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.
Latest 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 |
---|---|---|
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.
Patent | Proceeding Filing Date | Status | Respondent | Petitioner |
---|---|---|---|---|
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 |
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
Explore Our Curated Drug Screens
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 |
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Sanofi Aventis Us |
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Sanofi-aventis Us |
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Sanofi Us Services |
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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 |