Details for New Drug Application (NDA): 208658
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NDA 208658 describes SYNJARDY XR, which is a drug marketed by Boehringer Ingelheim and is included in one NDA. It is available from one supplier. There are fourteen patents protecting this drug and one Paragraph IV challenge. Additional details are available on the SYNJARDY XR profile page.
The generic ingredient in SYNJARDY XR 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.
The generic ingredient in SYNJARDY XR 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 208658
| Tradename: | SYNJARDY XR |
| Applicant: | Boehringer Ingelheim |
| Ingredient: | empagliflozin; metformin hydrochloride |
| Patents: | 14 |
Pharmacology for NDA: 208658
| Mechanism of Action | Sodium-Glucose Transporter 2 Inhibitors |
Suppliers and Packaging for NDA: 208658
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| SYNJARDY XR | empagliflozin; metformin hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 208658 | NDA | Boehringer Ingelheim Pharmaceuticals, Inc. | 0597-0280 | 0597-0280-73 | 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (0597-0280-73) |
| SYNJARDY XR | empagliflozin; metformin hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 208658 | NDA | Boehringer Ingelheim Pharmaceuticals, Inc. | 0597-0280 | 0597-0280-90 | 90 TABLET, EXTENDED RELEASE in 1 BOTTLE (0597-0280-90) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 5MG;1GM | ||||
| Approval Date: | Dec 9, 2016 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Dec 20, 2026 | ||||||||
| Regulatory Exclusivity Use: | PEDIATRIC EXCLUSIVITY | ||||||||
| Regulatory Exclusivity Expiration: | Jun 20, 2026 | ||||||||
| Regulatory Exclusivity Use: | REVISIONS TO THE LABELING TO INCLUDE RESULTS FROM PROTOCOL 1218- 0091 | ||||||||
| Patent: | 10,258,637*PED | Patent Expiration: | Oct 3, 2034 | Product Flag? | Substance Flag? | Delist Request? | Y | ||
Expired US Patents for NDA 208658
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Boehringer Ingelheim | SYNJARDY XR | empagliflozin; metformin hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 208658-002 | Dec 9, 2016 | 6,488,962 | ⤷ Get Started Free |
| Boehringer Ingelheim | SYNJARDY XR | empagliflozin; metformin hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 208658-003 | Dec 9, 2016 | 6,488,962 | ⤷ Get Started Free |
| Boehringer Ingelheim | SYNJARDY XR | empagliflozin; metformin hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 208658-001 | Dec 9, 2016 | 6,488,962 | ⤷ Get Started Free |
| Boehringer Ingelheim | SYNJARDY XR | empagliflozin; metformin hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 208658-004 | Dec 9, 2016 | 6,488,962 | ⤷ Get Started Free |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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