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HERCEPTIN

BLA

TRASTUZUMAB | B103792 | GENENTECH

1 product4 Purple Book patents

Biologic LOEProtected

Estimated date when biosimilar competition may begin

August 7, 2031(1861 days remaining)

Regulatory Exclusivities

Type	Expiry	Status	Source
12-Year BPCIA	Feb. 10, 2029	Active	Computed
7-Year Orphan	Oct. 20, 2017	Expired	Purple Book

Purple Book Patents (4)

Patent	Expiration	Status
8574869	Jul. 8, 2028	Active
10662237	Aug. 7, 2031	Active
11078294	Jul. 8, 2028	Active
10808037	Jul. 8, 2028	Active

Discovered Patents

View all 357 patents →

Top 50 of 357 AI-discovered patents by relevance.

Composition

(31)

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

95/1006949245Grant: 2005-09-27 | Exp: 2025-09-22

95/1008840896Grant: 2014-09-23 | Exp: 2034-09-18

95/1008241630Grant: 2012-08-14 | Exp: 2032-08-09

95/1006800738Grant: 2004-10-05 | Exp: 2024-09-30

95/10012110341Grant: 2024-10-08 | Exp: 2044-10-03

95/1008722362Grant: 2014-05-13 | Exp: 2034-05-08

95/1006719971Grant: 2004-04-13 | Exp: 2024-04-08

94/1009321843Grant: 2016-04-26 | Exp: 2036-04-21

94/10010556966Grant: 2020-02-11 | Exp: 2040-02-06

94/1007560111Grant: 2009-07-14 | Exp: 2029-07-09

93/1008883980Grant: 2014-11-11 | Exp: 2034-11-06

93/10011597776Grant: 2023-03-07 | Exp: 2043-03-02

92/10011795236Grant: 2023-10-24 | Exp: 2043-10-19

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

92/1007537931Grant: 2009-05-26 | Exp: 2029-05-21

92/1008652474Grant: 2014-02-18 | Exp: 2034-02-13

92/1008753829Grant: 2014-06-17 | Exp: 2034-06-12

92/10011692043Grant: 2023-07-04 | Exp: 2043-06-29

92/10010584178Grant: 2020-03-10 | Exp: 2040-03-05

90/1006891022Grant: 2005-05-10 | Exp: 2025-05-05

90/10010314846Grant: 2019-06-11 | Exp: 2039-06-06

90/1007575748Grant: 2009-08-18 | Exp: 2029-08-13

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

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

90/1007879325Grant: 2011-02-01 | Exp: 2031-01-27

90/1009518118Grant: 2016-12-13 | Exp: 2036-12-08

89/10011414498Grant: 2022-08-16 | Exp: 2042-08-11

89/1008999324Grant: 2015-04-07 | Exp: 2035-04-02

88/1009181346Grant: 2015-11-10 | Exp: 2035-11-05

88/1008663643Grant: 2014-03-04 | Exp: 2034-02-27

Formulation

(6)

96/10012427193Grant: 2025-09-30 | Exp: 2045-09-25

92/1007682609Grant: 2010-03-23 | Exp: 2030-03-18

92/10010377831Grant: 2019-08-13 | Exp: 2039-08-08

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

90/10010280227Grant: 2019-05-07 | Exp: 2039-05-02

88/1009968676Grant: 2018-05-15 | Exp: 2038-05-10

Method of Use

(10)

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

95/1008591897Grant: 2013-11-26 | Exp: 2033-11-21

92/1008425908Grant: 2013-04-23 | Exp: 2033-04-18

92/10011879012Grant: 2024-01-23 | Exp: 2044-01-18

92/10011992529Grant: 2024-05-28 | Exp: 2044-05-23

92/10011077189Grant: 2021-08-03 | Exp: 2041-07-29

92/10010898570Grant: 2021-01-26 | Exp: 2041-01-21

92/1009090700Grant: 2015-07-28 | Exp: 2035-07-23

90/10011406715Grant: 2022-08-09 | Exp: 2042-08-04

89/1007041292Grant: 2006-05-09 | Exp: 2026-05-04

Manufacturing

(1)

95/10012173080Grant: 2024-12-24 | Exp: 2044-12-19

Diagnostic

(2)

95/1007858300Grant: 2010-12-28 | Exp: 2030-12-23

88/1007993834Grant: 2011-08-09 | Exp: 2031-08-04

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

5 cases 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	—
Genentech, Inc. v. Amgen Inc. 1:2018cv00924 36 patentstrastuzumab	D. Del.	2018-06-21	Terminated 2020-07-07	—
Celltrion, Inc. et al v. Genentech, Inc. et al 4:2018cv00274 38 patentstrastuzumab	CAND	2018-01-11	Terminated 2018-06-11	—
Genentech, Inc. et al v. Pfizer, Inc. 1:2017cv01672 40 patentstrastuzumab	D. Del.	2017-11-17	Terminated 2018-12-04	—
Genentech, Inc. v. Trustees of the University of Pennsylvania 5:2010cv02037 1 patenttrastuzumab	CAND	2010-05-11	Terminated 2012-06-08	—

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

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 103792 | 2 presentations | 4 patents

351(a) ReferenceLicensedCDERFor Injection

Proper Name

trastuzumab

Applicant

Genentech, Inc.

Approval Date

25-Sep-98

Orphan Exclusivity

20-Oct-17

Expired

Listed Patents

Patent Number	Expiration
8574869	July 8, 2028
10662237	August 7, 2031
11078294	July 8, 2028
10808037	July 8, 2028

Presentations

420MG — Multi-Dose Vial (Intravenous)

150MG — Single-Dose Vial (Intravenous)

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

Approval Letters

24 letters from Drugs@FDA

Date	Submission	Document
May 19, 2026	SUPPL -5359	View Letter (PDF)
Jun 20, 2024	SUPPL -5354	View Letter (PDF)
Aug 6, 2020	SUPPL -5349	View Letter (PDF)
Dec 20, 2018	SUPPL -5347	View Letter (PDF)
Oct 1, 2018	SUPPL -5344	View Letter (PDF)
May 2, 2017	SUPPL -5337	View Letter (PDF)
Mar 18, 2016	SUPPL -5330	View Letter (PDF)
Apr 24, 2015	SUPPL -5327	View Letter (PDF)
Jul 1, 2014	SUPPL -5313	View Letter (PDF)
Jul 1, 2014	SUPPL -5318	View Letter (PDF)
Mar 11, 2014	SUPPL -5311	View Letter (PDF)
Jan 2, 2014	SUPPL -5187	View Letter (PDF)
Jan 2, 2014	SUPPL -5189	View Letter (PDF)
Dec 3, 2010	SUPPL -5256	View Letter (PDF)
Oct 26, 2010	SUPPL -5250	View Letter (PDF)
May 29, 2008	SUPPL -5187	View Letter (PDF)
May 29, 2008	SUPPL -5189	View Letter (PDF)
Jan 23, 2008	SUPPL -5175	View Letter (PDF)
Dec 4, 2006	SUPPL -5150	View Letter (PDF)
Mar 15, 2004	SUPPL -5008	View Letter (PDF)
Mar 15, 2004	SUPPL -5004	View Letter (PDF)
Mar 15, 2004	SUPPL -1005	View Letter (PDF)
Mar 15, 2004	ORIG -1	View Letter (PDF)
Nov 6, 2003	SUPPL -5046	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 21MG/ML

▴

VIAL; INTRAVENOUS | Approved: 1998-09-25 00:00:00

No patent or exclusivity listings for this strength.