What is Lucentis in the FDA Purple Book?

Lucentis, BLA 125156, is listed as a 351(a) reference biologic with 4 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 125156?

Lucentis, BLA 125156, lists Genentech, 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 Lucentis?

Lucentis, BLA 125156, has 4 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 Lucentis's reference-product relationship?

Lucentis, BLA 125156, is supported as a reference biologic by exact-BLA evidence and has 3 name-linked 351(k) follow-on products in the loaded snapshot. This answer is limited to the current FDA Purple Book record and its exact BLA-level fields.

Is Lucentis interchangeable?

Lucentis, BLA 125156, is not presented as an interchangeable product. Interchangeability is an FDA designation attached to an individual 351(k) follow-on, not a property inferred from this 351(a) BLA or its family.

When was Lucentis licensed by FDA?

Lucentis, BLA 125156, has a listed FDA approval date of Oct 13, 2016. 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 Lucentis's FDA label?

Lucentis, BLA 125156, 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 Lucentis?

Lucentis, BLA 125156, has 11 published Purple Book patent rows, with the latest listed expiration on Nov 05, 2035. 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 Lucentis?

Lucentis, BLA 125156, 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 · 351(a) biologic

Lucentis

ranibizumab

Lucentis, BLA 125156, is listed in the FDA Purple Book as a 351(a) reference biologic. This page consolidates 4 exact FDA presentation rows, and 3 FDA rows name-link 351(k) follow-on products to its reference family. It separates the BLA applicant from any unverified manufacturer and does not infer clinical labeling, pharmacy substitution, commercial availability, or patent conclusions.

351(a)BLA 125156 4 presentationsRxLicensed Genentech, Inc.

Approved

Oct 13, 2016

License type

351(a)

Marketing

Listed patents

Lucentis (ranibizumab) is Genentech, Inc.'s FDA-licensed 351(a) biologic under BLA 125156, approved in 2016. The FDA Purple Book lists 11 published patents for it, the last expiring 2035. 3 distinct approved follow-on biologics explicitly reference Lucentis (Byooviz, Cimerli, and Nufymco), making its reference-product role visible in the loaded family data.

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

What this Purple Book record establishes

Regulatory interpretation

BLA number

125156

Regulatory role

351(a) reference biologic

Applicant

Genentech, Inc.

Applicant is not automatically the physical manufacturer.

Presentations

Exact FDA presentation rows under this BLA.

Approval

Oct 13, 2016

Follow-on biologics

Lucentis is a 351(a) reference biologic supported by exact-BLA evidence.

3 distinct licensed follow-on biologics in the loaded Purple Book data name Lucentis as their reference product; exact-BLA patent or exclusivity fields, or an unambiguous single-BLA name match, support this page's role.

Substitution boundary

Substitution status belongs to an individual follow-on product; it cannot be inferred from the reference product alone.

Key dates

Licensure & exclusivity

Approval
Approval date of this BLA submission.
Oct 13, 2016
10 yr 1 mo ago
Today

Strengths & presentations

4 FDA presentation rows · BLA 125156

Strength

10MG/ML (0.5MG/0.05ML)

Dosage form

Injection

Route

Intravitreal

Presentation

Single-Dose Vial

Center

CDER

License number

1048

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	10MG/ML (0.5MG/0.05ML)	Injection	Intravitreal	Single-Dose Vial	Licensed	Disc*
002	6MG/ML (0.3MG/0.05ML)	Injection	Intravitreal	Single-Dose Vial	Licensed	Disc*
003	10MG/ML (0.5MG/0.05ML)	Injection	Intravitreal	Pre-Filled Syringe	Licensed	Rx
004	6MG/ML (0.3MG/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

Not applicable to 351(a)

A biosimilar totality-of-evidence summary is not applicable to this 351(a) record. Product-specific clinical content still requires an exact-BLA label or review source.

Human review pending

Automated BLA-level interpretation has not been marked human-reviewed. The research queue contains 1 exact-source task. Labeling and approval-review claims stay unavailable until their own match gate passes.

Reference product family

Biosimilars & interchangeables

View full family

3 distinct 351(k) follow-on biologics are linked through FDA-stated reference names to Lucentis; 3 are designated interchangeable and 3 have a licensed status in the loaded snapshot.

Exact-BLA patent, exclusivity, or unambiguous linked-family evidence supports this page's reference role. Name-linked licensed biosimilars and interchangeables are listed below.

Reference-family comparison

Purple Book comparison of products in this reference family
Product	Designation	BLA	Approved	Presentation	Marketing
Lucentisranibizumab	351(a) reference biologic	125156	Oct 13, 2016	10MG/ML (0.5MG/0.05ML) · Intravitreal	Rx
Byoovizranibizumab-nuna	351(k) interchangeable biosimilar	761202	Sep 17, 2021	10MG/ML · Intravitreal	Rx
Cimerliranibizumab-eqrn	351(k) interchangeable biosimilar	761165	Aug 02, 2022	10MG/ML (0.5MG/0.05ML) · Intravitreal	Rx
Nufymcoranibizumab-leyk	351(k) interchangeable biosimilar	761473	Dec 18, 2025	10MG/ML (0.5MG/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
6,716,602	Nov 01, 2021	4 yr 11 mo ago	FDA
6,828,121	Jul 08, 2022	4 yr 3 mo ago	FDA
9,688,775	Dec 31, 2022	3 yr 9 mo ago	FDA
6,921,659	Oct 17, 2023	2 yr 11 mo ago	FDA
8,383,773	Dec 13, 2023	2 yr 10 mo ago	FDA
8,574,869	Jul 08, 2028	in 1 yr 10 mo	FDA
10,421,984	Sep 19, 2033	in 7 yr 1 mo	FDA
9,765,379	Mar 10, 2034	in 7 yr 7 mo	FDA
10,017,732	Mar 14, 2034	in 7 yr 7 mo	FDA
10,829,732	Mar 14, 2034	in 7 yr 7 mo	FDA
10,112,994	Nov 05, 2035	in 9 yr 3 mo	FDA

Practical characteristics and limits

Source-bounded interpretation

Presentation coverage

4 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

Genentech, 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

Lucentis is a 351(a) reference biologic supported by exact-BLA evidence. 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

v4Aug 11, 2026
v3Jul 02, 2026
v2Jul 02, 2026

Lucentis: 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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