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MVASI

Biosimilar

BEVACIZUMAB-AWWB | B761028 | AMGEN INC

2 products0 Purple Book patents2 biosimilars

Biologic LOEBiosimilar competition

2 approved biosimilars

September 14, 2029(1169 days remaining)

Regulatory Exclusivities

Type	Expiry	Status	Source
12-Year BPCIA	Sep. 14, 2029	Active	Computed

Purple Book Patents

No listed patents in Purple Book.

Estimated Patent LOE

Jul. 24, 20456961 days remaining

Based on latest discovered patent 12371510(manufacturing) · relevance 65/100

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

Approved Biosimilars

MvasiBLA 761028MvasiBLA 761028

Discovered Patents

View all 234 patents →

Top 50 of 234 AI-discovered patents by relevance.

Composition

(26)

85/1007427596Grant: 2008-09-23 | Exp: 2028-09-18

85/10010428125Grant: 2019-10-01 | Exp: 2039-09-26

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

85/10010696721Grant: 2020-06-30 | Exp: 2040-06-25

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

82/1007342104Grant: 2008-03-11 | Exp: 2028-03-06

80/10012209121Grant: 2025-01-28 | Exp: 2045-01-23

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

75/10011407794Grant: 2022-08-09 | Exp: 2042-08-04

75/1006395707Grant: 2002-05-28 | Exp: 2022-05-23

75/1006194551Grant: 2001-02-27 | Exp: 2021-02-22

75/1007803576Grant: 2010-09-28 | Exp: 2030-09-23

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

75/1007090834Grant: 2006-08-15 | Exp: 2026-08-10

75/10010294298Grant: 2019-05-21 | Exp: 2039-05-16

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

72/10011555076Grant: 2023-01-17 | Exp: 2043-01-12

70/1008178082Grant: 2012-05-15 | Exp: 2032-05-10

70/1009273113Grant: 2016-03-01 | Exp: 2036-02-25

70/1006407213Grant: 2002-06-18 | Exp: 2022-06-13

70/1007449551Grant: 2008-11-11 | Exp: 2028-11-06

68/1006350450Grant: 2002-02-26 | Exp: 2022-02-21

65/10011198732Grant: 2021-12-14 | Exp: 2041-12-09

65/1007741072Grant: 2010-06-22 | Exp: 2030-06-17

65/1007115415Grant: 2006-10-03 | Exp: 2026-09-28

65/1009562108Grant: 2017-02-07 | Exp: 2037-02-02

Formulation

(5)

72/1009254321Grant: 2016-02-09 | Exp: 2036-02-04

72/10011103584Grant: 2021-08-31 | Exp: 2041-08-26

70/10010188735Grant: 2019-01-29 | Exp: 2039-01-24

65/10011813328Grant: 2023-11-14 | Exp: 2043-11-09

65/1009320797Grant: 2016-04-26 | Exp: 2036-04-21

Method of Use

(4)

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

75/1007078382Grant: 2006-07-18 | Exp: 2026-07-13

72/10012186590Grant: 2025-01-07 | Exp: 2045-01-02

72/1008828666Grant: 2014-09-09 | Exp: 2034-09-04

Manufacturing

(13)

81/10010590186Grant: 2020-03-17 | Exp: 2040-03-12

72/10010377793Grant: 2019-08-13 | Exp: 2039-08-08

72/1008685893Grant: 2014-04-01 | Exp: 2034-03-27

72/10010723762Grant: 2020-07-28 | Exp: 2040-07-23

70/10011680110Grant: 2023-06-20 | Exp: 2043-06-15

70/10011312745Grant: 2022-04-26 | Exp: 2042-04-21

70/10010501491Grant: 2019-12-10 | Exp: 2039-12-05

68/1009422329Grant: 2016-08-23 | Exp: 2036-08-18

68/10010421950Grant: 2019-09-24 | Exp: 2039-09-19

68/10010676710Grant: 2020-06-09 | Exp: 2040-06-04

65/10011767370Grant: 2023-09-26 | Exp: 2043-09-21

65/1008809051Grant: 2014-08-19 | Exp: 2034-08-14

65/10012371510Grant: 2025-07-29 | Exp: 2045-07-24

Diagnostic

(2)

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

70/10012174184Grant: 2024-12-24 | Exp: 2044-12-19

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 761028 | 2 presentations

BiosimilarLicensedCDERInjection

Proper Name

bevacizumab-awwb

Applicant

Amgen Inc.

Approval Date

14-Sep-17

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
Nov 16, 2021	SUPPL -8	View Letter (PDF)
Apr 22, 2021	SUPPL -6	View Letter (PDF)
Jun 25, 2019	SUPPL -4	View Letter (PDF)
Sep 14, 2017	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — 100MG/4ML (25MG/ML)

▴

INJECTABLE; INJECTION | Approved: 2017-09-14 00:00:00

No patent or exclusivity listings for this strength.

#002 — 400MG/16ML (25MG/ML)

▾

INJECTABLE; INJECTION | Approved: 2017-09-14 00:00:00