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POMBILITI

BLA

CIPAGLUCOSIDASE ALFA-ATGA | B761204 | AMICUS THERAP US

1 product0 Purple Book patents

Biologic LOEProtected

Estimated date when biosimilar competition may begin

September 28, 2035(3374 days remaining)

Regulatory Exclusivities

Type	Expiry	Status	Source
12-Year BPCIA	Sep. 28, 2035	Active	Computed

Purple Book Patents

No listed patents in Purple Book.

Estimated Patent LOE

Jan. 16, 20456772 days remaining

Based on latest discovered patent 12203103(manufacturing) · relevance 55/100

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

Discovered Patents

View all 24 patents →

24 AI-discovered patents, sorted by relevance.

Composition

(3)

70/10011160874Grant: 2021-11-02 | Exp: 2041-10-28

65/10011208644Grant: 2021-12-28 | Exp: 2041-12-23

62/10010064952Grant: 2018-09-04 | Exp: 2038-08-30

Formulation

(2)

55/1008192975Grant: 2012-06-05 | Exp: 2032-05-31

50/1006734164Grant: 2004-05-11 | Exp: 2024-05-06

Manufacturing

(19)

72/10011839861Grant: 2023-12-12 | Exp: 2043-12-07

68/10010968252Grant: 2021-04-06 | Exp: 2041-04-01

65/10011912741Grant: 2024-02-27 | Exp: 2044-02-22

65/10011884703Grant: 2024-01-30 | Exp: 2044-01-25

65/1009657056Grant: 2017-05-23 | Exp: 2037-05-18

60/1009650412Grant: 2017-05-16 | Exp: 2037-05-11

60/10010087214Grant: 2018-10-02 | Exp: 2038-09-27

55/10012203103Grant: 2025-01-21 | Exp: 2045-01-16

55/1009650413Grant: 2017-05-16 | Exp: 2037-05-11

55/10010421949Grant: 2019-09-24 | Exp: 2039-09-19

55/10010071364Grant: 2018-09-11 | Exp: 2038-09-06

55/10011384342Grant: 2022-07-12 | Exp: 2042-07-07

52/10011685943Grant: 2023-06-27 | Exp: 2043-06-22

50/10011369703Grant: 2022-06-28 | Exp: 2042-06-23

50/10011912739Grant: 2024-02-27 | Exp: 2044-02-22

50/10011306341Grant: 2022-04-19 | Exp: 2042-04-14

50/10011060058Grant: 2021-07-13 | Exp: 2041-07-08

50/10011635363Grant: 2023-04-25 | Exp: 2043-04-20

50/1009365832Grant: 2016-06-14 | Exp: 2036-06-09

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 761204

351(a) ReferenceLicensedCDERInjection

Proper Name

cipaglucosidase alfa-atga

Applicant

Amicus Therapeutics US, LLC

Approval Date

28-Sep-23

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

Approval Letters

2 letters from Drugs@FDA

Date	Submission	Document
Jul 26, 2024	SUPPL -4	View Letter (PDF)
Oct 30, 2023	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 105MG

▴

INJECTABLE;INJECTION | Approved: 2023-09-28 00:00:00

No patent or exclusivity listings for this strength.