Simeprevir sodium - Generic Drug Details
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What are the generic sources for simeprevir sodium and what is the scope of patent protection?
Simeprevir sodium
is the generic ingredient in one branded drug marketed by Janssen Prods and is included in one NDA. There are nine patents protecting this compound. Additional information is available in the individual branded drug profile pages.Simeprevir sodium has one hundred and thirty-nine patent family members in forty-three countries.
Summary for simeprevir sodium
| International Patents: | 139 |
| US Patents: | 9 |
| Tradenames: | 1 |
| Applicants: | 1 |
| NDAs: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 46 |
| Patent Applications: | 1,708 |
| DailyMed Link: | simeprevir sodium at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for simeprevir sodium
Generic Entry Date for simeprevir sodium*:
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 simeprevir sodium
US Patents and Regulatory Information for simeprevir sodium
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Janssen Prods | OLYSIO | simeprevir sodium | CAPSULE;ORAL | 205123-001 | Nov 22, 2013 | DISCN | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
| Janssen Prods | OLYSIO | simeprevir sodium | CAPSULE;ORAL | 205123-001 | Nov 22, 2013 | DISCN | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | Y | Y | ⤷ Try a Trial | ||
| Janssen Prods | OLYSIO | simeprevir sodium | CAPSULE;ORAL | 205123-001 | Nov 22, 2013 | DISCN | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Janssen Prods | OLYSIO | simeprevir sodium | CAPSULE;ORAL | 205123-001 | Nov 22, 2013 | DISCN | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
International Patents for simeprevir sodium
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Slovenia | 1912999 | ⤷ Try a Trial | |
| Honduras | 2008000134 | INHIBIDORES MACROCICLICOS DEL VIRUS HEPATITIS C | ⤷ Try a Trial |
| Ecuador | SP066726 | INHIBIDORES DE SERINA PROTEASA NS-3 DEL VHC | ⤷ Try a Trial |
| Argentina | 104445 | COMPUESTOS INHIBIDORES DE LA SERINA PROTEASA NS3 DEL VHC Y COMPOSICIÓN FARMACÉUTICA | ⤷ Try a Trial |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for simeprevir sodium
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1713823 | 92595 | Luxembourg | ⤷ Try a Trial | PRODUCT NAME: SIMEPREVIR, OU L UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES, INCLUANT SIMEPREVIR SODIUM. FIRST REGISTRATION: 20140516 |
| 1713823 | 1490064-1 | Sweden | ⤷ Try a Trial | PRODUCT NAME: SIMEPREVIR, OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, INCLUDING SIMEPREVIR SODIUM; REG. NO/DATE: EU/1/14/924 20140516 |
| 1912999 | C01912999/01 | Switzerland | ⤷ Try a Trial | PRODUCT NAME: SIMEPREVIR; REGISTRATION NO/DATE: SWISSMEDIC 63215 04.03.2015 |
| 1912999 | 122014000098 | Germany | ⤷ Try a Trial | PRODUCT NAME: SIMEPREVIR ODER EIN SALZ DAVON; REGISTRATION NO/DATE: EU/1/14/924 20140514 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
