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XOLAIR Drug Profile
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Summary for Tradename: XOLAIR
| Patents: | 122 |
| Applicants: | 1 |
| BLAs: | 1 |
| Suppliers: see list | 1 |
| Recent Clinical Trials: | See clinical trials for XOLAIR |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for XOLAIR |
Recent Clinical Trials for XOLAIR
Identify potential brand extensions & biosimilar entrants
| Sponsor | Phase |
|---|---|
| Novartis | Phase 1 |
| Beth Israel Deaconess Medical Center | Phase 1 |
| Zhe Jiang Hisun Bioray Bio-pharmaceu tical Co.Ltd | Phase 1 |
Recent Litigation for XOLAIR
Identify key patents and potential future biosimilar entrants
PTAB Litigation
| Petitioner | Date |
|---|---|
| GEMoaB Monoclonals GmbH | 2019-12-20 |
| 2017-12-20 |
Pharmacology for XOLAIR
| Mechanism of Action | IgE-directed Antibody Interactions |
| Physiological Effect | Decreased IgE Activity |
Patent Text Search: US Patents for XOLAIR
| Applicant | Tradename | Biologic Ingredient | Dosage Form | BLA | Number | Approval Date | Patent No. | Assignee | Estimated Patent Expiration | Status | Orphan | Source |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Genentech | XOLAIR | omalizumab | VIAL | 103976 | 001 | 2003-06-20 | Start Trial | ATOPIX THERAPEUTICS LIMITED (London, GB) | 2034-05-02 | RX | search | |
| Genentech | XOLAIR | omalizumab | VIAL | 103976 | 001 | 2003-06-20 | Start Trial | SIO2 MEDICAL PRODUCTS, INC. (Auburn, AL) | 2033-03-11 | RX | search | |
| Genentech | XOLAIR | omalizumab | VIAL | 103976 | 001 | 2003-06-20 | Start Trial | Knopp Biosciences LLC (Pittsburgh, PA) | 2033-08-13 | RX | search | |
| Genentech | XOLAIR | omalizumab | VIAL | 103976 | 001 | 2003-06-20 | Start Trial | AbbVie Inc. (North Chicago, IL) | 2026-09-08 | RX | search | |
| Genentech | XOLAIR | omalizumab | VIAL | 103976 | 001 | 2003-06-20 | Start Trial | CureVac AG (Tubingen, DE) | 2032-02-15 | RX | search | |
| Genentech | XOLAIR | omalizumab | VIAL | 103976 | 001 | 2003-06-20 | Start Trial | ALEXION PHARMACEUTICALS, INC. (New Haven, CT) | 2024-12-29 | RX | search | |
| >Applicant | >Tradename | >Biologic Ingredient | >Dosage Form | >BLA | >Number | >Approval Date | >Patent No. | >Assignee | >Estimated Patent Expiration | >Status | >Orphan | >Source |
International Patents for XOLAIR
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Mexico | 2016000272 | Start Trial |
| European Patent Office | 3024460 | Start Trial |
| Brazil | PI0810472 | Start Trial |
| China | 104645329 | Start Trial |
| Russian Federation | 2642295 | Start Trial |
| Japan | 5902766 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for XOLAIR
| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|
| PA2016022 | Lithuania | Start Trial | PRODUCT NAME: RITUKSIMABAS; REGISTRATION NO/DATE: EU/1/98/067/001-002 20140321 |
| 132016000025345 | Italy | Start Trial | PRODUCT NAME: TRASTUZUMAB PER USO SOTTOCUTANEO(HERCEPTIN); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/00/145/002, 20130828 |
| 122015000061 | Germany | Start Trial | PRODUCT NAME: TRASTUZUMAB UND RECOMBINANTE HUMANE HYALURONIDASE; REGISTRATION NO/DATE: EU/1/00/145/002 20130826 |
| 122016000049 | Germany | Start Trial | PRODUCT NAME: RITUXIMAB UND REKOMBINANTE HUMANE HYALURONIDASE; NAT. REGISTRATION NO/DATE: EU/1/98/067/003 20140321; FIRST REGISTRATION: EU EU/1/98/067/003 20140621 |
| PA2015031 | Lithuania | Start Trial | PRODUCT NAME: TRASTUZUMABAS IR REKOMBINANTINE ZMOGAUS HIALURONIDAZE; REGISTRATION NO/DATE: EU/1/00/145/002 20130826 |
| 132016000070123 | Italy | Start Trial | PRODUCT NAME: RITUXIMAB IN ASSOCIAZIONE CON IALURONIDASI RICOMBINANTE UMANA - SOLUZIONE PER INIEZIONE SOTTOCUTANEA(MABTHERA); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/98/067/001-003, 20140326 |
| >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
