APIDRA Drug Profile
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Summary for Tradename: APIDRA
| High Confidence Patents: | 1 |
| Applicants: | 1 |
| BLAs: | 1 |
| Drug Prices: | Drug price information for APIDRA |
| Recent Clinical Trials: | See clinical trials for APIDRA |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for APIDRA |
Recent Clinical Trials for APIDRA
Identify potential brand extensions & biosimilar entrants
| Sponsor | Phase |
|---|---|
| Medical University of Warsaw | Phase 4 |
| Massachusetts General Hospital | Phase 2/Phase 3 |
| Boston University | Phase 2/Phase 3 |
Recent Litigation for APIDRA
Identify key patents and potential future biosimilar entrants
District Court Litigation
| Case Name | Date |
|---|---|
| SANOFI-AVENTIS U.S. LLC v. MERCK SHARP & DOHME CORP. | 2017-08-08 |
Pharmacology for APIDRA
| Ingredient-type | Insulin |
| Established Pharmacologic Class | Insulin Analog |
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 APIDRA Derived from Brand-Side Litigation
No patents found based on brand-side litigation
2) High Certainty: US Patents for APIDRA Derived from Company Disclosures
| Applicant | Tradename | Biologic Ingredient | Dosage Form | BLA | Patent No. | Estimated Patent Expiration | Source |
|---|---|---|---|---|---|---|---|
| Sanofi-aventis U.s. Llc | APIDRA | insulin glulisine | Injection | 021629 | ⤷ Try a Trial | 2017-06-20 | Company disclosures |
| >Applicant | >Tradename | >Biologic Ingredient | >Dosage Form | >BLA | >Patent No. | >Estimated Patent Expiration | >Source |
3) Low Certainty: US Patents for APIDRA Derived from Patent Text Search
| Applicant | Tradename | Biologic Ingredient | Dosage Form | BLA | Patent No. | Estimated Patent Expiration | Source |
|---|---|---|---|---|---|---|---|
| Sanofi-aventis U.s. Llc | APIDRA | insulin glulisine | Injection | 021629 | ⤷ Try a Trial | 2025-05-23 | Patent claims search |
| Sanofi-aventis U.s. Llc | APIDRA | insulin glulisine | Injection | 021629 | ⤷ Try a Trial | 2033-03-11 | Patent claims search |
| Sanofi-aventis U.s. Llc | APIDRA | insulin glulisine | Injection | 021629 | ⤷ Try a Trial | 2034-07-21 | Patent claims search |
| >Applicant | >Tradename | >Biologic Ingredient | >Dosage Form | >BLA | >Patent No. | >Estimated Patent Expiration | >Source |
International Patents for APIDRA
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Slovakia | 285267 | ⤷ Try a Trial |
| Slovakia | 83698 | ⤷ Try a Trial |
| Norway | 321720 | ⤷ Try a Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for APIDRA
| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|
| 91138 | Luxembourg | ⤷ Try a Trial | 91138, EXPIRES: 20190927 |
| 122004000049 | Germany | ⤷ Try a Trial | PRODUCT NAME: INSULIN GLULISINE; REGISTRATION NO/DATE: EU/1/04/285/001-020 20040927 |
| SZ 2/2005 | Austria | ⤷ Try a Trial | PRODUCT NAME: INSULIN GLULISINE |
| >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
