DAPAGLIFLOZIN - Generic Drug Details
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What are the generic drug sources for dapagliflozin and what is the scope of freedom to operate?
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-five 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: | 435 |
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 |
London School of Hygiene and Tropical Medicine | Phase 4 |
Region Örebro County | 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 | 202293-001 | 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 | 202293-002 | 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 |
---|---|---|---|
New Zealand | 551290 | Poly (lactide-co-glycolide)-based sustained release microcapsules comprising a polypeptide and a sugar | ⤷ Try a Trial |
Slovenia | 1971362 | ⤷ Try a Trial | |
European Patent Office | 2139494 | PRÉPARATIONS PHARMACEUTIQUES CONTENANT DE L'HYDRATE DE PROPYLÈNEGLYCOL DE DAPAGLIFLOZINE (PHARMACEUTICAL FORMULATIONS CONTAINING DAPAGLIFLOZIN PROPYLENE GLYCOL HYDRATE) | ⤷ Try a Trial |
South Korea | 20150038555 | 다파글리플로진 프로필렌 글리콜 수화물을 함유하는 제약 제형 (PHARMACEUTICAL FORMULATIONS CONTAINING DAPAGLIFLOZIN PROPYLENE GLYCOL HYDRATE) | ⤷ Try a Trial |
Singapore | 11202100417R | METHODS OF TREATING HFPEF EMPLOYING DAPAGLIFLOZIN AND COMPOSITIONS COMPRISING THE SAME | ⤷ Try a Trial |
Luxembourg | 92182 | ⤷ Try a Trial | |
Croatia | P20041084 | C-ARYL GLUCOSIDE SGLT2 INHIBITORS AND METHOD | ⤷ 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 | SPC/GB14/050 | United Kingdom | ⤷ Try a Trial | PRODUCT NAME: A COMBINATION OF DAPAGLIFLOZIN OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF AND METFORMIN OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTERED: UK EU/1/13/900 20140121 |
1506211 | PA2014026,C1506211 | Lithuania | ⤷ Try a Trial | PRODUCT NAME: DAPAGLIFLOZINUM + METFORMINUM; REGISTRATION NO/DATE: EU/1/13/900 20140116 |
1734971 | CA 2012 00015 | Denmark | ⤷ Try a Trial | PRODUCT NAME: EXENATIDE; REG. NO/DATE: EU/1/11/696/001-002 20110623 |
1506211 | C300677 | Netherlands | ⤷ Try a Trial | 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 |
1506211 | CA 2013 00019 | Denmark | ⤷ Try a Trial | |
1506211 | C 2013 012 | Romania | ⤷ Try a Trial | PRODUCT NAME: DAPAGLIFLOZIN SI SARURILE ACCEPTABILE FARMACEUTIC ALEACESTUIA (2S, 3R, 4R, 5S, 6R)-2-[4-CLOR-3-(4-ETOXIBENZIL)FENIL]-6-(HIDROXIMETIL)TETRAHIDRO-2H-PIRAN-3,4,5-TRIOL; NATIONAL AUTHORISATION NUMBER: RO EU/1/12/795/001, RO EU/1/12/795/002, RO EU/1/12/795/003, RO EU/1/12/795/004, RO EU/1/12/795/005, RO EU/1/12/795/006, RO EU/1/12/795/007, RO EU/1/12/795/008, RO EU/1/12/795/009, RO EU/1/12/795/001/010; DATE OF NATIONAL AUTHORISATION: 20121112; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EMEA EU/1/12/795/001, EMEA EU/1/12/795/002, EMEA EU/1/12/795/003, EMEA EU/1/12/795/004, EMEA EU/1/12/795/005, EMEA EU/1/12/795/006, EMEA EU/1/12/795/007, EMEA EU/1/12/795/008 [...] |
2498758 | 132020000000034 | Italy | ⤷ Try a Trial | 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 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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