What is Enzeevu in the FDA Purple Book?

Enzeevu, BLA 761382, is listed as a 351(k) biosimilar with 2 exact FDA presentation rows. The page preserves the BLA-level regulatory role and does not substitute clinical, inventory, or legal conclusions for the source record.

Who is responsible for BLA 761382?

Enzeevu, BLA 761382, lists Sandoz Inc. as the BLA applicant. The applicant field identifies responsibility for the application; it does not, by itself, prove that the organization physically manufactures, labels, distributes, or currently sells every presentation.

What presentations are listed for Enzeevu?

Enzeevu, BLA 761382, has 2 exact FDA presentation rows consolidated on this page. Strength, dosage form, route, product number, licensure, and marketing fields remain attached to their own row rather than being merged into disconnected lists.

What is Enzeevu's reference-product relationship?

Enzeevu, BLA 761382, lists Eylea as its FDA reference product. The loaded row does not supply a reference BLA number, so this page does not invent one from a name match.

Is Enzeevu interchangeable?

Enzeevu, BLA 761382, is a biosimilar without an interchangeability designation in the loaded Purple Book record. Biosimilar status alone does not establish automatic pharmacy substitution, and this page does not infer interchangeability from shared names, strengths, or routes.

When was Enzeevu licensed by FDA?

Enzeevu, BLA 761382, has a listed FDA approval date of Aug 09, 2024. The date is reproduced from this exact Purple Book BLA record and is not a statement about commercial launch or current availability.

Does this page summarize Enzeevu's FDA label?

Enzeevu, BLA 761382, No exact-BLA label candidate is stored for this record. Approved uses, dosing, and warnings are intentionally unavailable and queued for exact-source research. Therefore the page does not publish product-specific approved uses, dosing, boxed warnings, or safety claims from a reference product or same-ingredient document.

What patent information is published for Enzeevu?

Enzeevu, BLA 761382, has 88 published Purple Book patent rows, with the latest listed expiration on May 10, 2042. FDA publishes sponsor-provided patent information ministerially; these rows are not conclusions about validity, infringement, freedom to operate, or market entry.

What exclusivity information is listed for Enzeevu?

Enzeevu, BLA 761382, has no populated exclusivity date in the loaded Purple Book row. Missing database fields do not prove that no regulatory or legal constraints exist, and this page does not calculate a market-entry date.

FDA Purple Book product · Biosimilar 351(k)

Enzeevu

aflibercept-abzv

Enzeevu, BLA 761382, is listed in the FDA Purple Book as a 351(k) biosimilar. This page consolidates 2 exact FDA presentation rows, and FDA names Eylea as its reference product. It separates the BLA applicant from any unverified manufacturer and does not infer clinical labeling, pharmacy substitution, commercial availability, or patent conclusions.

351(k) BiosimilarBLA 761382 2 presentationsRxLicensed Sandoz Inc.

Approved

Aug 09, 2024

License type

351(k) Biosimilar

Marketing

Listed patents

Enzeevu (aflibercept-abzv) is a Biosimilar 351(k) referencing aflibercept, licensed under a 351(k) BLA in 2024; the Purple Book lists Sandoz Inc. as the BLA applicant, not necessarily the manufacturer or commercial supplier. The Purple Book lists 88 published patents for this product.

Sourced from the FDA Purple Book · verified Aug 11, 2026

What this Purple Book record establishes

Regulatory interpretation

BLA number

761382

Regulatory role

351(k) biosimilar

Applicant

Sandoz Inc.

Applicant is not automatically the physical manufacturer.

Presentations

Exact FDA presentation rows under this BLA.

Approval

Aug 09, 2024

Reference product

Eylea

Enzeevu is an FDA-licensed biosimilar without an interchangeability designation in this record.

Enzeevu was licensed through the 351(k) pathway as biosimilar to Eylea.

Substitution boundary

Biosimilar status alone is not an FDA interchangeability designation and does not establish automatic pharmacy substitution.

Key dates

Licensure & exclusivity

Approval
Approval date of this BLA submission.
Aug 09, 2024
2 yr 2 mo ago
Today

Strengths & presentations

2 FDA presentation rows · BLA 761382

Strength

2MG/0.05ML

Dosage form

Injection

Route

Intravitreal

Presentation

Single-Dose Vial

Center

CDER

License number

2003

Product number

001

Submission type

Original

Supplement number

Not listed

Change type

Not listed

Exact presentation matrix

One row per FDA presentation under this exact BLA. Missing cells remain unavailable rather than being borrowed from another product.

Exact FDA Purple Book presentation rows for this BLA
Product	Strength	Dosage form	Route	Presentation	Licensure	Marketing
001	2MG/0.05ML	Injection	Intravitreal	Single-Dose Vial	Licensed	Rx
002	2MG/0.05ML	Injection	Intravitreal	Pre-Filled Syringe	Licensed	Rx

Exact-source evidence coverage

Labeling & approval review

Current product label

Exact-source research required

No exact-BLA label candidate is stored for this record. Approved uses, dosing, and warnings are intentionally unavailable and queued for exact-source research.

