (ANCA)-ASSOCIATED VASCULITIS (GRANULOMATOSIS WITH POLYANGIITIS [GPA] AND MICROSCOPIC POLYANGIITIS [MPA]) | ||||||||
| Regulatory Exclusivity Expiration: | Oct 7, 2026 | ||||||||
| Regulatory Exclusivity Use: | NEW CHEMICAL ENTITY | ||||||||
| Patent: | 11,603,356 | Patent Expiration: | Nov 27, 2039 | Product Flag? | Y | Substance Flag? | Y | Delist Request? | |
| Patented Use: | AN ADJUNCTIVE TREATMENT OF ADULT PATIENTS WITH TAVNEOS (AVACOPAN) WITH SEVERE ACTIVE ANCA-ASSOCIATED VASCULITIS (GPA AND MPA) IN COMBINATION WITH STANDARD THERAPY INCLUDING GLUCOCORTICOIDS | ||||||||
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