Adlyxin is a drug owned by Sanofi-aventis Us Llc. It is protected by 16 US drug patents filed from 2016 to 2019. Out of these, 15 drug patents are active and 1 has expired. Adlyxin'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 Mar 10, 2034. Details of Adlyxin'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). | |||
| US10201663 | Assembly for a drug delivery device |
Mar, 2034
(8 years from now) | Active |
| US9408893 | Pharmaceutical combination for use in glycemic control in diabetes type 2 patients |
Aug, 2032
(7 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 |
| US9072836 | Drive mechanism for a drug delivery device and drug delivery device |
Mar, 2032
(6 years from now) | Active |
| US9440029 | Drive mechanism for a drug delivery device and drug delivery device |
Jan, 2032
(6 years from now) | Active |
| US9511193 | Assembly and indicator for a drug delivery device |
Jan, 2032
(6 years from now) | Active |
| US9084853 | Drive mechanism for a drug delivery device and drug delivery device |
Oct, 2031
(6 years from now) | Active |
| US8882721 | Drive assembly suitable for use in a drug delivery device and drug delivery device |
Jun, 2031
(6 years from now) | Active |
| US9308329 | Medication delivery device and method for operating a medication delivery device |
Dec, 2030
(5 years from now) | Active |
| US8475414 | Medication delivery device and method for operating a medication delivery device |
Dec, 2030
(5 years from now) | Active |
| US10028910 | Pharmaceutical composition comprising a GLP-1-agonist 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 |
| US9981013 | Use of AVE0010 for the treatment of diabetes mellitus type 2 |
Aug, 2030
(5 years from now) | Active |
| US8915888 | Dosing and drive mechanism for drug delivery device |
Jun, 2030
(5 years from now) | Active |
| US9855388 | Dosing and drive mechanism for drug delivery device |
Apr, 2029
(3 years from now) | Active |
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 Adlyxin's patents.
Latest Legal Activities on Adlyxin's Patents
Given below is the list of recent legal activities going on the following patents of Adlyxin.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 8th Year, Large Entity | 22 May, 2024 | US9511193 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 28 Feb, 2024 | US9440029 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 25 Jan, 2024 | US9408893 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 27 Sep, 2023 | US9308329 |
| Post Issue Communication - Certificate of Correction | 27 Jan, 2023 | US10201663 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 06 Jan, 2023 | US9084853 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 21 Dec, 2022 | US9072836 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 27 Jul, 2022 | US10201663 |
| Post Issue Communication - Certificate of Correction | 23 Jun, 2022 | US10201663 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 08 Jun, 2022 | US8915888 |
FDA has granted several exclusivities to Adlyxin. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Adlyxin, 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 Adlyxin.
Exclusivity Information
Adlyxin holds 1 exclusivities. All of its exclusivities have expired in 2021. Details of Adlyxin's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | Jul 27, 2021 |
US patents provide insights into the exclusivity only within the United States, but Adlyxin 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 Adlyxin's family patents as well as insights into ongoing legal events on those patents.
Adlyxin's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Adlyxin's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Mar 10, 2034 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Adlyxin Generics:
There are no approved generic versions for Adlyxin as of now.
Alternative Brands for Adlyxin
Adlyxin which is used for improving glycemic control in patients with type 2 diabetes mellitus., has several other brand drugs using the same active ingredient (Lixisenatide). 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 | |
|---|---|---|
| Sanofi-aventis Us |
|
About Adlyxin
Adlyxin is a drug owned by Sanofi-Aventis Us Llc. It is used for improving glycemic control in patients with type 2 diabetes mellitus. Adlyxin uses Lixisenatide as an active ingredient. Adlyxin was launched by Sanofi-Aventis Us in 2016.
Approval Date:
Adlyxin was approved by FDA for market use on 27 July, 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 Adlyxin is 27 July, 2016, its NCE-1 date is estimated to be 27 July, 2020.
Active Ingredient:
Adlyxin uses Lixisenatide as the active ingredient. Check out other Drugs and Companies using Lixisenatide ingredient
Treatment:
Adlyxin is used for improving glycemic control in patients with type 2 diabetes mellitus.
Dosage:
Adlyxin is available in solution form for subcutaneous use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 0.3MG/3ML (0.1MG/ML) | SOLUTION | Prescription | SUBCUTANEOUS |
| 0.15MG/3ML (0.05MG/ML) | SOLUTION | Prescription | SUBCUTANEOUS |