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BLA

BEVACIZUMAB | B125085 | GENENTECH

2 products22 Purple Book patents

Biologic LOEProtected

Estimated date when biosimilar competition may begin

July 31, 2035(3315 days remaining)

Regulatory Exclusivities

Type	Expiry	Status	Source
7-Year Orphan	May. 29, 2027	Active	Purple Book

Purple Book Patents (22)

Patent	Expiration	Status
10208355	Jul. 14, 2035	Active
10017732	Mar. 14, 2034	Active
10011856	May. 26, 2031	Active
9795672	May. 28, 2024	Expired
10676710	Mar. 14, 2034	Active
9714293	Aug. 6, 2030	Active
9487809	Jan. 14, 2032	Active
9441035	Apr. 23, 2034	Active
8574869	Jul. 8, 2028	Active
8512983	Jan. 4, 2031	Active
8460895	Aug. 8, 2029	Active
7485704	Mar. 8, 2025	Expired
10336983	Jul. 31, 2035	Active
10274466	Jul. 11, 2035	Active
11078294	Jul. 8, 2028	Active
10982003	Aug. 6, 2030	Active
10906986	Jul. 8, 2028	Active
10906934	Oct. 12, 2033	Active
10829732	Mar. 14, 2034	Active
10704071	Aug. 18, 2031	Active
10662237	Aug. 7, 2031	Active
10513697	Sep. 17, 2032	Active

Discovered Patents

View all 274 patents →

Top 50 of 274 AI-discovered patents by relevance.

Composition

(18)

95/1007910098Grant: 2011-03-22 | Exp: 2031-03-17

95/10011820816Grant: 2023-11-21 | Exp: 2043-11-16

95/1009079953Grant: 2015-07-14 | Exp: 2035-07-09

90/1009815893Grant: 2017-11-14 | Exp: 2037-11-09

90/10010683345Grant: 2020-06-16 | Exp: 2040-06-11

90/1008921537Grant: 2014-12-30 | Exp: 2034-12-25

88/10011111304Grant: 2021-09-07 | Exp: 2041-09-02

88/1009815788Grant: 2017-11-14 | Exp: 2037-11-09

85/10012084503Grant: 2024-09-10 | Exp: 2044-09-05

85/10011254738Grant: 2022-02-22 | Exp: 2042-02-17

85/1009777059Grant: 2017-10-03 | Exp: 2037-09-28

85/1007090834Grant: 2006-08-15 | Exp: 2026-08-10

85/1009273113Grant: 2016-03-01 | Exp: 2036-02-25

82/1007427596Grant: 2008-09-23 | Exp: 2028-09-18

82/1008604185Grant: 2013-12-10 | Exp: 2033-12-05

82/1008268314Grant: 2012-09-18 | Exp: 2032-09-13

82/1007378507Grant: 2008-05-27 | Exp: 2028-05-22

80/1008945552Grant: 2015-02-03 | Exp: 2035-01-29

Formulation

(8)

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

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

92/10011370833Grant: 2022-06-28 | Exp: 2042-06-23

90/10010010611Grant: 2018-07-03 | Exp: 2038-06-28

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

88/1009226961Grant: 2016-01-05 | Exp: 2035-12-31

85/1008008447Grant: 2011-08-30 | Exp: 2031-08-25

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

Method of Use

(16)

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

90/10011384142Grant: 2022-07-12 | Exp: 2042-07-07

88/1009918950Grant: 2018-03-20 | Exp: 2038-03-15

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

88/10010617755Grant: 2020-04-14 | Exp: 2040-04-09

85/1009795672Grant: 2017-10-24 | Exp: 2037-10-19

85/1007622115Grant: 2009-11-24 | Exp: 2029-11-19

85/10012409178Grant: 2025-09-09 | Exp: 2045-09-04

85/1009895441Grant: 2018-02-20 | Exp: 2038-02-15

85/10010208355Grant: 2019-02-19 | Exp: 2039-02-14

85/10011034757Grant: 2021-06-15 | Exp: 2041-06-10

85/1008840887Grant: 2014-09-23 | Exp: 2034-09-18

85/1008778340Grant: 2014-07-15 | Exp: 2034-07-10

82/1008940302Grant: 2015-01-27 | Exp: 2035-01-22

82/10010975146Grant: 2021-04-13 | Exp: 2041-04-08

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

Manufacturing

(4)

92/1009896478Grant: 2018-02-20 | Exp: 2038-02-15

90/1009441035Grant: 2016-09-13 | Exp: 2036-09-08

85/10010906986Grant: 2021-02-02 | Exp: 2041-01-28

82/10011680110Grant: 2023-06-20 | Exp: 2043-06-15

Diagnostic

(4)

