Details for New Drug Application (NDA): 205123
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The generic ingredient in OLYSIO is simeprevir sodium. There is one drug master file entry for this compound. Additional details are available on the simeprevir sodium profile page.
Summary for 205123
Tradename: | OLYSIO |
Applicant: | Janssen Prods |
Ingredient: | simeprevir sodium |
Patents: | 9 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 205123
Generic Entry Date for 205123*:
Constraining patent/regulatory exclusivity:
Dosage:
CAPSULE;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.
Medical Subject Heading (MeSH) Categories for 205123
Profile for product number 001
Active Rx/OTC/Discontinued: | DISCN | Dosage: | CAPSULE;ORAL | Strength | EQ 150MG BASE | ||||
Approval Date: | Nov 22, 2013 | TE: | RLD: | Yes | |||||
Patent: | ⤷ Sign Up | Patent Expiration: | May 19, 2025 | Product Flag? | Y | Substance Flag? | Y | Delist Request? | |
Patent: | ⤷ Sign Up | Patent Expiration: | Sep 5, 2029 | Product Flag? | Y | Substance Flag? | Y | Delist Request? | |
Patented Use: | METHOD OF TREATING HEPATITIS C | ||||||||
Patent: | ⤷ Sign Up | Patent Expiration: | Jul 28, 2026 | Product Flag? | Y | Substance Flag? | Y | Delist Request? | |
Patented Use: | METHOD OF TREATING HEPATITIS C |
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