ranibizumab (Lucentis)
ranibizumab is an FDA-licensed reference biologic from Genentech, Inc., with 3 approved follow-on biologics. Reference exclusivity, biosimilar lineage, and published patents from official FDA Purple Book records.
0
Biosimilars
3
Interchangeables
11
Listed patents
2016
Reference approved
Reference product
Lucentis ranibizumab
Genentech, Inc.
- Approved
- Oct 13, 2016
- Marketing
- Rx
- Center
- CDER
- Patents
- 11 listed
Molecular structure
Experimental 3D structure for ranibizumab from the RCSB Protein Data Bank (PDB 1CZ8).
Interactive biological assembly from PDB entry 1CZ8. Drag to rotate, scroll to zoom, and inspect the full atomic structure right here — no need to leave the page.
Exclusivity & patent cliffs
Approval, exclusivity, and published-patent expiration dates for ranibizumab, in chronological order.
Reference approval
Approval date of the reference ranibizumab product.
9 yr 9 mo ago
Patent 6,716,602 expires
Published Purple Book patent expiration.
4 yr 8 mo ago
Patent 6,828,121 expires
Published Purple Book patent expiration.
3 yr 11 mo ago
Patent 9,688,775 expires
Published Purple Book patent expiration.
3 yr 6 mo ago
Patent 6,921,659 expires
Published Purple Book patent expiration.
2 yr 8 mo ago
Patent 8,383,773 expires
Published Purple Book patent expiration.
2 yr 6 mo ago
Patent 8,574,869 expires
Published Purple Book patent expiration.
in 2 yr 2 mo
Patent 10,421,984 expires
Published Purple Book patent expiration.
in 7 yr 5 mo
Patent 9,765,379 expires
Published Purple Book patent expiration.
in 7 yr 11 mo
Patent 10,017,732 expires
Published Purple Book patent expiration.
in 7 yr 11 mo
Patent 10,829,732 expires
Published Purple Book patent expiration.
in 7 yr 11 mo
Patent 10,112,994 expires
Published Purple Book patent expiration.
in 9 yr 7 mo
Biosimilars & interchangeables for ranibizumab
3 FDA-licensed follow-on biologics referencing ranibizumab.
| Product | Proper name | Applicant | Type | BLA | Approved |
|---|---|---|---|---|---|
| Byooviz | ranibizumab-nuna | Samsung Bioepis Co., Ltd. | Interchangeable | 761202 | Sep 17, 2021 |
| Cimerli | ranibizumab-eqrn | Sandoz Inc. | Interchangeable | 761165 | Aug 02, 2022 |
| Nufymco | ranibizumab-leyk | Formycon AG | Interchangeable | 761473 | Dec 18, 2025 |
Published patents
Patents the BLA holder has published in the FDA Purple Book Patent List for ranibizumab.
| Patent | Expires | In |
|---|---|---|
| 6,716,602 | Nov 01, 2021 | 4 yr 8 mo ago |
| 6,828,121 | Jul 08, 2022 | 3 yr 11 mo ago |
| 9,688,775 | Dec 31, 2022 | 3 yr 6 mo ago |
| 6,921,659 | Oct 17, 2023 | 2 yr 8 mo ago |
| 8,383,773 | Dec 13, 2023 | 2 yr 6 mo ago |
| 8,574,869 | Jul 08, 2028 | in 2 yr 2 mo |
| 10,421,984 | Sep 19, 2033 | in 7 yr 5 mo |
| 9,765,379 | Mar 10, 2034 | in 7 yr 11 mo |
| 10,017,732 | Mar 14, 2034 | in 7 yr 11 mo |
| 10,829,732 | Mar 14, 2034 | in 7 yr 11 mo |
| 10,112,994 | Nov 05, 2035 | in 9 yr 7 mo |
Frequently asked questions
What biosimilars are approved for ranibizumab (Lucentis)?
The FDA Purple Book lists 3 approved follow-on biologics referencing ranibizumab: Byooviz, Cimerli, and Nufymco. Of these, 3 are interchangeable biosimilars and 0 are 351(k) biosimilars.
Is there an interchangeable biosimilar for ranibizumab?
Yes. Byooviz, Cimerli, and Nufymco are approved as interchangeable biosimilars for ranibizumab, meaning they may be substituted for the reference product at the pharmacy without prescriber involvement, subject to state law.
Who makes ranibizumab biosimilars?
Companies with FDA-approved follow-on biologics referencing ranibizumab include Samsung Bioepis Co., Ltd., Sandoz Inc., and Formycon AG.
How many patents are listed for ranibizumab (Lucentis) in the Purple Book?
11 patents are published in the FDA Purple Book Patent List for ranibizumab.
Explore the full FDA Purple Book
Search every FDA-licensed biologic, biosimilar, and interchangeable with exclusivity timelines and patent records.