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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 five branded drugs marketed by Boehringer Ingelheim and is included in five NDAs. There are nineteen 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 twenty-one patent family members in forty-four countries.
There are twenty-two drug master file entries for empagliflozin. Four suppliers are listed for this compound. There are two tentative approvals for this compound.
Summary for empagliflozin
International Patents: | 221 |
US Patents: | 19 |
Tradenames: | 5 |
Applicants: | 1 |
NDAs: | 5 |
Drug Master File Entries: | 22 |
Suppliers / Packagers: | 4 |
Bulk Api Vendors: | 73 |
Clinical Trials: | 199 |
Patent Applications: | 758 |
Formulation / Manufacturing: | see details |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for empagliflozin |
DailyMed Link: | empagliflozin at DailyMed |
Recent Clinical Trials for empagliflozin
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
EMS | Phase 3 |
Fondazione Schena | Phase 4 |
University of Bari | Phase 4 |
Generic filers with tentative approvals for EMPAGLIFLOZIN
Applicant | Application No. | Strength | Dosage Form |
Start Trial | Start Trial | 25MG/5MG | TABLET;ORAL |
Start Trial | Start Trial | 10MG/5MG | TABLET; ORAL |
Start Trial | Start Trial | UNKNOWN | UNKNOWN |
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 | NDA | Submissiondate |
---|---|---|---|---|
JARDIANCE | TABLET;ORAL | empagliflozin | 204629 | 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 | SYNJARDY XR | empagliflozin; metformin hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 208658-003 | Dec 9, 2016 | RX | Yes | No | Start Trial | Start Trial | Y | Start Trial | |||
Boehringer Ingelheim | SYNJARDY XR | empagliflozin; metformin hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 208658-002 | Dec 9, 2016 | RX | Yes | No | Start Trial | Start Trial | Start Trial | ||||
Boehringer Ingelheim | SYNJARDY XR | empagliflozin; metformin hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 208658-004 | Dec 9, 2016 | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | |||
Boehringer Ingelheim | TRIJARDY XR | empagliflozin; linagliptin; metformin hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 212614-003 | Jan 27, 2020 | RX | Yes | No | Start Trial | Start Trial | Start Trial | ||||
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
International Patents for empagliflozin
Country | Patent Number | Estimated Expiration |
---|---|---|
World Intellectual Property Organization (WIPO) | 2005092877 | Start Trial |
Portugal | 1730131 | Start Trial |
Argentina | 053720 | Start Trial |
Israel | 241102 | Start Trial |
>Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for empagliflozin
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
2187879 | 20/2017 | Austria | Start Trial | PRODUCT NAME: KOMBINATION VON EMPAGLIFLOZIN UND LINAGLIPTIN ODER PHARMAZEUTISCH VERTRETBARE SALZE; REGISTRATION NO/DATE: EU/1/16/1146 (MITTEILUNG) 20161115 |
1730131 | CA 2014 00054 | Denmark | Start Trial | PRODUCT NAME: EMPAGLIFLOZIN OG SALTE DERAF, SAERLIGT EMPAGLIFLOZIN; REG. NO/DATE: EU1/14/930/001/018 20140522 |
1730131 | 568 | Finland | Start Trial | |
1730131 | PA2014035 | Lithuania | Start 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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