EMPAGLIFLOZIN Drug Patent Profile
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Which patents cover Empagliflozin, and when can generic versions of Empagliflozin launch?
Empagliflozin is a drug marketed by Zydus Pharms and is included in two NDAs.
The generic ingredient in EMPAGLIFLOZIN is empagliflozin; metformin hydrochloride. There are twenty-two drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the empagliflozin; metformin hydrochloride profile page.
Summary for EMPAGLIFLOZIN
| US Patents: | 0 |
| Applicants: | 1 |
| NDAs: | 2 |
| Raw Ingredient (Bulk) Api Vendors: | 91 |
| Clinical Trials: | 302 |
| Patent Applications: | 846 |
| 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 |
|---|---|
| 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 |
Anatomical Therapeutic Chemical (ATC) Classes for EMPAGLIFLOZIN
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Zydus Pharms | EMPAGLIFLOZIN | empagliflozin | TABLET;ORAL | 212138-001 | Aug 3, 2022 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Zydus Pharms | EMPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE | empagliflozin; metformin hydrochloride | TABLET;ORAL | 212198-001 | Jul 7, 2022 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Zydus Pharms | EMPAGLIFLOZIN | empagliflozin | TABLET;ORAL | 212138-002 | Aug 3, 2022 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Zydus Pharms | EMPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE | empagliflozin; metformin hydrochloride | TABLET;ORAL | 212198-002 | Jul 7, 2022 | DISCN | No | 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 |