FDA approval evidence

Exact-source research required

No independently matched exact-BLA FDA approval letter or review package is stored, so product-specific biosimilarity or switching evidence is not summarized.

Human review pending

Automated BLA-level interpretation has not been marked human-reviewed. The research queue contains 2 exact-source tasks. Labeling and approval-review claims stay unavailable until their own match gate passes.

Reference product family

Biosimilars & interchangeables

View full family

Enzeevu names Eylea as its reference product. The comparison below shows locally matched BLA candidates and follow-ons; it does not invent a reference BLA number when FDA did not state one in the loaded row.

Biosimilar of Eylea

Reference-family comparison

Purple Book comparison of products in this reference family
Product	Designation	BLA	Approved	Presentation	Marketing
Eyleaaflibercept	351(a) ambiguous reference candidate	125387	Nov 18, 2011	2MG/0.05ML · Intravitreal	Rx
Eylea HDaflibercept	351(a) ambiguous reference candidate	761355	Aug 18, 2023	8MG/0.07ML · Intravitreal	Rx
Enzeevuaflibercept-abzv	351(k) biosimilar	761382	Aug 09, 2024	2MG/0.05ML · Intravitreal	Rx

Published patents

BPCIA patent list

Patents published in the FDA Purple Book Patent List for this product, with expiration date and source link.
Patent	Expires	In	Source
10,857,231	Mar 14, 2022	4 yr 7 mo ago	FDA
7,070,959	Jun 16, 2023	3 yr 4 mo ago	FDA
10,406,226	Mar 22, 2026	6 mo ago	FDA
10,464,992	Jun 14, 2027	in 9 mo	FDA
11,066,458	Jun 14, 2027	in 9 mo	FDA
11,084,865	Jun 14, 2027	in 9 mo	FDA
11,732,024	Jun 14, 2027	in 9 mo	FDA
10,415,055	Jun 04, 2028	in 1 yr 9 mo	FDA
9,562,238	Jun 04, 2028	in 1 yr 9 mo	FDA
9,932,605	Jun 04, 2028	in 1 yr 9 mo	FDA
7,771,997	Jul 02, 2028	in 1 yr 10 mo	FDA
9,222,106	Jul 02, 2028	in 1 yr 10 mo	FDA
10,130,681	Jan 11, 2032	in 5 yr 5 mo	FDA
10,828,345	Jan 11, 2032	in 5 yr 5 mo	FDA
10,857,205	Jan 11, 2032	in 5 yr 5 mo	FDA
10,888,601	Jan 11, 2032	in 5 yr 5 mo	FDA
11,253,572	Jan 11, 2032	in 5 yr 5 mo	FDA
11,559,564	Jan 11, 2032	in 5 yr 5 mo	FDA
11,707,506	Jan 11, 2032	in 5 yr 5 mo	FDA
11,975,045	Jan 11, 2032	in 5 yr 5 mo	FDA
11,986,511	Jan 11, 2032	in 5 yr 5 mo	FDA
12,268,730	Jan 11, 2032	in 5 yr 5 mo	FDA
9,669,069	Jan 11, 2032	in 5 yr 5 mo	FDA
9,254,338	May 22, 2032	in 5 yr 9 mo	FDA
11,332,771	Mar 14, 2034	in 7 yr 7 mo	FDA
11,970,724	Mar 14, 2034	in 7 yr 7 mo	FDA
D858,754	Sep 03, 2034	in 8 yr 1 mo	FDA
9,315,281	Sep 16, 2034	in 8 yr 1 mo	FDA
11,268,109	Oct 21, 2035	in 9 yr 3 mo	FDA
11,788,102	Oct 21, 2035	in 9 yr 3 mo	FDA
9,816,110	Oct 21, 2035	in 9 yr 3 mo	FDA
D906,102	Dec 29, 2035	in 9 yr 5 mo	FDA
10,927,342	Aug 03, 2036	in 10 yr	FDA
11,312,936	Aug 03, 2036	in 10 yr	FDA
12,221,619	Aug 03, 2036	in 10 yr	FDA
D934,069	Oct 26, 2036	in 10 yr 3 mo	FDA
11,549,154	Dec 25, 2036	in 10 yr 5 mo	FDA
10,669,594	Feb 12, 2037	in 10 yr 7 mo	FDA
11,918,785	Jun 29, 2037	in 10 yr 11 mo	FDA
10,182,969	Jul 13, 2037	in 11 yr	FDA
D961,376	Aug 23, 2037	in 11 yr 1 mo	FDA
D961,377	Aug 23, 2037	in 11 yr 1 mo	FDA
11,577,025	Oct 06, 2037	in 11 yr 3 mo	FDA
11,680,930	Oct 25, 2037	in 11 yr 3 mo	FDA
10,905,786	Mar 06, 2038	in 11 yr 8 mo	FDA
10,918,754	Mar 06, 2038	in 11 yr 8 mo	FDA
12,116,622	May 25, 2038	in 11 yr 10 mo	FDA
11,769,597	Aug 15, 2038	in 12 yr 1 mo	FDA
11,433,186	Dec 12, 2038	in 12 yr 5 mo	FDA
12,168,036	May 10, 2039	in 12 yr 10 mo	FDA
11,103,552	May 15, 2039	in 12 yr 10 mo	FDA
10,973,879	May 17, 2039	in 12 yr 10 mo	FDA
12,280,093	May 17, 2039	in 12 yr 10 mo	FDA
D1,035,436	Jul 16, 2039	in 13 yr	FDA
D1,042,107	Sep 17, 2039	in 13 yr 2 mo	FDA
11,850,407	Sep 18, 2039	in 13 yr 2 mo	FDA
D1,047,700	Oct 22, 2039	in 13 yr 4 mo	FDA
10,961,500	Jan 27, 2040	in 13 yr 7 mo	FDA
11,286,460	Jan 27, 2040	in 13 yr 7 mo	FDA
11,555,176	Jan 27, 2040	in 13 yr 7 mo	FDA
11,821,001	Jan 27, 2040	in 13 yr 7 mo	FDA
11,439,758	Jun 04, 2040	in 13 yr 11 mo	FDA
11,478,588	Jul 25, 2040	in 14 yr 1 mo	FDA
11,160,918	Jul 29, 2040	in 14 yr 1 mo	FDA
11,793,926	Jul 29, 2040	in 14 yr 1 mo	FDA
11,053,280	Aug 18, 2040	in 14 yr 2 mo	FDA
11,104,715	Aug 18, 2040	in 14 yr 2 mo	FDA
11,174,283	Aug 18, 2040	in 14 yr 2 mo	FDA
11,186,625	Aug 18, 2040	in 14 yr 2 mo	FDA
11,299,532	Aug 18, 2040	in 14 yr 2 mo	FDA
11,306,135	Aug 18, 2040	in 14 yr 2 mo	FDA
11,459,373	Aug 18, 2040	in 14 yr 2 mo	FDA
11,459,374	Aug 18, 2040	in 14 yr 2 mo	FDA
11,472,861	Aug 18, 2040	in 14 yr 2 mo	FDA
11,485,770	Aug 18, 2040	in 14 yr 2 mo	FDA
11,505,593	Aug 18, 2040	in 14 yr 2 mo	FDA
11,535,663	Aug 18, 2040	in 14 yr 2 mo	FDA
11,542,317	Aug 18, 2040	in 14 yr 2 mo	FDA
11,548,932	Aug 18, 2040	in 14 yr 2 mo	FDA
11,649,273	Aug 18, 2040	in 14 yr 2 mo	FDA
11,732,025	Aug 18, 2040	in 14 yr 2 mo	FDA
11,753,459	Aug 18, 2040	in 14 yr 2 mo	FDA
12,054,533	Aug 18, 2040	in 14 yr 2 mo	FDA
12,077,570	Aug 18, 2040	in 14 yr 2 mo	FDA
12,202,883	Aug 18, 2040	in 14 yr 2 mo	FDA
11,525,833	Nov 29, 2040	in 14 yr 5 mo	FDA
12,282,004	Dec 09, 2041	in 15 yr 5 mo	FDA
12,163,122	May 10, 2042	in 15 yr 11 mo	FDA

