NOVOLOG Drug Profile
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Summary for Tradename: NOVOLOG
| High Confidence Patents: | 18 |
| Applicants: | 1 |
| BLAs: | 3 |
| Drug Prices: | Drug price information for NOVOLOG |
| Recent Clinical Trials: | See clinical trials for NOVOLOG |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for NOVOLOG |
Recent Clinical Trials for NOVOLOG
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
Identify key patents and potential future biosimilar entrants
District Court Litigation
| Case Name | Date |
|---|---|
| NOVO NORDISK INC. v. RIO BIOPHARMACEUTICALS, INC. | 2024-01-19 |
| NOVO NORDISK INC. v. DR. REDDY'S LABORATORIES, LTD. | 2023-11-08 |
| SANOFI-AVENTIS U.S. LLC v. MYLAN N.V. | 2017-10-24 |
Pharmacology for NOVOLOG
| 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 Derived from Brand-Side Litigation
No patents found based on brand-side litigation
2) High Certainty: US Patents for NOVOLOG Derived from Company Disclosures
| Applicant | Tradename | Biologic Ingredient | Dosage Form | BLA | Patent No. | Estimated Patent Expiration | Source |
|---|---|---|---|---|---|---|---|
| Novo Nordisk Inc. | NOVOLOG | insulin aspart | Injection | 020986 | ⤷ Sign Up | Company disclosures | |
| Novo Nordisk Inc. | NOVOLOG | insulin aspart | Injection | 020986 | ⤷ Sign Up | 2014-04-08 | Company disclosures |
| Novo Nordisk Inc. | NOVOLOG | insulin aspart | Injection | 020986 | ⤷ Sign Up | 2014-05-06 | Company disclosures |
| Novo Nordisk Inc. | NOVOLOG | insulin aspart | Injection | 020986 | ⤷ Sign Up | 2014-12-02 | Company disclosures |
| Novo Nordisk Inc. | NOVOLOG | insulin aspart | Injection | 020986 | ⤷ Sign Up | 2016-06-20 | Company disclosures |
| Novo Nordisk Inc. | NOVOLOG | insulin aspart | Injection | 020986 | ⤷ Sign Up | 2018-01-30 | Company disclosures |
| >Applicant | >Tradename | >Biologic Ingredient | >Dosage Form | >BLA | >Patent No. | >Estimated Patent Expiration | >Source |
3) Low Certainty: US Patents for NOVOLOG Derived from Patent Text Search
| Applicant | Tradename | Biologic Ingredient | Dosage Form | BLA | Patent No. | Estimated Patent Expiration | Source |
|---|---|---|---|---|---|---|---|
| Novo Nordisk Inc. | NOVOLOG | insulin aspart | Injection | 020986 | ⤷ Sign Up | 2025-05-23 | Patent claims search |
| Novo Nordisk Inc. | NOVOLOG | insulin aspart | Injection | 020986 | ⤷ Sign Up | 2033-03-11 | Patent claims search |
| Novo Nordisk Inc. | NOVOLOG | insulin aspart | Injection | 020986 | ⤷ Sign Up | 2034-12-01 | Patent claims search |
| Novo Nordisk Inc. | NOVOLOG | insulin aspart | Injection | 020986 | ⤷ Sign Up | 2034-07-21 | Patent claims search |
| Novo Nordisk Inc. | NOVOLOG | insulin aspart | Injection | 020986 | ⤷ Sign Up | 2034-05-08 | Patent claims search |
| Novo Nordisk Inc. | NOVOLOG | insulin aspart | Injection | 020986 | ⤷ Sign Up | 2024-12-29 | Patent claims search |
| >Applicant | >Tradename | >Biologic Ingredient | >Dosage Form | >BLA | >Patent No. | >Estimated Patent Expiration | >Source |
International Patents for NOVOLOG
Supplementary Protection Certificates for NOVOLOG
| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|
| C300021 | Netherlands | ⤷ Sign Up | PRODUCT NAME: INSULINE ASPART EN GEKRISTALLISEERD PROTAMINE-INSULINE ASPART; NAT. REGISTRATION NO/DATE: EU/1/00/142/001 20000801; FIRST REGISTRATION: 55414015541502 2000230623 |
| SZ 50/1999 | Austria | ⤷ Sign Up | PRODUCT NAME: INSULIN ASPART |
| SPC/GB99/045 | United Kingdom | ⤷ Sign Up | SPC/GB99/045: 20060829, EXPIRES: 20110828 |
| CA 2005 00046 | Denmark | ⤷ Sign Up | PRODUCT NAME: OPLOSELIGT INSULIN ASPART / PROTAMINKRYSTALLERET INSULIN ASPART 100E/ML I FORHOLDET 50/50 |
| 32/2000 | Austria | ⤷ Sign Up | PRODUCT NAME: INSULIN ASPART/PROTAMIN; NAT. REGISTRATION NO/DATE: EU/1/00/142/001-008 20000801; FIRST REGISTRATION: LI 55414-55416 20000623 |
| 40/2005 | Austria | ⤷ Sign Up | PRODUCT NAME: NOVOMIX 50 - SUSPENSION, ENTHALTEND LOESLICHES INSULIN ASPART UND PROTAMINKRISTALLISIERTES INSULIN ASPART IM VERHAELTNIS 50:50; REGISTRATION NO/DATE: EU/1/00/142/011 - EU/1/00/142/016 20051005 |
| >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
