Apidra Solostar Patent Expiration

Apidra Solostar is a drug owned by Sanofi Aventis Us Llc. It is protected by 23 US drug patents filed from 2013 to 2018. Out of these, 3 drug patents are active and 20 have expired. Based on its patents and exclusivities, its generic launch date is estimated to be Apr 08, 2033. Details of Apidra Solostar'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).
US9717852 Cartridge holder and pen-type injector
Apr, 2033

(8 years from now)

Active
US7918833 Pen-type injector
Sep, 2027

(2 years from now)

Active
US8679069 Pen-type injector
Apr, 2025

(3 months from now)

Active
US8512297 Pen-type injector
Sep, 2024

(2 months ago)

Expired
US9561331 Drive mechanisms suitable for use in drug delivery devices
Aug, 2024

(3 months ago)

Expired
US9623189 Relating to drive mechanisms suitable for use in drug delivery devices
Aug, 2024

(3 months ago)

Expired
US9533105 Drive mechanisms suitable for use in drug delivery devices
Aug, 2024

(3 months ago)

Expired
US9604009 Drive mechanisms suitable for use in drug delivery devices
Aug, 2024

(3 months ago)

Expired
US8992486 Pen-type injector
Jun, 2024

(6 months ago)

Expired
US9011391 Pen-type injector
Mar, 2024

(8 months ago)

Expired
US8556864 Drive mechanisms suitable for use in drug delivery devices
Mar, 2024

(9 months ago)

Expired
US9604008 Drive mechanisms suitable for use in drug delivery devices
Mar, 2024

(9 months ago)

Expired
US9526844 Pen-type injector
Mar, 2024

(9 months ago)

Expired
US9827379 Drive mechanisms suitable for use in drug delivery devices
Mar, 2024

(9 months ago)

Expired
US9408979 Pen-type injector
Mar, 2024

(9 months ago)

Expired
US8603044 Pen-type injector
Mar, 2024

(9 months ago)

Expired
US9775954 Pen-type injector
Mar, 2024

(9 months ago)

Expired
US9610409 Drive mechanisms suitable for use in drug delivery devices
Mar, 2024

(9 months ago)

Expired
US9233211 Relating to a pen-type injector
Mar, 2024

(9 months ago)

Expired
US6960561 Zinc-free and low-zinc insulin preparations having improved stability
Jan, 2023

(1 year, 10 months ago)

Expired
US7696162 Zinc-free and low-zinc insulin preparations having improved stability
Mar, 2022

(2 years ago)

Expired
US7452860 Zinc-free and low-zinc insulin preparations having improved stability
Mar, 2022

(2 years ago)

Expired
US6221633 Insulin derivatives having a rapid onset of action
Jun, 2018

(6 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 Apidra Solostar's patents.

Given below is the list of recent legal activities going on the following patents of Apidra Solostar.

Activity Date Patent Number
Patent litigations
Payment of Maintenance Fee, 8th Year, Large Entity 19 Jun, 2024 US9533105
Payment of Maintenance Fee, 8th Year, Large Entity 25 Jan, 2024 US9408979
Payment of Maintenance Fee, 8th Year, Large Entity 28 Jun, 2023 US9233211 (Litigated)
Payment of Maintenance Fee, 8th Year, Large Entity 05 Oct, 2022 US9011391 (Litigated)
Payment of Maintenance Fee, 12th Year, Large Entity 21 Sep, 2022 US7918833 (Litigated)
Payment of Maintenance Fee, 8th Year, Large Entity 14 Sep, 2022 US8992486 (Litigated)
Review Certificate Mailed 30 Aug, 2022 US9526844
Review Certificate Mailed 26 Aug, 2022 US8603044
Review Certificate Mailed 18 Aug, 2022 US8992486 (Litigated)
Review Certificate Mailed 18 Aug, 2022 US9604008


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 Apidra Solostar and ongoing litigations to help you estimate the early arrival of Apidra Solostar generic.

Apidra Solostar's Litigations

Apidra Solostar been subject to various legal proceedings, including patent litigations. The earliest legal proceeding was initiated on Sep 10, 2018, against patent number US8992486. The petitioner Mylan Pharmaceuticals Inc et al., challenged the validity of this patent, with Sanofi-Aventis Deutschland GmbH et al. as the respondent. Click below to track the latest information on how companies are challenging Apidra Solostar's patents.

