Purple Book product · Interchangeable
Cimerli
ranibizumab-eqrn
Aug 02, 2022
Approved
Interchangeable
License type
Rx
Marketing
11
Listed patents
Sourced from the FDA Purple Book · verified Jul 02, 2026
Key dates
Approval
Approval date of this BLA submission.
Aug 02, 2022
4 yr ago
First interchangeable exclusivity ends
Window blocking subsequent interchangeable approvals for the reference product.
Oct 03, 2023
2 yr 10 mo ago
Today
Pharmaceutical detail
Strength
6MG/ML (0.3MG/0.05ML)
Dosage form
Injection
Route
Intravitreal
Presentation
Single-Dose Vial
Center
CDER
License number
2003
Product number
002
Submission type
Original
Supplement number
Not listed
Change type
Not listed
Reference product family
View full familyBiosimilar of ranibizumab (Lucentis)
Patent list (11)
| Patent | Expires | In | Source |
|---|---|---|---|
| 6,716,602 | Nov 01, 2021 | 4 yr 9 mo ago | FDA |
| 6,828,121 | Jul 08, 2022 | 4 yr 1 mo ago | FDA |
| 9,688,775 | Dec 31, 2022 | 3 yr 7 mo ago | FDA |
| 6,921,659 | Oct 17, 2023 | 2 yr 10 mo ago | FDA |
| 8,383,773 | Dec 13, 2023 | 2 yr 8 mo ago | FDA |
| 8,574,869 | Jul 08, 2028 | in 2 yr | FDA |
| 10,421,984 | Sep 19, 2033 | in 7 yr 3 mo | FDA |
| 9,765,379 | Mar 10, 2034 | in 7 yr 9 mo | FDA |
| 10,017,732 | Mar 14, 2034 | in 7 yr 9 mo | FDA |
| 10,829,732 | Mar 14, 2034 | in 7 yr 9 mo | FDA |
| 10,112,994 | Nov 05, 2035 | in 9 yr 5 mo | FDA |
Source provenance
- 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 Cimerli's patents expire?
The FDA Purple Book lists 11 published patents for Cimerli, 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.
Is Cimerli a biosimilar?
Yes. Cimerli is a Interchangeable referencing ranibizumab, licensed under a 351(k) BLA.
Is Cimerli interchangeable?
Yes. Cimerli 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 Cimerli's BLA number?
Cimerli is licensed under BLA 761165, held by Sandoz Inc..
When was Cimerli approved by the FDA?
Cimerli was approved by the FDA on Aug 02, 2022.
Related FDA reference tools
- FDA Orange BookApproved drugs, generics, therapeutic-equivalence codes, patents, and exclusivity.
- FDA BiosimilarsThe list of FDA-approved biosimilars and interchangeable biosimilars, by reference product.
- 510(k) Predicate DatabaseSearch FDA 510(k) clearances and map predicate-device lineage.
- FDA 483 & Inspection DatabaseFDA Form 483 observations and inspection records by firm, date, and citation.