Practical characteristics and limits

Source-bounded interpretation

Presentation coverage

2 exact FDA presentation rows are consolidated under this BLA rather than split across duplicate pages.

Administration fields

The loaded rows list Intravitreal and Injection; these are regulatory presentation fields, not dosing instructions.

Applicant boundary

Sandoz Inc. is the listed BLA applicant. The page does not relabel the applicant as manufacturer, labeler, distributor, or commercial supplier without an exact product-specific source.

Regulatory comparison

Enzeevu is an FDA-licensed biosimilar without an interchangeability designation in this record. Family comparisons preserve each BLA's own designation and do not use Orange Book therapeutic-equivalence terminology.

Source provenance

FDA Purple Book data

Source kind · Monthly download

Checked Aug 11, 2026

FDA release · June 2026

FDA source FDA source

advanced-searchAdvanced Search · Jul 02, 2026
monthly-downloadMonthly download · Jul 02, 2026

What this record does not establish

Purple Book marketing status is a regulatory field, not real-time commercial inventory or launch status.
The listed applicant or BLA holder is not automatically the product’s physical manufacturer, labeler, or distributor.
Biosimilar status and interchangeability are distinct FDA designations; neither is a therapeutic-equivalence code from the Orange Book.
A missing patent or exclusivity row is not proof that no relevant rights exist, and listed patent information is not a freedom-to-operate opinion.
Approved uses, dosing, warnings, and clinical evidence require the exact current product label or approval package and are not inferred from the reference product.

Change history

Record versions

v5Aug 11, 2026
v4Jul 02, 2026
v3Jul 02, 2026
v2Jul 02, 2026

Enzeevu: frequently asked questions

Licensure, biosimilar status, exclusivity, and patents for this biologic, from the FDA Purple Book.

Built directly from the FDA Purple Book database of licensed biological products. License types, approval and exclusivity dates, and the patent list match the official FDA record. The Purple Book patent list reflects the statutory BPCIA patent exchange and is not exhaustive.

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