Soliqua 100/33 is a drug owned by Sanofi-aventis Us Llc. It is protected by 26 US drug patents filed from 2016 to 2018. Out of these, 9 drug patents are active and 17 have expired. Soliqua 100/33's patents have been open to challenges since 27 July, 2020. Based on its patents and exclusivities, its generic launch date is estimated to be Dec 10, 2035. Details of Soliqua 100/33's patents and their expiration are given in the table below.
| Drug Patent Number | Drug Patent Title | Drug Patent Expiry | Status |
|---|---|---|---|
| These drug patents protect the active ingredient(API) of the drug. Only drug patent owner can launch products that use this active ingredient until these patents expire. | |||
| USRE45313 | Exendin variant peptides |
Jul, 2020
(4 years ago) |
Expired
|
| These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| US9950039 | Insulin glargine/lixisenatide fixed ratio formulation |
Dec, 2035
(10 years from now) | Active |
| US9717852 | Cartridge holder and pen-type injector |
Apr, 2033
(8 years from now) | Active |
| US9821032 | Pharmaceutical combination for improving glycemic control as add-on therapy to basal insulin |
May, 2032
(7 years from now) | Active |
| US10029011 | Pharmaceutical composition comprising a GLP-1 agonist, an insulin and methionine |
Nov, 2030
(5 years from now) | Active |
| US9707176 | Pharmaceutical composition comprising a GLP-1 agonist and methionine |
Nov, 2030
(5 years from now) | Active |
| US10117909 | Combination of an insulin and a GLP-1 agonist |
Oct, 2029
(4 years from now) | Active |
| US9526764 | Combination of an insulin and a GLP-1-agonist |
Oct, 2029
(4 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
(3 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
(4 months ago) |
Expired
|
| US9604009 | Drive mechanisms suitable for use in drug delivery devices |
Aug, 2024
(4 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
|
| US9610409 | 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
|
| US9408979 | Pen-type injector |
Mar, 2024
(9 months ago) |
Expired
|
| US9233211 | Relating to a pen-type injector |
Mar, 2024
(9 months ago) |
Expired
|
| US9526844 | 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
|
| US9827379 | Drive mechanisms suitable for use in drug delivery devices |
Mar, 2024
(9 months 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 Soliqua 100/33's patents.
Latest Legal Activities on Soliqua 100/33's Patents
Given below is the list of recent legal activities going on the following patents of Soliqua 100/33.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 8th Year, Large Entity | 12 Jun, 2024 | US9526764 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 20 Apr, 2022 | US10117909 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 12 Jan, 2022 | US10029011 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 06 Oct, 2021 | US9950039 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 11 Jun, 2020 | US9526764 |
| Patent Issue Date Used in PTA Calculation Critical | 06 Nov, 2018 | US10117909 |
| Recordation of Patent Grant Mailed Critical | 06 Nov, 2018 | US10117909 |
| Issue Notification Mailed Critical | 17 Oct, 2018 | US10117909 |
| Dispatch to FDC | 01 Oct, 2018 | US10117909 |
| Application Is Considered Ready for Issue Critical | 01 Oct, 2018 | US10117909 |
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 Soliqua 100/33 and ongoing litigations to help you estimate the early arrival of Soliqua 100/33 generic.
Soliqua 100/33's Litigations
Soliqua 100/33 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 Soliqua 100/33'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 Soliqua 100/33. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Soliqua 100/33, 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 Soliqua 100/33.
Exclusivity Information
Soliqua 100/33 holds 2 exclusivities. All of its exclusivities have expired in 2021. Details of Soliqua 100/33's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Combination(NC) | Nov 21, 2019 |
| New Chemical Entity Exclusivity(NCE) | Jul 27, 2021 |
US patents provide insights into the exclusivity only within the United States, but Soliqua 100/33 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 Soliqua 100/33's family patents as well as insights into ongoing legal events on those patents.
Soliqua 100/33's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Soliqua 100/33's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Dec 10, 2035 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Soliqua 100/33 Generics:
There are no approved generic versions for Soliqua 100/33 as of now.
Alternative Brands for Soliqua 100/33
Soliqua 100/33 which is used for improving glycemic control in type 2 diabetes mellitus patients., has several other brand drugs in the same treatment category . 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 | ||||
|---|---|---|---|---|---|---|
| Sanofi Aventis Us |
| |||||
| Sanofi-aventis Us |
| |||||
| Sanofi Us Services |
| |||||
About Soliqua 100/33
Soliqua 100/33 is a drug owned by Sanofi-Aventis Us Llc. It is used for improving glycemic control in type 2 diabetes mellitus patients. Soliqua 100/33 uses Insulin Glargine; Lixisenatide as an active ingredient. Soliqua 100/33 was launched by Sanofi-Aventis Us in 2016.
Approval Date:
Soliqua 100/33 was approved by FDA for market use on 21 November, 2016.
NCE-1 date:
NCE-1 date also known as the four year date occurs four years after the original drug approval and marks the first opportunity for a generic manufacturer to file an ANDA with a Paragraph IV certification. This is the earliest point when generic competition might begin, provided the challenge is successful. Since the approval date for Soliqua 100/33 is 21 November, 2016, its NCE-1 date is estimated to be 27 July, 2020.
Active Ingredient:
Soliqua 100/33 uses Insulin Glargine; Lixisenatide as the active ingredient. Check out other Drugs and Companies using Insulin Glargine; Lixisenatide ingredient
Treatment:
Soliqua 100/33 is used for improving glycemic control in type 2 diabetes mellitus patients.
Dosage:
Soliqua 100/33 is available in solution form for subcutaneous use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 300 UNITS/3ML;99MCG/3ML (100 UNITS/ML;33MCG/ML) | SOLUTION | Prescription | SUBCUTANEOUS |