What is Perjeta in the FDA Purple Book?

Perjeta, BLA 125409, is listed as a 351(a) reference biologic with 1 exact FDA presentation row. 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 125409?

Perjeta, BLA 125409, 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 Perjeta?

Perjeta, BLA 125409, has 1 exact FDA presentation row 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 Perjeta's reference-product relationship?

Perjeta, BLA 125409, is supported as a reference biologic by exact-BLA evidence and has 1 name-linked 351(k) follow-on product in the loaded snapshot. This answer is limited to the current FDA Purple Book record and its exact BLA-level fields.

Is Perjeta interchangeable?

Perjeta, BLA 125409, 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 Perjeta licensed by FDA?

Perjeta, BLA 125409, has a listed FDA first-licensure date of Jun 08, 2012. 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 Perjeta's FDA label?

Perjeta, BLA 125409, No exact-BLA label candidate is stored for this record. Approved uses, dosing, and warnings are intentionally unavailable and queued for exact-source research. 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 Perjeta?

Perjeta, BLA 125409, has 47 published Purple Book patent rows, with the latest listed expiration on Mar 14, 2039. 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 Perjeta?

Perjeta, BLA 125409, has 1 populated Purple Book exclusivity field, with the latest listed date on Jun 08, 2024. Regulatory exclusivity dates are not patent opinions, inventory signals, or guaranteed market-entry dates.

FDA Purple Book product · 351(a) biologic

Perjeta

pertuzumab

Perjeta, BLA 125409, is listed in the FDA Purple Book as a 351(a) reference biologic. This page consolidates 1 exact FDA presentation row, and 1 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 125409RxLicensed Genentech, Inc.

Approved

Jun 08, 2012

License type

351(a)

Marketing

Listed patents

Perjeta (pertuzumab) is Genentech, Inc.'s FDA-licensed 351(a) biologic under BLA 125409, approved in 2012. The FDA Purple Book lists 47 published patents for it, the last expiring 2039. 1 distinct approved follow-on biologic explicitly reference Perjeta (Poherdy), making its reference-product role visible in the loaded family data. Its 12-year reference-product exclusivity under the BPCIA is listed as ending Jun 08, 2024.

Sourced from the FDA Purple Book · verified Aug 11, 2026

What this Purple Book record establishes

Regulatory interpretation

BLA number

125409

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

Jun 08, 2012

Follow-on biologics

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

1 distinct licensed follow-on biologic in the loaded Purple Book data name Perjeta 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

First licensure
Date the BLA was first licensed.
Jun 08, 2012
14 yr 6 mo ago
Approval
Approval date of this BLA submission.
Jun 08, 2012
14 yr 6 mo ago
Reference product exclusivity ends
12-year reference-product exclusivity window per BPCIA §351(k)(7).
Jun 08, 2024
2 yr 4 mo ago
Today

Pharmaceutical detail

FDA product record

Strength

420MG/14ML

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	420MG/14ML	Injection	Intravenous	Single-Dose Vial	Licensed	Rx

Exact-source evidence coverage

Labeling & approval review

Current product label

Exact-source research required

No exact-BLA label candidate is stored for this record. Approved uses, dosing, and warnings are intentionally unavailable and queued for exact-source research.

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

1 distinct 351(k) follow-on biologic are linked through FDA-stated reference names to Perjeta; 1 is designated interchangeable and 1 has 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.

