DAPAGLIFLOZIN - Generic Drug Details
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What are the generic sources for dapagliflozin and what is the scope of patent protection?
Dapagliflozin
is the generic ingredient in four branded drugs marketed by Astrazeneca Ab and is included in four NDAs. There are nineteen patents protecting this compound. Additional information is available in the individual branded drug profile pages.Dapagliflozin has four hundred and thirty-four patent family members in fifty-one countries.
There are twenty-six drug master file entries for dapagliflozin. Five suppliers are listed for this compound. There are twelve tentative approvals for this compound.
Summary for DAPAGLIFLOZIN
International Patents: | 434 |
US Patents: | 19 |
Tradenames: | 4 |
Applicants: | 1 |
NDAs: | 4 |
Drug Master File Entries: | 26 |
Finished Product Suppliers / Packagers: | 5 |
Raw Ingredient (Bulk) Api Vendors: | 109 |
Clinical Trials: | 402 |
Patent Applications: | 3,227 |
Formulation / Manufacturing: | see details |
Drug Prices: | Drug price trends for DAPAGLIFLOZIN |
What excipients (inactive ingredients) are in DAPAGLIFLOZIN? | DAPAGLIFLOZIN excipients list |
DailyMed Link: | DAPAGLIFLOZIN at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for DAPAGLIFLOZIN
Generic Entry Date for DAPAGLIFLOZIN*:
Constraining patent/regulatory exclusivity:
Dosage:
TABLET;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
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
EMS | Phase 3 |
Aarhus University Hospital | Phase 4 |
Skane University Hospital | Phase 4 |
Generic filers with tentative approvals for DAPAGLIFLOZIN
Applicant | Application No. | Strength | Dosage Form |
⤷ Try a Trial | ⤷ Try a Trial | 2.5MG;1GM | TABLET, EXTENDED RELEASE;ORAL |
⤷ Try a Trial | ⤷ Try a Trial | 10MG;1GM | TABLET, EXTENDED RELEASE;ORAL |
⤷ Try a Trial | ⤷ Try a Trial | 10MG;500MG | TABLET, EXTENDED RELEASE;ORAL |
The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.
Pharmacology for DAPAGLIFLOZIN
Drug Class | Sodium-Glucose Cotransporter 2 Inhibitor |
Mechanism of Action | Sodium-Glucose Transporter 2 Inhibitors |
Paragraph IV (Patent) Challenges for DAPAGLIFLOZIN
Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
---|---|---|---|---|---|---|
FARXIGA | Tablets | dapagliflozin | 5 mg and 10 mg | 202293 | 20 | 2018-01-08 |
US Patents and Regulatory Information for DAPAGLIFLOZIN
Expired US Patents for DAPAGLIFLOZIN
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Astrazeneca Ab | FARXIGA | dapagliflozin | TABLET;ORAL | 202293-001 | Jan 8, 2014 | ⤷ Try a Trial | ⤷ Try a Trial |
Astrazeneca Ab | FARXIGA | dapagliflozin | TABLET;ORAL | 202293-001 | Jan 8, 2014 | ⤷ Try a Trial | ⤷ Try a Trial |
Astrazeneca Ab | FARXIGA | dapagliflozin | TABLET;ORAL | 202293-002 | Jan 8, 2014 | ⤷ Try a Trial | ⤷ Try a Trial |
Astrazeneca Ab | FARXIGA | dapagliflozin | TABLET;ORAL | 202293-001 | Jan 8, 2014 | ⤷ Try a Trial | ⤷ Try a Trial |
Astrazeneca Ab | FARXIGA | dapagliflozin | TABLET;ORAL | 202293-002 | Jan 8, 2014 | ⤷ Try a Trial | ⤷ Try a Trial |
Astrazeneca Ab | FARXIGA | dapagliflozin | TABLET;ORAL | 202293-001 | Jan 8, 2014 | ⤷ Try a Trial | ⤷ Try a Trial |
Astrazeneca Ab | FARXIGA | dapagliflozin | TABLET;ORAL | 202293-001 | Jan 8, 2014 | ⤷ Try a Trial | ⤷ Try a Trial |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
EU/EMA Drug Approvals for DAPAGLIFLOZIN
Company | Drugname | Inn | Product Number / Indication | Status | Generic | Biosimilar | Orphan | Marketing Authorisation | Marketing Refusal |
---|---|---|---|---|---|---|---|---|---|
AstraZeneca AB | Forxiga | dapagliflozin | EMEA/H/C/002322 Type 2 diabetes mellitusForxiga is indicated in adults and children aged 10 years and above for the treatment of insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exerciseas monotherapy when metformin is considered inappropriate due to intolerance.in addition to other medicinal products for the treatment of type 2 diabetes.For study results with respect to combination of therapies, effects on glycaemic control, cardiovascular and renal events, and the populations studied, see sections 4.4, 4.5 and 5.1.Heart failureForxiga is indicated in adults for the treatment of symptomatic chronic heart failure.Chronic kidney diseaseForxiga is indicated in adults for the treatment of chronic kidney disease. |
