Levemir is a drug owned by Novo Nordisk Inc. It is protected by 4 US drug patents filed in 2013 out of which all have expired. Based on its patents and exclusivities, its generic launch date is estimated to be Jun 16, 2019. Details of Levemir's patents and their expiration are given in the table below.
| Drug Patent Number | Drug Patent Title | Drug Patent Expiry | Status |
|---|---|---|---|
| These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| US5750497 | Acylated insulin |
Jun, 2019
(5 years ago) |
Expired
|
| US5866538 | Insulin preparations containing NaCl |
Jun, 2017
(7 years ago) |
Expired
|
| US6869930 | Acylated insulin |
Feb, 2014
(10 years ago) |
Expired
|
| US6011007 | Acylated insulin |
Feb, 2014
(10 years ago) |
Expired
|
FDA has granted several exclusivities to Levemir. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Levemir, regardless of the status of it's patents. These exclusivities hence play a crucial role in delaying the generic launch. Given below are details of the exclusivities granted to Levemir.
Exclusivity Information
Levemir holds 2 exclusivities. All of its exclusivities have expired in 2015. Details of Levemir's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| M(M-115) | Apr 06, 2015 |
| M(M-117) | May 18, 2015 |
US patents provide insights into the exclusivity only within the United States, but Levemir is protected by patents in multiple countries. Understanding the full scope of patent protection is crucial in strategizing market entry. By looking at the broader patent landscape, you can identify markets with weaker patent protection which could be ideal generic entry points. The following section offers details on Levemir's family patents as well as insights into ongoing legal events on those patents.
Levemir's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Levemir's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Jun 16, 2019 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Levemir Generics:
There are no approved generic versions for Levemir as of now.
Alternative Brands for Levemir
Levemir which is used for managing diabetes mellitus by providing long-acting basal insulin., has several other brand drugs in the same treatment category and using the same active ingredient (Insulin Detemir Recombinant). Given below is the list of those companies and their brand drugs, to help you identify new opportunities, assess competitors, and plan your market strategies more effectively.
| Drug Owner | Drug Name | Treatment Area | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Novo Nordisk Inc |
| |||||||||
About Levemir
Levemir is a drug owned by Novo Nordisk Inc. It is used for managing diabetes mellitus by providing long-acting basal insulin. Levemir uses Insulin Detemir Recombinant as an active ingredient. Levemir was launched by Novo Nordisk Inc in 2013.
Approval Date:
Levemir was approved by FDA for market use on 31 October, 2013.
Active Ingredient:
Levemir uses Insulin Detemir Recombinant as the active ingredient. Check out other Drugs and Companies using Insulin Detemir Recombinant ingredient
Treatment:
Levemir is used for managing diabetes mellitus by providing long-acting basal insulin.
Dosage:
Levemir is available in injectable form for subcutaneous use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 1000 UNITS/10ML (100 UNITS/ML) | INJECTABLE | Prescription | SUBCUTANEOUS |