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Details for New Drug Application (NDA): 202155
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NDA 202155 describes ELIQUIS, which is a drug marketed by Bristol Myers Squibb and is included in one NDA. It is available from five suppliers. There are two patents protecting this drug and one Paragraph IV challenge. Additional details are available on the ELIQUIS profile page.
The generic ingredient in ELIQUIS is apixaban. There are thirty drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the apixaban profile page.
The generic ingredient in ELIQUIS is apixaban. There are thirty drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the apixaban profile page.
Summary for 202155
| Tradename: | ELIQUIS |
| Applicant: | Bristol Myers Squibb |
| Ingredient: | apixaban |
| Patents: | 2 |
| Formulation / Manufacturing: | see details |
Pharmacology for NDA: 202155
| Mechanism of Action | Factor Xa Inhibitors |
Suppliers and Packaging for NDA: 202155
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ELIQUIS | apixaban | TABLET;ORAL | 202155 | NDA | E.R. Squibb & Sons, L.L.C. | 0003-0893 | 0003-0893-21 | 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0003-0893-21) |
| ELIQUIS | apixaban | TABLET;ORAL | 202155 | NDA | E.R. Squibb & Sons, L.L.C. | 0003-0893 | 0003-0893-31 | 10 BLISTER PACK in 1 CARTON (0003-0893-31) > 10 TABLET, FILM COATED in 1 BLISTER PACK |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 2.5MG | ||||
| Approval Date: | Dec 28, 2012 | TE: | AB | RLD: | Yes | ||||
| Patent: | Start Trial | Patent Expiration: | Nov 21, 2026 | Product Flag? | Y | Substance Flag? | Y | Delist Request? | |
| Patented Use: | PROPHYLAXIS OF DEEP VEIN THROMBOSIS (DVT) | ||||||||
| Patent: | Start Trial | Patent Expiration: | Nov 21, 2026 | Product Flag? | Y | Substance Flag? | Y | Delist Request? | |
| Patented Use: | PROPHYLAXIS OF DEEP VEIN THROMBOSIS AND PULMONARY EMBOLISM | ||||||||
| Patent: | Start Trial | Patent Expiration: | Nov 21, 2026 | Product Flag? | Y | Substance Flag? | Y | Delist Request? | |
| Patented Use: | PROPHYLAXIS OF PULMONARY EMBOLISM | ||||||||
Expired US Patents for NDA 202155
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Bristol Myers Squibb | ELIQUIS | apixaban | TABLET;ORAL | 202155-001 | Dec 28, 2012 | Start Trial | Start Trial |
| Bristol Myers Squibb | ELIQUIS | apixaban | TABLET;ORAL | 202155-002 | Dec 28, 2012 | Start Trial | Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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