Details for New Drug Application (NDA): 217171
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NDA 217171 describes SYFOVRE, 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 SYFOVRE profile page.
The generic ingredient in SYFOVRE is pegcetacoplan. One supplier is listed for this compound. Additional details are available on the pegcetacoplan profile page.
The generic ingredient in SYFOVRE is pegcetacoplan. One supplier is listed for this compound. Additional details are available on the pegcetacoplan profile page.
Summary for 217171
| Tradename: | SYFOVRE |
| Applicant: | Apellis Pharms |
| Ingredient: | pegcetacoplan |
| Patents: | 11 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 217171
Generic Entry Date for 217171*:
Constraining patent/regulatory exclusivity:
Dosage:
SOLUTION;INTRAVITREAL |
*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: 217171
| Mechanism of Action | Complement Inhibitors |
Suppliers and Packaging for NDA: 217171
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| SYFOVRE | pegcetacoplan | SOLUTION;INTRAVITREAL | 217171 | NDA | Apellis Pharmaceuticals, Inc. | 73606-020 | 73606-020-01 | 1 VIAL, GLASS in 1 CARTON (73606-020-01) / 3 mL in 1 VIAL, GLASS |
| SYFOVRE | pegcetacoplan | SOLUTION;INTRAVITREAL | 217171 | NDA | Apellis Pharmaceuticals, Inc. | 73606-020 | 73606-020-11 | 1 VIAL, GLASS in 1 CARTON (73606-020-11) / 3 mL in 1 VIAL, GLASS |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INTRAVITREAL | Strength | 15MG/0.1ML (15MG/0.1ML) | ||||
| Approval Date: | Feb 17, 2023 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | May 14, 2026 | ||||||||
| Regulatory Exclusivity Use: | NEW CHEMICAL ENTITY | ||||||||
| Regulatory Exclusivity Expiration: | Feb 22, 2026 | ||||||||
| Regulatory Exclusivity Use: | NEW PRODUCT | ||||||||
| Patent: | 10,035,822 | Patent Expiration: | Nov 15, 2033 | Product Flag? | Substance Flag? | Y | Delist Request? | ||
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