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Details for New Drug Application (NDA): 204629
NDA 204629 describes JARDIANCE, which is a drug marketed by Boehringer Ingelheim and is included in one NDA. It is available from five suppliers. There are six patents protecting this drug and one Paragraph IV challenge. Additional details are available on the JARDIANCE profile page.
The generic ingredient in JARDIANCE is empagliflozin. There are twenty-two drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the empagliflozin profile page.
The generic ingredient in JARDIANCE is empagliflozin. There are twenty-two drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the empagliflozin profile page.
Summary for 204629
| Tradename: | JARDIANCE |
| Applicant: | Boehringer Ingelheim |
| Ingredient: | empagliflozin |
| Patents: | 6 |
| Formulation / Manufacturing: | see details |
Generic Entry Opportunity Date for 204629
Generic Entry Date for 204629*:
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.
Pharmacology for NDA: 204629
| Mechanism of Action | Sodium-Glucose Transporter 2 Inhibitors |
Suppliers and Packaging for NDA: 204629
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| JARDIANCE | empagliflozin | TABLET;ORAL | 204629 | NDA | Boehringer Ingelheim Pharmaceuticals, Inc. | 0597-0152 | 0597-0152-07 | 1 BOTTLE in 1 CARTON (0597-0152-07) > 7 TABLET, FILM COATED in 1 BOTTLE |
| JARDIANCE | empagliflozin | TABLET;ORAL | 204629 | NDA | Boehringer Ingelheim Pharmaceuticals, Inc. | 0597-0152 | 0597-0152-30 | 30 TABLET, FILM COATED in 1 BOTTLE (0597-0152-30) |
Paragraph IV (Patent) Challenges for 204629
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| JARDIANCE | TABLET;ORAL | empagliflozin | 204629 | 2018-08-01 |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 10MG | ||||
| Approval Date: | Aug 1, 2014 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Mar 18, 2019 | ||||||||
| Regulatory Exclusivity Use: | INFORMATION ADDED TO CLINICAL STUDIES SECTION OF THE LABELING REGARDING INITIAL COMBINATION THERAPY OF EMPAGLIFLOZIN WITH METFORMIN | ||||||||
| Regulatory Exclusivity Expiration: | Aug 1, 2019 | ||||||||
| Regulatory Exclusivity Use: | NEW CHEMICAL ENTITY | ||||||||
| Regulatory Exclusivity Expiration: | Dec 2, 2019 | ||||||||
| Regulatory Exclusivity Use: | TO REDUCE THE RISK OF CARDIOVASCULAR DEATH IN ADULT PATIENTS WITH TYPE 2 DIABETES MELLITUS AND ESTABLISHED CARDIOVASCULAR DISEASE | ||||||||
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