Purple Book product · Reference 351(a)

Perjeta

pertuzumab

351(a)BLA 125409RxLicensed Genentech, Inc.

View pertuzumab family Label PDF Open on FDA Purple Book

Jun 08, 2012

Approved

Reference 351(a)

License type

Marketing

Listed patents

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

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

Key dates

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

Pharmaceutical detail

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

Reference product family

View full family

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

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

Patent list (47)

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 2 mo ago	FDA
9,017,671	Oct 19, 2025	9 mo ago	FDA
7,449,184	Mar 12, 2026	4 mo ago	FDA
11,034,754	May 23, 2026	2 mo ago	FDA
9,631,007	May 23, 2026	2 mo ago	FDA
8,404,234	Jul 03, 2026	15 d ago	FDA
8,372,396	Jul 19, 2026	in 1 d	FDA
11,261,238	May 28, 2028	in 1 yr 11 mo	FDA
10,808,037	Jul 08, 2028	in 2 yr	FDA
11,078,294	Jul 08, 2028	in 2 yr	FDA
11,976,127	Jul 08, 2028	in 2 yr	FDA
11,987,637	Jul 08, 2028	in 2 yr	FDA
11,987,638	Jul 08, 2028	in 2 yr	FDA
11,999,791	Jul 08, 2028	in 2 yr	FDA
12,098,211	Jul 08, 2028	in 2 yr	FDA
12,145,997	Jul 08, 2028	in 2 yr	FDA
12,173,080	Jul 08, 2028	in 2 yr	FDA
8,574,869	Jul 08, 2028	in 2 yr	FDA
11,597,776	Jan 28, 2029	in 2 yr 7 mo	FDA
12,110,341	Jan 28, 2029	in 2 yr 7 mo	FDA
10,689,457	Jun 15, 2029	in 2 yr 11 mo	FDA
11,655,305	Jun 15, 2029	in 2 yr 11 mo	FDA
9,493,548	Jun 22, 2029	in 3 yr	FDA
9,181,346	Jul 18, 2029	in 3 yr 1 mo	FDA
11,639,395	Jul 30, 2029	in 3 yr 1 mo	FDA
10,982,003	Aug 06, 2030	in 4 yr 1 mo	FDA
11,225,513	Aug 06, 2030	in 4 yr 1 mo	FDA
12,103,975	Aug 06, 2030	in 4 yr 1 mo	FDA
9,714,293	Aug 06, 2030	in 4 yr 1 mo	FDA
11,414,498	Dec 23, 2030	in 4 yr 6 mo	FDA
8,512,983	Jan 04, 2031	in 4 yr 6 mo	FDA
10,662,237	Aug 07, 2031	in 5 yr 2 mo	FDA
8,652,474	Sep 28, 2031	in 5 yr 3 mo	FDA
10,087,237	Jan 21, 2032	in 5 yr 7 mo	FDA
10,184,106	Mar 15, 2033	in 6 yr 9 mo	FDA
9,493,744	Feb 24, 2034	in 7 yr 9 mo	FDA
10,017,732	Mar 14, 2034	in 7 yr 9 mo	FDA
10,131,873	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
9,815,904	Apr 15, 2034	in 7 yr 10 mo	FDA
9,969,811	Apr 15, 2034	in 7 yr 10 mo	FDA
12,145,998	Sep 07, 2034	in 8 yr 3 mo	FDA
11,638,756	Feb 28, 2038	in 11 yr 9 mo	FDA
12,128,103	Feb 28, 2038	in 11 yr 9 mo	FDA
11,077,189	Mar 14, 2039	in 12 yr 10 mo	FDA
11,992,529	Mar 14, 2039	in 12 yr 10 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 Perjeta's patents expire?

The FDA Purple Book lists 47 published patents for Perjeta, with the last listed patent expiring Mar 14, 2039. Every patent below links to its FDA source record so you can verify the expiration date.

Does Perjeta have approved biosimilars?

Yes. 1 approved follow-on biologic reference Perjeta in the Purple Book: Poherdy.

When does Perjeta lose reference-product exclusivity?

Perjeta's 12-year reference-product exclusivity under the BPCIA is listed in the Purple Book as ending Jun 08, 2024.

What is Perjeta's BLA number?

Perjeta is licensed under BLA 125409, held by Genentech, Inc..

When was Perjeta approved by the FDA?

Perjeta was first licensed by the FDA on Jun 08, 2012.

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