Viewing data from:

AVZIVI

Biosimilar

BEVACIZUMAB-TNJN | B761198 | BIO-THERA SOLUTIONS LTD

2 products0 Purple Book patents2 biosimilars

Biologic LOEBiosimilar competition

2 approved biosimilars

December 6, 2035(3443 days remaining)

Regulatory Exclusivities

Type	Expiry	Status	Source
12-Year BPCIA	Dec. 6, 2035	Active	Computed

Purple Book Patents

No listed patents in Purple Book.

Estimated Patent LOE

Oct. 17, 20446681 days remaining

Based on latest discovered patent 12121586(composition) · relevance 85/100

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

Approved Biosimilars

AvziviBLA 761198AvziviBLA 761198

Discovered Patents

View all 310 patents →

Top 50 of 310 AI-discovered patents by relevance.

Composition

(32)

95/1007758859Grant: 2010-07-20 | Exp: 2030-07-15

93/1008492527Grant: 2013-07-23 | Exp: 2033-07-18

92/1008975381Grant: 2015-03-10 | Exp: 2035-03-05

92/1006884879Grant: 2005-04-26 | Exp: 2025-04-21

92/1007297334Grant: 2007-11-20 | Exp: 2027-11-15

92/1009353177Grant: 2016-05-31 | Exp: 2036-05-26

92/1009856462Grant: 2018-01-02 | Exp: 2037-12-28

92/1008512699Grant: 2013-08-20 | Exp: 2033-08-15

92/10011820816Grant: 2023-11-21 | Exp: 2043-11-16

92/1007365166Grant: 2008-04-29 | Exp: 2028-04-24

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

90/1007060269Grant: 2006-06-13 | Exp: 2026-06-08

88/1007375193Grant: 2008-05-20 | Exp: 2028-05-15

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

88/1007169901Grant: 2007-01-30 | Exp: 2027-01-25

88/1009777059Grant: 2017-10-03 | Exp: 2037-09-28

88/1007811785Grant: 2010-10-12 | Exp: 2030-10-07

88/10010072075Grant: 2018-09-11 | Exp: 2038-09-06

88/10011111291Grant: 2021-09-07 | Exp: 2041-09-02

87/1007910098Grant: 2011-03-22 | Exp: 2031-03-17

86/1008147830Grant: 2012-04-03 | Exp: 2032-03-29

86/10010906968Grant: 2021-02-02 | Exp: 2041-01-28

85/1007691977Grant: 2010-04-06 | Exp: 2030-04-01

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

85/10011407794Grant: 2022-08-09 | Exp: 2042-08-04

85/10011732036Grant: 2023-08-22 | Exp: 2043-08-17

85/10012121586Grant: 2024-10-22 | Exp: 2044-10-17

85/10011891437Grant: 2024-02-06 | Exp: 2044-02-01

85/1008211864Grant: 2012-07-03 | Exp: 2032-06-28

85/1008921537Grant: 2014-12-30 | Exp: 2034-12-25

85/1007115415Grant: 2006-10-03 | Exp: 2026-09-28

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

Formulation

(3)

92/1009226961Grant: 2016-01-05 | Exp: 2035-12-31

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

85/10010925966Grant: 2021-02-23 | Exp: 2041-02-18

Method of Use

(10)

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

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

88/1007482005Grant: 2009-01-27 | Exp: 2029-01-22

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

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

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

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

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

Manufacturing

(2)

85/10011999791Grant: 2024-06-04 | Exp: 2044-05-30

85/1009850514Grant: 2017-12-26 | Exp: 2037-12-21

Diagnostic

(3)

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

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 761198 | 2 presentations

BiosimilarLicensedCDERInjection

Proper Name

bevacizumab-tnjn

Applicant

Bio-Thera Solutions, Ltd.

Approval Date

6-Dec-23

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

1 letter from Drugs@FDA

Date	Submission	Document
Dec 7, 2023	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — 100MG/4ML(25MG/ML)

▴

INJECTABLE;INJECTION | Approved: 2023-12-06 00:00:00

No patent or exclusivity listings for this strength.

#002 — 400MG/16ML(25MG/ML)

▾

INJECTABLE;INJECTION | Approved: 2023-12-06 00:00:00