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BLA

PEGLOTICASE | B125293 | HORIZON PHARMA

1 product0 Purple Book patents

Biologic LOELOE has passed

Estimated date when biosimilar competition may begin

September 14, 2022(1388 days ago)

Regulatory Exclusivities

Type	Expiry	Status	Source
12-Year BPCIA	Sep. 14, 2022	Expired	Computed
7-Year Orphan	Sep. 14, 2017	Expired	Purple Book

Purple Book Patents

No listed patents in Purple Book.

Estimated Patent LOE

Aug. 14, 20456982 days remaining

Based on latest discovered patent 12390485(composition) · relevance 85/100

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

Discovered Patents

View all 41 patents →

41 AI-discovered patents, sorted by relevance.

Composition

(16)

95/10010815461Grant: 2020-10-27 | Exp: 2040-10-22

94/1008465735Grant: 2013-06-18 | Exp: 2033-06-13

92/10011098289Grant: 2021-08-24 | Exp: 2041-08-19

92/1008178334Grant: 2012-05-15 | Exp: 2032-05-10

90/1007964381Grant: 2011-06-21 | Exp: 2031-06-16

89/10010883087Grant: 2021-01-05 | Exp: 2040-12-31

89/1007811800Grant: 2010-10-12 | Exp: 2030-10-07

88/1008293228Grant: 2012-10-23 | Exp: 2032-10-18

85/10012390485Grant: 2025-08-19 | Exp: 2045-08-14

85/1008034594Grant: 2011-10-11 | Exp: 2031-10-06

75/1007189827Grant: 2007-03-13 | Exp: 2027-03-08

75/1006552170Grant: 2003-04-22 | Exp: 2023-04-17

70/1007842784Grant: 2010-11-30 | Exp: 2030-11-25

50/1008592562Grant: 2013-11-26 | Exp: 2033-11-21

50/1008143380Grant: 2012-03-27 | Exp: 2032-03-22

50/10011427627Grant: 2022-08-30 | Exp: 2042-08-25

Formulation

(4)

60/1009352043Grant: 2016-05-31 | Exp: 2036-05-26

55/10011813328Grant: 2023-11-14 | Exp: 2043-11-09

55/10010653781Grant: 2020-05-19 | Exp: 2040-05-14

50/10010166189Grant: 2019-01-01 | Exp: 2038-12-27

Method of Use

(7)

92/10012188927Grant: 2025-01-07 | Exp: 2045-01-02

92/10011982670Grant: 2024-05-14 | Exp: 2044-05-09

90/10012121566Grant: 2024-10-22 | Exp: 2044-10-17

90/10011598767Grant: 2023-03-07 | Exp: 2043-03-02

88/1008148123Grant: 2012-04-03 | Exp: 2032-03-29

80/10011426451Grant: 2022-08-30 | Exp: 2042-08-25

75/10012194078Grant: 2025-01-14 | Exp: 2045-01-09

Manufacturing

(13)

55/10012195779Grant: 2025-01-14 | Exp: 2045-01-09

55/1008354105Grant: 2013-01-15 | Exp: 2033-01-10

55/1007381545Grant: 2008-06-03 | Exp: 2028-05-29

54/10011384378Grant: 2022-07-12 | Exp: 2042-07-07

52/1009371554Grant: 2016-06-21 | Exp: 2036-06-16

50/10010822630Grant: 2020-11-03 | Exp: 2040-10-29

50/10011384140Grant: 2022-07-12 | Exp: 2042-07-07

50/1009388447Grant: 2016-07-12 | Exp: 2036-07-07

50/10011077404Grant: 2021-08-03 | Exp: 2041-07-29

50/10010513723Grant: 2019-12-24 | Exp: 2039-12-19

50/10012312381Grant: 2025-05-27 | Exp: 2045-05-22

50/1009133493Grant: 2015-09-15 | Exp: 2035-09-10

50/10010106829Grant: 2018-10-23 | Exp: 2038-10-18

Diagnostic

(1)

85/10011639927Grant: 2023-05-02 | Exp: 2043-04-27

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 125293 | 2 presentations

351(a) ReferenceLicensedCDERInjection

Proper Name

pegloticase

Applicant

Horizon Therapeutics Ireland DAC

Approval Date

14-Sep-10

Orphan Exclusivity

14-Sep-17

Expired

Presentations

8MG/ML — Single-Dose Vial (Intravenous)

8MG/50ML (0.16MG/ML) — Single-Dose Vial (Intravenous)

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

Approval Letters

12 letters from Drugs@FDA

Date	Submission	Document
Jul 8, 2022	SUPPL -104	View Letter (PDF)
Jul 16, 2018	SUPPL -92	View Letter (PDF)
Sep 15, 2016	SUPPL -89	View Letter (PDF)
May 16, 2016	SUPPL -85	View Letter (PDF)
Apr 12, 2016	SUPPL -86	View Letter (PDF)
Jul 31, 2015	SUPPL -83	View Letter (PDF)
Jul 20, 2015	SUPPL -81	View Letter (PDF)
Oct 16, 2013	SUPPL -60	View Letter (PDF)
Apr 18, 2012	SUPPL -40	View Letter (PDF)
Apr 18, 2012	SUPPL -34	View Letter (PDF)
Oct 26, 2010	SUPPL -1	View Letter (PDF)
Sep 20, 2010	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 8MG

▴

INJECTABLE; INJECTION | Approved: 2010-09-14 00:00:00

No patent or exclusivity listings for this strength.