QTERNMET XR Drug Patent Profile
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When do Qternmet Xr patents expire, and when can generic versions of Qternmet Xr launch?
Qternmet Xr is a drug marketed by Astrazeneca Ab and is included in one NDA. There are six patents protecting this drug.
This drug has three hundred and forty-six patent family members in forty-eight countries.
The generic ingredient in QTERNMET XR is dapagliflozin; metformin hydrochloride; saxagliptin hydrochloride. There are twenty-six drug master file entries for this compound. Additional details are available on the dapagliflozin; metformin hydrochloride; saxagliptin hydrochloride profile page.
DrugPatentWatch® Generic Entry Outlook for Qternmet Xr
By analyzing the patents and regulatory protections it appears that the earliest date
for generic entry will be November 12, 2030. This may change due to patent challenges or generic licensing.
There have been sixteen patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.
Indicators of Generic Entry
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Questions you can ask:
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Summary for QTERNMET XR
| International Patents: | 346 |
| US Patents: | 6 |
| Applicants: | 1 |
| NDAs: | 1 |
| Formulation / Manufacturing: | see details |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for QTERNMET XR |
| DailyMed Link: | QTERNMET XR at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for QTERNMET XR
*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.
US Patents and Regulatory Information for QTERNMET XR
QTERNMET XR is protected by six US patents.
Based on analysis by DrugPatentWatch, the earliest date for a generic version of QTERNMET XR is ⤷ Sign Up.
This potential generic entry date is based on patent ⤷ Sign Up.
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.
Patents protecting QTERNMET XR
C-aryl glucoside SGLT2 inhibitors and method
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF TYPE 2 DIABETES MELLITUS
Crystal structures of SGLT2 inhibitors and processes for preparing same
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Crystal structures of SGLT2 inhibitors and processes for preparing same
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF TYPE 2 DIABETES MELLITUS
Coated tablet formulation and method
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Pharmaceutical formulations containing an SGLT2 inhibitor
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Bilayer tablet formulations
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Astrazeneca Ab | QTERNMET XR | dapagliflozin; metformin hydrochloride; saxagliptin hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 210874-001 | May 2, 2019 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | Y | ⤷ Sign Up | ||
| Astrazeneca Ab | QTERNMET XR | dapagliflozin; metformin hydrochloride; saxagliptin hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 210874-003 | May 2, 2019 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| Astrazeneca Ab | QTERNMET XR | dapagliflozin; metformin hydrochloride; saxagliptin hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 210874-004 | May 2, 2019 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| Astrazeneca Ab | QTERNMET XR | dapagliflozin; metformin hydrochloride; saxagliptin hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 210874-002 | May 2, 2019 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | Y | ⤷ Sign Up | ||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
Expired US Patents for QTERNMET XR
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Astrazeneca Ab | QTERNMET XR | dapagliflozin; metformin hydrochloride; saxagliptin hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 210874-003 | May 2, 2019 | ⤷ Sign Up | ⤷ Sign Up |
| Astrazeneca Ab | QTERNMET XR | dapagliflozin; metformin hydrochloride; saxagliptin hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 210874-003 | May 2, 2019 | ⤷ Sign Up | ⤷ Sign Up |
| Astrazeneca Ab | QTERNMET XR | dapagliflozin; metformin hydrochloride; saxagliptin hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 210874-001 | May 2, 2019 | ⤷ Sign Up | ⤷ Sign Up |
| Astrazeneca Ab | QTERNMET XR | dapagliflozin; metformin hydrochloride; saxagliptin hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 210874-003 | May 2, 2019 | ⤷ Sign Up | ⤷ Sign Up |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for QTERNMET XR
When does loss-of-exclusivity occur for QTERNMET XR?
Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:
Australia
Patent: 10319343
Patent: Bilayer tablet formulations
Estimated Expiration: ⤷ Sign Up
Brazil
Patent: 2012011726
Patent: comprimidos de duas camadas, seu uso, e suas combinações farmacêuticas
Estimated Expiration: ⤷ Sign Up
Canada
Patent: 80939
Patent: FORMULATIONS DE COMPRIME BICOUCHE (BILAYER TABLET FORMULATIONS)
Estimated Expiration: ⤷ Sign Up
Patent: 87757
Patent: FORMULATIONS DE COMPRIME BICOUCHE (BILAYER TABLET FORMULATIONS)
Estimated Expiration: ⤷ Sign Up
China
Patent: 2711739
Patent: Bilayer tablet formulations
Estimated Expiration: ⤷ Sign Up
Patent: 5193761
Patent: BILAYER TABLET FORMULATIONS
Estimated Expiration: ⤷ Sign Up
Croatia
Patent: 0181347
Estimated Expiration: ⤷ Sign Up
Denmark
Patent: 98758
Estimated Expiration: ⤷ Sign Up
European Patent Office
Patent: 98758
Patent: FORMULATIONS DE COMPRIMÉ BICOUCHE (BILAYER TABLET FORMULATIONS)
Estimated Expiration: ⤷ Sign Up
Patent: 15124
Patent: FORMULATIONS DE COMPRIMÉS BICOUCHES (BILAYER TABLET FORMULATIONS)
Estimated Expiration: ⤷ Sign Up
Hungary
Patent: 40486
Estimated Expiration: ⤷ Sign Up
Patent: 000009
Estimated Expiration: ⤷ Sign Up
Japan
Patent: 75522
Estimated Expiration: ⤷ Sign Up
Patent: 67299
Estimated Expiration: ⤷ Sign Up
Patent: 22862
Estimated Expiration: ⤷ Sign Up
Patent: 13510873
Estimated Expiration: ⤷ Sign Up
Patent: 15110630
Patent: 二層錠製剤 (BILAYER TABLET FORMULATIONS)
Estimated Expiration: ⤷ Sign Up
Patent: 17081943
Patent: 二層錠製剤 (BILAYER TABLET FORMULATIONS)
Estimated Expiration: ⤷ Sign Up
Patent: 18172418
Patent: 二層錠製剤 (BILAYER TABLET FORMULATIONS)
Estimated Expiration: ⤷ Sign Up
Lithuania
Patent: 498758
Estimated Expiration: ⤷ Sign Up
Patent: 2020003
Estimated Expiration: ⤷ Sign Up
Patent: 98758
Estimated Expiration: ⤷ Sign Up
Mexico
Patent: 5777
Patent: FORMULACIONES DE TABLETAS BICAPA. (BILAYER TABLET FORMULATIONS.)
Estimated Expiration: ⤷ Sign Up
Patent: 12005416
Patent: FORMULACIONES DE TABLETAS BICAPA. (BILAYER TABLET FORMULATIONS.)
Estimated Expiration: ⤷ Sign Up
Norway
Patent: 20009
Estimated Expiration: ⤷ Sign Up
Poland
Patent: 98758
Estimated Expiration: ⤷ Sign Up
Portugal
Patent: 98758
Estimated Expiration: ⤷ Sign Up
Russian Federation
Patent: 83920
Patent: КОМПОЗИЦИЯ ДВУХСЛОЙНОЙ ТАБЛЕТКИ (BI-LAYER TABLET COMPOSITION)
Estimated Expiration: ⤷ Sign Up
Patent: 12757
Patent: КОМПОЗИЦИЯ ДВУХСЛОЙНОЙ ТАБЛЕТКИ (DOUBLE-LAYER TABLET COMPOSITION)
Estimated Expiration: ⤷ Sign Up
Patent: 12123947
Patent: КОМПОЗИЦИЯ ДВУХСЛОЙНОЙ ТАБЛЕТКИ
Estimated Expiration: ⤷ Sign Up
Patent: 16112599
Patent: КОМПОЗИЦИЯ ДВУХСЛОЙНОЙ ТАБЛЕТКИ
Estimated Expiration: ⤷ Sign Up
Serbia
Patent: 756
Patent: FORMULACIJE TABLETA SA DVA SLOJA (BILAYER TABLET FORMULATIONS)
Estimated Expiration: ⤷ Sign Up
Slovenia
Patent: 98758
Estimated Expiration: ⤷ Sign Up
Spain
Patent: 89107
Estimated Expiration: ⤷ Sign Up
Patent: 56888
Estimated Expiration: ⤷ Sign Up
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.
See the table below for additional patents covering QTERNMET XR around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Taiwan | I310770 | ⤷ Sign Up | |
| Denmark | 1753406 | ⤷ Sign Up | |
| Norway | 2012009 | ⤷ Sign Up | |
| Brazil | 122017021516 | processo de preparação de uma estrutura de cristal de solvato de (s)-propileno glicol de fórmula ia | ⤷ Sign Up |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for QTERNMET XR
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1506211 | 588 | Finland | ⤷ Sign Up | |
| 1506211 | PA2013008 | Lithuania | ⤷ Sign Up | PRODUCT NAME: DAPAGLIFLOZINUM; REGISTRATION NO/DATE: EU/1/12/795/001 - EU/1/12/795/010 20121112 |
| 1261586 | 12C0028 | France | ⤷ Sign Up | PRODUCT NAME: ASSOCIATION COMPRENANT LA SAXAGLIPTINE OU UN DE SES SELS ET LA METFORMINE OU UN DE SES SELS, Y COMPRIS L'ASSOCIATION CHLORHYDRATE DE SAXAGLIPTINE ET CHLORHYDRATE DE METFORMINE; REGISTRATION NO/DATE: EU/1/11/731/001 20111124 |
| 2498758 | CR 2020 00017 | Denmark | ⤷ Sign Up | PRODUCT NAME: METFORMIN ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; SAXAGLIPTIN ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; DAPAGLIFLOZIN ELLER ET FARMACEUTISK ACCEPTABELT SOLVAT DERAF; REG. NO/DATE: EU/1/19/1401 20191113 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
Make Better Decisions: Try a trial or see plans & pricing
Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
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