Viewing data from:

LUMIZYME

BLA

ALGLUCOSIDASE ALFA | B125291 | GENZYME

1 product0 Purple Book patents

Biologic LOELOE has passed

Estimated date when biosimilar competition may begin

May 24, 2022(1501 days ago)

Regulatory Exclusivities

Type	Expiry	Status	Source
12-Year BPCIA	May. 24, 2022	Expired	Computed

Purple Book Patents

No listed patents in Purple Book.

Estimated Patent LOE

Sep. 11, 20457010 days remaining

Based on latest discovered patent 12414985(composition) · relevance 88/100

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

Discovered Patents

View all 99 patents →

Top 50 of 99 AI-discovered patents by relevance.

Composition

(16)

95/10012305187Grant: 2025-05-20 | Exp: 2045-05-15

94/100OB10208299Grant: 2019-02-19 | Exp: 2039-02-14

92/10011591583Grant: 2023-02-28 | Exp: 2043-02-23

92/1007785856Grant: 2010-08-31 | Exp: 2030-08-26

92/100OB11753632Grant: 2023-09-12 | Exp: 2043-09-07

92/100OB10961522Grant: 2021-03-30 | Exp: 2041-03-25

91/100OB12246062Grant: 2025-03-11 | Exp: 2045-03-06

90/10012139709Grant: 2024-11-12 | Exp: 2044-11-07

90/10012251430Grant: 2025-03-18 | Exp: 2045-03-13

90/10011339406Grant: 2022-05-24 | Exp: 2042-05-19

88/100OB12414985Grant: 2025-09-16 | Exp: 2045-09-11

88/100OB10857212Grant: 2020-12-08 | Exp: 2040-12-03

88/1006905856Grant: 2005-06-14 | Exp: 2025-06-09

88/10010172924Grant: 2019-01-08 | Exp: 2039-01-03

88/10011421211Grant: 2022-08-23 | Exp: 2042-08-18

86/10011970722Grant: 2024-04-30 | Exp: 2044-04-25

Formulation

(3)

92/10010512676Grant: 2019-12-24 | Exp: 2039-12-19

90/10011491211Grant: 2022-11-08 | Exp: 2042-11-03

87/10011998643Grant: 2024-06-04 | Exp: 2044-05-30

Method of Use

(22)

92/1007351410Grant: 2008-04-01 | Exp: 2028-03-27

92/10011944628Grant: 2024-04-02 | Exp: 2044-03-28

92/1007910545Grant: 2011-03-22 | Exp: 2031-03-17

92/1007655226Grant: 2010-02-02 | Exp: 2030-01-28

92/10011090368Grant: 2021-08-17 | Exp: 2041-08-12

92/10010829764Grant: 2020-11-10 | Exp: 2040-11-05

92/10010993995Grant: 2021-05-04 | Exp: 2041-04-29

92/100OB11278601Grant: 2022-03-22 | Exp: 2042-03-17

92/10011236338Grant: 2022-02-01 | Exp: 2042-01-27

90/10010308940Grant: 2019-06-04 | Exp: 2039-05-30

90/10011859186Grant: 2024-01-02 | Exp: 2043-12-28

88/100OB8697748Grant: 2014-04-15 | Exp: 2034-04-10

88/10011712463Grant: 2023-08-01 | Exp: 2043-07-27

88/10012208144Grant: 2025-01-28 | Exp: 2045-01-23

88/10011060089Grant: 2021-07-13 | Exp: 2041-07-08

88/10010080783Grant: 2018-09-25 | Exp: 2038-09-20

88/10012290549Grant: 2025-05-06 | Exp: 2045-05-01

87/1008809282Grant: 2014-08-19 | Exp: 2034-08-14

85/10010028993Grant: 2018-07-24 | Exp: 2038-07-19

85/10011672802Grant: 2023-06-13 | Exp: 2043-06-08

85/1008679478Grant: 2014-03-25 | Exp: 2034-03-20

85/10012213979Grant: 2025-02-04 | Exp: 2045-01-30

Manufacturing

(9)

92/1007723296Grant: 2010-05-25 | Exp: 2030-05-20

90/1006670165Grant: 2003-12-30 | Exp: 2023-12-25

90/10011441138Grant: 2022-09-13 | Exp: 2042-09-08

88/10010973887Grant: 2021-04-13 | Exp: 2041-04-08

88/1006861242Grant: 2005-03-01 | Exp: 2025-02-24

88/10010227577Grant: 2019-03-12 | Exp: 2039-03-07

85/1007001994Grant: 2006-02-21 | Exp: 2026-02-16

82/1009687531Grant: 2017-06-27 | Exp: 2037-06-22

82/10010363291Grant: 2019-07-30 | Exp: 2039-07-25

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 125291

351(a) ReferenceLicensedCDERFor Injection

Proper Name

alglucosidase alfa

Applicant

Genzyme Corporation

Approval Date

24-May-10

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

Approval Letters

12 letters from Drugs@FDA

Date	Submission	Document
Jan 2, 2025	SUPPL -161	View Letter (PDF)
Mar 25, 2024	SUPPL -160	View Letter (PDF)
May 25, 2023	SUPPL -159	View Letter (PDF)
May 13, 2022	SUPPL -156	View Letter (PDF)
May 13, 2022	SUPPL -157	View Letter (PDF)
Feb 19, 2020	SUPPL -151	View Letter (PDF)
Jun 4, 2019	SUPPL -148	View Letter (PDF)
Aug 4, 2014	SUPPL -136	View Letter (PDF)
May 27, 2014	SUPPL -133	View Letter (PDF)
Jul 18, 2012	SUPPL -79	View Letter (PDF)
Jul 13, 2012	SUPPL -63	View Letter (PDF)
May 27, 2010	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 5MG/ML

▴

POWDER; IV (INFUSION) | Approved: 2010-05-24 00:00:00

No patent or exclusivity listings for this strength.