Adlyxin Patent Expiration

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

(9 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

(7 years from now)

Active
US9440029 Drive mechanism for a drug delivery device and drug delivery device
Jan, 2032

(7 years from now)

Active
US9511193 Assembly and indicator for a drug delivery device
Jan, 2032

(7 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

(6 years from now)

Active
US8475414 Medication delivery device and method for operating a medication delivery device
Dec, 2030

(6 years from now)

Active
US10028910 Pharmaceutical composition comprising a GLP-1-agonist and methionine
Nov, 2030

(6 years from now)

Active
US9707176 Pharmaceutical composition comprising a GLP-1 agonist and methionine
Nov, 2030

(6 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

(4 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.

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

Activity Date Patent Number
Patent litigations
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

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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


Family Patents

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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
Soliqua 100/33






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