Viewing data from:

ELAPRASE

BLA

IDURSULFASE | B125151 | SHIRE

1 product0 Purple Book patents

Biologic LOELOE has passed

Estimated date when biosimilar competition may begin

July 24, 2013(4727 days ago)

Regulatory Exclusivities

Type	Expiry	Status	Source
7-Year Orphan	Jul. 24, 2013	Expired	Purple Book

Purple Book Patents

No listed patents in Purple Book.

Estimated Patent LOE

Dec. 26, 20446751 days remaining

Based on latest discovered patent 12178861(formulation) · relevance 68/100

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

Discovered Patents

View all 33 patents →

33 AI-discovered patents, sorted by relevance.

Composition

(11)

90/1006541254Grant: 2003-04-01 | Exp: 2023-03-27

86/10010722559Grant: 2020-07-28 | Exp: 2040-07-23

85/1008227212Grant: 2012-07-24 | Exp: 2032-07-19

75/10011116823Grant: 2021-09-14 | Exp: 2041-09-09

72/10011845935Grant: 2023-12-19 | Exp: 2043-12-14

72/1007833742Grant: 2010-11-16 | Exp: 2030-11-11

68/1008580922Grant: 2013-11-12 | Exp: 2033-11-07

65/1009932568Grant: 2018-04-03 | Exp: 2038-03-29

65/1009267166Grant: 2016-02-23 | Exp: 2036-02-18

62/1009523113Grant: 2016-12-20 | Exp: 2036-12-15

55/1007135452Grant: 2006-11-14 | Exp: 2026-11-09

Formulation

(14)

88/1009770410Grant: 2017-09-26 | Exp: 2037-09-21

82/10011998643Grant: 2024-06-04 | Exp: 2044-05-30

75/1009072785Grant: 2015-07-07 | Exp: 2035-07-02

70/1009937244Grant: 2018-04-10 | Exp: 2038-04-05

68/10012178861Grant: 2024-12-31 | Exp: 2044-12-26

65/1007833766Grant: 2010-11-16 | Exp: 2030-11-11

65/1009662376Grant: 2017-05-30 | Exp: 2037-05-25

65/10011779635Grant: 2023-10-10 | Exp: 2043-10-05

55/1009352027Grant: 2016-05-31 | Exp: 2036-05-26

50/10011020459Grant: 2021-06-01 | Exp: 2041-05-27

50/1009694057Grant: 2017-07-04 | Exp: 2037-06-29

50/10010238720Grant: 2019-03-26 | Exp: 2039-03-21

50/1009669076Grant: 2017-06-06 | Exp: 2037-06-01

50/1006190702Grant: 2001-02-20 | Exp: 2021-02-15

Method of Use

(1)

85/10011020461Grant: 2021-06-01 | Exp: 2041-05-27

Manufacturing

(6)

72/1007241442Grant: 2007-07-10 | Exp: 2027-07-05

60/1009075057Grant: 2015-07-07 | Exp: 2035-07-02

55/1009488625Grant: 2016-11-08 | Exp: 2036-11-03

50/1009222075Grant: 2015-12-29 | Exp: 2035-12-24

50/10010221400Grant: 2019-03-05 | Exp: 2039-02-28

50/1009809796Grant: 2017-11-07 | Exp: 2037-11-02

Diagnostic

(1)

65/1009562904Grant: 2017-02-07 | Exp: 2037-02-02

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 125151

351(a) ReferenceLicensedCDERInjection

Proper Name

idursulfase

Applicant

Takeda Pharmaceuticals U.S.A., Inc.

Approval Date

24-Jul-06

Orphan Exclusivity

24-Jul-13

Expired

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

Approval Letters

5 letters from Drugs@FDA

Date	Submission	Document
Dec 7, 2018	SUPPL -197	View Letter (PDF)
Jun 26, 2013	SUPPL -152	View Letter (PDF)
Jun 26, 2013	SUPPL -184	View Letter (PDF)
Nov 8, 2007	SUPPL -32	View Letter (PDF)
Oct 5, 2006	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 6MG/3ML

▴

INJECTABLE; IV (INFUSION) | Approved: 2006-07-24 00:00:00

No patent or exclusivity listings for this strength.