Details for New Drug Application (NDA): 215014
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NDA 215014 describes EMPAVELI, which is a drug marketed by Apellis Pharms and is included in one NDA. It is available from one supplier. There are eleven patents protecting this drug. Additional details are available on the EMPAVELI profile page.
The generic ingredient in EMPAVELI is pegcetacoplan. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the pegcetacoplan profile page.
The generic ingredient in EMPAVELI is pegcetacoplan. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the pegcetacoplan profile page.
Summary for 215014
| Tradename: | EMPAVELI |
| Applicant: | Apellis Pharms |
| Ingredient: | pegcetacoplan |
| Patents: | 11 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 215014
Generic Entry Date for 215014*:
Constraining patent/regulatory exclusivity:
Dosage:
SOLUTION;SUBCUTANEOUS |
*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: 215014
| Mechanism of Action | Complement Inhibitors |
Suppliers and Packaging for NDA: 215014
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| EMPAVELI | pegcetacoplan | SOLUTION;SUBCUTANEOUS | 215014 | NDA | Apellis Pharmaceuticals, Inc. | 73606-010 | 73606-010-01 | 1 VIAL in 1 CARTON (73606-010-01) / 20 mL in 1 VIAL |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;SUBCUTANEOUS | Strength | 1080MG/20ML (54MG/ML) | ||||
| Approval Date: | May 14, 2021 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Feb 8, 2026 | ||||||||
| Regulatory Exclusivity Use: | INFORMATION ADDED TO THE LABELING TO DESCRIBE THE RESULTS OF STUDY APL2-308 | ||||||||
| Regulatory Exclusivity Expiration: | May 14, 2026 | ||||||||
| Regulatory Exclusivity Use: | NEW CHEMICAL ENTITY | ||||||||
| Regulatory Exclusivity Expiration: | Jul 28, 2028 | ||||||||
| Regulatory Exclusivity Use: | TREATMENT OF ADULT AND PEDIATRIC PATIENTS AGED 12 YEARS AND OLDER WITH C3 GLOMERULOPATHY (C3G) OR PRIMARY IMMUNE-COMPLEX MEMBRANOPROLIFERATIVE GLOMERULONEPHRITIS (IC-MPGN) TO REDUCE PROTEINURIA | ||||||||
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