Last updated on December 10, 2024
Patent Proceeding Filing Date Status Respondent Petitioner
Patent litigations
US8679069 May, 2019 FWD Entered
(11 Aug, 2020)
Sanofi-Aventis Deutschland Pfizer Inc.
US8603044 September, 2018 FWD Entered
(29 May, 2020)
Sanofi-Aventis Deutschland GmbH Mylan Pharmaceuticals Inc.
US8992486 September, 2018 FWD Entered
(29 May, 2020)
Sanofi-Aventis Deutschland GmbH Mylan Pharmaceuticals Inc.
US8992486 October, 2018 FWD Entered
(29 May, 2020)
Sanofi-Aventis Deutschland GmbH Mylan Pharmaceuticals Inc.
US9526844 September, 2018 FWD Entered
(29 May, 2020)
Sanofi-Aventis Deutschland GmbH Mylan Pharmaceuticals Inc
US9526844 September, 2018 FWD Entered
(29 May, 2020)
Sanofi-Aventis Deutschland GmbH Mylan Pharmaceuticals Inc.
US9604008 September, 2018 FWD Entered
(29 May, 2020)
Sanofi-Aventis Deutschland GmbH Mylan Pharmaceuticals Inc.
US8679069 September, 2018 FWD Entered
(02 Apr, 2020)
Sanofi-Aventis Deutshland GmbH Mylan Pharmaceuticals Inc.
US9526844 May, 2019 Terminated-Other
(20 Aug, 2019)
Sanofi-Aventis Deutschland Pfizer Inc.
US9526844 May, 2019 Terminated-Other
(19 Aug, 2019)
Sanofi-Aventis Deutschland Pfizer Inc.
US8603044 May, 2019 Terminated-Other
(15 Aug, 2019)
Sanofi-Aventis Deutschland Pfizer Inc.
US8992486 May, 2019 Terminated-Other
(15 Aug, 2019)
Sanofi-Aventis Deutschland Pfizer Inc.
US9604008 May, 2019 Terminated-Other
(15 Aug, 2019)
Sanofi-Aventis Deutschland Pfizer Inc.
US9526844 September, 2018 Terminated-Denied
(03 Apr, 2019)
Sanofi-Aventis Deutschland GmbH Mylan Pharmaceuticals Inc.
US8992486 September, 2018 Terminated
(19 Dec, 2018)
Sanofi-Aventis Deutschland GmbH et al. Mylan Pharmaceuticals Inc et al.


FDA has granted some exclusivities to Apidra Solostar. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Apidra Solostar, 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 Apidra Solostar.

Exclusivity Information

Apidra Solostar holds 1 exclusivities. All of its exclusivities have expired in 2011. Details of Apidra Solostar's exclusivity codes and their expiration dates are given below.


Drug Exclusivity Drug Exclusivity Expiration
New Patient Population(NPP) Oct 24, 2011

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

Apidra Solostar's Family Patents


Family Patents

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Generic Launch

Generic Release Date:

Apidra Solostar's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Apr 08, 2033 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)

Apidra Solostar Generics:

There are no approved generic versions for Apidra Solostar as of now.

Alternative Brands for Apidra Solostar

Apidra Solostar which is used for improving glycemic control in diabetes mellitus patients., has several other brand drugs in the same treatment category and using the same active ingredient (Insulin Glulisine 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 Used for managing diabetes mellitus.
Novolog Mix 70/30 Used for managing diabetes mellitus.
Novolog Mix 70/30 Flexpen Used for managing diabetes mellitus.
Novolog Mix 70/30 Penfill Used for managing diabetes mellitus.
Sanofi Aventis Us
Apidra

(uses Insulin Glulisine Recombinant)

used for managing diabetes mellitus.
Lantus Solostar Used for improving glycemic control in diabetes mellitus patients.
Sanofi-aventis Us
Soliqua 100/33 Used for improving glycemic control in type 2 diabetes mellitus patients.
Admelog Solostar Used for improving glycemic control in diabetes mellitus patients.
Sanofi Us Services
Toujeo Solostar used for managing glycemic control in diabetes mellitus patients.
Toujeo Max Solostar Used for improving glycemic control in diabetes mellitus patients.





About Apidra Solostar

Apidra Solostar is a drug owned by Sanofi Aventis Us Llc. It is used for improving glycemic control in diabetes mellitus patients. Apidra Solostar uses Insulin Glulisine Recombinant as an active ingredient. Apidra Solostar was launched by Sanofi Aventis Us in 2004.

Approval Date:

Apidra Solostar was approved by FDA for market use on 16 April, 2004.

Active Ingredient:

Apidra Solostar uses Insulin Glulisine Recombinant as the active ingredient. Check out other Drugs and Companies using Insulin Glulisine Recombinant ingredient

Treatment:

Apidra Solostar is used for improving glycemic control in diabetes mellitus patients.

Dosage:

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

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