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 | 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 | |||
| Janssen Prods | OLYSIO | simeprevir sodium | CAPSULE;ORAL | 205123-001 | Nov 22, 2013 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ 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 |
|---|---|---|---|
| Malaysia | 144217 | MACROCYLIC INHIBITORS OF HEPATITIS C VIRUS | ⤷ Sign Up |
| Uruguay | 29703 | "INHIBIDORES MACROCÍCLICOS DEL VIRUS DE LA HEPATITIS C" | ⤷ Sign Up |
| South Korea | 101217036 | ⤷ Sign Up | |
| Ukraine | 84050 | ІНГІБІТОРИ СЕРИН-ПРОТЕАЗИ NS-3 HCV[ИНГИБИТОРЫ СЕРИН-ПРОТЕАЗЫ NS-3 HCV (HCV NS-3-SERINE PROTEASE INHIBITORS) | ⤷ 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 | CR 2014 00059 | Denmark | ⤷ Sign Up | PRODUCT NAME: SIMEPREVIR ELLER ET FARMACEUTISK SALT DERAF, HERUNDER SIMEPREVIRNATRIUM; REG. NO/DATE: EU/1/14/924 20140516 |
| 1912999 | PA2014036 | Lithuania | ⤷ Sign Up | PRODUCT NAME: SIMEPREVIRUM; REGISTRATION NO/DATE: EU/1/14/924 20140514 |
| 1713823 | CA 2014 00059 | Denmark | ⤷ Sign Up | PRODUCT NAME: SIMEPREVIR ELLER ET FARMACEUTISK SALT DERAF, HERUNDER SIMEPREVIRNATRIUM; REG. NO/DATE: EU/1/14/924 20140514 |
| 1713823 | 122014000103 | Germany | ⤷ Sign Up | PRODUCT NAME: SIMEPREVIR ODER EIN PHARMAZEUTISCH AKZEPTABLES SALZ DAVON, EINSCHLIESSLICH SIMEPREVIR NATRIUM; NAT. REGISTRATION NO/DATE: EU /1/14/924 20140514; FIRST REGISTRATION: EU EU/1/14/924 20140514 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
