Details for New Drug Application (NDA): 205123
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NDA 205123 describes OLYSIO, which is a drug marketed by Janssen Prods and is included in one NDA. There are nine patents protecting this drug. Additional details are available on the OLYSIO profile page.
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.
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: | 7,671,032 | Patent Expiration: | May 19, 2025 | Product Flag? | Y | Substance Flag? | Y | Delist Request? | |
| Patent: | 8,148,399 | Patent Expiration: | Sep 5, 2029 | Product Flag? | Y | Substance Flag? | Y | Delist Request? | |
| Patented Use: | METHOD OF TREATING HEPATITIS C | ||||||||
| Patent: | 8,349,869 | Patent Expiration: | Jul 28, 2026 | Product Flag? | Y | Substance Flag? | Y | Delist Request? | |
| Patented Use: | METHOD OF TREATING HEPATITIS C | ||||||||
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