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Cetuximab - Biologic Drug Details
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Summary for cetuximab
| Tradenames: | 1 |
| Patents: | 580 |
| Applicants: | 1 |
| BLAs: | 1 |
| Suppliers: see list | 1 |
| Recent Clinical Trials: | See clinical trials for cetuximab |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for cetuximab |
Recent Clinical Trials for cetuximab
Identify potential brand extensions & biosimilar entrants
| Sponsor | Phase |
|---|---|
| Yanhong Deng | Phase 3 |
| GERCOR - Multidisciplinary Oncology Cooperative Group | Phase 2 |
| Takeda | Early Phase 1 |
Recent Litigation for cetuximab
Identify key patents and potential future biosimilar entrants
District Court Litigation
| Case Name | Date |
|---|---|
| CELGENE CORPORATION v. DR. REDDY'S LABORATORIES, LTD. | 2019-07-12 |
| 2654 Highway 169, LLC | 2016-04-13 |
| Reckitt Benckiser Pharmaceuticals Inc. v. Watson Laboratories Inc. | 2013-10-08 |
PTAB Litigation
| Petitioner | Date |
|---|---|
| Forty Seven, Inc. | 2018-01-08 |
| Forty Seven, Inc. | 2016-08-08 |
| Forty Seven, Inc. | 2016-08-05 |
Pharmacology for cetuximab
| Mechanism of Action | HER1 Antagonists |
Company Disclosures: US Patents for cetuximab
| Applicant | Tradename | Biologic Ingredient | Dosage Form | BLA | Number | Approval Date | Patent No. | Assignee | Estimated Patent Expiration | Status | Orphan | Source |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Imclone | ERBITUX | cetuximab | VIAL; INTRAVENOUS | 125084 | 001 | 2004-06-18 | Start Trial | Rhone-Poulenc Rorer International (Holdings), Inc. (Greenville, DE) | 2018-04-17 | RX | Orphan | company |
| >Applicant | >Tradename | >Biologic Ingredient | >Dosage Form | >BLA | >Number | >Approval Date | >Patent No. | >Assignee | >Estimated Patent Expiration | >Status | >Orphan | >Source |
Patent Text Search: US Patents for cetuximab
| Applicant | Tradename | Biologic Ingredient | Dosage Form | BLA | Number | Approval Date | Patent No. | Assignee | Estimated Patent Expiration | Status | Orphan | Source |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Imclone | ERBITUX | cetuximab | VIAL; INTRAVENOUS | 125084 | 001 | 2004-06-18 | Start Trial | SAMSUNG LIFE PUBLIC WELFARE FOUNDATION (Seoul, KR) | 2032-09-12 | RX | Orphan | search |
| Imclone | ERBITUX | cetuximab | VIAL; INTRAVENOUS | 125084 | 001 | 2004-06-18 | Start Trial | Yeda Research and Development Co. Ltd. (Rehovot, IL) | 2034-09-08 | RX | Orphan | search |
| Imclone | ERBITUX | cetuximab | VIAL; INTRAVENOUS | 125084 | 001 | 2004-06-18 | Start Trial | SIO2 MEDICAL PRODUCTS, INC. (Auburn, AL) | 2033-03-11 | RX | Orphan | search |
| Imclone | ERBITUX | cetuximab | VIAL; INTRAVENOUS | 125084 | 001 | 2004-06-18 | Start Trial | OP NANO CO., LTD. (Taipei, TW) TRENDMED CO., LTD. (Beitou Dist., Taipei, TW) | 2039-02-26 | RX | Orphan | search |
| Imclone | ERBITUX | cetuximab | VIAL; INTRAVENOUS | 125084 | 001 | 2004-06-18 | Start Trial | VentiRx Pharmaceuticals, Inc. (Seattle, WA) | 2030-04-21 | RX | Orphan | search |
| Imclone | ERBITUX | cetuximab | VIAL; INTRAVENOUS | 125084 | 001 | 2004-06-18 | Start Trial | Wake Forest University Health Sciences (Winston-Salem, NC) | 2033-09-13 | RX | Orphan | search |
| Imclone | ERBITUX | cetuximab | VIAL; INTRAVENOUS | 125084 | 001 | 2004-06-18 | Start Trial | University of Georgia Research Foundation, Inc. (Athens, GA) | 2039-02-26 | RX | Orphan | search |
| >Applicant | >Tradename | >Biologic Ingredient | >Dosage Form | >BLA | >Number | >Approval Date | >Patent No. | >Assignee | >Estimated Patent Expiration | >Status | >Orphan | >Source |
International Patents for cetuximab
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| South Korea | 20070008710 | Start Trial |
| South Korea | 101661405 | Start Trial |
| Australia | 2013337768 | Start Trial |
| Japan | 2019088330 | Start Trial |
| Japan | 5898687 | Start Trial |
| World Intellectual Property Organization (WIPO) | 2012138591 | Start Trial |
| European Patent Office | 1907444 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for cetuximab
| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|
| 0822 | Netherlands | Start Trial | PRODUCT NAME: RITUXIMAB EN RECOMBINANT HUMAAN HYALURONIDASE; REGISTRATION NO/DATE: EU/1/98/067/003 - UITVOERINGSBESLUIT C(2014)2048 20140326 |
| C0022 | France | Start Trial | PRODUCT NAME: PANITUMUMAB; REGISTRATION NO/DATE IN FRANCE: EU/1/07/423/001 DU 20071203; REGISTRATION NO/DATE AT EEC: EU/1/07/423/001 DU 20071203 |
| 2015 | Austria | Start Trial | PRODUCT NAME: POMALIDOMID UND SEINE PHARMAZEUTISCH AKZEPTABLEN SALZE, SOLVATE, HYDRATE ODER STEREOISOMERE; REGISTRATION NO/DATE: EU/1/13/850 20130805 |
| 642 | Luxembourg | Start Trial | PRODUCT NAME: POMALIDOMIDE ET SES SELS, SOLVATES, HYDRATES OU STEREOISOMERES PHARMACEUTIQUEMENT ACCEPTABLES QUI EN DERIVENT (IMNOVID); FIRST REGISTRATION DATE: 20130805 |
| 448 | Luxembourg | Start Trial | 91448, EXPIRES: 20140915 |
| 2008000028 | Germany | Start Trial | PRODUCT NAME: PANITUMUMAB MIT EINEM ANTINEOPLASTISCHEN WIRKSTOFF, INSBESONDERE PANITUMUMAB MIT EINEM ODER MEHREREN DER FOLGENDEN 1 BIS 22: 1 IRINOTECAN 2 CISPLATIN 3 5-FLUORURACIL 4 FOLINSAEURE 5 CISPLATIN UND/ODER DOCETAXEL 6 OXALIPLATIN UND/ODER CAPECITABIN 7 IRINOTECAN UND/ODER CYCLOSPORIN 8 FOLINSAEURE, 5-FLUORURACIL UND IRINOTECAN =FOLFIRI 9 FOLINSAEURE, 5-FLUORURACIL UND OXALI; REGISTRATION NO/DATE: EU/1/07/423/001-003 20071203 |
| 2015 00006 | Denmark | Start Trial | PRODUCT NAME: POMALIDOMID OG FARMACEUTISK ACCEPTABLE SALTE, SOLVATER, HYDRATER ELLER STEREOISOMERER HERAF; REG. NO/DATE: EU/1/13/850 20130805 |
| >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
