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Purple Book product · Reference 351(a)

Lucentis

ranibizumab

351(a)BLA 125156RxLicensed Genentech, Inc.
View ranibizumab family Label PDFOpen on FDA Purple Book

Oct 13, 2016

Approved

Reference 351(a)

License type

Rx

Marketing

11

Listed patents

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

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

Key dates

  1. Approval

    Approval date of this BLA submission.

    Oct 13, 2016

    9 yr 11 mo ago

  2. Today

Pharmaceutical detail

Strength

10MG/ML (0.5MG/0.05ML)

Dosage form

Injection

Route

Intravitreal

Presentation

Pre-Filled Syringe

Center

CDER

License number

1048

Product number

003

Submission type

Supplement

Supplement number

110

Change type

Not listed

Reference product family

View full family

This is the reference (originator) product. Its approved biosimilars and interchangeables are listed below.

3 additional BLA records for this product (other strengths or presentations) are in the same reference family.

Patent list (11)

Patents published in the FDA Purple Book Patent List for this product, with expiration date and source link.
PatentExpiresInSource
6,716,602Nov 01, 20214 yr 9 mo agoFDA
6,828,121Jul 08, 20224 yr 1 mo agoFDA
9,688,775Dec 31, 20223 yr 7 mo agoFDA
6,921,659Oct 17, 20232 yr 10 mo agoFDA
8,383,773Dec 13, 20232 yr 8 mo agoFDA
8,574,869Jul 08, 2028in 2 yrFDA
10,421,984Sep 19, 2033in 7 yr 3 moFDA
9,765,379Mar 10, 2034in 7 yr 9 moFDA
10,017,732Mar 14, 2034in 7 yr 9 moFDA
10,829,732Mar 14, 2034in 7 yr 9 moFDA
10,112,994Nov 05, 2035in 9 yr 5 moFDA

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

  • v3Jul 02, 2026
  • v2Jul 02, 2026

Frequently asked questions

When do Lucentis's patents expire?

The FDA Purple Book lists 11 published patents for Lucentis, with the last listed patent expiring Nov 05, 2035. Every patent below links to its FDA source record so you can verify the expiration date.

Does Lucentis have approved biosimilars?

Yes. 3 approved follow-on biologics reference Lucentis in the Purple Book: Byooviz, Cimerli, and Nufymco.

What is Lucentis's BLA number?

Lucentis is licensed under BLA 125156, held by Genentech, Inc..

When was Lucentis approved by the FDA?

Lucentis was approved by the FDA on Oct 13, 2016.

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