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 |
|---|---|
| Hospital de Especialidades, Centro Medico Nacional "La Raza", Instituto Mexicano del Seguro Social | Phase 4 |
| National Polytechnic Institute, Mexico | Phase 4 |
| Tonghua Dongbao Pharmaceutical Co.,Ltd | Phase 1 |
Recent Litigation for LANTUS
Identify key patents and potential future biosimilar entrants
District Court Litigation
| Case Name | Date |
|---|---|
| United States v. Pobre | 2019-07-22 |
| Par Pharmaceutical, Inc. v. Eagle Pharmaceuticals, Inc. | 2018-05-31 |
| SANOFI-AVENTIS U.S. LLC v. MYLAN N v. | 2017-10-24 |
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 | ⤷ Try a Trial | 2012-02-21 | Company disclosures |
| Sanofi-aventis U.s. Llc | LANTUS | insulin glargine | Injection | 021081 | ⤷ Try a Trial | 2013-04-23 | Company disclosures |
| Sanofi-aventis U.s. Llc | LANTUS | insulin glargine | Injection | 021081 | ⤷ Try a Trial | 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 | ⤷ Try a Trial | 2025-05-23 | Patent claims search |
| Sanofi-aventis U.s. Llc | LANTUS | insulin glargine | Injection | 021081 | ⤷ Try a Trial | 2033-03-11 | Patent claims search |
| Sanofi-aventis U.s. Llc | LANTUS | insulin glargine | Injection | 021081 | ⤷ Try a Trial | 2029-11-13 | Patent claims search |
| Sanofi-aventis U.s. Llc | LANTUS | insulin glargine | Injection | 021081 | ⤷ Try a Trial | 2033-04-03 | Patent claims search |
| Sanofi-aventis U.s. Llc | LANTUS | insulin glargine | Injection | 021081 | ⤷ Try a Trial | 2028-10-17 | Patent claims search |
| Sanofi-aventis U.s. Llc | LANTUS | insulin glargine | Injection | 021081 | ⤷ Try a Trial | 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 |
|---|---|---|
| Ireland | 63338 | ⤷ Try a Trial |
| European Patent Office | 0581925 | ⤷ Try a Trial |
| European Patent Office | 0581924 | ⤷ Try a Trial |
| South Korea | 900007435 | ⤷ Try a Trial |
| Switzerland | 682806 | ⤷ Try a Trial |
| Australia | 621680 | ⤷ Try a Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for LANTUS
| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|
| SZ 34/2000 | Austria | ⤷ Try a Trial | PRODUCT NAME: LANTUS - INSULIN GLARGIN |
| 2017/022 | Ireland | ⤷ Try a Trial | 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 |
| 34/2000 | Austria | ⤷ Try a Trial | PRODUCT NAME: LANTUS - INSULIN GLARGIN; REGISTRATION NO/DATE: EU/1/00/134/001 - EU/1/00/134/007 20000609 |
| 0091020-8 0090020-9 | Sweden | ⤷ Try a Trial | PRODUCT NAME: LANTUS - INSULIN GLARGIN; REGISTRATION NO/DATE: EU/1/00/134/001 20000609 |
| CR 2017 00020 | Denmark | ⤷ Try a Trial | PRODUCT NAME: INSULIN GLARGINE/LIXISENATID; REG. NO/DATE: EU/1/16/1157/001-004 20170113 |
| 10075022 | Germany | ⤷ Try a Trial | PRODUCT NAME: INSULIN GLARGIN (LANTUS ); REGISTRATION NO/DATE: EU/1/00/134/001-007 20000609 |
| >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
