Details for New Drug Application (NDA): 203093
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NDA 203093 describes VITEKTA, which is a drug marketed by Gilead Sciences Inc and is included in one NDA. There are three patents protecting this drug. Additional details are available on the VITEKTA profile page.
The generic ingredient in VITEKTA is elvitegravir. There are six drug master file entries for this compound. Additional details are available on the elvitegravir profile page.
The generic ingredient in VITEKTA is elvitegravir. There are six drug master file entries for this compound. Additional details are available on the elvitegravir profile page.
Summary for 203093
| Tradename: | VITEKTA |
| Applicant: | Gilead Sciences Inc |
| Ingredient: | elvitegravir |
| Patents: | 3 |
| Formulation / Manufacturing: | see details |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 203093
Generic Entry Date for 203093*:
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 | 85MG | ||||
| Approval Date: | Sep 24, 2014 | TE: | RLD: | Yes | |||||
| Patent: | ⤷ Try a Trial | Patent Expiration: | Feb 27, 2027 | Product Flag? | Substance Flag? | Delist Request? | Y | ||
| Patent: | ⤷ Try a Trial | Patent Expiration: | Apr 26, 2027 | Product Flag? | Substance Flag? | Delist Request? | Y | ||
| Patent: | ⤷ Try a Trial | Patent Expiration: | Apr 26, 2027 | Product Flag? | Substance Flag? | Delist Request? | Y | ||
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