Details for New Drug Application (NDA): 213716
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NDA 213716 describes LUPKYNIS, which is a drug marketed by Aurinia and is included in one NDA. It is available from one supplier. There are three patents protecting this drug. Additional details are available on the LUPKYNIS profile page.
The generic ingredient in LUPKYNIS is voclosporin. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the voclosporin profile page.
The generic ingredient in LUPKYNIS is voclosporin. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the voclosporin profile page.
Summary for 213716
| Tradename: | LUPKYNIS |
| Applicant: | Aurinia |
| Ingredient: | voclosporin |
| Patents: | 3 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 213716
Generic Entry Date for 213716*:
Constraining patent/regulatory exclusivity:
NEW CHEMICAL ENTITY 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: 213716
Suppliers and Packaging for NDA: 213716
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| LUPKYNIS | voclosporin | CAPSULE;ORAL | 213716 | NDA | Aurinia Pharma U.S., Inc. | 75626-001 | 75626-001-02 | 3 PACKET in 1 CARTON (75626-001-02) / 4 BLISTER PACK in 1 PACKET (75626-001-01) / 15 CAPSULE in 1 BLISTER PACK |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 7.9MG | ||||
| Approval Date: | Jan 22, 2021 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Jan 22, 2026 | ||||||||
| Regulatory Exclusivity Use: | NEW CHEMICAL ENTITY | ||||||||
| Patent: | 10,286,036 | Patent Expiration: | Dec 7, 2037 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | TREATMENT OF PATIENTS WITH ACTIVE LUPUS NEPHRITIS | ||||||||
| Patent: | 11,622,991 | Patent Expiration: | Dec 7, 2037 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | TREATMENT OF PATIENTS WITH ACTIVE LUPUS NEPHRITIS | ||||||||
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