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
(6 years from now) | Active |
| USRE41956 | Dose setting limiter |
Jan, 2021
(5 years ago) |
Expired
|
| US5750497 | Acylated insulin |
Jun, 2019
(6 years ago) |
Expired
|
| USRE43834 | Injection syringe |
Jan, 2019
(7 years ago) |
Expired
|
| US6004297 | Injection syringe |
Jan, 2019
(7 years ago) |
Expired
|
| US5866538 | Insulin preparations containing NaCl |
Jun, 2017
(8 years ago) |
Expired
|
| US6011007 | Acylated insulin |
Feb, 2014
(12 years ago) |
Expired
|
| US6869930 | Acylated insulin |
Feb, 2014
(12 years ago) |
Expired
|
A patent's expiry date may change depending upon legal activities going on that patent. Critical
activities like
abandoning of a patent, term extension of a patent or amendment of its claims can increase or decrease
the life of a
patent hence affecting its expiry date and in turn affecting the generic launch date of that drug.
Tracking these
ongoing activities on a patent application helps to keep an eye on the latest developments in the
patent process of
the drug which can give an idea of how early a drug's generic could be available. The next section
provides a list of
recent legal activities on Levemir Flexpen's patents.
Latest Legal Activities on Levemir Flexpen's Patents
Given below is the list of recent legal activities going on the following patents of Levemir Flexpen.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 8th Year, Large Entity | 21 Jul, 2023 | US9265893 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 21 Aug, 2019 | US9265893 |
| Patent Issue Date Used in PTA Calculation | 23 Feb, 2016 | US9265893 |
| Recordation of Patent Grant Mailed | 23 Feb, 2016 | US9265893 |
| Email Notification | 04 Feb, 2016 | US9265893 |
| Issue Notification Mailed | 03 Feb, 2016 | US9265893 |
| Dispatch to FDC | 22 Jan, 2016 | US9265893 |
| Application Is Considered Ready for Issue | 21 Jan, 2016 | US9265893 |
| Issue Fee Payment Verified | 14 Jan, 2016 | US9265893 |
| Issue Fee Payment Received | 14 Jan, 2016 | US9265893 |
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.
| Patent | Proceeding Filing Date | Status | Respondent | Petitioner |
|---|---|---|---|---|
 | ||||
| US9265893 | January, 2014 |
Decision
(08 Sep, 2015) | Torben Stroem Hansen et al | |
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 |
|---|---|---|---|
| | |||
| 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
Explore Our Curated Drug Screens
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 |
| |||||||||
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 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 |