92/10012078638Grant: 2024-09-03 | Exp: 2044-08-29

88/10010031141Grant: 2018-07-24 | Exp: 2038-07-19

85/10011402382Grant: 2022-08-02 | Exp: 2042-07-28

82/10010456470Grant: 2019-10-29 | Exp: 2039-10-24

PTAB Proceedings

1 challenge on OB patents at the Patent Trial and Appeal Board

Trial #	Patent	Type	Petitioner	Status	Filed	Decision
IPR2018-00373	9795672	IPR	Pfizer Inc.	Institution Denied	2018-01-05	—

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

3 cases on OB patents from PACER

Case	Court	Filed	Status	Judge
Genentech, Inc. v. Centus Biotherapeutics Limited et al 2:2020cv00361 10 patentsbevacizumab	E.D. Tex.	2020-11-12	Terminated 2021-07-02	—
Genentech, Inc. et al v. Amgen, Inc. 1:2017cv01471 5 patentsbevacizumab	D. Del.	2017-10-18	Terminated 2020-07-07	—
Genentech, Inc. et al v. Amgen Inc. 1:2017cv01407 25 patentsbevacizumab	D. Del.	2017-10-06	Terminated 2020-07-07	—

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 125085 | 2 presentations | 22 patents

351(a) ReferenceLicensedCDERInjection

Proper Name

bevacizumab

Applicant

Genentech, Inc.

Approval Date

26-Feb-04

Orphan Exclusivity

29-May-27

10mo 29d remaining

Listed Patents

Patent Number	Expiration
10208355	July 14, 2035
10017732	March 14, 2034
10011856	May 26, 2031
9795672	May 28, 2024
10676710	March 14, 2034
9714293	August 6, 2030
9487809	January 14, 2032
9441035	April 23, 2034
8574869	July 8, 2028
8512983	January 4, 2031
8460895	August 8, 2029
7485704	March 8, 2025
10336983	July 31, 2035
10274466	July 11, 2035
11078294	July 8, 2028
10982003	August 6, 2030
10906986	July 8, 2028
10906934	October 12, 2033
10829732	March 14, 2034
10704071	August 18, 2031
10662237	August 7, 2031
10513697	September 17, 2032

Presentations

100MG/4ML (25MG/ML) — Single-Dose Vial (Intravenous)

400MG/16ML (25MG/ML) — Single-Dose Vial (Intravenous)

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

Approval Letters

37 letters from Drugs@FDA

Date	Submission	Document
Sep 19, 2022	SUPPL -340	View Letter (PDF)
Dec 17, 2020	SUPPL -337	View Letter (PDF)
Oct 14, 2020	SUPPL -336	View Letter (PDF)
Oct 1, 2020	SUPPL -334	View Letter (PDF)
Jun 2, 2020	SUPPL -332	View Letter (PDF)
Jun 21, 2019	SUPPL -331	View Letter (PDF)
May 13, 2019	SUPPL -329	View Letter (PDF)
Jun 14, 2018	SUPPL -323	View Letter (PDF)
May 3, 2018	SUPPL -324	View Letter (PDF)
Dec 7, 2017	SUPPL -319	View Letter (PDF)
Dec 8, 2016	SUPPL -317	View Letter (PDF)
Dec 2, 2015	SUPPL -312	View Letter (PDF)
Oct 1, 2015	SUPPL -310	View Letter (PDF)
May 11, 2015	SUPPL -308	View Letter (PDF)
Nov 17, 2014	SUPPL -305	View Letter (PDF)
Sep 3, 2014	SUPPL -297	View Letter (PDF)
Aug 15, 2014	SUPPL -301	View Letter (PDF)
Dec 17, 2013	SUPPL -285	View Letter (PDF)
Mar 28, 2013	SUPPL -267	View Letter (PDF)
Jan 25, 2013	SUPPL -263	View Letter (PDF)
Nov 23, 2012	SUPPL -265	View Letter (PDF)
Oct 29, 2012	SUPPL -239	View Letter (PDF)
May 8, 2012	SUPPL -238	View Letter (PDF)
Dec 27, 2011	SUPPL -241	View Letter (PDF)
Oct 4, 2011	SUPPL -225	View Letter (PDF)
Feb 15, 2011	SUPPL -208	View Letter (PDF)
Jan 10, 2011	SUPPL -204	View Letter (PDF)
Aug 6, 2009	SUPPL -168	View Letter (PDF)
May 13, 2009	SUPPL -169	View Letter (PDF)
Mar 28, 2008	SUPPL -145	View Letter (PDF)
Feb 27, 2008	SUPPL -91	View Letter (PDF)
Oct 23, 2006	SUPPL -85	View Letter (PDF)
Sep 25, 2006	SUPPL -82	View Letter (PDF)
Jun 27, 2006	SUPPL -74	View Letter (PDF)
Apr 21, 2006	SUPPL -67	View Letter (PDF)
Oct 20, 2005	SUPPL -45	View Letter (PDF)
Feb 27, 2004	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — 100MG

▴

VIAL; INTRAVENOUS | Approved: 2004-02-26 00:00:00

No patent or exclusivity listings for this strength.

#002 — 400MG

▾

VIAL; INTRAVENOUS | Approved: 2004-02-26 00:00:00