xigduo xr Drug Patent Profile
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When do Xigduo Xr patents expire, and what generic alternatives are available?
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-six 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 May 12, 2031. This may change due to patent challenges or generic licensing.
There have been seven 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
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Summary for xigduo xr
| International Patents: | 236 |
| US Patents: | 5 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 2 |
| Raw Ingredient (Bulk) Api Vendors: | 1 |
| Clinical Trials: | 5 |
| Patent Applications: | 10 |
| 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
*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 |
| AstraZeneca | Phase 1 |
Pharmacology for xigduo xr
| Drug Class | Biguanide Sodium-Glucose Cotransporter 2 Inhibitor |
| Mechanism of Action | Sodium-Glucose Transporter 2 Inhibitors |
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 and two FDA Regulatory Exclusivities.
Based on analysis by DrugPatentWatch, the earliest date for a generic version of xigduo 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 xigduo xr
C-aryl glucoside SGLT2 inhibitors and method
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
Crystal structures of SGLT2 inhibitors and processes for preparing same
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
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: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Bilayer tablet formulations
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
FDA Regulatory Exclusivity protecting xigduo xr
NEW PATIENT POPULATION
Exclusivity Expiration: ⤷ Sign Up
PEDIATRIC EXCLUSIVITY
Exclusivity 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 | XIGDUO XR | dapagliflozin; metformin hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 205649-003 | Oct 29, 2014 | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| Astrazeneca Ab | XIGDUO XR | dapagliflozin; metformin hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 205649-004 | Oct 29, 2014 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Astrazeneca Ab | XIGDUO XR | dapagliflozin; metformin hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 205649-003 | Oct 29, 2014 | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| Astrazeneca Ab | XIGDUO XR | dapagliflozin; metformin hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 205649-003 | Oct 29, 2014 | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| Astrazeneca Ab | XIGDUO XR | dapagliflozin; metformin hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 205649-005 | Jul 28, 2017 | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | 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 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 | 205649-002 | Oct 29, 2014 | ⤷ Sign Up | ⤷ Sign Up |
| Astrazeneca Ab | XIGDUO XR | dapagliflozin; metformin hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 205649-004 | Oct 29, 2014 | ⤷ Sign Up | ⤷ Sign Up |
| Astrazeneca Ab | XIGDUO XR | dapagliflozin; metformin hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 205649-004 | Oct 29, 2014 | ⤷ Sign Up | ⤷ Sign Up |
| Astrazeneca Ab | XIGDUO XR | dapagliflozin; metformin hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 205649-005 | Jul 28, 2017 | ⤷ Sign Up | ⤷ Sign Up |
| Astrazeneca Ab | XIGDUO XR | dapagliflozin; metformin hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 205649-002 | Oct 29, 2014 | ⤷ Sign Up | ⤷ Sign Up |
| >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
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 xigduo xr around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Brazil | 122017015106 | estrutura de cristal de formula 1b e composição farmacêutica | ⤷ Sign Up |
| European Patent Office | 2508188 | Formulations pharmaceutiques contenant un hydrate de propylèneglycol dapagliflozine (Pharmaceutical formulations containing dapagliflozin propylene glycol hydrate) | ⤷ Sign Up |
| Spain | 2769130 | ⤷ Sign Up | |
| Denmark | 2069374 | ⤷ Sign Up | |
| China | 102743340 | Pharmaceutical formulations containing dapagliflozin propylene glycol hydrate | ⤷ Sign Up |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for xigduo xr
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 2139494 | CA 2020 00035 | Denmark | ⤷ Sign Up | PRODUCT NAME: SAXAGLIPTIN OG DAPAGLIFLOZIN; REG. NO/DATE: EU/1/16/1108 20160719 |
| 2139494 | 2020C/533 | Belgium | ⤷ Sign Up | PRODUCT NAME: QTERN -SAXAGLIPTINE ET DAPAGLIFLOZINE; AUTHORISATION NUMBER AND DATE: EU/1/16/1108 20160719 |
| 2498758 | 132020000000034 | Italy | ⤷ Sign Up | PRODUCT NAME: METFORMINA O UN SUO SALE FARMACEUTICAMENTE ACCETTABILE; SAXAGLIPTIN O UN SUO SALE FARMACEUTICAMENTE ACCETTABILE; DAPAGLIFLOZIN O UN SUO SOLVATO FARMACEUTICAMENTE ACCETTABILE.(QTRILMET); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/19/1401, 20191113 |
| 2139494 | 2090034-6 | Sweden | ⤷ Sign Up | PRODUCT NAME: SAXAGLIPTIN AND DAPAGLIFLOZIN PROPYLENE GLYCOL HYDRATE; REG. NO/DATE: EU/1/16/1108 20160719 |
| 1506211 | C300677 | Netherlands | ⤷ Sign Up | PRODUCT NAME: COMBINATIE VAN DAPAGLIFLOZINE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN EN METFORMINE OF EEN FARMACEITISCH AANVAARDBAAR ZOUT DAARVAN, ZOALS BESCHERMD DOOR HET BASISOCTROOI EP 1506211B1; REGISTRATION NO/DATE: EU/1/13/900 20140121 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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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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