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Byetta Patent Expiration

Byetta is a drug owned by Astrazeneca Ab. It is protected by 8 US drug patents filed in 2013 out of which all have expired. Based on its patents and exclusivities, its generic launch date is estimated to be Nov 04, 2024. Details of Byetta'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).
US6872700 Methods for glucagon suppression
Jan, 2020

(4 years ago)

Expired
US6902744 Exendin agonist formulations and methods of administration thereof
Jan, 2020

(4 years ago)

Expired
US6956026 Use of exendins for the reduction of food intake
Jan, 2018

(6 years ago)

Expired
US7741269 Exendins and exendin agonists for weight reduction and obesity
Jan, 2018

(6 years ago)

Expired
US7297761 Pharmaceutical compositions containing exendins
Oct, 2017

(7 years ago)

Expired
US7521423 Exendin pharmaceutical compositions
Oct, 2017

(7 years ago)

Expired
US6858576 Methods for regulating gastrointestinal motility
Jan, 2017

(7 years ago)

Expired
US5424286 Exendin-3 and exendin-4 polypeptides, and pharmaceutical compositions comprising same
Dec, 2016

(8 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 Byetta's patents.

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

Activity Date Patent Number
Patent litigations
Expire Patent 25 Jul, 2022 US7741269 (Litigated)
Maintenance Fee Reminder Mailed 07 Feb, 2022 US7741269 (Litigated)
Expire Patent 24 May, 2021 US7521423 (Litigated)
Maintenance Fee Reminder Mailed 07 Dec, 2020 US7521423 (Litigated)
Expire Patent 23 Dec, 2019 US7297761 (Litigated)
Maintenance Fee Reminder Mailed 08 Jul, 2019 US7297761 (Litigated)
Payment of Maintenance Fee, 8th Year, Large Entity 07 Dec, 2017 US7741269 (Litigated)
Termination or Final Written Decision 28 Aug, 2017 US7297761 (Litigated)
Request for Trial Denied 28 Jun, 2016 US7297761 (Litigated)
Petition Requesting Trial 16 Dec, 2015 US7297761 (Litigated)


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 Byetta and ongoing litigations to help you estimate the early arrival of Byetta generic.

Byetta's Litigations

Byetta been subject to various legal proceedings, including patent litigations. The earliest legal proceeding was initiated on Dec 16, 2015, against patent number US7297761. The petitioner Sanofi-Aventis U.S. LLC, challenged the validity of this patent, with Amylin Pharmaceuticals, LLC as the respondent. Click below to track the latest information on how companies are challenging Byetta's patents.

Last updated on December 17, 2024
Patent Proceeding Filing Date Status Respondent Petitioner
Patent litigations
US7297761 December, 2015 Terminated-Denied
(28 Jun, 2016)
Amylin Pharmaceuticals, LLC Sanofi-Aventis U.S. LLC


FDA has granted some exclusivities to Byetta. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Byetta, 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 Byetta.

Exclusivity Information

Byetta holds 4 exclusivities. All of its exclusivities have expired in 2024. Details of Byetta's exclusivity codes and their expiration dates are given below.


Drug Exclusivity Drug Exclusivity Expiration
M(M-111) Oct 19, 2014
M(M-113) Oct 19, 2014
M(M-148) Nov 24, 2017
M(M-232) Nov 04, 2024

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US patents provide insights into the exclusivity only within the United States, but Byetta 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 Byetta's family patents as well as insights into ongoing legal events on those patents.

Byetta's Family Patents


Family Patents

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Generic Launch

Generic Release Date:

Byetta's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Nov 04, 2024 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)

Byetta Generic API suppliers:

Exenatide Synthetic is the generic name for the brand Byetta. 1 company has already filed for the generic of Byetta. Check out the entire list of companies who have already received approval for Byetta's generic

How can I launch a generic of Byetta before its drug patent expiration? :

You can seek FDA approval to launch a generic drug before the expiration of Byetta's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Byetta's sponsor is invalid, unenforceable, or will not be infringed by your generic product.

Given below are the details of the already filed Para IV certificates on Byetta -

Strength Submission Date ANDA(s) Filed First applicant approval Last patent expiry 180 day status
250 mg/mL, 1.2 mL and 2.4 mL prefilled syringe 11 Jun, 2014 1 14 Jan, 2020 Extinguished

Alternative Brands for Byetta

Byetta which is used for managing type 2 diabetes by stimulating insulin release, reducing food intake, and delaying gastric emptying., has several other brand drugs in the same treatment category and using the same active ingredient (Exenatide Synthetic). 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
Astrazeneca Ab
Bydureon

(uses Exenatide Synthetic)

used for improving glycemic control in patients with type 2 diabetes mellitus.
Bydureon Pen

(uses Exenatide Synthetic)

used for improving glycemic control in patients with Type 2 diabetes, reducing food intake, delaying gastric motility, reducing body weight, and stimulating insulin release.
Bydureon Bcise

(uses Exenatide Synthetic)

Used for improving glycemic control and reducing food intake in patients with type 2 diabetes.

Apart from brand drugs containing the same ingredient, some generics have also been filed for Exenatide Synthetic, Byetta's active ingredient. Check the complete list of approved generic manufacturers for Byetta





About Byetta

Byetta is a drug owned by Astrazeneca Ab. It is used for managing type 2 diabetes by stimulating insulin release, reducing food intake, and delaying gastric emptying. Byetta uses Exenatide Synthetic as an active ingredient. Byetta was launched by Astrazeneca Ab in 2005.

Approval Date:

Byetta was approved by FDA for market use on 28 April, 2005.

Active Ingredient:

Byetta uses Exenatide Synthetic as the active ingredient. Check out other Drugs and Companies using Exenatide Synthetic ingredient

Treatment:

Byetta is used for managing type 2 diabetes by stimulating insulin release, reducing food intake, and delaying gastric emptying.

Dosage:

Byetta is available in injectable form for subcutaneous use. Given below is detailed information on Dosage -

Strength Dosage Form Availability Application Pathway
300MCG/1.2ML (250MCG/ML) INJECTABLE Prescription SUBCUTANEOUS
600MCG/2.4ML (250MCG/ML) INJECTABLE Prescription SUBCUTANEOUS