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Generated: September 23, 2019

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Simeprevir sodium - Generic Drug Details

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What are the generic drug sources for simeprevir sodium and what is the scope of simeprevir sodium 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-two patent family members in forty-one countries.

There is one drug master file entry for simeprevir sodium.

Summary for simeprevir sodium
International Patents:132
US Patents:9
Tradenames:1
Applicants:1
NDAs:1
Drug Master File Entries: 1
Bulk Api Vendors: 22
Patent Applications: 69
DailyMed Link:simeprevir sodium at DailyMed
Medical Subject Heading (MeSH) Categories for simeprevir sodium
Synonyms for simeprevir sodium
(2R,3aR,10Z,11aS,12aR,14aR)-N-(Cyclopropylsulfonyl)-2,3,3a,4,5,6,7,8,9,11a,12,13,14,14a-tetradecahydro-2-[[7-methoxy-8-methyl-2-[4-(1-methylethyl)-2-thiazolyl]-4-quinolinyl]oxy]-5-methyl-4,14-dioxocyc
(2R,3aR,11aS,12aR,14aR,Z)-N-(cyclopropylsulfonyl)-2-((2-(4-isopropylthiazol-2-yl)-7-methoxy-8-methylquinolin-4-yl)oxy)-5-methyl-4,14-dioxo-2,3,3
(2R,3aR,11aS,12aR,14aR,Z)-N-(cyclopropylsulfonyl)-2-((2-(4-isopropylthiazol-2-yl)-7-methoxy-8-methylquinolin-4-yl)oxy)-5-methyl-4,14-dioxo-2,3,3a,4,5,6,7,8,9,11a,12,13,14,14a-tetradecahydro
1241946-89-3
4041AH
923604-59-5
a,4,5,6,7,8,9,11a,12,13,14,14a-tetradecahydrocyclopenta[c]cyclopropa[g][1,6]diazacyclotetradecine-12a(1H)-carboxamide
AC-27651
AKOS025401966
AKOS030530428
BCP18937
BDBM50336504
C38H47N5O7S2
CHEBI:134743
CHEMBL3137358
CHEMBL501849
cyclopenta[c]cyclopropa[g][1,6]diazacyclotetradecine-12a(1H)-carboxamide
DB06290
GTPL7367
HCV-PI
KB-81172
lopenta[c]cyclopropa[g][1,6]diazacyclotetradecine-12a(1
N-[17-[2-(4-isopropylthiazole-2-yl)-7-methoxy-8-methylquinolin-4-yloxy]-13-methyl-2,14-dioxo-3,13-diazatricyclo [13.3.0.0''4,6]octadec-7-ene-4-carbonyl](cyclopropyl)sulfonamide
N-cyclopropylsulfonyl-[[2-(4-isopropylthiazol-2-yl)-7-methoxy-8-methyl-4-quinolyl]oxy]-methyl-dioxo-[?]carboxamide
Olysio
SCHEMBL826061
SIMEPREVIR
TMC 435
TMC 435350
TMC-00435350
TMC-435
TMC-435350
TMC435
TMC435350
US8741926, 47
US8754106, 47
W-6083
ZINC85540268

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 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
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Supplementary Protection Certificates for simeprevir sodium

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1912999 C 2014 040 Romania ➤ Sign Up 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 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 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 C300697 Netherlands ➤ Sign Up PRODUCT NAME: SIMEPREVIR, OF EEN ZOUT DAARVAN, WAARONDER SIMEPREVIRNATRIUM; REGISTRATION NO/DATE: EU/1/14/924 20140514
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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