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Insulin glargine recombinant - Biologic Drug Details
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Summary for insulin glargine recombinant
| Tradenames: | 4 |
| Patents: | 109 |
| Applicants: | 2 |
| BLAs: | 2 |
| Suppliers: see list | 2 |
| Recent Clinical Trials: | See clinical trials for insulin glargine recombinant |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for insulin glargine recombinant |
Recent Clinical Trials for insulin glargine recombinant
Identify potential brand extensions & biosimilar entrants
| Sponsor | Phase |
|---|---|
| Shenzhen Second People's Hospital | N/A |
| Dasman Diabetes Institute | Phase 4 |
| Ministry of Health, Kuwait | Phase 4 |
Recent Litigation for insulin glargine recombinant
Identify key patents and potential future biosimilar entrants
District Court Litigation
| Case Name | Date |
|---|---|
| SANOFI-AVENTIS U.S. LLC v. MYLAN N v. | 2017-10-24 |
| SANOFI-AVENTIS U.S. LLC v. MERCK SHARP & DOHME CORP. | 2017-08-08 |
| Allergan Sales, LLC v. Teva Pharmaceuticals USA, Inc. | 2016-11-30 |
See all insulin glargine recombinant litigation
PTAB Litigation
| Petitioner | Date |
|---|---|
| Pfizer Inc. | 2019-05-02 |
| Mylan Pharmaceuticals Inc. | 2018-10-29 |
| Mylan Pharmaceuticals Inc | 2018-09-10 |
Company Disclosures: US Patents for insulin glargine recombinant
| Applicant | Tradename | Biologic Ingredient | Dosage Form | BLA | Number | Approval Date | Patent No. | Assignee | Estimated Patent Expiration | Status | Orphan | Source |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Sanofi Aventis Us | LANTUS | insulin glargine recombinant | INJECTABLE;INJECTION | 021081 | 001 | 2000-11-17 | Start Trial | Medimpex Ets. (Balzers, LI) | 2012-02-21 | RX | company | |
| Sanofi Aventis Us | LANTUS | insulin glargine recombinant | INJECTABLE;INJECTION | 021081 | 001 | 2000-11-17 | Start Trial | Medimpex Ets (LI) | 2013-04-23 | RX | company | |
| Sanofi Aventis Us | LANTUS | insulin glargine recombinant | INJECTABLE;INJECTION | 021081 | 001 | 2000-11-17 | Start Trial | Hoechst Aktiengesellschaft (Frankfurt am Main, DE) | 2014-08-12 | RX | company | |
| Sanofi Aventis Us | LANTUS SOLOSTAR | insulin glargine recombinant | INJECTABLE;INJECTION | 021081 | 002 | 2000-11-17 | Start Trial | Medimpex Ets. (Balzers, LI) | 2012-02-21 | RX | company | |
| Sanofi Aventis Us | LANTUS SOLOSTAR | insulin glargine recombinant | INJECTABLE;INJECTION | 021081 | 002 | 2000-11-17 | Start Trial | Medimpex Ets (LI) | 2013-04-23 | RX | company | |
| Sanofi Aventis Us | LANTUS SOLOSTAR | insulin glargine recombinant | INJECTABLE;INJECTION | 021081 | 002 | 2000-11-17 | Start Trial | Hoechst Aktiengesellschaft (Frankfurt am Main, DE) | 2014-08-12 | RX | 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 insulin glargine recombinant
| Applicant | Tradename | Biologic Ingredient | Dosage Form | BLA | Number | Approval Date | Patent No. | Assignee | Estimated Patent Expiration | Status | Orphan | Source |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Sanofi Aventis Us | LANTUS | insulin glargine recombinant | INJECTABLE;INJECTION | 021081 | 001 | 2000-11-17 | Start Trial | Cognis Gesellschaft fuer Biotechnologie mbH (Duesseldorf, DE) | 2040-04-01 | RX | search | |
| Sanofi Aventis Us | LANTUS | insulin glargine recombinant | INJECTABLE;INJECTION | 021081 | 001 | 2000-11-17 | Start Trial | Lipocine, Inc. (Salt Lake City, UT) | 2039-02-26 | RX | search | |
| Sanofi Aventis Us | LANTUS | insulin glargine recombinant | INJECTABLE;INJECTION | 021081 | 001 | 2000-11-17 | Start Trial | Lipocine Inc. (Salt Lake City, UT) | 2039-02-26 | RX | search | |
| Sanofi Aventis Us | LANTUS | insulin glargine recombinant | INJECTABLE;INJECTION | 021081 | 001 | 2000-11-17 | Start Trial | Lipocine, Inc. (Salt Lake City, UT) | 2039-02-26 | RX | search | |
| Sanofi Aventis Us | LANTUS | insulin glargine recombinant | INJECTABLE;INJECTION | 021081 | 001 | 2000-11-17 | Start Trial | Novo Nordisk, Inc. (Bagsvaerd, DK) | 2020-06-23 | RX | search | |
| Sanofi Aventis Us | LANTUS | insulin glargine recombinant | INJECTABLE;INJECTION | 021081 | 001 | 2000-11-17 | Start Trial | Amylin Pharmaceuticals, Inc. (San Diego, CA) | 2018-01-09 | RX | search | |
| >Applicant | >Tradename | >Biologic Ingredient | >Dosage Form | >BLA | >Number | >Approval Date | >Patent No. | >Assignee | >Estimated Patent Expiration | >Status | >Orphan | >Source |
International Patents for insulin glargine recombinant
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Russian Federation | 2013155481 | Start Trial |
| Singapore | 173112 | Start Trial |
| China | 109384778 | Start Trial |
| Mexico | 2008013165 | Start Trial |
| Mexico | 2012014247 | Start Trial |
| Argentina | 083679 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for insulin glargine recombinant
| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|
| 2013 019 | Romania | Start Trial | PRODUCT NAME: INSULINA DEGLUDECIN TOATE FORMELE SALE ASA CUM SUNT PROTEJATE IN BREVETUL DEBAZA; NATIONAL AUTHORISATION NUMBER: EU/1/12/807/001; DATE OF NATIONAL AUTHORISATION: 20130121; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/12/807/001; DATE OF FIRST AUTHORISATION IN EEA: 20130121 |
| 5 12-2017 | Slovakia | Start Trial | PRODUCT NAME: INZULIN GLARGIN/LIXISENATID VO VSETKYCH FORMACH CHRANENYCH ZAKLADNYM PATENTOM; REGISTRATION NO/DATE: EU/1/16/1157 20170113 |
| 2017020,C2498802 | Lithuania | Start Trial | PRODUCT NAME: INSULINAS GLARGINAS + LIKSISENATIDAS; REGISTRATION NO/DATE: EU/1/16/1157 20170111 |
| 2004000049 | Germany | Start Trial | PRODUCT NAME: INSULIN GLULISINE; REGISTRATION NO/DATE: EU/1/04/285/001-020 20040927 |
| 2005901285503 | Italy | Start Trial | PRODUCT NAME: INSULINA GLULISINE(APIDRA); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/04/285/001-020, 20040927 |
| 00021 | Netherlands | Start Trial | PRODUCT NAME: INSULINE ASPART EN GEKRISTALLISEERD PROTAMINE-INSULINE ASPART; NAT. REGISTRATION NO/DATE: EU/1/00/142/001 20000801; FIRST REGISTRATION: 55414015541502 2000230623 |
| >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
