What is Avastin in the FDA Purple Book?

Avastin, BLA 125085, is listed as a 351(a) reference biologic with 2 exact FDA presentation rows. The page preserves the BLA-level regulatory role and does not substitute clinical, inventory, or legal conclusions for the source record.

Who is responsible for BLA 125085?

Avastin, BLA 125085, lists Genentech, Inc. as the BLA applicant. The applicant field identifies responsibility for the application; it does not, by itself, prove that the organization physically manufactures, labels, distributes, or currently sells every presentation.

What presentations are listed for Avastin?

Avastin, BLA 125085, has 2 exact FDA presentation rows consolidated on this page. Strength, dosage form, route, product number, licensure, and marketing fields remain attached to their own row rather than being merged into disconnected lists.

What is Avastin's reference-product relationship?

Avastin, BLA 125085, is supported as a reference biologic by exact-BLA evidence and has 6 name-linked 351(k) follow-on products in the loaded snapshot. This answer is limited to the current FDA Purple Book record and its exact BLA-level fields.

Is Avastin interchangeable?

Avastin, BLA 125085, is not presented as an interchangeable product. Interchangeability is an FDA designation attached to an individual 351(k) follow-on, not a property inferred from this 351(a) BLA or its family.

When was Avastin licensed by FDA?

Avastin, BLA 125085, has a listed FDA approval date of Feb 26, 2004. The date is reproduced from this exact Purple Book BLA record and is not a statement about commercial launch or current availability.

Does this page summarize Avastin's FDA label?

Avastin, BLA 125085, FDA exposes a label link on this Purple Book row, but labeling content remains unavailable until the document is independently matched to this exact BLA and its presentations. Therefore the page does not publish product-specific approved uses, dosing, boxed warnings, or safety claims from a reference product or same-ingredient document.

What patent information is published for Avastin?

Avastin, BLA 125085, has 22 published Purple Book patent rows, with the latest listed expiration on Jul 31, 2035. FDA publishes sponsor-provided patent information ministerially; these rows are not conclusions about validity, infringement, freedom to operate, or market entry.

What exclusivity information is listed for Avastin?

Avastin, BLA 125085, has 1 populated Purple Book exclusivity field, with the latest listed date on May 29, 2027. Regulatory exclusivity dates are not patent opinions, inventory signals, or guaranteed market-entry dates.

FDA Purple Book product · 351(a) biologic

Avastin

bevacizumab

Avastin, BLA 125085, is listed in the FDA Purple Book as a 351(a) reference biologic. This page consolidates 2 exact FDA presentation rows, and 6 FDA rows name-link 351(k) follow-on products to its reference family. It separates the BLA applicant from any unverified manufacturer and does not infer clinical labeling, pharmacy substitution, commercial availability, or patent conclusions.

351(a)BLA 125085 2 presentationsRxLicensed Genentech, Inc.

Approved

Feb 26, 2004

License type

351(a)

Marketing

Listed patents

Avastin (bevacizumab) is Genentech, Inc.'s FDA-licensed 351(a) biologic under BLA 125085, approved in 2004. The FDA Purple Book lists 22 published patents for it, the last expiring 2035. 6 distinct approved follow-on biologics explicitly reference Avastin (Mvasi, Zirabev, Alymsys, Vegzelma, Avzivi, and Jobevne), making its reference-product role visible in the loaded family data.

Sourced from the FDA Purple Book · verified Oct 08, 2026

What this Purple Book record establishes

Regulatory interpretation

BLA number

125085

Regulatory role

351(a) reference biologic

Applicant

Genentech, Inc.

Applicant is not automatically the physical manufacturer.

Presentations

Exact FDA presentation rows under this BLA.

Approval

Feb 26, 2004

Follow-on biologics

Avastin is a 351(a) reference biologic supported by exact-BLA evidence.

6 distinct licensed follow-on biologics in the loaded Purple Book data name Avastin as their reference product; exact-BLA patent or exclusivity fields, or an unambiguous single-BLA name match, support this page's role.

Substitution boundary

Substitution status belongs to an individual follow-on product; it cannot be inferred from the reference product alone.

Key dates

Licensure & exclusivity

Approval
Approval date of this BLA submission.
Feb 26, 2004
22 yr 11 mo ago
Today
Orphan exclusivity ends
7-year orphan-drug exclusivity window.
May 29, 2027
in 8 mo

Strengths & presentations

2 FDA presentation rows · BLA 125085

Strength

100MG/4ML (25MG/ML)

Dosage form

Injection

Route

Intravenous

Presentation

Single-Dose Vial

Center

CDER

License number

1048

Product number

001

Submission type

Original

Supplement number

Not listed

Change type

Not listed

Exact presentation matrix

One row per FDA presentation under this exact BLA. Missing cells remain unavailable rather than being borrowed from another product.

Exact FDA Purple Book presentation rows for this BLA
Product	Strength	Dosage form	Route	Presentation	Licensure	Marketing
001	100MG/4ML (25MG/ML)	Injection	Intravenous	Single-Dose Vial	Licensed	Rx
002	400MG/16ML (25MG/ML)	Injection	Intravenous	Single-Dose Vial	Licensed	Rx

Exact-source evidence coverage

Labeling & approval review

Current product label

Candidate awaiting exact-BLA match

FDA exposes a label link on this Purple Book row, but labeling content remains unavailable until the document is independently matched to this exact BLA and its presentations.

Inspect FDA label candidate

FDA approval evidence

Not applicable to 351(a)

A biosimilar totality-of-evidence summary is not applicable to this 351(a) record. Product-specific clinical content still requires an exact-BLA label or review source.

Human review pending

Automated BLA-level interpretation has not been marked human-reviewed. The research queue contains 1 exact-source task. Labeling and approval-review claims stay unavailable until their own match gate passes.

Reference product family

Biosimilars & interchangeables

View full family

6 distinct 351(k) follow-on biologics are linked through FDA-stated reference names to Avastin; 0 are designated interchangeable and 6 have a licensed status in the loaded snapshot.

Exact-BLA patent, exclusivity, or unambiguous linked-family evidence supports this page's reference role. Name-linked licensed biosimilars and interchangeables are listed below.

Reference-family comparison

Purple Book comparison of products in this reference family
Product	Designation	BLA	Approved	Presentation	Marketing
Avastinbevacizumab	351(a) reference biologic	125085	Feb 26, 2004	400MG/16ML (25MG/ML) · Intravenous	Rx
Mvasibevacizumab-awwb	351(k) biosimilar	761028	Sep 14, 2017	100MG/4ML (25MG/ML) · Intravenous	Rx
Zirabevbevacizumab-bvzr	351(k) biosimilar	761099	Jun 27, 2019	100MG/4ML (25MG/ML) · Intravenous	Rx
Alymsysbevacizumab-maly	351(k) biosimilar	761231	Apr 13, 2022	100MG/4ML (25MG/ML) · Intravenous	Rx
Vegzelmabevacizumab-adcd	351(k) biosimilar	761268	Sep 27, 2022	100MG/4ML (25MG/ML) · Intravenous	Rx
Avzivibevacizumab-tnjn	351(k) biosimilar	761198	Dec 06, 2023	100MG/4ML (25MG/ML) · Intravenous	Rx
Jobevnebevacizumab-nwgd	351(k) biosimilar	761175	Apr 09, 2025	100MG/4ML (25MG/ML) · Intravenous	Rx

Published patents

BPCIA patent list

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 5 mo ago	FDA
7,485,704	Mar 08, 2025	1 yr 7 mo ago	FDA
10,906,986	Jul 08, 2028	in 1 yr 9 mo	FDA
11,078,294	Jul 08, 2028	in 1 yr 9 mo	FDA
8,574,869	Jul 08, 2028	in 1 yr 9 mo	FDA
8,460,895	Aug 08, 2029	in 2 yr 10 mo	FDA
10,982,003	Aug 06, 2030	in 3 yr 11 mo	FDA
9,714,293	Aug 06, 2030	in 3 yr 11 mo	FDA
8,512,983	Jan 04, 2031	in 4 yr 4 mo	FDA
10,011,856	May 26, 2031	in 4 yr 8 mo	FDA
10,662,237	Aug 07, 2031	in 4 yr 11 mo	FDA
10,704,071	Aug 18, 2031	in 4 yr 11 mo	FDA
9,487,809	Jan 14, 2032	in 5 yr 4 mo	FDA
10,513,697	Sep 17, 2032	in 6 yr	FDA
10,906,934	Oct 12, 2033	in 7 yr 1 mo	FDA
10,017,732	Mar 14, 2034	in 7 yr 6 mo	FDA
10,676,710	Mar 14, 2034	in 7 yr 6 mo	FDA
10,829,732	Mar 14, 2034	in 7 yr 6 mo	FDA
9,441,035	Apr 23, 2034	in 7 yr 8 mo	FDA
10,274,466	Jul 11, 2035	in 8 yr 11 mo	FDA
10,208,355	Jul 14, 2035	in 8 yr 11 mo	FDA
10,336,983	Jul 31, 2035	in 8 yr 11 mo	FDA

Practical characteristics and limits

Source-bounded interpretation

Presentation coverage

2 exact FDA presentation rows are consolidated under this BLA rather than split across duplicate pages.

Administration fields

The loaded rows list Intravenous and Injection; these are regulatory presentation fields, not dosing instructions.

Applicant boundary

Genentech, Inc. is the listed BLA applicant. The page does not relabel the applicant as manufacturer, labeler, distributor, or commercial supplier without an exact product-specific source.

Regulatory comparison

Avastin is a 351(a) reference biologic supported by exact-BLA evidence. Family comparisons preserve each BLA's own designation and do not use Orange Book therapeutic-equivalence terminology.

Source provenance

FDA Purple Book data

Source kind · Monthly download

Checked Oct 08, 2026

FDA release · September 2026

FDA source FDA source FDA source

advanced-searchAdvanced Search · Oct 08, 2026
monthly-downloadMonthly download · Oct 08, 2026
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What this record does not establish

Purple Book marketing status is a regulatory field, not real-time commercial inventory or launch status.
The listed applicant or BLA holder is not automatically the product’s physical manufacturer, labeler, or distributor.
Biosimilar status and interchangeability are distinct FDA designations; neither is a therapeutic-equivalence code from the Orange Book.
A missing patent or exclusivity row is not proof that no relevant rights exist, and listed patent information is not a freedom-to-operate opinion.
Approved uses, dosing, warnings, and clinical evidence require the exact current product label or approval package and are not inferred from the reference product.

Change history

Record versions

v7Oct 08, 2026
v6Oct 08, 2026
v5Sep 21, 2026
v4Aug 11, 2026
v3Jul 02, 2026
v2Jul 02, 2026

Avastin: frequently asked questions

Licensure, biosimilar status, exclusivity, and patents for this biologic, from the FDA Purple Book.

Built directly from the FDA Purple Book database of licensed biological products. License types, approval and exclusivity dates, and the patent list match the official FDA record. The Purple Book patent list reflects the statutory BPCIA patent exchange and is not exhaustive.

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