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PERJETA

BLA

PERTUZUMAB | B125409 | GENENTECH

1 product47 Purple Book patents

Biologic LOEProtected

Estimated date when biosimilar competition may begin

March 14, 2039(4637 days remaining)

Regulatory Exclusivities

Type	Expiry	Status	Source
12-Year BPCIA	Jun. 8, 2024	Expired	Purple Book

Purple Book Patents (47)

Patent	Expiration	Status
9815904	Apr. 15, 2034	Active
9969811	Apr. 15, 2034	Active
10017732	Mar. 14, 2034	Active
10087237	Jan. 21, 2032	Active
11414498	Dec. 23, 2030	Active
8574869	Jul. 8, 2028	Active
10131873	Mar. 14, 2034	Active
10184106	Mar. 15, 2033	Active
10662237	Aug. 7, 2031	Active
10676710	Mar. 14, 2034	Active
10689457	Jun. 15, 2029	Active
10808037	Jul. 8, 2028	Active
9714293	Aug. 6, 2030	Active
9631007	May. 23, 2026	Expired
9493744	Feb. 24, 2034	Active
9493548	Jun. 22, 2029	Active
9181346	Jul. 18, 2029	Active
9017671	Oct. 19, 2025	Expired
8652474	Sep. 28, 2031	Active
8512983	Jan. 4, 2031	Active
8404234	Jul. 3, 2026	Expired
8372396	Jul. 19, 2026	Active
7862817	Jun. 1, 2025	Expired
7449184	Mar. 12, 2026	Expired
10982003	Aug. 6, 2030	Active
12173080	Jul. 8, 2028	Active
12145998	Sep. 7, 2034	Active
12145997	Jul. 8, 2028	Active
12128103	Feb. 28, 2038	Active
12110341	Jan. 28, 2029	Active
12103975	Aug. 6, 2030	Active
12098211	Jul. 8, 2028	Active
11999791	Jul. 8, 2028	Active
11992529	Mar. 14, 2039	Active
11987638	Jul. 8, 2028	Active
11987637	Jul. 8, 2028	Active
11655305	Jun. 15, 2029	Active
11976127	Jul. 8, 2028	Active
10829732	Mar. 14, 2034	Active
11034754	May. 23, 2026	Expired
11077189	Mar. 14, 2039	Active
11078294	Jul. 8, 2028	Active
11225513	Aug. 6, 2030	Active
11261238	May. 28, 2028	Active
11597776	Jan. 28, 2029	Active
11638756	Feb. 28, 2038	Active
11639395	Jul. 30, 2029	Active

Discovered Patents

View all 301 patents →

Top 50 of 301 AI-discovered patents by relevance.

Composition

(21)

98/10011787873Grant: 2023-10-17 | Exp: 2043-10-12

96/1009815904Grant: 2017-11-14 | Exp: 2037-11-09

95/10012252549Grant: 2025-03-18 | Exp: 2045-03-13

95/10012145998Grant: 2024-11-19 | Exp: 2044-11-14

92/1009518118Grant: 2016-12-13 | Exp: 2036-12-08

92/1008597654Grant: 2013-12-03 | Exp: 2033-11-28

90/1007850966Grant: 2010-12-14 | Exp: 2030-12-09

90/1007435797Grant: 2008-10-14 | Exp: 2028-10-09

90/10011325982Grant: 2022-05-10 | Exp: 2042-05-05

88/10010584178Grant: 2020-03-10 | Exp: 2040-03-05

88/10010556966Grant: 2020-02-11 | Exp: 2040-02-06

88/10010314846Grant: 2019-06-11 | Exp: 2039-06-06

88/10012331134Grant: 2025-06-17 | Exp: 2045-06-12

88/1009969811Grant: 2018-05-15 | Exp: 2038-05-10

86/1008840896Grant: 2014-09-23 | Exp: 2034-09-18

85/10010808038Grant: 2020-10-20 | Exp: 2040-10-15

85/1009623041Grant: 2017-04-18 | Exp: 2037-04-13

85/10011530275Grant: 2022-12-20 | Exp: 2042-12-15

85/10010179820Grant: 2019-01-15 | Exp: 2039-01-10

85/10010377825Grant: 2019-08-13 | Exp: 2039-08-08

85/1006800738Grant: 2004-10-05 | Exp: 2024-09-30

Formulation

(6)

96/10011654105Grant: 2023-05-23 | Exp: 2043-05-18

95/10012427193Grant: 2025-09-30 | Exp: 2045-09-25

90/1009017671Grant: 2015-04-28 | Exp: 2035-04-23

90/10010849849Grant: 2020-12-01 | Exp: 2040-11-26

82/1009345661Grant: 2016-05-24 | Exp: 2036-05-19

82/1008372396Grant: 2013-02-12 | Exp: 2033-02-07

Method of Use

(21)

