Novolog Flexpen is a drug owned by Novo Nordisk Inc. It is protected by 12 US drug patents filed from 2013 to 2019. Out of these, 1 drug patents are active and 11 have expired. Based on its patents and exclusivities, its generic launch date is estimated to be Sep 23, 2032. Details of Novolog 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 |
| US7762994 | Needle mounting system and a method for mounting a needle assembly |
May, 2024
(6 months ago) |
Expired
|
| US8579869 | Needle mounting system and a method for mounting a needle assembly |
Jun, 2023
(1 year, 5 months ago) |
Expired
|
|
USRE41956 (Pediatric) | Dose setting limiter |
Jul, 2021
(3 years ago) |
Expired
|
| USRE41956 | Dose setting limiter |
Jan, 2021
(3 years ago) |
Expired
|
|
US6004297 (Pediatric) | Injection syringe |
Jul, 2019
(5 years ago) |
Expired
|
| US6004297 | Injection syringe |
Jan, 2019
(5 years ago) |
Expired
|
| USRE43834 | Injection syringe |
Jan, 2019
(5 years ago) |
Expired
|
|
US5866538 (Pediatric) | Insulin preparations containing NaCl |
Dec, 2017
(7 years ago) |
Expired
|
| US5866538 | Insulin preparations containing NaCl |
Jun, 2017
(7 years ago) |
Expired
|
|
US5618913 (Pediatric) | Insulin analogues |
Dec, 2014
(10 years ago) |
Expired
|
| US5618913 | Insulin analogues |
Jun, 2014
(10 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 Novolog Flexpen's patents.
Latest Legal Activities on Novolog Flexpen's Patents
Given below is the list of recent legal activities going on the following patents of Novolog Flexpen.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 12th Year, Large Entity | 16 Dec, 2021 | US7762994 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 22 Apr, 2021 | US8579869 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 22 Dec, 2017 | US7762994 |
| Patent Issue Date Used in PTA Calculation Critical | 12 Nov, 2013 | US8579869 |
| Recordation of Patent Grant Mailed Critical | 12 Nov, 2013 | US8579869 |
| Email Notification Critical | 24 Oct, 2013 | US8579869 |
| Issue Notification Mailed Critical | 23 Oct, 2013 | US8579869 |
| Dispatch to FDC | 14 Oct, 2013 | US8579869 |
| Application Is Considered Ready for Issue Critical | 08 Oct, 2013 | US8579869 |
| Printer Rush- No mailing | 05 Oct, 2013 | US8579869 |
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 Novolog Flexpen and ongoing litigations to help you estimate the early arrival of Novolog Flexpen generic.
Novolog Flexpen's Litigations
Novolog 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 Novolog 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 Novolog 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 Novolog Flexpen's generic, the next section provides detailed information on ongoing and past EP oppositions related to Novolog Flexpen patents.
Novolog Flexpen's Oppositions Filed in EPO
Novolog Flexpen has faced multiple oppositions in the European Patent Office. The earliest opposition was filed on May 18, 2010, by Sanofi-Aventis Deutschland Gmbh. This opposition was filed on patent number EP06121820A. Click below to reveal the latest opposition data.
| Application | Filing Date | Opposition Party | Legal Status |
|---|---|---|---|
| | |||
| EP08708028A | Jul, 2011 | Bock Wolfgang | Patent maintained as amended |
| EP06121820A | May, 2010 | SANOFI-AVENTIS DEUTSCHLAND GMBH | Opposition rejected |
US patents provide insights into the exclusivity only within the United States, but Novolog 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 Novolog Flexpen's family patents as well as insights into ongoing legal events on those patents.
Novolog Flexpen's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Novolog 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)
Novolog Flexpen Generics:
There are no approved generic versions for Novolog Flexpen as of now.
Alternative Brands for Novolog Flexpen
There are several other brand drugs using the same active ingredient (Insulin Aspart Recombinant) as Novolog Flexpen. 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 | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| Novo Nordisk Inc |
|
About Novolog Flexpen
Novolog Flexpen is a drug owned by Novo Nordisk Inc. Novolog Flexpen uses Insulin Aspart Recombinant as an active ingredient. Novolog Flexpen was launched by Novo Nordisk Inc in 2013.
Approval Date:
Novolog Flexpen was approved by FDA for market use on 31 October, 2013.
Active Ingredient:
Novolog Flexpen uses Insulin Aspart Recombinant as the active ingredient. Check out other Drugs and Companies using Insulin Aspart Recombinant ingredient
Dosage:
Novolog 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 |