Details for New Drug Application (NDA): 217225
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NDA 217225 describes IZERVAY, which is a drug marketed by Astellas and is included in one NDA. It is available from one supplier. There are nine patents protecting this drug. Additional details are available on the IZERVAY profile page.
The generic ingredient in IZERVAY is avacincaptad pegol sodium. One supplier is listed for this compound. Additional details are available on the avacincaptad pegol sodium profile page.
The generic ingredient in IZERVAY is avacincaptad pegol sodium. One supplier is listed for this compound. Additional details are available on the avacincaptad pegol sodium profile page.
Summary for 217225
| Tradename: | IZERVAY |
| Applicant: | Astellas |
| Ingredient: | avacincaptad pegol sodium |
| Patents: | 9 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 217225
Generic Entry Date for 217225*:
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: 217225
| Mechanism of Action | Complement Inhibitors |
Suppliers and Packaging for NDA: 217225
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| IZERVAY | avacincaptad pegol sodium | SOLUTION;INTRAVITREAL | 217225 | NDA | Astellas Pharma US, Inc. | 82829-002 | 82829-002-01 | 1 VIAL, SINGLE-DOSE in 1 CARTON (82829-002-01) / .35 mL in 1 VIAL, SINGLE-DOSE |
| IZERVAY | avacincaptad pegol sodium | SOLUTION;INTRAVITREAL | 217225 | NDA | Astellas Pharma US, Inc. | 82829-002 | 82829-002-99 | 1 VIAL, SINGLE-DOSE in 1 CARTON (82829-002-99) / .35 mL in 1 VIAL, SINGLE-DOSE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INTRAVITREAL | Strength | EQ 2MG BASE/0.1ML (EQ 2MG BASE/0.1ML) | ||||
| Approval Date: | Aug 4, 2023 | TE: | RLD: | Yes | |||||
| Patent: | 10,947,544 | Patent Expiration: | Feb 14, 2025 | Product Flag? | Substance Flag? | Y | Delist Request? | ||
| Patented Use: | TREATMENT OF GEOGRAPHIC ATROPHY SECONDARY TO AGE-RELATED MACULAR DEGENERATION BY ADMINISTERTING AVACINCAPTAD PEGOL TO THE EYE | ||||||||
| Patent: | 11,273,171 | Patent Expiration: | Jul 11, 2034 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | TREATMENT OF GEOGRAPHIC ATROPHY SECONDARY TO AGE-RELATED MACULAR DEGENERATION BY ADMINISTERTING AVACINCAPTAD PEGOL TO THE EYE | ||||||||
| Patent: | 11,491,176 | Patent Expiration: | Jul 11, 2034 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | TREATMENT OF GEOGRAPHIC ATROPHY SECONDARY TO AGE-RELATED MACULAR DEGENERATION BY ADMINISTERTING AVACINCAPTAD PEGOL TO THE EYE | ||||||||
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