Onglyza is a drug owned by Astrazeneca Ab. It is protected by 3 US drug patents filed in 2013. Out of these, 1 drug patents are active and 2 have expired. Onglyza's patents have been open to challenges since 31 July, 2013. Based on its patents and exclusivities, its generic launch date is estimated to be Nov 30, 2028. Details of Onglyza'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). | |||
| US7951400 | Coated tablet formulation and method |
Nov, 2028
(3 years from now) | Active |
| USRE44186 | Cyclopropyl-fused pyrrolidine-based inhibitors of dipeptidyl peptidase IV and method |
Jul, 2023
(1 year, 9 months ago) |
Expired
|
| US6395767 | Cyclopropyl-fused pyrrolidine-based inhibitors of dipeptidyl peptidase IV and method |
Feb, 2021
(4 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 Onglyza's patents.
Latest Legal Activities on Onglyza's Patents
Given below is the list of recent legal activities going on the following patents of Onglyza.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 12th Year, Large Entity | 16 Nov, 2022 | US7951400 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 15 Nov, 2018 | US7951400 |
| Correspondence Address Change Critical | 16 Sep, 2014 | US6395767 (Litigated) |
| Patent Term Extension Certificate Critical | 29 Apr, 2013 | US6395767 (Litigated) |
| Notice of Final Determination -Eligible | 31 Jul, 2012 | US6395767 (Litigated) |
| Recordation of Patent Grant Mailed Critical | 31 May, 2011 | US7951400 |
| Patent Issue Date Used in PTA Calculation Critical | 31 May, 2011 | US7951400 |
| Issue Notification Mailed Critical | 11 May, 2011 | US7951400 |
| FDA Final Eligibility Letter Critical | 04 May, 2011 | US6395767 (Litigated) |
| Dispatch to FDC | 25 Apr, 2011 | US7951400 |
FDA has granted several exclusivities to Onglyza. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Onglyza, 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 Onglyza.
Exclusivity Information
Onglyza holds 5 exclusivities. All of its exclusivities have expired in 2020. Details of Onglyza's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | Jul 31, 2014 |
| M(M-108) | Dec 16, 2014 |
| M(M-134) | May 24, 2016 |
| M(M-175) | Apr 05, 2019 |
| M(M-198) | Feb 27, 2020 |
Several oppositions have been filed on Onglyza's European patents. EP oppositions can significantly impact the timeline for the generic launch of drugs. If an opposition results in the revocation or amendment of a patent, it can shorten the exclusivity period of the original drug. This can lead to an earlier entry of generic versions into the market. To help you estimate the potential early arrival of Onglyza's generic, the next section provides detailed information on ongoing and past EP oppositions related to Onglyza patents.
Onglyza's Oppositions Filed in EPO
Onglyza has faced multiple oppositions in the European Patent Office. The earliest opposition was filed on Jan 20, 2017, by Galenicum Health S.L.. This opposition was filed on patent number EP05756474A. Click below to reveal the latest opposition data.
| Application | Filing Date | Opposition Party | Legal Status |
|---|---|---|---|
 | |||
| EP10179007A | Mar, 2017 | Galenicum Health S.L. | Patent maintained as amended |
| EP05756474A | Jan, 2017 | Galenicum Health S.L. | Patent maintained as amended |
US patents provide insights into the exclusivity only within the United States, but Onglyza 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 Onglyza's family patents as well as insights into ongoing legal events on those patents.
Onglyza's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Onglyza's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Nov 30, 2028 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Onglyza Generic API suppliers:
Saxagliptin Hydrochloride is the generic name for the brand Onglyza. 5 different companies have already filed for the generic of Onglyza, with Amneal having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Onglyza's generic
How can I launch a generic of Onglyza before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Onglyza's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Onglyza'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 Onglyza -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 2.5 mg and 5 mg | 31 Jul, 2013 | 8 | 31 Jul, 2023 | 30 Nov, 2028 | Eligible |
Alternative Brands for Onglyza
Onglyza which is used for managing type II diabetes., has several other brand drugs using the same active ingredient (Saxagliptin Hydrochloride). 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 | |||
|---|---|---|---|---|
| Astrazeneca Ab |
|
Apart from brand drugs containing the same ingredient, some generics have also been filed for Saxagliptin Hydrochloride, Onglyza's active ingredient. Check the complete list of approved generic manufacturers for Onglyza
About Onglyza
Onglyza is a drug owned by Astrazeneca Ab. It is used for managing type II diabetes. Onglyza uses Saxagliptin Hydrochloride as an active ingredient. Onglyza was launched by Astrazeneca Ab in 2009.
Approval Date:
Onglyza was approved by FDA for market use on 31 July, 2009.
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 Onglyza is 31 July, 2009, its NCE-1 date is estimated to be 31 July, 2013.
Active Ingredient:
Onglyza uses Saxagliptin Hydrochloride as the active ingredient. Check out other Drugs and Companies using Saxagliptin Hydrochloride ingredient
Treatment:
Onglyza is used for managing type II diabetes.
Dosage:
Onglyza is available in tablet form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| EQ 2.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET | Discontinued | ORAL |
| EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET | Discontinued | ORAL |