Viewing data from:

MYOZYME

BLA

ALGLUCOSIDASE ALFA | B125141 | GENZYME

1 product0 Purple Book patents

Biologic LOELOE has passed

Estimated date when biosimilar competition may begin

April 28, 2013(4814 days ago)

Regulatory Exclusivities

Type	Expiry	Status	Source
7-Year Orphan	Apr. 28, 2013	Expired	Purple Book

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 106 patents →

Top 50 of 106 AI-discovered patents by relevance.

Composition

(17)

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

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

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

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

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

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

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

90/10010781434Grant: 2020-09-22 | Exp: 2040-09-17

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

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

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

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

88/10010660972Grant: 2020-05-26 | Exp: 2040-05-21

88/10012215138Grant: 2025-02-04 | Exp: 2045-01-30

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

85/10011208458Grant: 2021-12-28 | Exp: 2041-12-23

85/10010202591Grant: 2019-02-12 | Exp: 2039-02-07

Formulation

(5)

95/100OB10857212Grant: 2020-12-08 | Exp: 2040-12-03

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

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

88/100OB11278601Grant: 2022-03-22 | Exp: 2042-03-17

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

Method of Use

(20)

95/10012139709Grant: 2024-11-12 | Exp: 2044-11-07

92/10010869906Grant: 2020-12-22 | Exp: 2040-12-17

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

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

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

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

92/10012036190Grant: 2024-07-16 | Exp: 2044-07-11

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

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

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

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

88/10010059947Grant: 2018-08-28 | Exp: 2038-08-23

88/1008679478Grant: 2014-03-25 | Exp: 2034-03-20

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

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

85/10012091665Grant: 2024-09-17 | Exp: 2044-09-12

85/10010993995Grant: 2021-05-04 | Exp: 2041-04-29

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

Manufacturing

(8)

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

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

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

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

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

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

85/1009545450Grant: 2017-01-17 | Exp: 2037-01-12

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

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 125141

351(a) ReferenceVoluntarily RevokedCDERFor Injection

Proper Name

alglucosidase alfa

Applicant

Genzyme Corporation

Approval Date

28-Apr-06

Orphan Exclusivity

28-Apr-13

Expired

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

Approval Letters

6 letters from Drugs@FDA

Date	Submission	Document
Feb 19, 2020	SUPPL -223	View Letter (PDF)
Jun 4, 2019	SUPPL -222	View Letter (PDF)
May 22, 2014	SUPPL -219	View Letter (PDF)
Jul 13, 2012	SUPPL -176	View Letter (PDF)
Dec 24, 2008	SUPPL -74	View Letter (PDF)
May 2, 2006	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 20MG/KG

▴

INJECTABLE; IV (INFUSION) | Approved: 2006-04-28 00:00:00

No patent or exclusivity listings for this strength.