Details for New Drug Application (NDA): 206073
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NDA 206073 describes GLYXAMBI, which is a drug marketed by Boehringer Ingelheim and is included in one NDA. It is available from one supplier. There are twelve patents protecting this drug and one Paragraph IV challenge. Additional details are available on the GLYXAMBI profile page.
The generic ingredient in GLYXAMBI is empagliflozin; linagliptin. 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; linagliptin profile page.
The generic ingredient in GLYXAMBI is empagliflozin; linagliptin. 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; linagliptin profile page.
Summary for 206073
| Tradename: | GLYXAMBI |
| Applicant: | Boehringer Ingelheim |
| Ingredient: | empagliflozin; linagliptin |
| Patents: | 12 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 206073
Generic Entry Date for 206073*:
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: 206073
| Mechanism of Action | Dipeptidyl Peptidase 4 Inhibitors Sodium-Glucose Transporter 2 Inhibitors |
Suppliers and Packaging for NDA: 206073
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| GLYXAMBI | empagliflozin; linagliptin | TABLET;ORAL | 206073 | NDA | Boehringer Ingelheim Pharmaceuticals, Inc. | 0597-0164 | 0597-0164-07 | 1 BOTTLE in 1 CARTON (0597-0164-07) / 7 TABLET, FILM COATED in 1 BOTTLE |
| GLYXAMBI | empagliflozin; linagliptin | TABLET;ORAL | 206073 | NDA | Boehringer Ingelheim Pharmaceuticals, Inc. | 0597-0164 | 0597-0164-30 | 30 TABLET, FILM COATED in 1 BOTTLE (0597-0164-30) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 10MG;5MG | ||||
| Approval Date: | Jan 30, 2015 | TE: | RLD: | Yes | |||||
| Patent: | 10,258,637*PED | Patent Expiration: | Oct 3, 2034 | Product Flag? | Substance Flag? | Delist Request? | Y | ||
| Patent: | 11,033,552*PED | Patent Expiration: | Nov 4, 2027 | Product Flag? | Substance Flag? | Delist Request? | Y | ||
| Patent: | 11,090,323*PED | Patent Expiration: | Oct 3, 2034 | Product Flag? | Substance Flag? | Delist Request? | Y | ||
Expired US Patents for NDA 206073
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Boehringer Ingelheim | GLYXAMBI | empagliflozin; linagliptin | TABLET;ORAL | 206073-002 | Jan 30, 2015 | 7,459,428 | ⤷ Subscribe |
| Boehringer Ingelheim | GLYXAMBI | empagliflozin; linagliptin | TABLET;ORAL | 206073-002 | Jan 30, 2015 | 8,178,541 | ⤷ Subscribe |
| Boehringer Ingelheim | GLYXAMBI | empagliflozin; linagliptin | TABLET;ORAL | 206073-001 | Jan 30, 2015 | 8,119,648 | ⤷ Subscribe |
| Boehringer Ingelheim | GLYXAMBI | empagliflozin; linagliptin | TABLET;ORAL | 206073-001 | Jan 30, 2015 | 6,303,661 | ⤷ Subscribe |
| Boehringer Ingelheim | GLYXAMBI | empagliflozin; linagliptin | TABLET;ORAL | 206073-002 | Jan 30, 2015 | 6,303,661 | ⤷ Subscribe |
| Boehringer Ingelheim | GLYXAMBI | empagliflozin; linagliptin | TABLET;ORAL | 206073-002 | Jan 30, 2015 | 8,119,648 | ⤷ Subscribe |
| Boehringer Ingelheim | GLYXAMBI | empagliflozin; linagliptin | TABLET;ORAL | 206073-002 | Jan 30, 2015 | 7,078,381 | ⤷ Subscribe |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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