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 forty patent family members in forty-three countries.
Summary for simeprevir sodium
| International Patents: | 140 |
| US Patents: | 9 |
| Tradenames: | 1 |
| Applicants: | 1 |
| NDAs: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 46 |
| 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
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 | 9,623,022 | ⤷ Get Started Free | ⤷ Get Started Free | ||||
| Janssen Prods | OLYSIO | simeprevir sodium | CAPSULE;ORAL | 205123-001 | Nov 22, 2013 | DISCN | Yes | No | 8,349,869 | ⤷ Get Started Free | Y | Y | ⤷ Get Started Free | ||
| Janssen Prods | OLYSIO | simeprevir sodium | CAPSULE;ORAL | 205123-001 | Nov 22, 2013 | DISCN | Yes | No | 9,353,103 | ⤷ Get Started Free | ⤷ Get Started Free | ||||
| Janssen Prods | OLYSIO | simeprevir sodium | CAPSULE;ORAL | 205123-001 | Nov 22, 2013 | DISCN | Yes | No | 8,741,926 | ⤷ Get Started Free | Y | ⤷ Get Started Free | |||
| Janssen Prods | OLYSIO | simeprevir sodium | CAPSULE;ORAL | 205123-001 | Nov 22, 2013 | DISCN | Yes | No | 9,856,265 | ⤷ Get Started Free | Y | Y | ⤷ Get Started Free | ||
| Janssen Prods | OLYSIO | simeprevir sodium | CAPSULE;ORAL | 205123-001 | Nov 22, 2013 | DISCN | Yes | No | 8,148,399 | ⤷ Get Started Free | Y | Y | ⤷ Get Started Free | ||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
Expired US Patents for simeprevir sodium
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Janssen Prods | OLYSIO | simeprevir sodium | CAPSULE;ORAL | 205123-001 | Nov 22, 2013 | 7,671,032 | ⤷ Get Started Free |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for simeprevir sodium
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Nicaragua | 200600168 | INHIBIDORES DE SERINA PROTEASA NS-3 DEL VHC | ⤷ Get Started Free |
| Luxembourg | 92595 | ⤷ Get Started Free | |
| El Salvador | 2008002642 | INHIBIDORES MACROCICLICOS DEL VIRUS DE HEPATITIS C REF. PIT 111 SLV | ⤷ Get Started Free |
| European Patent Office | 2937339 | Inhibiteurs macrocycliques du virus de l'hépatite C (Macrocylic inhibitors of hepatitis c virus) | ⤷ Get Started Free |
| Eurasian Patent Organization | 200800476 | МАКРОЦИКЛИЧЕСКИЕ ИНГИБИТОРЫ ВИРУСА ГЕПАТИТА С | ⤷ Get Started Free |
| Denmark | 2322516 | ⤷ Get Started Free | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for simeprevir sodium
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1912999 | 2014/058 | Ireland | ⤷ Get Started Free | PRODUCT NAME: SIMEPREVIR, OR A SALT THEREOF, INCLUDING SIMEPREVIR SODIUM; REGISTRATION NO/DATE: EU/1/14/924/001-002 20140516 |
| 1912999 | CR 2014 00053 | Denmark | ⤷ Get Started Free | PRODUCT NAME: SIMEPREVIR ELLER ET SALT DERAF, HERUNDER SIMEPREVIRNATRIUM; REG. NO/DATE: EU/1/14/924 20140516 |
| 1912999 | 204 5025-2014 | Slovakia | ⤷ Get Started Free | FORMER OWNER(S): JANSSEN R&D IRELAND, IE; MEDIVIR AB, SE; DATUM ZAPISU DO REGISTRA: 20161206 |
| 1912999 | 14C0076 | France | ⤷ Get Started Free | PRODUCT NAME: SIMEPREVIR OU L'UN DE SES SELS, INCLUANT LE SEL DE SODIUM DE SIMEPREVIR; REGISTRATION NO/DATE: EU/1/14/924 20140516 |
| 1713823 | C300703 | Netherlands | ⤷ Get Started Free | PRODUCT NAME: SIMEPREVIR, OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN, WAARONDER SIMEPREVIRNATRIUM; REGISTRATION NO/DATE: EU/1/14/924/001-002 20140514 |
| 1912999 | 122014000098 | Germany | ⤷ Get Started Free | 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 |
Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: Simeprevir Sodium
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