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BLA

ABCIXIMAB | B103575 | CENTOCOR INC

1 product0 Purple Book patents

Biologic LOENo LOE data

No exclusivity dates or listed patents found in Purple Book

Purple Book Patents

No listed patents in Purple Book.

Estimated Patent LOE

Feb. 13, 20404973 days remaining

Based on latest discovered patent 10562982(composition) · relevance 70/100

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

Discovered Patents

View all 14 patents →

14 AI-discovered patents, sorted by relevance.

Composition

(7)

92/1007332162Grant: 2008-02-19 | Exp: 2028-02-14

90/1007498410Grant: 2009-03-03 | Exp: 2029-02-26

88/10010112989Grant: 2018-10-30 | Exp: 2038-10-25

82/1009028816Grant: 2015-05-12 | Exp: 2035-05-07

70/1006652863Grant: 2003-11-25 | Exp: 2023-11-20

70/10010562982Grant: 2020-02-18 | Exp: 2040-02-13

55/1007037496Grant: 2006-05-02 | Exp: 2026-04-27

Formulation

(1)

50/1008871201Grant: 2014-10-28 | Exp: 2034-10-23

Method of Use

(4)

88/1007166612Grant: 2007-01-23 | Exp: 2027-01-18

85/1006346517Grant: 2002-02-12 | Exp: 2022-02-07

82/1008877710Grant: 2014-11-04 | Exp: 2034-10-30

72/1009381243Grant: 2016-07-05 | Exp: 2036-06-30

Manufacturing

(2)

50/10010047167Grant: 2018-08-14 | Exp: 2038-08-09

50/1008017325Grant: 2011-09-13 | Exp: 2031-09-08

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 103575

351(a) ReferenceVoluntarily RevokedCDERInjection

Proper Name

abciximab

Applicant

Janssen Biotech, Inc.

Approval Date

22-Dec-94

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

Approval Letters

6 letters from Drugs@FDA

Date	Submission	Document
Aug 8, 2019	SUPPL -5138	View Letter (PDF)
Nov 27, 2013	SUPPL -5126	View Letter (PDF)
Mar 29, 2004	SUPPL -1008	View Letter (PDF)
Mar 29, 2004	SUPPL -1010	View Letter (PDF)
Dec 4, 2003	SUPPL -5025	View Letter (PDF)
Dec 4, 2003	SUPPL -5022	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 2MG/ML

▴

INJECTABLE; INJECTION | Approved: 1994-12-22 00:00:00

No patent or exclusivity listings for this strength.