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 | ⤷ 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 | 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 | Y | Y | ⤷ 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 |
|---|---|---|---|
| Japan | 2009502889 | ⤷ Try a Trial | |
| Eurasian Patent Organization | 015131 | МАКРОЦИКЛИЧЕСКИЕ ИНГИБИТОРЫ ВИРУСА ГЕПАТИТА С (MACROCYCLIC INHIBITORS OF HEPATITIS C VIRUS) | ⤷ Try a Trial |
| Luxembourg | 92568 | ⤷ Try a Trial | |
| Montenegro | 02415 | Intermedijari za pripremu makrocikličkih inhibitora virusa hepatitisa C (Intermediates for the preparation of Macrocyclic inhibitors of hepatitis c virus) | ⤷ 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 |
|---|---|---|---|---|
| 1912999 | C 2014 040 | Romania | ⤷ Try a Trial | PRODUCT NAME: SIMEPREVIR SAU O SARE A ACESTUIA, INCLUSIV SIMEPREVIRSODIU; NATIONAL AUTHORISATION NUMBER: EU/1/14/924; DATE OF NATIONAL AUTHORISATION: 20140514; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/14/924; DATE OF FIRST AUTHORISATION IN EEA: 20140514 |
| 1713823 | 92595 | Luxembourg | ⤷ Try a Trial | PRODUCT NAME: SIMEPREVIR, OU L UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES, INCLUANT SIMEPREVIR SODIUM. FIRST REGISTRATION: 20140516 |
| 1713823 | 300703 | Netherlands | ⤷ Try a Trial | PRODUCT NAME: SIMEPREVIR, OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN, WAARONDER SIMEPREVIRNATRIUM; REGISTRATION NO/DATE: EU/1/14/924/001-002 20140516 |
| 1912999 | 14C0076 | France | ⤷ Try a Trial | PRODUCT NAME: SIMEPREVIR OU L'UN DE SES SELS, INCLUANT LE SEL DE SODIUM DE SIMEPREVIR; REGISTRATION NO/DATE: EU/1/14/924 20140516 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
