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.

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
Critical Events This Week
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
Live updates
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.

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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

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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.