Is there a generic for Avacincaptad pegol sodium?

The FDA Orange Book does not currently list an approved generic (ANDA) for Avacincaptad pegol sodium. It is available as 1 brand (NDA) application.

What is the reference-listed drug for Avacincaptad pegol sodium?

IZERVAY (NDA 217225, ASTELLAS) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What patents protect Avacincaptad pegol sodium?

The Orange Book lists 6 patents against Avacincaptad pegol sodium products, with the earliest listed expiry in 2026. Listed patents cover the drug substance, drug product, or approved methods of use, and a generic launching before they expire must file a Paragraph IV certification.

What dosage forms of Avacincaptad pegol sodium are approved?

Avacincaptad pegol sodium is approved in the following dosage form: solution.

FDA Orange Book · active-ingredient family

Avacincaptad pegol sodium

Avacincaptad pegol sodium: 1 brand, 0 generics; first approved Aug 04, 2023; on patent until Nov 11, 2026.

On patent

Generic status & protection

Protected until Nov 11, 2026 (earliest listed patent expiry).

Earliest patent expiry Nov 11, 2026

Brands (NDA)

Generics (ANDA)

Listed patents

Next patent expiry

Nov 11, 2026

in 4 mo

Originator applications

Brand (NDA) products

IZERVAYRLDRS

ASTELLASNDA 2172252023

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 2MG BASE/0.1ML (EQ 2MG BASE/0.1ML)	SOLUTION	INTRAVITREAL	Rx	—

Protection horizon

Patent & exclusivity timeline

Patent expiryExclusivity endToday

Orange Book patent file

Listed patents

Listed patents (6)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
Patent	Expires	In	Type
8236773	Nov 11, 2026	in 4 mo	U-3673
9617546	Feb 14, 2027	in 7 mo	SubstanceU-3673
7579456	Feb 14, 2027	in 7 mo	Substance
11491176	Jul 11, 2034	in 8 yr 1 mo	U-3673
11273171	Jul 11, 2034	in 8 yr 1 mo	U-3673
12016875	Jul 11, 2034	in 8 yr 1 mo	U-3673

FDA approval span

Approval history

First approval

Aug 04, 2023

3 yr ago

Most recent approval

Aug 04, 2023

3 yr ago

All 1 application were approved in 2023.

Brand (NDA) 1100%

Generic (ANDA) 00%

Avacincaptad pegol sodium — frequently asked questions

Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.

Built directly from the FDA Orange Book data file (products, patents, and exclusivity). TE codes, RLD/RS flags, patent expirations, and exclusivity dates match the official FDA record. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.

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