Dapagliflozin; metformin hydrochloride; saxagliptin hydrochloride - Generic Drug Details
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What are the generic sources for dapagliflozin; metformin hydrochloride; saxagliptin hydrochloride and what is the scope of freedom to operate?
Dapagliflozin; metformin hydrochloride; saxagliptin hydrochloride
is the generic ingredient in one branded drug marketed by Astrazeneca Ab and is included in one NDA. There are six patents protecting this compound. Additional information is available in the individual branded drug profile pages.Dapagliflozin; metformin hydrochloride; saxagliptin hydrochloride has three hundred and forty-six patent family members in forty-eight countries.
Summary for dapagliflozin; metformin hydrochloride; saxagliptin hydrochloride
| International Patents: | 346 |
| US Patents: | 6 |
| Tradenames: | 1 |
| Applicants: | 1 |
| NDAs: | 1 |
| Clinical Trials: | 19 |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for dapagliflozin; metformin hydrochloride; saxagliptin hydrochloride |
| DailyMed Link: | dapagliflozin; metformin hydrochloride; saxagliptin hydrochloride at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for dapagliflozin; metformin hydrochloride; saxagliptin hydrochloride
Generic Entry Date for dapagliflozin; metformin hydrochloride; saxagliptin hydrochloride*:
Constraining patent/regulatory exclusivity:
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 dapagliflozin; metformin hydrochloride; saxagliptin hydrochloride
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Sabyasachi Sen | Phase 4 |
| First People's Hospital, Shunde China | Phase 4 |
| Zhujiang Hospital | Phase 4 |
See all dapagliflozin; metformin hydrochloride; saxagliptin hydrochloride clinical trials
Anatomical Therapeutic Chemical (ATC) Classes for dapagliflozin; metformin hydrochloride; saxagliptin hydrochloride
US Patents and Regulatory Information for dapagliflozin; metformin hydrochloride; saxagliptin hydrochloride
| 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 | 210874-002 | May 2, 2019 | DISCN | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
| Astrazeneca Ab | QTERNMET XR | dapagliflozin; metformin hydrochloride; saxagliptin hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 210874-003 | May 2, 2019 | DISCN | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
| Astrazeneca Ab | QTERNMET XR | dapagliflozin; metformin hydrochloride; saxagliptin hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 210874-001 | May 2, 2019 | DISCN | 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 dapagliflozin; metformin hydrochloride; saxagliptin hydrochloride
| 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 | 210874-002 | May 2, 2019 | ⤷ Try a Trial | ⤷ Try a Trial |
| Astrazeneca Ab | QTERNMET XR | dapagliflozin; metformin hydrochloride; saxagliptin hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 210874-001 | May 2, 2019 | ⤷ Try a Trial | ⤷ Try a Trial |
| Astrazeneca Ab | QTERNMET XR | dapagliflozin; metformin hydrochloride; saxagliptin hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 210874-003 | May 2, 2019 | ⤷ Try a Trial | ⤷ Try a Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for dapagliflozin; metformin hydrochloride; saxagliptin hydrochloride
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| European Patent Office | 3363807 | COMPOSITION PHARMACEUTIQUE COMPRENANT SOLVATE DE (S)-PROPYLENE GLYCOL DE (2S,3R,4S,5S,6R)-2-[4-CHLORO-3-(4-ÉTHOXY-BENZYL)-PHÉNYL]-6-HYDROXYMÉTHYL-2-MÉTHOXY-TETRAHYDRO-PYRAN-3,4,5-TRIOL CRISTALLINE (PHARMACEUTICAL COMPOSITION COMPRISING CRYSTALLINE (2S,3R,4S,5S,6R)-2-[4-CHLORO-3-(4-ETHOXY-BENZYL)-PHENYL]-6-HYDROXYMETHYL-2-METHOXY-TETRAHYDRO-PYRAN-3,4,5-TRIOL (S)-PROPYLENE GLYCOL SOLVATE) | ⤷ Try a Trial |
| Israel | 165119 | ⤷ Try a Trial | |
| Japan | 5340077 | ⤷ Try a Trial | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for dapagliflozin; metformin hydrochloride; saxagliptin hydrochloride
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 2498758 | 2090013-0 | Sweden | ⤷ Try a Trial | PRODUCT NAME: A COMBINATION OF METFORMIN HYDROCHLORIDE, SAXAGLIPTIN OR A PHARMACEUTICALLY ACCEPABLE SALT THEREOF, AND DAPAGLIFLOZIN OR PH ARMACEUTICALLY ACCEPTABLE SOLVATE THEREOF; REG. NO/DATE: EU/1/19/1401 20191113 |
| 1506211 | 18/2013 | Austria | ⤷ Try a Trial | PRODUCT NAME: DAPAGLIFLOZIN UND PHARMAZEUTISCH VERTRAEGLICHE SALZE DAVON; REGISTRATION NO/DATE: EU/1/12/795/001 - EU/1/12/795/010 20121112 |
| 1506211 | PA2014026 | Lithuania | ⤷ Try a Trial | PRODUCT NAME: DAPAGLIFOZINUM + METFORMINUM; REGISTRATION NO/DATE: EU/1/13/900 20140116 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
