Details for New Drug Application (NDA): 215014

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 ten patents protecting this drug. Additional details are available on the EMPAVELI profile page.

The generic ingredient in EMPAVELI is pegcetacoplan. 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:	10

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for 215014

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:	May 14, 2028
Regulatory Exclusivity Use:	TREATMENT OF ADULT PATIENTS WITH PAROXYSMAL NOCTURNAL HEMOGLOBINURIA (PNH)

Complete Access Available with Subscription