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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 six suppliers. There are three 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. Six 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. Six 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: | 3 |
| Formulation / Manufacturing: | see details |
Generic Entry Opportunity Date for 202155
Generic Entry Date for 202155*:
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: 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: | RLD: | Yes | |||||
| Patent: | Start Trial | Patent Expiration: | Dec 22, 2019 | Product Flag? | Y | Substance Flag? | Y | Delist Request? | |
| Patented Use: | PROPHYLAXIS OF DEEP VEIN THROMBOSIS AND PULMONARY EMBOLISM | ||||||||
| Patent: | Start Trial | Patent Expiration: | Dec 22, 2019 | Product Flag? | Y | Substance Flag? | Y | Delist Request? | |
| Patented Use: | REDUCING THE RISK OF STROKE AND SYSTEMIC EMBOLISM | ||||||||
| Patent: | Start Trial | Patent Expiration: | Dec 22, 2019 | Product Flag? | Y | Substance Flag? | Y | Delist Request? | |
| Patented Use: | TREATMENT OF DEEP VEIN THROMBOSIS (DVT) | ||||||||
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