Purple Book product · Interchangeable

Opuviz

aflibercept-yszy

351(k) InterchangeableBLA 761350RxLicensed Samsung Bioepis Co., Ltd.

View aflibercept family Label PDF Open on FDA Purple Book

May 20, 2024

Approved

Interchangeable

License type

Marketing

Listed patents

Opuviz (aflibercept-yszy) is a Interchangeable referencing aflibercept, licensed under a 351(k) BLA in 2024 and marketed by Samsung Bioepis Co., Ltd.. As an interchangeable biosimilar it may be substituted for the reference product at the pharmacy without prescriber involvement, subject to state law. The Purple Book lists 88 published patents for this product.

Sourced from the FDA Purple Book · verified Jul 02, 2026

Key dates

Approval
Approval date of this BLA submission.
May 20, 2024
2 yr 2 mo ago
Today
First interchangeable exclusivity ends
Window blocking subsequent interchangeable approvals for the reference product.
Oct 22, 2026
in 3 mo

Pharmaceutical detail

Strength

2MG/0.05ML

Dosage form

Injection

Route

Intravitreal

Presentation

Single-Dose Vial

Center

CDER

License number

2046

Product number

001

Submission type

Original

Supplement number

Not listed

Change type

Not listed

Reference product family

View full family

Biosimilar of aflibercept (Eylea)

Patent list (88)

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

Source provenance

Source kind · Advanced Search

Checked Jul 02, 2026

FDA source FDA source

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

Change history

v4Jul 02, 2026
v3Jul 02, 2026
v2Jul 02, 2026

Frequently asked questions

When do Opuviz's patents expire?

The FDA Purple Book lists 88 published patents for Opuviz, with the last listed patent expiring May 10, 2042. Every patent below links to its FDA source record so you can verify the expiration date.

Is Opuviz a biosimilar?

Yes. Opuviz is a Interchangeable referencing aflibercept, licensed under a 351(k) BLA.

Is Opuviz interchangeable?

Yes. Opuviz carries an FDA interchangeability designation, so it may be substituted for the reference product at the pharmacy without prescriber involvement, subject to state law.

What is Opuviz's BLA number?

Opuviz is licensed under BLA 761350, held by Samsung Bioepis Co., Ltd..

When was Opuviz approved by the FDA?

Opuviz was approved by the FDA on May 20, 2024.

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