Novolog Mix 70/30 Flexpen Patent Expiration

Novolog Mix 70/30 Flexpen is a drug owned by Novo Nordisk Inc. It is protected by 13 US drug patents filed from 2013 to 2019. Out of these, 1 drug patents are active and 12 have expired. Based on its patents and exclusivities, its generic launch date is estimated to be Sep 23, 2032. Details of Novolog Mix 70/30 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 Dose setting limiter
Jan, 2021

(3 years ago)

Expired
USRE43834 Injection syringe
Jan, 2019

(5 years ago)

Expired
US6004297 Injection syringe
Jan, 2019

(5 years ago)

Expired
US5866538

(Pediatric)

Insulin preparations containing NaCl
Dec, 2017

(6 years ago)

Expired
US5866538 Insulin preparations containing NaCl
Jun, 2017

(7 years ago)

Expired
US5618913

(Pediatric)

Insulin analogues
Dec, 2014

(9 years ago)

Expired
US5618913 Insulin analogues
Jun, 2014

(10 years ago)

Expired
US5840680 ASPB28 insulin crystals
Sep, 2013

(11 years ago)

Expired
US5547930 AspB28 insulin crystals
Sep, 2013

(11 years ago)

Expired
US5834422 AspB28 insulin compositions
Sep, 2013

(11 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 Mix 70/30 Flexpen's patents.

Given below is the list of recent legal activities going on the following patents of Novolog Mix 70/30 Flexpen.

Activity Date Patent Number
Patent litigations
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 12 Nov, 2013 US8579869
Recordation of Patent Grant Mailed 12 Nov, 2013 US8579869
Email Notification 24 Oct, 2013 US8579869
Issue Notification Mailed 23 Oct, 2013 US8579869
Dispatch to FDC 14 Oct, 2013 US8579869
Application Is Considered Ready for Issue 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 Mix 70/30 Flexpen and ongoing litigations to help you estimate the early arrival of Novolog Mix 70/30 Flexpen generic.

Novolog Mix 70/30 Flexpen's Litigations

Novolog Mix 70/30 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 Mix 70/30 Flexpen's patents.

Last updated on November 26, 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 Novolog Mix 70/30 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 Mix 70/30 Flexpen's generic, the next section provides detailed information on ongoing and past EP oppositions related to Novolog Mix 70/30 Flexpen patents.

Novolog Mix 70/30 Flexpen's Oppositions Filed in EPO

Novolog Mix 70/30 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
Patent litigations
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 Mix 70/30 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 Mix 70/30 Flexpen's family patents as well as insights into ongoing legal events on those patents.

Novolog Mix 70/30 Flexpen's Family Patents

Novolog Mix 70/30 Flexpen has patent protection in a total of 14 countries. It's US patent count contributes only to 19.5% of its total global patent coverage. Click below to unlock the full patent family tree for Novolog Mix 70/30 Flexpen.

Family Patents

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Generic Launch

Generic Release Date:

Novolog Mix 70/30 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 Mix 70/30 Flexpen Generics:

There are no approved generic versions for Novolog Mix 70/30 Flexpen as of now.

Alternative Brands for Novolog Mix 70/30 Flexpen

Novolog Mix 70/30 Flexpen which is used for managing diabetes mellitus., has several other brand drugs in the same treatment category and using the same active ingredient (Insulin Aspart Protamine Recombinant; Insulin Aspart 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
Novolog Mix 50/50

(uses Insulin Aspart Protamine Recombinant; Insulin Aspart Recombinant)

Used for managing diabetes mellitus.
Novolog Mix 70/30

(uses Insulin Aspart Protamine Recombinant; Insulin Aspart Recombinant)

Used for managing diabetes mellitus.
Novolog Mix 70/30 Penfill

(uses Insulin Aspart Protamine Recombinant; Insulin Aspart Recombinant)

Used for managing diabetes mellitus.
Sanofi Aventis Us
Apidra used for managing diabetes mellitus.
Apidra Solostar Used for improving glycemic control in diabetes mellitus patients.





About Novolog Mix 70/30 Flexpen

Novolog Mix 70/30 Flexpen is a drug owned by Novo Nordisk Inc. It is used for managing diabetes mellitus. Novolog Mix 70/30 Flexpen uses Insulin Aspart Protamine Recombinant; Insulin Aspart Recombinant as an active ingredient. Novolog Mix 70/30 Flexpen was launched by Novo Nordisk Inc in 2001.

Approval Date:

Novolog Mix 70/30 Flexpen was approved by FDA for market use on 01 November, 2001.

Active Ingredient:

Novolog Mix 70/30 Flexpen uses Insulin Aspart Protamine Recombinant; Insulin Aspart Recombinant as the active ingredient. Check out other Drugs and Companies using Insulin Aspart Protamine Recombinant; Insulin Aspart Recombinant ingredient

Treatment:

Novolog Mix 70/30 Flexpen is used for managing diabetes mellitus.

Dosage:

Novolog Mix 70/30 Flexpen is available in injectable form for subcutaneous use. Given below is detailed information on Dosage -

Strength Dosage Form Availability Application Pathway
210 UNITS/3ML; 90 UNITS/3ML (70 UNITS/ML; 30 UNITS/ML) INJECTABLE Prescription SUBCUTANEOUS