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
(5 years ago) |
Expired
|
| US6902744 | Exendin agonist formulations and methods of administration thereof |
Jan, 2020
(5 years ago) |
Expired
|
| US6956026 | Use of exendins for the reduction of food intake |
Jan, 2018
(7 years ago) |
Expired
|
| US7741269 | Exendins and exendin agonists for weight reduction and obesity |
Jan, 2018
(7 years ago) |
Expired
|
| US7297761 | Pharmaceutical compositions containing exendins |
Oct, 2017
(8 years ago) |
Expired
|
| US7521423 | Exendin pharmaceutical compositions |
Oct, 2017
(8 years ago) |
Expired
|
| US6858576 | Methods for regulating gastrointestinal motility |
Jan, 2017
(8 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.
Latest 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 |
|---|---|---|
 | ||
| Expire Patent
Critical | 25 Jul, 2022 | US7741269 (Litigated) |
| Maintenance Fee Reminder Mailed
Critical | 07 Feb, 2022 | US7741269 (Litigated) |
| Expire Patent
Critical | 24 May, 2021 | US7521423 (Litigated) |
| Maintenance Fee Reminder Mailed
Critical | 07 Dec, 2020 | US7521423 (Litigated) |
| Expire Patent
Critical | 23 Dec, 2019 | US7297761 (Litigated) |
| Maintenance Fee Reminder Mailed
Critical | 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
Critical | 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.
| Patent | Proceeding Filing Date | Status | Respondent | Petitioner |
|---|---|---|---|---|
 | ||||
| US7297761 | December, 2015 |
Institution Denied
(28 Jun, 2016) | Amylin Pharmaceuticals, LLC et al. | Sanofi-Aventis U.S. LLC et al. |
| 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 |
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
Explore Our Curated Drug Screens
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 |
| |||||||
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 | Discontinued | SUBCUTANEOUS |
| 600MCG/2.4ML (250MCG/ML) | INJECTABLE | Discontinued | SUBCUTANEOUS |