LANTUS Drug Profile
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Summary for Tradename: LANTUS
| High Confidence Patents: | 3 |
| Applicants: | 1 |
| BLAs: | 1 |
| Drug Prices: | Drug price information for LANTUS |
| Recent Clinical Trials: | See clinical trials for LANTUS |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for LANTUS |
Recent Clinical Trials for LANTUS
Identify potential brand extensions & biosimilar entrants
| Sponsor | Phase |
|---|---|
| University of Basrah | N/A |
| National Polytechnic Institute, Mexico | Phase 4 |
| Hospital de Especialidades, Centro Medico Nacional "La Raza", Instituto Mexicano del Seguro Social | Phase 4 |
Recent Litigation for LANTUS
Identify key patents and potential future biosimilar entrants
District Court Litigation
| Case Name | Date |
|---|---|
| Jazz Pharmaceuticals, Inc. v. Avadel CNS Pharmaceuticals, LLC | 2021-11-10 |
| Jazz Pharmaceuticals, Inc. v. Avadel CNS Pharmaceuticals, LLC | 2021-05-12 |
| United States v. Pobre | 2019-07-22 |
PTAB Litigation
| Petitioner | Date |
|---|---|
| Mylan Pharmaceuticals Inc., | 2017-06-05 |
Pharmacology for LANTUS
| Established Pharmacologic Class | Insulin Analog |
| Chemical Structure | Insulin |
Note on Biologic Patents
Matching patents to biologic drugs is far more complicated than for small-molecule drugs.
DrugPatentWatch employs three methods to identify biologic patents:
- Brand-side disclosures in response to biosimilar applications
- General brand-side disclosures
- Patents from broad patent text search
These patents were identified from disclosures by the brand-side company, in response to a potential biosimilar seeking to launch. They have a high certainty of blocking biosimilar entry. The expiration dates listed are not estimates — they're expiration dates as indicated by the brand-side company.
These patents were identified from searching drug labels and other general disclosures from the brand-side company. This list may exclude some of the patents which block biosimilar launch, and some of these patents listed may not actually block biosimilar launch. The expiration dates listed for these patents are estimates, based on the grant date of the patent.
For completeness, these patents were identified by searching the patent literature for mentions of the branded or ingredient name of the drug. Some of these patents protect the original drug, whereas others may protect follow-on inventions or even inventions casually mentioning the drug. The expiration dates listed for these patents are estimates, based on the grant date of the patent.
1) High Certainty: US Patents for LANTUS Derived from Brand-Side Litigation
No patents found based on brand-side litigation
2) High Certainty: US Patents for LANTUS Derived from Company Disclosures
| Applicant | Tradename | Biologic Ingredient | Dosage Form | BLA | Patent No. | Estimated Patent Expiration | Source |
|---|---|---|---|---|---|---|---|
| Sanofi-aventis U.s. Llc | LANTUS | insulin glargine | Injection | 021081 | ⤷ Sign Up | 2012-02-21 | Company disclosures |
| Sanofi-aventis U.s. Llc | LANTUS | insulin glargine | Injection | 021081 | ⤷ Sign Up | 2013-04-23 | Company disclosures |
| Sanofi-aventis U.s. Llc | LANTUS | insulin glargine | Injection | 021081 | ⤷ Sign Up | 2014-08-12 | Company disclosures |
| >Applicant | >Tradename | >Biologic Ingredient | >Dosage Form | >BLA | >Patent No. | >Estimated Patent Expiration | >Source |
3) Low Certainty: US Patents for LANTUS Derived from Patent Text Search
| Applicant | Tradename | Biologic Ingredient | Dosage Form | BLA | Patent No. | Estimated Patent Expiration | Source |
|---|---|---|---|---|---|---|---|
| Sanofi-aventis U.s. Llc | LANTUS | insulin glargine | Injection | 021081 | ⤷ Sign Up | 2025-05-23 | Patent claims search |
| Sanofi-aventis U.s. Llc | LANTUS | insulin glargine | Injection | 021081 | ⤷ Sign Up | 2033-03-11 | Patent claims search |
| Sanofi-aventis U.s. Llc | LANTUS | insulin glargine | Injection | 021081 | ⤷ Sign Up | 2029-11-13 | Patent claims search |
| Sanofi-aventis U.s. Llc | LANTUS | insulin glargine | Injection | 021081 | ⤷ Sign Up | 2033-04-03 | Patent claims search |
| Sanofi-aventis U.s. Llc | LANTUS | insulin glargine | Injection | 021081 | ⤷ Sign Up | 2028-10-17 | Patent claims search |
| Sanofi-aventis U.s. Llc | LANTUS | insulin glargine | Injection | 021081 | ⤷ Sign Up | 2034-12-01 | Patent claims search |
| >Applicant | >Tradename | >Biologic Ingredient | >Dosage Form | >BLA | >Patent No. | >Estimated Patent Expiration | >Source |
International Patents for LANTUS
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Germany | 58905456 | ⤷ Sign Up |
| Denmark | 554789 | ⤷ Sign Up |
| European Patent Office | 0581924 | ⤷ Sign Up |
| Germany | 3837825 | ⤷ Sign Up |
| World Intellectual Property Organization (WIPO) | 9316743 | ⤷ Sign Up |
| Switzerland | 682806 | ⤷ Sign Up |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for LANTUS
| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|
| SZ 34/2000 | Austria | ⤷ Sign Up | PRODUCT NAME: LANTUS - INSULIN GLARGIN |
| 2017/022 | Ireland | ⤷ Sign Up | PRODUCT NAME: A COMPOSITION COMPRISING INSULIN GLARGINE, OR A PHARMACOLOGICALLY TOLERABLE SAFT THEREOF, AND LIXISENATIDE, OR A PHARMACOLOGICALLY TOLERABLE SALT THEREOF.; REGISTRATION NO/DATE: EU/1/16/1157 20170111 |
| 0091020-8 0090020-9 | Sweden | ⤷ Sign Up | PRODUCT NAME: LANTUS - INSULIN GLARGIN; REGISTRATION NO/DATE: EU/1/00/134/001 20000609 |
| SPC/GB00/022 | United Kingdom | ⤷ Sign Up | PRODUCT NAME: INSULIN GLARGINE (LANTUS) OPTIONALLY IN THE FORM OF ESTERS THEREOF OR PHYSIOLOGICALLY TOLERATED SALTS THEREOF.; REGISTERED: UK EU/1/00/134/001 20000609; UK EU/1/00/134/002 20000609; UK EU/1/00/134/003 20000609; UK EU/1/00/134/004 20000609; UK EU/1/00/134/005 20000609; UK EU/1/00/134/006 20000609; UK EU/1/00/134/007 20000609 |
| CR 2017 00020 | Denmark | ⤷ Sign Up | PRODUCT NAME: INSULIN GLARGINE/LIXISENATID; REG. NO/DATE: EU/1/16/1157/001-004 20170113 |
| C300019 | Netherlands | ⤷ Sign Up | PRODUCT NAME: INSULINE GLARGINE,DESGEWENST IN DE VORM VAN EEN FYSIOLOGISCH GESCHIKT ZOUT; REGISTRATION NO/DATE: EU/1/00/134/001 - 007 20000609 |
| >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
