Viewing data from:

ZEVALIN

BLA

IBRITUMOMAB TIUXETAN | B125019 | SPECTRUM PHARMS

1 product0 Purple Book patents

Biologic LOELOE has passed

Estimated date when biosimilar competition may begin

February 19, 2009(6343 days ago)

Regulatory Exclusivities

Type	Expiry	Status	Source
7-Year Orphan	Feb. 19, 2009	Expired	Purple Book

Purple Book Patents

No listed patents in Purple Book.

Estimated Patent LOE

Aug. 7, 20456975 days remaining

Based on latest discovered patent 12384852(composition) · relevance 75/100

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

Discovered Patents

View all 60 patents →

Top 50 of 60 AI-discovered patents by relevance.

Composition

(29)

92/1009045543Grant: 2015-06-02 | Exp: 2035-05-28

90/10010808039Grant: 2020-10-20 | Exp: 2040-10-15

88/1007498298Grant: 2009-03-03 | Exp: 2029-02-26

88/1007491696Grant: 2009-02-17 | Exp: 2029-02-12

88/1008652479Grant: 2014-02-18 | Exp: 2034-02-13

88/1008703714Grant: 2014-04-22 | Exp: 2034-04-17

86/1007994135Grant: 2011-08-09 | Exp: 2031-08-04

86/1007745394Grant: 2010-06-29 | Exp: 2030-06-24

85/1007947839Grant: 2011-05-24 | Exp: 2031-05-19

85/1007855275Grant: 2010-12-21 | Exp: 2030-12-16

85/1007964566Grant: 2011-06-21 | Exp: 2031-06-16

85/1007799900Grant: 2010-09-21 | Exp: 2030-09-16

84/1008436147Grant: 2013-05-07 | Exp: 2033-05-02

82/1007964567Grant: 2011-06-21 | Exp: 2031-06-16

82/1008853161Grant: 2014-10-07 | Exp: 2034-10-02

80/1008142784Grant: 2012-03-27 | Exp: 2032-03-22

78/1007727525Grant: 2010-06-01 | Exp: 2030-05-27

78/10011013816Grant: 2021-05-25 | Exp: 2041-05-20

78/10010414826Grant: 2019-09-17 | Exp: 2039-09-12

76/10010253099Grant: 2019-04-09 | Exp: 2039-04-04

75/1008076292Grant: 2011-12-13 | Exp: 2031-12-08

75/10012384852Grant: 2025-08-12 | Exp: 2045-08-07

75/1008557780Grant: 2013-10-15 | Exp: 2033-10-10

72/10010647779Grant: 2020-05-12 | Exp: 2040-05-07

72/1007521541Grant: 2009-04-21 | Exp: 2029-04-16

72/1008168590Grant: 2012-05-01 | Exp: 2032-04-26

72/1007887804Grant: 2011-02-15 | Exp: 2031-02-10

70/1008309300Grant: 2012-11-13 | Exp: 2032-11-08

68/10011518810Grant: 2022-12-06 | Exp: 2042-12-01

Formulation

(1)

85/10011951168Grant: 2024-04-09 | Exp: 2044-04-04

Method of Use

(10)

85/1007534427Grant: 2009-05-19 | Exp: 2029-05-14

82/10011865175Grant: 2024-01-09 | Exp: 2044-01-04

80/10011220552Grant: 2022-01-11 | Exp: 2042-01-06

80/1009011864Grant: 2015-04-21 | Exp: 2035-04-16

78/1007452538Grant: 2008-11-18 | Exp: 2028-11-13

75/1007569554Grant: 2009-08-04 | Exp: 2029-07-30

75/10011364235Grant: 2022-06-21 | Exp: 2042-06-16

75/10010758526Grant: 2020-09-01 | Exp: 2040-08-27

72/10011844799Grant: 2023-12-19 | Exp: 2043-12-14

72/10012133849Grant: 2024-11-05 | Exp: 2044-10-31

Manufacturing

(2)

75/1008558060Grant: 2013-10-15 | Exp: 2033-10-10

75/1009486546Grant: 2016-11-08 | Exp: 2036-11-03

Diagnostic

(8)

95/10011686734Grant: 2023-06-27 | Exp: 2043-06-22

92/10010705095Grant: 2020-07-07 | Exp: 2040-07-02

90/1009879325Grant: 2018-01-30 | Exp: 2038-01-25

90/1008871449Grant: 2014-10-28 | Exp: 2034-10-23

88/1008124350Grant: 2012-02-28 | Exp: 2032-02-23

82/1009709575Grant: 2017-07-18 | Exp: 2037-07-13

82/1006329531Grant: 2001-12-11 | Exp: 2021-12-06

72/1008771966Grant: 2014-07-08 | Exp: 2034-07-03

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 125019

351(a) ReferenceLicensedCDERInjection

Proper Name

ibritumomab tiuxetan

Applicant

Acrotech Biopharma Inc.

Approval Date

19-Feb-02

Orphan Exclusivity

19-Feb-09

Expired

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

Approval Letters

12 letters from Drugs@FDA

Date	Submission	Document
Dec 20, 2018	SUPPL -227	View Letter (PDF)
Sep 5, 2013	SUPPL -210	View Letter (PDF)
Sep 5, 2013	SUPPL -213	View Letter (PDF)
Dec 2, 2011	SUPPL -194	View Letter (PDF)
Sep 10, 2009	SUPPL -156	View Letter (PDF)
Mar 28, 2008	SUPPL -135	View Letter (PDF)
Nov 8, 2007	SUPPL -132	View Letter (PDF)
Sep 15, 2005	SUPPL -92	View Letter (PDF)
Aug 8, 2005	SUPPL -88	View Letter (PDF)
Jan 26, 2005	SUPPL -58	View Letter (PDF)
Jan 26, 2005	SUPPL -70	View Letter (PDF)
Mar 30, 2004	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 3.2MG/2ML

▴

INJECTABLE; INJECTION | Approved: 2002-02-19 00:00:00

No patent or exclusivity listings for this strength.