Qtern is a drug owned by Astrazeneca Ab. It is protected by 11 US drug patents filed from 2017 to 2019. Out of these, 7 drug patents are active and 4 have expired. Qtern's patents have been open to challenges since 08 January, 2018. Based on its patents and exclusivities, its generic launch date is estimated to be Dec 16, 2029. Details of Qtern'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. | |||
| US7919598 | Crystal structures of SGLT2 inhibitors and processes for preparing same |
Dec, 2029
(5 years from now) | Active |
| US6515117 | C-aryl glucoside SGLT2 inhibitors and method |
Oct, 2025
(10 months from now) | Active |
| USRE44186 | Cyclopropyl-fused pyrrolidine-based inhibitors of dipeptidyl peptidase IV and method |
Jul, 2023
(1 year, 3 months ago) |
Expired
|
| US6414126 | C-aryl glucoside SGLT2 inhibitors and method |
Oct, 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). | |||
| US8716251 | Pharmaceutical formulations containing an SGLT2 inhibitor |
Mar, 2028
(3 years from now) | Active |
| US8221786 | Pharmaceutical formulations containing an SGLT2 inhibitor |
Mar, 2028
(3 years from now) | Active |
| US8361972 | Pharmaceutical formulations containing an SGLT2 inhibitor |
Mar, 2028
(3 years from now) | Active |
| US8501698 | Crystal structures of SGLT2 inhibitors and processes for preparing same |
Jun, 2027
(2 years from now) | Active |
| US8628799 | Coated tablet formulation and method |
Jul, 2025
(7 months from now) | Active |
| US9198925 | Pharmaceutical formulations containing an SGLT2 inhibitor |
Oct, 2020
(4 years ago) |
Expired
|
| US6936590 | C-aryl glucoside SGLT2 inhibitors and method |
Oct, 2020
(4 years ago) |
Expired
|
FDA has granted several exclusivities to Qtern. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Qtern, 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 Qtern.
Exclusivity Information
Qtern holds 5 exclusivities. All of its exclusivities have expired in 2022. Details of Qtern's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | Jan 08, 2019 |
| M(M-175) | Apr 05, 2019 |
| New Combination(NC) | Feb 27, 2020 |
| New Indication(I-804) | May 02, 2022 |
| New Strength(NS) | May 02, 2022 |
Several oppositions have been filed on Qtern'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 Qtern's generic, the next section provides detailed information on ongoing and past EP oppositions related to Qtern patents.
Qtern's Oppositions Filed in EPO
Qtern has faced multiple oppositions in the European Patent Office. The earliest opposition was filed on Apr 30, 2015, by Lek Pharmaceuticals D.D.. This opposition was filed on patent number EP07784499A. Click below to reveal the latest opposition data.
| Application | Filing Date | Opposition Party | Legal Status |
|---|---|---|---|
 | |||
| EP08732695A | Dec, 2020 | Stada-Arzneimittel Aktiengesellschaft | Granted and Under Opposition |
| EP08732695A | Dec, 2020 | Kraus & Weisert Patentanwälte PartGmbB | Granted and Under Opposition |
| EP08732695A | Dec, 2020 | Gedeon Richter Plc. | Granted and Under Opposition |
| EP08732695A | Dec, 2020 | Galenicum Health S.L.U. | Granted and Under Opposition |
| EP08732695A | Dec, 2020 | Generics [UK] Limited | Granted and Under Opposition |
| EP08732695A | Dec, 2020 | Zentiva, k.s. | Granted and Under Opposition |
| EP17203302A | Aug, 2020 | Generics (U.K.) Limited | Granted and Under Opposition |
| EP15181545A | Sep, 2018 | Generics (U.K.) Limited | Granted and Under Opposition |
| EP10179007A | Mar, 2017 | Galenicum Health S.L. | Patent maintained as amended |
| EP05756474A | Jan, 2017 | Galenicum Health S.L. | Patent maintained as amended |
| EP07784499A | Apr, 2015 | LEK Pharmaceuticals d.d. | Patent maintained as amended |
US patents provide insights into the exclusivity only within the United States, but Qtern 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 Qtern's family patents as well as insights into ongoing legal events on those patents.
Qtern's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Qtern's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Dec 16, 2029 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Qtern Generics:
There are no approved generic versions for Qtern as of now.
How can I launch a generic of Qtern before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Qtern's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Qtern'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 Qtern -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 5 mg/5 mg | 29 Jul, 2020 | 1 | 16 Dec, 2029 | ||
| 10 mg/5 mg | 08 Jan, 2018 | 5 | 16 Dec, 2029 |
Alternative Brands for Qtern
Qtern which is used for the treatment of type 2 diabetes mellitus in patients who have inadequate control with dapagliflozin., has several other brand drugs in the same treatment category . 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 |
| |||||||
| Boehringer Ingelheim |
| |||||||
| Cosette |
| |||||||
| Janssen Pharms |
| |||||||
| Sb Pharmco |
| |||||||
About Qtern
Qtern is a drug owned by Astrazeneca Ab. It is used for the treatment of type 2 diabetes mellitus in patients who have inadequate control with dapagliflozin. Qtern uses Dapagliflozin; Saxagliptin Hydrochloride as an active ingredient. Qtern was launched by Astrazeneca Ab in 2019.
Approval Date:
Qtern was approved by FDA for market use on 02 May, 2019.
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 Qtern is 02 May, 2019, its NCE-1 date is estimated to be 08 January, 2018.
Active Ingredient:
Qtern uses Dapagliflozin; Saxagliptin Hydrochloride as the active ingredient. Check out other Drugs and Companies using Dapagliflozin; Saxagliptin Hydrochloride ingredient
Treatment:
Qtern is used for the treatment of type 2 diabetes mellitus in patients who have inadequate control with dapagliflozin.
Dosage:
Qtern is available in tablet form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 5MG;EQ 5MG BASE | TABLET | Prescription | ORAL |
| 10MG;EQ 5MG BASE | TABLET | Prescription | ORAL |