Authorised | no | no | no | 2012-11-11 | |
AstraZeneca AB | Edistride | dapagliflozin | EMEA/H/C/004161 Type 2 diabetes mellitusEdistride is indicated in adults and children aged 10 years and above for the treatment of insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exerciseas monotherapy when metformin is considered inappropriate due to intolerance.in addition to other medicinal products for the treatment of type 2 diabetes.For study results with respect to combination of therapies, effects on glycaemic control, cardiovascular and renal events, and the populations studied, see sections 4.4, 4.5 and 5.1.Heart failureEdistride is indicated in adults for the treatment of symptomatic chronic heart failure.Chronic kidney diseaseEdistride is indicated in adults for the treatment of chronic kidney disease. |
Authorised | no | no | no | 2015-11-09 | |
Viatris Limited | Dapagliflozin Viatris | dapagliflozin | EMEA/H/C/006006 Type 2 diabetes mellitusDapagliflozin Viatris is indicated in adults and children aged 10 years and above for the treatment of insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exercise- as monotherapy when metformin is considered inappropriate due to intolerance.- in addition to other medicinal products for the treatment of type 2 diabetes.For study results with respect to combination of therapies, effects on glycaemic control, cardiovascular and renal events, and the populations studied, see sections 4.4, 4.5 and 5.1.Heart failureDapagliflozin Viatris is indicated in adults for the treatment of symptomatic chronic heart failure with reduced ejection fraction.Chronic kidney diseaseDapagliflozin Viatris is indicated in adults for the treatment of chronic kidney disease. |
Authorised | yes | no | no | 2023-03-24 | |
>Company | >Drugname | >Inn | >Product Number / Indication | >Status | >Generic | >Biosimilar | >Orphan | >Marketing Authorisation | >Marketing Refusal |
International Patents for DAPAGLIFLOZIN
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Iceland | 7529 | C-arýl glúkósíð SGLT2-tálmar og aðferð | ⤷ Try a Trial |
World Intellectual Property Organization (WIPO) | 2005110425 | ⤷ Try a Trial | |
Russian Federation | 2489151 | ФАРМАЦЕВТИЧЕСКАЯ КОМБИНАЦИЯ, СОДЕРЖАЩАЯ ИНГИБИТОР SGLT2 (PHARMACEUTICAL COMBINATION CONTAINING SGLT2 INHIBITOR) | ⤷ Try a Trial |
Serbia | 53814 | EKSENDIN ZA LEČENJE ŠEĆERNE BOLESTI I SMANJENJE TELESNE TEŽINE (EXENDIN FOR TREATING DIABETES AND REDUCING BODY WEIGHT) | ⤷ Try a Trial |
South Africa | 200810475 | CRYSTALLINE SOLVATES AND COMPLEXES OF (IS)-1,5-ANHYDRO-L-C-(3-((PHENYL)METHYL)PHENYL)-D-GLUCITOL DERIVATIVES WITH AMINO ACIDS AS SGLT2 INHIBITORS FOR THE TREATMENT OF DIABETES | ⤷ Try a Trial |
Lithuania | 2139494 | ⤷ Try a Trial | |
Peru | 20090185 | FORMULACIONES FARMACEUTICAS QUE CONTIENEN UN INHIBIDOR SGLT2 | ⤷ Try a Trial |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for DAPAGLIFLOZIN
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
1506211 | 1390017-0 | Sweden | ⤷ Try a Trial | PRODUCT NAME: DAPAGLIFLOZIN OCH FARMACEUTISKT GODTAGBARA SALTER DAERAV; REG. NO/DATE: EU/1/12/795/001 20121112 |
2139494 | 2020C/533 | Belgium | ⤷ Try a Trial | PRODUCT NAME: QTERN -SAXAGLIPTINE ET DAPAGLIFLOZINE; AUTHORISATION NUMBER AND DATE: EU/1/16/1108 20160719 |
1506211 | 2014C/041 | Belgium | ⤷ Try a Trial | PRODUCT NAME: LA COMBINAISON DE DAPAGLIFLOZINE (OU SON SEL PHARMACEUTIQUEMENT ACCEPTABLE); AUTHORISATION NUMBER AND DATE: EU/1/13/900 20140121 |
2139494 | 132020000000115 | Italy | ⤷ Try a Trial | PRODUCT NAME: SAXAGLIPTIN E DAPAGLIFLOZIN(QTERN); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/16/1108, 20160719 |
1734971 | C01734971/01 | Switzerland | ⤷ Try a Trial | PRODUCT NAME: EXENATIDE; REGISTRATION NO/DATE: SWISSMEDIC 61629 17.02.2012 |
1734971 | 16/2012 | Austria | ⤷ Try a Trial | PRODUCT NAME: EXENATID; REGISTRATION NO/DATE: EU/1/11/696/001-002 (MITTEILUNG) 20110623 |
2139494 | LUC00176 | Luxembourg | ⤷ Try a Trial | PRODUCT NAME: SAXAGLIPTINE ET DAPAGLIFLOZINE; AUTHORISATION NUMBER AND DATE: EU/1/16/1108 20160719 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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