PoherdyInterchangeable
pertuzumab-dpzb · Shanghai Henlius Biotech, Inc.
2025

Reference-family comparison

Purple Book comparison of products in this reference family
Product	Designation	BLA	Approved	Presentation	Marketing
Perjetapertuzumab	351(a) reference biologic	125409	Jun 08, 2012	420MG/14ML · Intravenous	Rx
Poherdypertuzumab-dpzb	351(k) interchangeable biosimilar	761450	Nov 13, 2025	420MG/14ML (30MG/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
7,862,817	Jun 01, 2025	1 yr 4 mo ago	FDA
9,017,671	Oct 19, 2025	11 mo ago	FDA
7,449,184	Mar 12, 2026	6 mo ago	FDA
11,034,754	May 23, 2026	4 mo ago	FDA
9,631,007	May 23, 2026	4 mo ago	FDA
8,404,234	Jul 03, 2026	3 mo ago	FDA
8,372,396	Jul 19, 2026	2 mo ago	FDA
11,261,238	May 28, 2028	in 1 yr 9 mo	FDA
10,808,037	Jul 08, 2028	in 1 yr 10 mo	FDA
11,078,294	Jul 08, 2028	in 1 yr 10 mo	FDA
11,976,127	Jul 08, 2028	in 1 yr 10 mo	FDA
11,987,637	Jul 08, 2028	in 1 yr 10 mo	FDA
11,987,638	Jul 08, 2028	in 1 yr 10 mo	FDA
11,999,791	Jul 08, 2028	in 1 yr 10 mo	FDA
12,098,211	Jul 08, 2028	in 1 yr 10 mo	FDA
12,145,997	Jul 08, 2028	in 1 yr 10 mo	FDA
12,173,080	Jul 08, 2028	in 1 yr 10 mo	FDA
8,574,869	Jul 08, 2028	in 1 yr 10 mo	FDA
11,597,776	Jan 28, 2029	in 2 yr 5 mo	FDA
12,110,341	Jan 28, 2029	in 2 yr 5 mo	FDA
10,689,457	Jun 15, 2029	in 2 yr 9 mo	FDA
11,655,305	Jun 15, 2029	in 2 yr 9 mo	FDA
9,493,548	Jun 22, 2029	in 2 yr 10 mo	FDA
9,181,346	Jul 18, 2029	in 2 yr 10 mo	FDA
11,639,395	Jul 30, 2029	in 2 yr 11 mo	FDA
10,982,003	Aug 06, 2030	in 3 yr 11 mo	FDA
11,225,513	Aug 06, 2030	in 3 yr 11 mo	FDA
12,103,975	Aug 06, 2030	in 3 yr 11 mo	FDA
9,714,293	Aug 06, 2030	in 3 yr 11 mo	FDA
11,414,498	Dec 23, 2030	in 4 yr 4 mo	FDA
8,512,983	Jan 04, 2031	in 4 yr 4 mo	FDA
10,662,237	Aug 07, 2031	in 4 yr 11 mo	FDA
8,652,474	Sep 28, 2031	in 5 yr 1 mo	FDA
10,087,237	Jan 21, 2032	in 5 yr 5 mo	FDA
10,184,106	Mar 15, 2033	in 6 yr 7 mo	FDA
9,493,744	Feb 24, 2034	in 7 yr 6 mo	FDA
10,017,732	Mar 14, 2034	in 7 yr 7 mo	FDA
10,131,873	Mar 14, 2034	in 7 yr 7 mo	FDA
10,676,710	Mar 14, 2034	in 7 yr 7 mo	FDA
10,829,732	Mar 14, 2034	in 7 yr 7 mo	FDA
9,815,904	Apr 15, 2034	in 7 yr 8 mo	FDA
9,969,811	Apr 15, 2034	in 7 yr 8 mo	FDA
12,145,998	Sep 07, 2034	in 8 yr 1 mo	FDA
11,638,756	Feb 28, 2038	in 11 yr 7 mo	FDA
12,128,103	Feb 28, 2038	in 11 yr 7 mo	FDA
11,077,189	Mar 14, 2039	in 12 yr 8 mo	FDA
11,992,529	Mar 14, 2039	in 12 yr 8 mo	FDA

Practical characteristics and limits

Source-bounded interpretation

Presentation coverage

1 exact FDA presentation row is 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

Perjeta 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 Aug 11, 2026

FDA release · June 2026

FDA source FDA source

advanced-searchAdvanced Search · Jul 02, 2026
monthly-downloadMonthly download · Jul 02, 2026

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

v5Aug 11, 2026
v4Jul 02, 2026
v3Jul 02, 2026
v2Jul 02, 2026

Perjeta: 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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