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BLA

ADUCANUMAB-AVWA | B761178 | BIOGEN INC

2 products0 Purple Book patents

Biologic LOEProtected

Estimated date when biosimilar competition may begin

June 7, 2033(2531 days remaining)

Regulatory Exclusivities

Type	Expiry	Status	Source
12-Year BPCIA	Jun. 7, 2033	Active	Computed

Purple Book Patents

No listed patents in Purple Book.

Estimated Patent LOE

Sep. 7, 20436275 days remaining

Based on latest discovered patent 11753669(composition) · relevance 50/100

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

Discovered Patents

View all 34 patents →

34 AI-discovered patents, sorted by relevance.

Composition

(12)

85/1008173775Grant: 2012-05-08 | Exp: 2032-05-03

75/1009321840Grant: 2016-04-26 | Exp: 2036-04-21

72/1007888076Grant: 2011-02-15 | Exp: 2031-02-10

70/1009260520Grant: 2016-02-16 | Exp: 2036-02-11

60/1008557240Grant: 2013-10-15 | Exp: 2033-10-10

55/1007414123Grant: 2008-08-19 | Exp: 2028-08-14

50/10011753669Grant: 2023-09-12 | Exp: 2043-09-07

50/1006307025Grant: 2001-10-23 | Exp: 2021-10-18

50/1007863419Grant: 2011-01-04 | Exp: 2030-12-30

50/10010273310Grant: 2019-04-30 | Exp: 2039-04-25

50/1008318917Grant: 2012-11-27 | Exp: 2032-11-22

50/1009409950Grant: 2016-08-09 | Exp: 2036-08-04

Formulation

(4)

90/10011655289Grant: 2023-05-23 | Exp: 2043-05-18

55/1008562967Grant: 2013-10-22 | Exp: 2033-10-17

55/1009522174Grant: 2016-12-20 | Exp: 2036-12-15

50/10010869835Grant: 2020-12-22 | Exp: 2040-12-17

Method of Use

(3)

72/10011340225Grant: 2022-05-24 | Exp: 2042-05-19

70/1008349324Grant: 2013-01-08 | Exp: 2033-01-03

65/1009676849Grant: 2017-06-13 | Exp: 2037-06-08

Manufacturing

(12)

75/10011697670Grant: 2023-07-11 | Exp: 2043-07-06

55/1009163089Grant: 2015-10-20 | Exp: 2035-10-15

55/10010590454Grant: 2020-03-17 | Exp: 2040-03-12

55/1009127043Grant: 2015-09-08 | Exp: 2035-09-03

55/1007759117Grant: 2010-07-20 | Exp: 2030-07-15

50/1009005926Grant: 2015-04-14 | Exp: 2035-04-09

50/1007157276Grant: 2007-01-02 | Exp: 2026-12-28

50/1009752159Grant: 2017-09-05 | Exp: 2037-08-31

50/1009562252Grant: 2017-02-07 | Exp: 2037-02-02

50/1009212379Grant: 2015-12-15 | Exp: 2035-12-10

50/1007220356Grant: 2007-05-22 | Exp: 2027-05-17

50/1009109015Grant: 2015-08-18 | Exp: 2035-08-13

Diagnostic

(3)

65/1009581604Grant: 2017-02-28 | Exp: 2037-02-23

55/1009771617Grant: 2017-09-26 | Exp: 2037-09-21

55/1009784751Grant: 2017-10-10 | Exp: 2037-10-05

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 761178 | 2 presentations

351(a) ReferenceLicensedCDERInjection

Proper Name

aducanumab-avwa

Applicant

Biogen Inc.

Approval Date

7-Jun-21

Presentations

170MG/1.7ML (100MG/ML) — Single-Dose Vial (Intravenous)

300MG/3ML (100MG/ML) — Single-Dose Vial (Intravenous)

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

Approval Letters

6 letters from Drugs@FDA

Date	Submission	Document
Jul 2, 2024	SUPPL -12	View Letter (PDF)
Aug 31, 2023	SUPPL -11	View Letter (PDF)
Feb 9, 2023	SUPPL -7	View Letter (PDF)
May 3, 2022	SUPPL -5	View Letter (PDF)
Jul 8, 2021	SUPPL -3	View Letter (PDF)
Jun 7, 2021	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — 170MG/1.7ML (100MG/ML)

▴

INJECTABLE;INJECTION | Approved: 2021-06-07 00:00:00

No patent or exclusivity listings for this strength.

#002 — 300MG/3ML (100MG/ML)

▾

INJECTABLE;INJECTION | Approved: 2021-06-07 00:00:00