Purple Book product · Reference 351(a)

Susvimo

ranibizumab

351(a)BLA 761197RxLicensed Genentech, Inc.

View ranibizumab family Label PDF Open on FDA Purple Book

Oct 22, 2021

Approved

Reference 351(a)

License type

Marketing

Listed patents

Susvimo (ranibizumab) is Genentech, Inc.'s FDA-licensed reference biologic, approved under a 351(a) BLA in 2021. The FDA Purple Book lists 11 published patents for it, the last expiring 2035. 3 approved follow-on biologics reference Susvimo (Byooviz, Cimerli, and Nufymco).

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

Key dates

Approval
Approval date of this BLA submission.
Oct 22, 2021
4 yr 10 mo ago
Today

Pharmaceutical detail

Strength

100MG/ML

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

Reference product family

View full family

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

Patent list (11)

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 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

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 Susvimo's patents expire?

The FDA Purple Book lists 11 published patents for Susvimo, 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 Susvimo have approved biosimilars?

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

What is Susvimo's BLA number?

Susvimo is licensed under BLA 761197, held by Genentech, Inc..

When was Susvimo approved by the FDA?

Susvimo was approved by the FDA on Oct 22, 2021.

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