XIGDUO XR Drug Patent Profile
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Which patents cover Xigduo Xr, and when can generic versions of Xigduo Xr launch?
Xigduo Xr is a drug marketed by Astrazeneca Ab and is included in one NDA. There are five patents protecting this drug and two Paragraph IV challenges.
This drug has two hundred and thirty-five patent family members in forty-six countries.
The generic ingredient in XIGDUO XR is dapagliflozin; metformin hydrochloride. There are twenty-six drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the dapagliflozin; metformin hydrochloride profile page.
DrugPatentWatch® Generic Entry Outlook for Xigduo Xr
Xigduo Xr was eligible for patent challenges on January 8, 2018.
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 four 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.
There is one tentative approval for the generic drug (dapagliflozin; metformin hydrochloride), which indicates the potential for near-term generic launch.
Indicators of Generic Entry
Summary for XIGDUO XR
International Patents: | 235 |
US Patents: | 5 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 2 |
Raw Ingredient (Bulk) Api Vendors: | 1 |
Clinical Trials: | 5 |
Patent Applications: | 10 |
Formulation / Manufacturing: | see details |
Drug Prices: | Drug price information for XIGDUO XR |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for XIGDUO XR |
DailyMed Link: | XIGDUO XR at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for XIGDUO XR
Generic Entry Date for XIGDUO XR*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
TABLET, EXTENDED RELEASE;ORAL |
*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.
Recent Clinical Trials for XIGDUO XR
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Beni-Suef University | Phase 3 |
University of Guadalajara | Phase 4 |
Parexel | Phase 1 |
Pharmacology for XIGDUO XR
Drug Class | Biguanide Sodium-Glucose Cotransporter 2 Inhibitor |
Mechanism of Action | Sodium-Glucose Transporter 2 Inhibitors |
Anatomical Therapeutic Chemical (ATC) Classes for XIGDUO XR
Paragraph IV (Patent) Challenges for XIGDUO XR
Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
---|---|---|---|---|---|---|
XIGDUO XR | Extended-release Tablets | dapagliflozin; metformin hydrochloride | 2.5 mg/1000 mg | 205649 | 1 | 2018-10-29 |
XIGDUO XR | Extended-release Tablets | dapagliflozin; metformin hydrochloride | 5 mg/500 mg 5 mg/1000 mg 10 mg/500 mg 10 mg/1000 mg | 205649 | 10 | 2018-01-08 |
US Patents and Regulatory Information for XIGDUO XR
XIGDUO XR is protected by five US patents.
Based on analysis by DrugPatentWatch, the earliest date for a generic version of XIGDUO XR is ⤷ Try a Trial.
This potential generic entry date is based on patent ⤷ Try a Trial.
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 XIGDUO XR
C-aryl glucoside SGLT2 inhibitors and method
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF TYPE 2 DIABETES MELLITUS
Crystal structures of SGLT2 inhibitors and processes for preparing same
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Crystal structures of SGLT2 inhibitors and processes for preparing same
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF TYPE 2 DIABETES MELLITUS
Methods for treating extreme insulin resistance in patients resistant to previous treatment with other anti-diabetic drugs employing an SGLT2 inhibitor and compositions thereof
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF TYPE 2 DIABETES MELLITUS IN A PATIENT, WHEREIN GLYCEMIC CONTROL (HBA1C < 7.0%) IS NOT ACHIEVABLE USING ONE OR MORE OF INSULIN, METFORMIN, PIOGLITAZONE, OR ROSIGLITAZONE
Bilayer tablet formulations
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Astrazeneca Ab | XIGDUO XR | dapagliflozin; metformin hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 205649-005 | Jul 28, 2017 | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
Astrazeneca Ab | XIGDUO XR | dapagliflozin; metformin hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 205649-004 | Oct 29, 2014 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Astrazeneca Ab | XIGDUO XR | dapagliflozin; metformin hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 205649-003 | Oct 29, 2014 | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
Astrazeneca Ab | XIGDUO XR | dapagliflozin; metformin hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 205649-002 | Oct 29, 2014 | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
>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 XIGDUO XR
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Astrazeneca Ab | XIGDUO XR | dapagliflozin; metformin hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 205649-005 | Jul 28, 2017 | ⤷ Try a Trial | ⤷ Try a Trial |
Astrazeneca Ab | XIGDUO XR | dapagliflozin; metformin hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 205649-003 | Oct 29, 2014 | ⤷ Try a Trial | ⤷ Try a Trial |
Astrazeneca Ab | XIGDUO XR | dapagliflozin; metformin hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 205649-004 | Oct 29, 2014 | ⤷ Try a Trial | ⤷ Try a Trial |
Astrazeneca Ab | XIGDUO XR | dapagliflozin; metformin hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 205649-003 | Oct 29, 2014 | ⤷ Try a Trial | ⤷ Try a Trial |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for XIGDUO XR
When does loss-of-exclusivity occur for XIGDUO XR?
Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:
Australia
Patent: 10319343
Estimated Expiration: ⤷ Try a Trial
Brazil
Patent: 2012011726
Estimated Expiration: ⤷ Try a Trial
Canada
Patent: 80939
Estimated Expiration: ⤷ Try a Trial
Patent: 87757
Estimated Expiration: ⤷ Try a Trial
China
Patent: 2711739
Estimated Expiration: ⤷ Try a Trial
Patent: 5193761
Estimated Expiration: ⤷ Try a Trial
Croatia
Patent: 0181347
Estimated Expiration: ⤷ Try a Trial
Denmark
Patent: 98758
Estimated Expiration: ⤷ Try a Trial
European Patent Office
Patent: 98758
Estimated Expiration: ⤷ Try a Trial
Patent: 15124
Estimated Expiration: ⤷ Try a Trial
Hungary
Patent: 40486
Estimated Expiration: ⤷ Try a Trial
Patent: 000009
Estimated Expiration: ⤷ Try a Trial
Japan
Patent: 75522
Estimated Expiration: ⤷ Try a Trial
Patent: 67299
Estimated Expiration: ⤷ Try a Trial
Patent: 22862
Estimated Expiration: ⤷ Try a Trial
Patent: 13510873
Estimated Expiration: ⤷ Try a Trial
Patent: 15110630
Estimated Expiration: ⤷ Try a Trial
Patent: 17081943
Estimated Expiration: ⤷ Try a Trial
Patent: 18172418
Estimated Expiration: ⤷ Try a Trial
Lithuania
Patent: 498758
Estimated Expiration: ⤷ Try a Trial
Patent: 2020003
Estimated Expiration: ⤷ Try a Trial
Patent: 98758
Estimated Expiration: ⤷ Try a Trial
Mexico
Patent: 5777
Estimated Expiration: ⤷ Try a Trial
Patent: 12005416
Estimated Expiration: ⤷ Try a Trial
Norway
Patent: 20009
Estimated Expiration: ⤷ Try a Trial
Poland
Patent: 98758
Estimated Expiration: ⤷ Try a Trial
Portugal
Patent: 98758
Estimated Expiration: ⤷ Try a Trial
Russian Federation
Patent: 83920
Estimated Expiration: ⤷ Try a Trial
Patent: 12757
Estimated Expiration: ⤷ Try a Trial
Patent: 12123947
Estimated Expiration: ⤷ Try a Trial
Patent: 16112599
Estimated Expiration: ⤷ Try a Trial
Serbia
Patent: 756
Estimated Expiration: ⤷ Try a Trial
Slovenia
Patent: 98758
Estimated Expiration: ⤷ Try a Trial
Spain
Patent: 89107
Estimated Expiration: ⤷ Try a Trial
Patent: 56888
Estimated Expiration: ⤷ Try a Trial
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 XIGDUO XR around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Canada | 2929811 | PREPARATIONS PHARMACEUTIQUES CONTENANT DE L'HYDRATE DE PROPYLENEGLYCOL DE DAPAGLIFLOZINE (PHARMACEUTICAL FORMULATIONS CONTAINING DAPAGLIFLOZIN PROPYLENE GLYCOL HYDRATE) | ⤷ Try a Trial |
Eurasian Patent Organization | 200901277 | ФАРМАЦЕВТИЧЕСКИЕ СОСТАВЫ, СОДЕРЖАЩИЕ ПРОПИЛЕНГЛИКОЛЬГИДРАТ ДАПАГЛИФЛОЗИНА | ⤷ Try a Trial |
Poland | 2508188 | ⤷ Try a Trial | |
China | 100534997 | ⤷ Try a Trial | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for XIGDUO XR
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
2139494 | C20200028 00358 | Estonia | ⤷ Try a Trial | PRODUCT NAME: SAKSAGLIPTIIN JA DAPAGLIFLOSIIN;REG NO/DATE: EU/1/16/1108; 19.07.2016 |
1506211 | CA 2014 00037 | Denmark | ⤷ Try a Trial | PRODUCT NAME: ET KOMBINATIONSPRODUKT AF DAPAGLIFLOZIN ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF, HERUNDER DAPAGLIFLOZINPROPANDIOLMONOHYDRAT OG METFORMIN ELLER SALTE DERAF, HERUNDER METFORMINHYDROCHLORID; REG. NO/DATE: EU/1/13/900 20140116 |
2498758 | C20200010 00328 | Estonia | ⤷ Try a Trial | PRODUCT NAME: METFORMIIN/SAKSAGLIPTIIN/DAPAGLIFLOSIIN;REG NO/DATE: EU/1/19/1401 13.11.2019 |
1506211 | C20140021 00131 | Estonia | ⤷ Try a Trial | PRODUCT NAME: DAPAGLIFLOSIIN/METFORMIIN;REG NO/DATE: K(2014)308 (LOPLIK) 21.01.2014 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |