Viewing data from:

ZIRABEV

Biosimilar

BEVACIZUMAB-BVZR | B761099 | PFIZER INC

2 products0 Purple Book patents2 biosimilars

Biologic LOEBiosimilar competition

2 approved biosimilars

June 27, 2031(1820 days remaining)

Regulatory Exclusivities

Type	Expiry	Status	Source
12-Year BPCIA	Jun. 27, 2031	Active	Computed

Purple Book Patents

No listed patents in Purple Book.

Estimated Patent LOE

Dec. 19, 20446744 days remaining

Based on latest discovered patent 12174184(diagnostic) · relevance 75/100

Estimate based on AI-discovered patents. No patents are officially listed in the Purple Book for this product.

Approved Biosimilars

ZirabevBLA 761099ZirabevBLA 761099

Discovered Patents

View all 237 patents →

Top 50 of 237 AI-discovered patents by relevance.

Composition

(32)

85/1007803576Grant: 2010-09-28 | Exp: 2030-09-23

85/1008268313Grant: 2012-09-18 | Exp: 2032-09-13

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

85/1007378507Grant: 2008-05-27 | Exp: 2028-05-22

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

82/10010696721Grant: 2020-06-30 | Exp: 2040-06-25

75/10011078243Grant: 2021-08-03 | Exp: 2041-07-29

75/1007449551Grant: 2008-11-11 | Exp: 2028-11-06

75/1006639055Grant: 2003-10-28 | Exp: 2023-10-23

75/1007629145Grant: 2009-12-08 | Exp: 2029-12-03

75/1007364731Grant: 2008-04-29 | Exp: 2028-04-24

75/10010933112Grant: 2021-03-02 | Exp: 2041-02-25

75/1007741072Grant: 2010-06-22 | Exp: 2030-06-17

75/10010428125Grant: 2019-10-01 | Exp: 2039-09-26

75/1007208472Grant: 2007-04-24 | Exp: 2027-04-19

72/10011407794Grant: 2022-08-09 | Exp: 2042-08-04

72/1007700571Grant: 2010-04-20 | Exp: 2030-04-15

72/1006407213Grant: 2002-06-18 | Exp: 2022-06-13

72/1009284376Grant: 2016-03-15 | Exp: 2036-03-10

72/10011440971Grant: 2022-09-13 | Exp: 2042-09-08

72/1009803191Grant: 2017-10-31 | Exp: 2037-10-26

70/1006395707Grant: 2002-05-28 | Exp: 2022-05-23

70/10011180552Grant: 2021-11-23 | Exp: 2041-11-18

70/1007973138Grant: 2011-07-05 | Exp: 2031-06-30

70/1007427596Grant: 2008-09-23 | Exp: 2028-09-18

70/10011718678Grant: 2023-08-08 | Exp: 2043-08-03

68/1007700751Grant: 2010-04-20 | Exp: 2030-04-15

68/10010618965Grant: 2020-04-14 | Exp: 2040-04-09

68/10010472623Grant: 2019-11-12 | Exp: 2039-11-07

68/1008492531Grant: 2013-07-23 | Exp: 2033-07-18

65/1006194551Grant: 2001-02-27 | Exp: 2021-02-22

65/1008969526Grant: 2015-03-03 | Exp: 2035-02-26

Formulation

(1)

88/10010894083Grant: 2021-01-19 | Exp: 2041-01-14

Method of Use

(2)

92/1007622115Grant: 2009-11-24 | Exp: 2029-11-19

70/1008828666Grant: 2014-09-09 | Exp: 2034-09-04

Manufacturing

(11)

75/10011299539Grant: 2022-04-12 | Exp: 2042-04-07

72/1009150641Grant: 2015-10-06 | Exp: 2035-10-01

72/1007820799Grant: 2010-10-26 | Exp: 2030-10-21

72/1009631008Grant: 2017-04-25 | Exp: 2037-04-20

72/1007575893Grant: 2009-08-18 | Exp: 2029-08-13

70/10010377793Grant: 2019-08-13 | Exp: 2039-08-08

70/10010975168Grant: 2021-04-13 | Exp: 2041-04-08

70/1009469672Grant: 2016-10-18 | Exp: 2036-10-13

70/1008574907Grant: 2013-11-05 | Exp: 2033-10-31

70/1009365881Grant: 2016-06-14 | Exp: 2036-06-09

68/1008710196Grant: 2014-04-29 | Exp: 2034-04-24

Diagnostic

(3)

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

75/10012174184Grant: 2024-12-24 | Exp: 2044-12-19

68/1008227195Grant: 2012-07-24 | Exp: 2032-07-19

other

(1)

75/10011578428Grant: 2023-02-14 | Exp: 2043-02-09

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

No ANDA patent litigation cases (NOS 835) matched from PACER

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 761099 | 2 presentations

BiosimilarLicensedCDERInjection

Proper Name

bevacizumab-bvzr

Applicant

Pfizer Inc.

Approval Date

27-Jun-19

Reference Product: Avastin — bevacizumab

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

4 letters from Drugs@FDA

Date	Submission	Document
Aug 29, 2024	SUPPL -12	View Letter (PDF)
Feb 17, 2023	SUPPL -10	View Letter (PDF)
Feb 10, 2021	SUPPL -4	View Letter (PDF)
Jun 28, 2019	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — 100MG/4ML

▴

INJECTABLE;INJECTION | Approved: 2019-06-27 00:00:00

No patent or exclusivity listings for this strength.

#002 — 400MG/16ML

▾

INJECTABLE;INJECTION | Approved: 2019-06-27 00:00:00