Levemir Flexpen Patent Expiration

Levemir Flexpen is a drug owned by Novo Nordisk Inc. It is protected by 8 US drug patents filed from 2013 to 2016. Out of these, 1 drug patents are active and 7 have expired. Based on its patents and exclusivities, its generic launch date is estimated to be Sep 23, 2032. Details of Levemir Flexpen'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).
US9265893 Injection button
Sep, 2032

(7 years from now)

Active
USRE41956 Dose setting limiter
Jan, 2021

(3 years ago)

Expired
US5750497 Acylated insulin
Jun, 2019

(5 years ago)

Expired
USRE43834 Injection syringe
Jan, 2019

(5 years ago)

Expired
US6004297 Injection syringe
Jan, 2019

(5 years ago)

Expired
US5866538 Insulin preparations containing NaCl
Jun, 2017

(7 years ago)

Expired
US6011007 Acylated insulin
Feb, 2014

(10 years ago)

Expired
US6869930 Acylated insulin
Feb, 2014

(10 years ago)

Expired


While patent expiration is one way of estimating the generic date of a drug, if a patent gets invalidated somehow, the generic of the drug may arrive early. Being aware of all relevant patents can help in avoiding legal pitfalls. Given below are details of the litigation history of Levemir Flexpen and ongoing litigations to help you estimate the early arrival of Levemir Flexpen generic.

Levemir Flexpen's Litigations

Levemir Flexpen been subject to various legal proceedings, including patent litigations. The earliest legal proceeding was initiated on Jan 23, 2014, against patent number US9265893. The petitioner , challenged the validity of this patent, with Torben Stroem Hansen et al as the respondent. Click below to track the latest information on how companies are challenging Levemir Flexpen's patents.

Last updated on December 10, 2024
Patent Proceeding Filing Date Status Respondent Petitioner
Patent litigations
US9265893 January, 2014 Decision
(08 Sep, 2015)
Torben Stroem Hansen et al

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Several oppositions have been filed on Levemir Flexpen's European patents. EP oppositions can significantly impact the timeline for the generic launch of drugs. If an opposition results in the revocation or amendment of a patent, it can shorten the exclusivity period of the original drug. This can lead to an earlier entry of generic versions into the market. To help you estimate the potential early arrival of Levemir Flexpen's generic, the next section provides detailed information on ongoing and past EP oppositions related to Levemir Flexpen patents.

Levemir Flexpen's Oppositions Filed in EPO

Levemir Flexpen has faced multiple oppositions in the European Patent Office. The earliest opposition was filed on Jul 06, 2011, by Bock Wolfgang. This opposition was filed on patent number EP08708028A. Click below to reveal the latest opposition data.


Application Filing Date Opposition Party Legal Status
Patent litigations
EP08708028A Jul, 2011 Bock Wolfgang Patent maintained as amended


US patents provide insights into the exclusivity only within the United States, but Levemir Flexpen 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 Flexpen's family patents as well as insights into ongoing legal events on those patents.

Levemir Flexpen's Family Patents

Levemir Flexpen has patent protection in a total of 13 countries. It's US patent count contributes only to 12.5% of its total global patent coverage. 1 country has all of their patents expired or invalidated which has opened up potential generic launch opportunities in this particular country. Click below to unlock the full patent family tree for Levemir Flexpen.

Family Patents

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Generic Launch

Generic Release Date:

Levemir Flexpen's generic launch date based on the expiry of its last outstanding patent is estimated to be Sep 23, 2032 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)

Levemir Flexpen Generics:

There are no approved generic versions for Levemir Flexpen as of now.

Alternative Brands for Levemir Flexpen

Levemir Flexpen which is used for managing blood sugar levels in patients with diabetes mellitus., 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
Levemir

(uses Insulin Detemir Recombinant)

Used for managing diabetes mellitus by providing long-acting basal insulin.
Levemir Innolet

(uses Insulin Detemir Recombinant)

Used for managing blood sugar levels in patients with diabetes mellitus.
Levemir Penfill

(uses Insulin Detemir Recombinant)

used for managing blood sugar levels in patients with diabetes mellitus.
Levemir Flextouch

(uses Insulin Detemir Recombinant)

Used for managing blood sugar levels in patients with diabetes mellitus.





About Levemir Flexpen

Levemir Flexpen is a drug owned by Novo Nordisk Inc. It is used for managing blood sugar levels in patients with diabetes mellitus. Levemir Flexpen uses Insulin Detemir Recombinant as an active ingredient. Levemir Flexpen was launched by Novo Nordisk Inc in 2013.

Approval Date:

Levemir Flexpen was approved by FDA for market use on 31 October, 2013.

Active Ingredient:

Levemir Flexpen uses Insulin Detemir Recombinant as the active ingredient. Check out other Drugs and Companies using Insulin Detemir Recombinant ingredient

Treatment:

Levemir Flexpen is used for managing blood sugar levels in patients with diabetes mellitus.

Dosage:

Levemir Flexpen is available in injectable form for subcutaneous use. Given below is detailed information on Dosage -

Strength Dosage Form Availability Application Pathway
300 UNITS/3ML (100 UNITS/ML) INJECTABLE Prescription SUBCUTANEOUS