LEVEMIR Drug Profile
✉ Email this page to a colleague
Summary for Tradename: LEVEMIR
| High Confidence Patents: | 14 |
| Applicants: | 1 |
| BLAs: | 1 |
| Drug Prices: | Drug price information for LEVEMIR |
| Recent Clinical Trials: | See clinical trials for LEVEMIR |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for LEVEMIR |
Recent Clinical Trials for LEVEMIR
Identify potential brand extensions & biosimilar entrants
| Sponsor | Phase |
|---|---|
| Novo Nordisk A/S | Phase 1 |
| Hennepin Healthcare Research Institute | N/A |
| Minneapolis Medical Research Foundation | N/A |
Recent Litigation for LEVEMIR
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 |
| Jazz Pharmaceuticals, Inc. v. Avadel CNS Pharmaceuticals, LLC | 2021-11-10 |
Pharmacology for LEVEMIR
| 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 LEVEMIR Derived from Brand-Side Litigation
No patents found based on brand-side litigation
2) High Certainty: US Patents for LEVEMIR Derived from Company Disclosures
| Applicant | Tradename | Biologic Ingredient | Dosage Form | BLA | Patent No. | Estimated Patent Expiration | Source |
|---|---|---|---|---|---|---|---|
| Novo Nordisk Inc. | LEVEMIR | insulin detemir | Injection | 021536 | ⤷ Sign Up | 2026-07-17 | Company disclosures |
| Novo Nordisk Inc. | LEVEMIR | insulin detemir | Injection | 021536 | ⤷ Sign Up | 2037-11-17 | Company disclosures |
| Novo Nordisk Inc. | LEVEMIR | insulin detemir | Injection | 021536 | ⤷ Sign Up | 2037-02-24 | Company disclosures |
| Novo Nordisk Inc. | LEVEMIR | insulin detemir | Injection | 021536 | ⤷ Sign Up | 2039-01-17 | Company disclosures |
| Novo Nordisk Inc. | LEVEMIR | insulin detemir | Injection | 021536 | ⤷ Sign Up | Company disclosures | |
| >Applicant | >Tradename | >Biologic Ingredient | >Dosage Form | >BLA | >Patent No. | >Estimated Patent Expiration | >Source |
3) Low Certainty: US Patents for LEVEMIR Derived from Patent Text Search
| Applicant | Tradename | Biologic Ingredient | Dosage Form | BLA | Patent No. | Estimated Patent Expiration | Source |
|---|---|---|---|---|---|---|---|
| Novo Nordisk Inc. | LEVEMIR | insulin detemir | Injection | 021536 | ⤷ Sign Up | 2033-03-11 | Patent claims search |
| Novo Nordisk Inc. | LEVEMIR | insulin detemir | Injection | 021536 | ⤷ Sign Up | 2032-04-18 | Patent claims search |
| Novo Nordisk Inc. | LEVEMIR | insulin detemir | Injection | 021536 | ⤷ Sign Up | 2031-06-02 | Patent claims search |
| Novo Nordisk Inc. | LEVEMIR | insulin detemir | Injection | 021536 | ⤷ Sign Up | 2035-07-15 | Patent claims search |
| Novo Nordisk Inc. | LEVEMIR | insulin detemir | Injection | 021536 | ⤷ Sign Up | 2035-07-15 | Patent claims search |
| >Applicant | >Tradename | >Biologic Ingredient | >Dosage Form | >BLA | >Patent No. | >Estimated Patent Expiration | >Source |
International Patents for LEVEMIR
Supplementary Protection Certificates for LEVEMIR
| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|
| PA2004005,C0792290 | Lithuania | ⤷ Sign Up | PRODUCT NAME: INSULIN DETEMIR; REGISTRATION NO/DATE: EU/1/04/278/001, EU/1/04/278/002, EU/1/04/278/003, EU/1/04/278/004, EU/1/04/278/005, EU/1/04/278/006, EU/1/04/278/007, EU/1/04/278/008, EU/1/04/278/00 20040601 |
| 132004901247576 | Italy | ⤷ Sign Up | PRODUCT NAME: INSULINA DETEMIR(LEVEMIR); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/04/278/001; 002; 003; 004; 005; 006; 007; 008; 009;, 20040601 |
| SPC/GB04/036 | United Kingdom | ⤷ Sign Up | PRODUCT NAME: INSULIN DETEMIR, NEB29- TETRADECANOYL- DES(B30) HUMAN INSULIN; NATL REGISTRATION NO/DATE: EU/1/04/278/001-009 20040601; FIRST REGISTRATION: CH 56370, 56311, 56372 20031110 |
| SZ 28/2004 | Austria | ⤷ Sign Up | PRODUCT NAME: INSULIN-DETEMIR UND PHARMAZEUTISCH ANNEHMBARE ZN-SALZE DAVON |
| 99C0044 | Belgium | ⤷ Sign Up | PRODUCT NAME: INSULIN-ASPART; NAT. REGISTRATION NO/DATE: EU/1/99/119/001 19990907; FIRST REGISTRATION: CH 55045 01 19990615 |
| >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
