Details for New Drug Application (NDA): 205879
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NDA 205879 describes INVOKAMET XR, which is a drug marketed by Janssen Pharms and is included in one NDA. It is available from one supplier. There are five patents protecting this drug. Additional details are available on the INVOKAMET XR profile page.
The generic ingredient in INVOKAMET XR is canagliflozin; metformin hydrochloride. There are twenty-one drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the canagliflozin; metformin hydrochloride profile page.
The generic ingredient in INVOKAMET XR is canagliflozin; metformin hydrochloride. There are twenty-one drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the canagliflozin; metformin hydrochloride profile page.
Summary for 205879
| Tradename: | INVOKAMET XR |
| Applicant: | Janssen Pharms |
| Ingredient: | canagliflozin; metformin hydrochloride |
| Patents: | 5 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 205879
Generic Entry Date for 205879*:
Constraining patent/regulatory exclusivity:
Dosage:
TABLET, EXTENDED RELEASE;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: 205879
| Mechanism of Action | P-Glycoprotein Inhibitors Sodium-Glucose Transporter 2 Inhibitors |
Suppliers and Packaging for NDA: 205879
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| INVOKAMET XR | canagliflozin; metformin hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 205879 | NDA | Janssen Pharmaceuticals, Inc. | 50458-940 | 50458-940-01 | 60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (50458-940-01) |
| INVOKAMET XR | canagliflozin; metformin hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 205879 | NDA | Janssen Pharmaceuticals, Inc. | 50458-941 | 50458-941-01 | 60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (50458-941-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 50MG;500MG | ||||
| Approval Date: | Sep 20, 2016 | TE: | RLD: | Yes | |||||
| Patent: | ⤷ Try a Trial | Patent Expiration: | Feb 26, 2029 | Product Flag? | Y | Substance Flag? | Y | Delist Request? | |
| Patented Use: | REDUCTION OF RISK OF END STAGE KIDNEY DISEASE, DOUBLING OF SERUM CREATININE, CARDIOVASCULAR DEATH, AND HOSPITALIZATION FOR HEART FAILURE IN THE TREATMENT OF TYPE 2 DIABETES MELLITUS PATIENTS | ||||||||
| Patent: | ⤷ Try a Trial | Patent Expiration: | Feb 26, 2029 | Product Flag? | Y | Substance Flag? | Y | Delist Request? | |
| Patented Use: | REDUCTION OF RISK OF MAJOR ADVERSE CARDIOVASCULAR EVENTS IN THE TREATMENT OF TYPE 2 DIABETES MELLITUS PATIENTS | ||||||||
| Patent: | ⤷ Try a Trial | Patent Expiration: | Feb 26, 2029 | Product Flag? | Y | Substance Flag? | Y | Delist Request? | |
| Patented Use: | TREATMENT OF TYPE 2 DIABETES MELLITUS | ||||||||
Expired US Patents for NDA 205879
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Janssen Pharms | INVOKAMET XR | canagliflozin; metformin hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 205879-001 | Sep 20, 2016 | ⤷ Try a Trial | ⤷ Try a Trial |
| Janssen Pharms | INVOKAMET XR | canagliflozin; metformin hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 205879-003 | Sep 20, 2016 | ⤷ Try a Trial | ⤷ Try a Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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