Empagliflozin - Generic Drug Details
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What are the generic sources for empagliflozin and what is the scope of freedom to operate?
Empagliflozin
is the generic ingredient in seven branded drugs marketed by Zydus Pharms and Boehringer Ingelheim, and is included in seven NDAs. There are twenty-four patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.Empagliflozin has two hundred and seventy-seven patent family members in forty-five countries.
There are twenty-two drug master file entries for empagliflozin. Four suppliers are listed for this compound. There are thirteen tentative approvals for this compound.
Summary for empagliflozin
International Patents: | 277 |
US Patents: | 24 |
Tradenames: | 7 |
Applicants: | 2 |
NDAs: | 7 |
Drug Master File Entries: | 22 |
Finished Product Suppliers / Packagers: | 4 |
Raw Ingredient (Bulk) Api Vendors: | 91 |
Clinical Trials: | 302 |
Patent Applications: | 1,750 |
Formulation / Manufacturing: | see details |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for empagliflozin |
What excipients (inactive ingredients) are in empagliflozin? | empagliflozin excipients list |
DailyMed Link: | empagliflozin at DailyMed |
Recent Clinical Trials for empagliflozin
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Central Hospital, Nancy, France | Phase 3 |
University of Alabama at Birmingham | Phase 2 |
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | Phase 2 |
Generic filers with tentative approvals for EMPAGLIFLOZIN
Applicant | Application No. | Strength | Dosage Form |
⤷ Try a Trial | ⤷ Try a Trial | 25MG;5MG | TABLET;ORAL |
⤷ Try a Trial | ⤷ Try a Trial | 10MG | TABLET;ORAL |
⤷ Try a Trial | ⤷ Try a Trial | 2.5MG | TABLET;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 empagliflozin
Drug Class | Sodium-Glucose Cotransporter 2 Inhibitor |
Mechanism of Action | Sodium-Glucose Transporter 2 Inhibitors |
Paragraph IV (Patent) Challenges for EMPAGLIFLOZIN
Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
---|---|---|---|---|---|---|
JARDIANCE | Tablets | empagliflozin | 10 mg and 25 mg | 204629 | 14 | 2018-08-01 |
US Patents and Regulatory Information for empagliflozin
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Boehringer Ingelheim | TRIJARDY XR | empagliflozin; linagliptin; metformin hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 212614-003 | Jan 27, 2020 | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
Boehringer Ingelheim | SYNJARDY | empagliflozin; metformin hydrochloride | TABLET;ORAL | 206111-004 | Aug 26, 2015 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
Boehringer Ingelheim | SYNJARDY | empagliflozin; metformin hydrochloride | TABLET;ORAL | 206111-003 | Aug 26, 2015 | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ 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 |
EU/EMA Drug Approvals for empagliflozin
Company | Drugname | Inn | Product Number / Indication | Status | Generic | Biosimilar | Orphan | Marketing Authorisation | Marketing Refusal |
---|---|---|---|---|---|---|---|---|---|
Boehringer Ingelheim International GmbH | Jardiance | empagliflozin | EMEA/H/C/002677 Type 2 diabetes mellitusJardiance is indicated for the treatment of adults with insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exerciseas monotherapy when metformin is considered in addition to other medicinal products for the treatment of diabetesFor study results with respect to combinations of therapies, effects on glycaemic control, and cardiovascular and renal events, and the populations studied, see sections 4.4, 4.5 and 5.1. of the annex.Heart failureJardiance is indicated in adults for the treatment of symptomatic chronic heart failure. Chronic kidney diseaseJardiance is indicated in adults for the treatment of chronic kidney disease. |
Authorised | no | no | no | 2014-05-22 | |
>Company | >Drugname | >Inn | >Product Number / Indication | >Status | >Generic | >Biosimilar | >Orphan | >Marketing Authorisation | >Marketing Refusal |
International Patents for empagliflozin
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Eurasian Patent Organization | 033286 | СПОСОБ ЛЕЧЕНИЯ ИЛИ ОТСРОЧКИ РАЗВИТИЯ ХРОНИЧЕСКОЙ БОЛЕЗНИ ПОЧЕК (METHOD OF TREATING OR DELAYING THE PROGRESSION OF CHRONIC KIDNEY DISEASE) | ⤷ Try a Trial |
Mexico | 2007013144 | FORMA CRISTALINA DE 1-CLORO-4-((-D-GLUCOPIRANOS-1-IL)-2-[4-((S)- TETRAHIDROFURAN-3-ILOXI)-BENCIL]-BENCENO, UN METODO PARA SU PREPARACION Y EL USO DEL MISMO PARA PREPARAR MEDICAMENTOS. (CRYSTALLINE FORM OF 1-CHLORO-4-(????-D-GLUCOPYRANOS-1-YL)-2-[4-((S) -TETRAHYDROFURAN-3-YLOXY)-BENZYL]-BENZENE, A METHOD FOR ITS PREPARATION AND THE USE THEREOF FOR PREPARING MEDICAMENTS.) | ⤷ Try a Trial |
Poland | 2986304 | ⤷ Try a Trial | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for empagliflozin
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
1730131 | C 2014 039 | Romania | ⤷ Try a Trial | PRODUCT NAME: EMPAGLIFOZIN SI SARURILE ACESTUIA, IN SPECIAL EMPAGLIFOZIN(1S)-1,5-ANHIDRO-1-C-{4-CLORO-3-[(4-{[(3S)-OXOLAN-3-IL]OXI}FENIL)METIL}-D-GLUCITOL; NATIONAL AUTHORISATION NUMBER: EU/1/14/930; DATE OF NATIONAL AUTHORISATION: 20140522; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/14/930; DATE OF FIRST AUTHORISATION IN EEA: 20140522 |
1730131 | 200 5026-2014 | Slovakia | ⤷ Try a Trial | PRODUCT NAME: EMPAGLIFLOZIN; REGISTRATION NO/DATE: EU/1/14/930 20140527 |
1730131 | PA2014035,C1730131 | Lithuania | ⤷ Try a Trial | PRODUCT NAME: EMPAGLIFLOZINUM; REGISTRATION NO/DATE: EU/1/14/930 20140522 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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