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 fifteen 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 is one drug master file entry 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 is one drug master file entry 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: | 15 |
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) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 10MG | ||||
| Approval Date: | Aug 1, 2014 | TE: | AB | RLD: | Yes | ||||
| Regulatory Exclusivity Expiration: | Jun 20, 2026 | ||||||||
| Regulatory Exclusivity Use: | NEW PATIENT POPULATION | ||||||||
| Regulatory Exclusivity Expiration: | Dec 20, 2026 | ||||||||
| Regulatory Exclusivity Use: | PEDIATRIC EXCLUSIVITY | ||||||||
| Regulatory Exclusivity Expiration: | Sep 21, 2026 | ||||||||
| Regulatory Exclusivity Use: | USE OF EMPAGLIFLOZIN TO REDUCE THE RISK OF SUSTAINED DECLINE IN EGFR, END-STAGE KIDNEY DISEASE, CARDIOVASCULAR DEATH, AND HOSPITALIZATION IN ADULTS WITH CHRONIC KIDNEY DISEASE AT RISK OF PROGRESSION | ||||||||
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