98/10011992529Grant: 2024-05-28 | Exp: 2044-05-23

95/10011655305Grant: 2023-05-23 | Exp: 2043-05-18

95/10011638756Grant: 2023-05-02 | Exp: 2043-04-27

95/10012128103Grant: 2024-10-29 | Exp: 2044-10-24

92/1008333964Grant: 2012-12-18 | Exp: 2032-12-13

92/1008691232Grant: 2014-04-08 | Exp: 2034-04-03

90/10011077189Grant: 2021-08-03 | Exp: 2041-07-29

90/1008940302Grant: 2015-01-27 | Exp: 2035-01-22

88/1007981418Grant: 2011-07-19 | Exp: 2031-07-14

88/1008163287Grant: 2012-04-24 | Exp: 2032-04-19

88/10010689457Grant: 2020-06-23 | Exp: 2040-06-18

88/1007449184Grant: 2008-11-11 | Exp: 2028-11-06

87/10011406715Grant: 2022-08-09 | Exp: 2042-08-04

86/100OB11666572Grant: 2023-06-06 | Exp: 2043-06-01

85/100OB12048698Grant: 2024-07-30 | Exp: 2044-07-25

85/10012281153Grant: 2025-04-22 | Exp: 2045-04-17

82/100OB11207324Grant: 2021-12-28 | Exp: 2041-12-23

82/1008663643Grant: 2014-03-04 | Exp: 2034-02-27

82/1007618631Grant: 2009-11-17 | Exp: 2029-11-12

82/10010758526Grant: 2020-09-01 | Exp: 2040-08-27

82/1009522956Grant: 2016-12-20 | Exp: 2036-12-15

Manufacturing

(1)

85/10012173080Grant: 2024-12-24 | Exp: 2044-12-19

Diagnostic

(1)

85/10011851709Grant: 2023-12-26 | Exp: 2043-12-21

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

1 case on OB patents from PACER

Case	Court	Filed	Status	Judge
The Trustees of the University of Pennsylvania v. Genentech, Inc. 1:2022cv00145 2 patentstrastuzumab, pertuzumab	D. Del.	2022-01-31	Terminated 2025-03-14	—

Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).

ITC Section 337 Investigations

International Trade Commission investigations involving patents listed for this drug.

Pre-institution337-TA-3890

Certain Pertuzumab Biosimilars, Including Those Made by Certain Methods of Manufacturing, the Active Ingredient Thereof, and Products Containing the Same; Inv. No. 337-TA-3890 (Violation)

Source: USITC Investigative Data System (IDS). Matched via patent overlap.

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

Purple Book (Biologics)

BLA 125409 | 47 patents

351(a) ReferenceLicensedCDERInjection

Proper Name

pertuzumab

Applicant

Genentech, Inc.

Approval Date

8-Jun-12

First Licensure

8-Jun-12

Listed Patents

Patent Number	Expiration
9815904	April 15, 2034
9969811	April 15, 2034
10017732	March 14, 2034
10087237	January 21, 2032
11414498	December 23, 2030
8574869	July 8, 2028
10131873	March 14, 2034
10184106	March 15, 2033
10662237	August 7, 2031
10676710	March 14, 2034
10689457	June 15, 2029
10808037	July 8, 2028
9714293	August 6, 2030
9631007	May 23, 2026
9493744	February 24, 2034
9493548	June 22, 2029
9181346	July 18, 2029
9017671	October 19, 2025
8652474	September 28, 2031
8512983	January 4, 2031
8404234	July 3, 2026
8372396	July 19, 2026
7862817	June 1, 2025
7449184	March 12, 2026
10982003	August 6, 2030
12173080	July 8, 2028
12145998	September 7, 2034
12145997	July 8, 2028
12128103	February 28, 2038
12110341	January 28, 2029
12103975	August 6, 2030
12098211	July 8, 2028
11999791	July 8, 2028
11992529	March 14, 2039
11987638	July 8, 2028
11987637	July 8, 2028
11655305	June 15, 2029
11976127	July 8, 2028
10829732	March 14, 2034
11034754	May 23, 2026
11077189	March 14, 2039
11078294	July 8, 2028
11225513	August 6, 2030
11261238	May 28, 2028
11597776	January 28, 2029
11638756	February 28, 2038
11639395	July 30, 2029

Source: FDA Purple Book (purplebooksearch.fda.gov).

Approval Letters

14 letters from Drugs@FDA

Date	Submission	Document
Apr 27, 2026	SUPPL -141	View Letter (PDF)
Jun 30, 2025	SUPPL -139	View Letter (PDF)
May 15, 2025	SUPPL -137	View Letter (PDF)
Jan 17, 2020	SUPPL -124	View Letter (PDF)
Dec 21, 2018	SUPPL -123	View Letter (PDF)
Oct 1, 2018	SUPPL -121	View Letter (PDF)
Dec 27, 2017	SUPPL -118	View Letter (PDF)
Dec 27, 2017	SUPPL -113	View Letter (PDF)
Mar 24, 2016	SUPPL -109	View Letter (PDF)
Jun 2, 2015	SUPPL -105	View Letter (PDF)
Mar 18, 2015	SUPPL -104	View Letter (PDF)
Oct 1, 2013	SUPPL -51	View Letter (PDF)
Apr 16, 2013	SUPPL -32	View Letter (PDF)
Jun 11, 2012	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 420MG/14ML

▴

VIAL; SINGLE-USE | Approved: 2012-06-08 00:00:00

No patent or exclusivity listings for this strength.