NOVOLOG MIX 70/30 Drug Profile
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Summary for Tradename: NOVOLOG MIX 70/30
| High Confidence Patents: | 12 |
| Applicants: | 1 |
| BLAs: | 1 |
| Recent Clinical Trials: | See clinical trials for NOVOLOG MIX 70/30 |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for NOVOLOG MIX 70/30 |
Recent Clinical Trials for NOVOLOG MIX 70/30
Identify potential brand extensions & biosimilar entrants
| Sponsor | Phase |
|---|---|
| Amphastar Pharmaceuticals, Inc. | Phase 2/Phase 3 |
| The Cleveland Clinic | Phase 4 |
| Boston Medical Center | Phase 3 |
Recent Litigation for NOVOLOG MIX 70/30
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. MYLAN N v. | 2017-10-24 |
| Novo Nordisk Inc. v. Teva Pharmaceuticals USA, Inc. | 2017-03-03 |
Pharmacology for NOVOLOG MIX 70/30
| 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 NOVOLOG MIX 70/30 Derived from Brand-Side Litigation
No patents found based on brand-side litigation
2) High Certainty: US Patents for NOVOLOG MIX 70/30 Derived from Company Disclosures
| Applicant | Tradename | Biologic Ingredient | Dosage Form | BLA | Patent No. | Estimated Patent Expiration | Source |
|---|---|---|---|---|---|---|---|
| Novo Nordisk Inc. | NOVOLOG MIX 70/30 | insulin aspart protamine and insulin aspart | Injectable Suspension | 021172 | ⤷ Try a Trial | 2013-08-20 | Company disclosures |
| Novo Nordisk Inc. | NOVOLOG MIX 70/30 | insulin aspart protamine and insulin aspart | Injectable Suspension | 021172 | ⤷ Try a Trial | 2014-04-08 | Company disclosures |
| Novo Nordisk Inc. | NOVOLOG MIX 70/30 | insulin aspart protamine and insulin aspart | Injectable Suspension | 021172 | ⤷ Try a Trial | 2014-12-02 | Company disclosures |
| Novo Nordisk Inc. | NOVOLOG MIX 70/30 | insulin aspart protamine and insulin aspart | Injectable Suspension | 021172 | ⤷ Try a Trial | 2013-06-21 | Company disclosures |
| >Applicant | >Tradename | >Biologic Ingredient | >Dosage Form | >BLA | >Patent No. | >Estimated Patent Expiration | >Source |
3) Low Certainty: US Patents for NOVOLOG MIX 70/30 Derived from Patent Text Search
No patents found based on company disclosures
International Patents for NOVOLOG MIX 70/30
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Yugoslavia | 148486 | ⤷ Try a Trial |
| Denmark | 159274 | ⤷ Try a Trial |
| Japan | H08511779 | ⤷ Try a Trial |
| Ukraine | 49890 | ⤷ Try a Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for NOVOLOG MIX 70/30
| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|
| 32/2000 | Austria | ⤷ Try a Trial | PRODUCT NAME: INSULIN ASPART/PROTAMIN; NAT. REGISTRATION NO/DATE: EU/1/00/142/001-008 20000801; FIRST REGISTRATION: LI 55414-55416 20000623 |
| 41/2005 | Austria | ⤷ Try a Trial | PRODUCT NAME: NOVOMIX 70 - SUSPENSION, ENTHALTEND LOESLICHES INSULIN ASPART UND PROTAMINKRISTALLISIERTES INSULIN ASPART IM VERHAELTNIS 70:30; REGISTRATION NO/DATE: EU/1/00/142/017 - EU/1/00/142/022 20051005 |
| SPC/GB99/045 | United Kingdom | ⤷ Try a Trial | SPC/GB99/045: 20060829, EXPIRES: 20110828 |
| SPC/GB00/027 | United Kingdom | ⤷ Try a Trial | PRODUCT NAME: INSULIN ASPART AND PROTAMINE (NOVOMIX 30); REGISTERED: CH 55414 01 20000623; CH 55415 02 20000623; CH 55416 02 20000623; UK EU/1/00/142/001-008 20000801 |
| >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
