Viewing data from:

XOLAIR

BLA

OMALIZUMAB | B103976 | GENENTECH

4 products8 Purple Book patents

Biologic LOEProtected

Estimated date when biosimilar competition may begin

July 20, 2043(6226 days remaining)

Regulatory Exclusivities

Type	Expiry	Status	Source
12-Year BPCIA	Sep. 28, 2030	Active	Computed

Purple Book Patents (8)

Patent	Expiration	Status
12030959	Jul. 20, 2043	Active
11987637	Jul. 8, 2028	Active
11078294	Jul. 8, 2028	Active
10829732	Mar. 14, 2034	Active
10676710	Mar. 14, 2034	Active
10034940	Nov. 4, 2025	Expired
10017732	Mar. 14, 2034	Active
8574869	Jul. 8, 2028	Active

Discovered Patents

View all 204 patents →

Top 50 of 204 AI-discovered patents by relevance.

Composition

(19)

95/1007351816Grant: 2008-04-01 | Exp: 2028-03-27

95/1006699472Grant: 2004-03-02 | Exp: 2024-02-26

93/1008632775Grant: 2014-01-21 | Exp: 2034-01-16

92/1006685939Grant: 2004-02-03 | Exp: 2024-01-29

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

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

85/1006423512Grant: 2002-07-23 | Exp: 2022-07-18

82/1008586040Grant: 2013-11-19 | Exp: 2033-11-14

75/1009409979Grant: 2016-08-09 | Exp: 2036-08-04

70/1007741072Grant: 2010-06-22 | Exp: 2030-06-17

70/1006407213Grant: 2002-06-18 | Exp: 2022-06-13

70/10010047162Grant: 2018-08-14 | Exp: 2038-08-09

70/1006242195Grant: 2001-06-05 | Exp: 2021-05-31

65/1006639055Grant: 2003-10-28 | Exp: 2023-10-23

65/10011434287Grant: 2022-09-06 | Exp: 2042-09-01

65/1007364731Grant: 2008-04-29 | Exp: 2028-04-24

65/1007749500Grant: 2010-07-06 | Exp: 2030-07-01

Formulation

(12)

95/1009180189Grant: 2015-11-10 | Exp: 2035-11-05

95/10012427193Grant: 2025-09-30 | Exp: 2045-09-25

92/10010377831Grant: 2019-08-13 | Exp: 2039-08-08

90/10010280227Grant: 2019-05-07 | Exp: 2039-05-02

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

82/1009345661Grant: 2016-05-24 | Exp: 2036-05-19

70/10010188735Grant: 2019-01-29 | Exp: 2039-01-24

70/10011103584Grant: 2021-08-31 | Exp: 2041-08-26

68/10010525137Grant: 2020-01-07 | Exp: 2040-01-02

65/1009662395Grant: 2017-05-30 | Exp: 2037-05-25

65/10010933141Grant: 2021-03-02 | Exp: 2041-02-25

65/1008758747Grant: 2014-06-24 | Exp: 2034-06-19

Method of Use

(3)

92/10012030959Grant: 2024-07-09 | Exp: 2044-07-04

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

65/1007727527Grant: 2010-06-01 | Exp: 2030-05-27

Manufacturing

(12)

95/10012371510Grant: 2025-07-29 | Exp: 2045-07-24

95/10011767370Grant: 2023-09-26 | Exp: 2043-09-21

72/1007863042Grant: 2011-01-04 | Exp: 2030-12-30

70/10011661579Grant: 2023-05-30 | Exp: 2043-05-25

70/10011802165Grant: 2023-10-31 | Exp: 2043-10-26

70/1009150641Grant: 2015-10-06 | Exp: 2035-10-01

70/1009243224Grant: 2016-01-26 | Exp: 2036-01-21

68/10010377793Grant: 2019-08-13 | Exp: 2039-08-08

65/10010723762Grant: 2020-07-28 | Exp: 2040-07-23

65/1009884904Grant: 2018-02-06 | Exp: 2038-02-01

65/10010377794Grant: 2019-08-13 | Exp: 2039-08-08

65/1007575893Grant: 2009-08-18 | Exp: 2029-08-13

Diagnostic

(4)

85/1009315583Grant: 2016-04-19 | Exp: 2036-04-14

78/1009995755Grant: 2018-06-12 | Exp: 2038-06-07

75/1008227195Grant: 2012-07-24 | Exp: 2032-07-19

75/10012174184Grant: 2024-12-24 | Exp: 2044-12-19

PTAB Proceedings

1 challenge on OB patents at the Patent Trial and Appeal Board

Trial #	Patent	Type	Petitioner	Status	Filed	Decision
IPR2026-00260	12030959	IPR	Amneal Pharmaceuticals, Inc. et al.	Pending	2026-05-26	—

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 103976 | 7 presentations | 8 patents

351(a) ReferenceLicensedCDERFor Injection

Proper Name

omalizumab

Applicant

Genentech, Inc.

Approval Date

20-Jun-03

Listed Patents

Patent Number	Expiration
12030959	July 20, 2043
11987637	July 8, 2028
11078294	July 8, 2028
10829732	March 14, 2034
10676710	March 14, 2034
10034940	November 4, 2025
10017732	March 14, 2034
8574869	July 8, 2028

Presentations

150MG — Single-Dose Vial (Subcutaneous)

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

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

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

75MG/0.5ML — Autoinjector (Subcutaneous)

150MG/ML — Autoinjector (Subcutaneous)

300MG/2ML — Autoinjector (Subcutaneous)

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

Approval Letters

15 letters from Drugs@FDA

Date	Submission	Document
Feb 20, 2024	SUPPL -5245	View Letter (PDF)
Mar 20, 2023	SUPPL -5243	View Letter (PDF)
Apr 13, 2021	SUPPL -5238	View Letter (PDF)
Dec 2, 2020	SUPPL -5235	View Letter (PDF)
May 2, 2019	SUPPL -5234	View Letter (PDF)
Oct 1, 2018	SUPPL -5231	View Letter (PDF)
Jul 7, 2016	SUPPL -5225	View Letter (PDF)
Dec 8, 2015	SUPPL -5224	View Letter (PDF)
Oct 1, 2014	SUPPL -5161	View Letter (PDF)
Mar 25, 2014	SUPPL -5211	View Letter (PDF)
Jan 5, 2012	SUPPL -5191	View Letter (PDF)
Jan 10, 2011	SUPPL -5180	View Letter (PDF)
Feb 5, 2010	SUPPL -5166	View Letter (PDF)
Apr 14, 2006	SUPPL -5087	View Letter (PDF)
Mar 30, 2004	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (4)

Sort:

#001 — 150MG/VIAL

▴

VIAL | Approved: 2003-06-20 00:00:00

No patent or exclusivity listings for this strength.

#002 — 75MG/0.5ML

▾

SYRINGE | Approved: 2003-06-20 00:00:00

#003 — 150MG/ML

▾

SYRINGE | Approved: 2003-06-20 00:00:00

#004 — 300MG/2ML

▾

SYRINGE | Approved: 2003-06-20 00:00:00