Details for New Drug Application (NDA): 204886
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NDA 204886 describes ZONTIVITY, which is a drug marketed by Key Therap and is included in one NDA. There is one patent protecting this drug. Additional details are available on the ZONTIVITY profile page.
The generic ingredient in ZONTIVITY is vorapaxar sulfate. There is one drug master file entry for this compound. Additional details are available on the vorapaxar sulfate profile page.
The generic ingredient in ZONTIVITY is vorapaxar sulfate. There is one drug master file entry for this compound. Additional details are available on the vorapaxar sulfate profile page.
Summary for 204886
| Tradename: | ZONTIVITY |
| Applicant: | Key Therap |
| Ingredient: | vorapaxar sulfate |
| Patents: | 1 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 204886
Generic Entry Date for 204886*:
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.
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | EQ 2.08MG BASE | ||||
| Approval Date: | May 8, 2014 | TE: | RLD: | Yes | |||||
| Patent: | ⤷ Start Trial | Patent Expiration: | Dec 23, 2027 | Product Flag? | Y | Substance Flag? | Y | Delist Request? | |
| Patented Use: | REDUCTION OF THROMBOTIC CARDIOVASCULAR EVENTS | ||||||||
Expired US Patents for NDA 204886
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Key Therap | ZONTIVITY | vorapaxar sulfate | TABLET;ORAL | 204886-001 | May 8, 2014 | ⤷ Start Trial | ⤷ Start Trial |
| Key Therap | ZONTIVITY | vorapaxar sulfate | TABLET;ORAL | 204886-001 | May 8, 2014 | ⤷ Start Trial | ⤷ Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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