Purple Book product · Reference 351(a)

Avastin

bevacizumab

351(a)BLA 125085RxLicensed Genentech, Inc.

View bevacizumab family Label PDF Open on FDA Purple Book

Feb 26, 2004

Approved

Reference 351(a)

License type

Marketing

Listed patents

Avastin (bevacizumab) is Genentech, Inc.'s FDA-licensed reference biologic, approved under a 351(a) BLA in 2004. The FDA Purple Book lists 22 published patents for it, the last expiring 2035. 6 approved follow-on biologics reference Avastin (Mvasi, Zirabev, Alymsys, Vegzelma, Avzivi, and Jobevne).

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

Key dates

Approval
Approval date of this BLA submission.
Feb 26, 2004
22 yr 9 mo ago
Today
Orphan exclusivity ends
7-year orphan-drug exclusivity window.
May 29, 2027
in 11 mo

Pharmaceutical detail

Strength

400MG/16ML (25MG/ML)

Dosage form

Injection

Route

Intravenous

Presentation

Single-Dose Vial

Center

CDER

License number

1048

Product number

002

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.

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

Patent list (22)

Patents published in the FDA Purple Book Patent List for this product, with expiration date and source link.
Patent	Expires	In	Source
9,795,672	May 28, 2024	2 yr 2 mo ago	FDA
7,485,704	Mar 08, 2025	1 yr 5 mo ago	FDA
10,906,986	Jul 08, 2028	in 2 yr	FDA
11,078,294	Jul 08, 2028	in 2 yr	FDA
8,574,869	Jul 08, 2028	in 2 yr	FDA
8,460,895	Aug 08, 2029	in 3 yr 1 mo	FDA
10,982,003	Aug 06, 2030	in 4 yr 1 mo	FDA
9,714,293	Aug 06, 2030	in 4 yr 1 mo	FDA
8,512,983	Jan 04, 2031	in 4 yr 6 mo	FDA
10,011,856	May 26, 2031	in 4 yr 11 mo	FDA
10,662,237	Aug 07, 2031	in 5 yr 2 mo	FDA
10,704,071	Aug 18, 2031	in 5 yr 2 mo	FDA
9,487,809	Jan 14, 2032	in 5 yr 7 mo	FDA
10,513,697	Sep 17, 2032	in 6 yr 3 mo	FDA
10,906,934	Oct 12, 2033	in 7 yr 4 mo	FDA
10,017,732	Mar 14, 2034	in 7 yr 9 mo	FDA
10,676,710	Mar 14, 2034	in 7 yr 9 mo	FDA
10,829,732	Mar 14, 2034	in 7 yr 9 mo	FDA
9,441,035	Apr 23, 2034	in 7 yr 11 mo	FDA
10,274,466	Jul 11, 2035	in 9 yr 1 mo	FDA
10,208,355	Jul 14, 2035	in 9 yr 1 mo	FDA
10,336,983	Jul 31, 2035	in 9 yr 2 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

v3Jul 02, 2026
v2Jul 02, 2026

Frequently asked questions

When do Avastin's patents expire?

The FDA Purple Book lists 22 published patents for Avastin, with the last listed patent expiring Jul 31, 2035. Every patent below links to its FDA source record so you can verify the expiration date.

Does Avastin have approved biosimilars?

Yes. 6 approved follow-on biologics reference Avastin in the Purple Book: Mvasi, Zirabev, Alymsys, Vegzelma, Avzivi, and Jobevne.

What is Avastin's BLA number?

Avastin is licensed under BLA 125085, held by Genentech, Inc..

When was Avastin approved by the FDA?

Avastin was approved by the FDA on Feb 26, 2004.

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