Simeprevir sodium - Generic Drug Details
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What are the generic drug 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
*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
Anatomical Therapeutic Chemical (ATC) Classes 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 | ⤷ Sign Up | ⤷ Sign Up | Y | Y | ⤷ Sign Up | ||
| Janssen Prods | OLYSIO | simeprevir sodium | CAPSULE;ORAL | 205123-001 | Nov 22, 2013 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Janssen Prods | OLYSIO | simeprevir sodium | CAPSULE;ORAL | 205123-001 | Nov 22, 2013 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | Y | ⤷ Sign Up | ||
| Janssen Prods | OLYSIO | simeprevir sodium | CAPSULE;ORAL | 205123-001 | Nov 22, 2013 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Janssen Prods | OLYSIO | simeprevir sodium | CAPSULE;ORAL | 205123-001 | Nov 22, 2013 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | Y | ⤷ Sign Up | ||
| Janssen Prods | OLYSIO | simeprevir sodium | CAPSULE;ORAL | 205123-001 | Nov 22, 2013 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| >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 |
|---|---|---|---|
| Denmark | 2322516 | ⤷ Sign Up | |
| Nicaragua | 200600168 | INHIBIDORES DE SERINA PROTEASA NS-3 DEL VHC | ⤷ Sign Up |
| Malaysia | 153011 | HCV NS-3 SERINE PROTEASE INHIBITORS | ⤷ Sign Up |
| Denmark | 1912999 | ⤷ Sign Up | |
| Germany | 602006019439 | ⤷ Sign Up | |
| Slovenia | 1912999 | ⤷ Sign Up | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for simeprevir sodium
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1713823 | 132014902308868 | Italy | ⤷ Sign Up | PRODUCT NAME: SIMEPREVIR O UN SUO SALE FARMACEUTICAMENTE ACCETTABILE, COMPRESO IL SALE SODICO(OLYSIO); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/14/924, 20140516 |
| 1713823 | 300703 | Netherlands | ⤷ Sign Up | PRODUCT NAME: SIMEPREVIR, OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN, WAARONDER SIMEPREVIRNATRIUM; REGISTRATION NO/DATE: EU/1/14/924/001-002 20140516 |
| 1713823 | C300703 | Netherlands | ⤷ Sign Up | PRODUCT NAME: SIMEPREVIR, OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN, WAARONDER SIMEPREVIRNATRIUM; REGISTRATION NO/DATE: EU/1/14/924/001-002 20140514 |
| 1912999 | 14C0076 | France | ⤷ Sign Up | PRODUCT NAME: SIMEPREVIR OU L'UN DE SES SELS, INCLUANT LE SEL DE SODIUM DE SIMEPREVIR; REGISTRATION NO/DATE: EU/1/14/924 20140516 |
| 1912999 | C20140034 00151 | Estonia | ⤷ Sign Up | PRODUCT NAME: SIMEPREVIIR;REG NO/DATE: EU/1/14/924 16.05.2014 |
| 1912999 | 1490062-5 | Sweden | ⤷ Sign Up | PRODUCT NAME: SIMEPREVIR, OR A SALT THEREOF, INCLUDING SIMEPREVIR SODIUM; REG. NO/DATE: EU/1/14/924 20140516 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
