Viewing data from:

OMLYCLO

Interchangeable Biosimilar

OMALIZUMAB-IGEC | B761399 | CELLTRION INC

3 products0 Purple Book patents3 biosimilars

Biologic LOEBiosimilar competition

3 approved biosimilars

March 7, 2037(3900 days remaining)

Regulatory Exclusivities

Type	Expiry	Status	Source
12-Year BPCIA	Mar. 7, 2037	Active	Computed

Purple Book Patents

No listed patents in Purple Book.

Estimated Patent LOE

Sep. 18, 20457017 days remaining

Based on latest discovered patent 12421299(manufacturing) · relevance 85/100

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

Approved Biosimilars

OmlycloBLA 761399ICOmlycloBLA 761399ICOmlycloBLA 761399IC

Discovered Patents

View all 1,028 patents →

Top 50 of 1,028 AI-discovered patents by relevance.

Composition

(35)

95/1009273113Grant: 2016-03-01 | Exp: 2036-02-25

95/1008226960Grant: 2012-07-24 | Exp: 2032-07-19

92/1009815869Grant: 2017-11-14 | Exp: 2037-11-09

92/1008114960Grant: 2012-02-14 | Exp: 2032-02-09

92/10011407794Grant: 2022-08-09 | Exp: 2042-08-04

90/1008252287Grant: 2012-08-28 | Exp: 2032-08-23

90/1006761889Grant: 2004-07-13 | Exp: 2024-07-08

89/1006682735Grant: 2004-01-27 | Exp: 2024-01-22

88/1008071097Grant: 2011-12-06 | Exp: 2031-12-01

88/10011530275Grant: 2022-12-20 | Exp: 2042-12-15

88/1007862827Grant: 2011-01-04 | Exp: 2030-12-30

88/10011639378Grant: 2023-05-02 | Exp: 2043-04-27

88/1008163522Grant: 2012-04-24 | Exp: 2032-04-19

88/1008618274Grant: 2013-12-31 | Exp: 2033-12-26

88/1006686455Grant: 2004-02-03 | Exp: 2024-01-29

85/1009926379Grant: 2018-03-27 | Exp: 2038-03-22

85/1006639055Grant: 2003-10-28 | Exp: 2023-10-23

85/1006870033Grant: 2005-03-22 | Exp: 2025-03-17

85/10010450381Grant: 2019-10-22 | Exp: 2039-10-17

85/10011999802Grant: 2024-06-04 | Exp: 2044-05-30

85/1008563683Grant: 2013-10-22 | Exp: 2033-10-17

85/1007427596Grant: 2008-09-23 | Exp: 2028-09-18

85/10010358465Grant: 2019-07-23 | Exp: 2039-07-18

85/1007427404Grant: 2008-09-23 | Exp: 2028-09-18

85/1006911321Grant: 2005-06-28 | Exp: 2025-06-23

85/1008119145Grant: 2012-02-21 | Exp: 2032-02-16

85/1007618636Grant: 2009-11-17 | Exp: 2029-11-12

85/10011111311Grant: 2021-09-07 | Exp: 2041-09-02

85/10011466087Grant: 2022-10-11 | Exp: 2042-10-06

85/1007291708Grant: 2007-11-06 | Exp: 2027-11-01

85/1006583272Grant: 2003-06-24 | Exp: 2023-06-19

85/1007318918Grant: 2008-01-15 | Exp: 2028-01-10

85/1008722859Grant: 2014-05-13 | Exp: 2034-05-08

85/1006407213Grant: 2002-06-18 | Exp: 2022-06-13

85/10010696721Grant: 2020-06-30 | Exp: 2040-06-25

Formulation

(2)

92/1008703126Grant: 2014-04-22 | Exp: 2034-04-17

90/1007060268Grant: 2006-06-13 | Exp: 2026-06-08

Method of Use

(4)

92/10012146187Grant: 2024-11-19 | Exp: 2044-11-14

92/10012240884Grant: 2025-03-04 | Exp: 2045-02-27

85/1009676870Grant: 2017-06-13 | Exp: 2037-06-08

85/1008802092Grant: 2014-08-12 | Exp: 2034-08-07

Manufacturing

(7)

88/1009631007Grant: 2017-04-25 | Exp: 2037-04-20

88/1007662934Grant: 2010-02-16 | Exp: 2030-02-11

85/10011976127Grant: 2024-05-07 | Exp: 2044-05-02

85/10010723762Grant: 2020-07-28 | Exp: 2040-07-23

85/10012421299Grant: 2025-09-23 | Exp: 2045-09-18

85/1008884096Grant: 2014-11-11 | Exp: 2034-11-06

85/1006555373Grant: 2003-04-29 | Exp: 2023-04-24

Device

(1)

85/1008118782Grant: 2012-02-21 | Exp: 2032-02-16

Diagnostic

(1)

85/10012174184Grant: 2024-12-24 | Exp: 2044-12-19

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 761399 | 3 presentations

InterchangeableLicensedCDERInjection

Proper Name

omalizumab-igec

Applicant

CELLTRION, Inc.

Approval Date

7-Mar-25

Reference Product: Xolair — omalizumab

Presentations

75MG/0.5ML — Pre-Filled Syringe (Subcutaneous)

150MG/ML — Pre-Filled Syringe (Subcutaneous)

300MG/2ML (150MG/ML) — Pre-Filled Syringe (Subcutaneous)

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

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Mar 7, 2025	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (3)

Sort:

#001 — 75MG/0.5ML

▴

INJECTABLE;INJECTION | Approved: 2025-03-07 00:00:00

No patent or exclusivity listings for this strength.

#002 — 150MG/ML

▾

INJECTABLE;INJECTION | Approved: 2025-03-07 00:00:00

#003 — 300MG/2ML

▾

INJECTABLE;INJECTION | Approved: 2025-03-07 00:00:00