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Generated: September 25, 2018

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Simeprevir sodium - Generic Drug Details

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What are the generic 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.

There is one drug master file entry for simeprevir sodium.

Summary for simeprevir sodium
US Patents:9
Tradenames:1
Applicants:1
NDAs:1
Drug Master File Entries: 1
Bulk Api Vendors: 14
Patent Applications: 67
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-({7-methoxy-8-methyl-2-[4-(1-methylethyl)-1,3-thiazol-2-yl]quinolin-4-yl}oxy)-5-methyl-4,14-dioxo-2,3,3a,4,5,6,7,8,9,11a,12,13,14,14a-tetradecahydrocyclopenta[c]cyclopropa
(2R,3aR,10Z,11aS,12aR,14aR)-N-(Cyclopropylsulfonyl)-2-({7-methoxy-8-methyl-2-[4-(propan-2-yl)-1,3-thiazol-2-yl]quinolin-4-yl}oxy)-5-methyl-4,14-dioxo-2,3,3a,4,5,6,7,8,9,11a,12,13,14,14a-tetradecahydrocyclopenta[c]cyclopropa[g
(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,10Z,12S,13R,15aR)-N-(Cyclopropylsulfonyl)-2-[[2-(4-isopropylthiazole-2-yl)-7-methoxy-8-methyl-4-quinolyl]oxy]-5-methyl-4,15-dioxo-2,3,3a,4,5,6,7,8,9,12,13,14,15,15a-tetradecahydro-12,13-methano-5,14-diaza-1H-cyclopent
(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-1,2,3,3a,4,5,6,7,8,9,11a,12,12a,13,14,14a-hexadecahydrocyclopenta[c]cyclopropa[g][1,6]
(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
(2R,3aR,11aS,12aR,14aR,Z)-N-(cyclopropylsulfonyl)-2-(2-(4-isopropylthiazol-2-yl)-7-methoxy-8-methylquinolin-4-yloxy)-5-methyl-4,14-dioxo-1,2,3,3a,4,5,6,7,8,9,11a,12,12a,13,14,14a-hexadecahydrocyclopenta[c]cyclopropa[g][1,6]di
(2R,3aR,11aS,12aR,14aR)-N-(cyclopropylsulfonyl)-2-(2-(4-isopropylthiazol-2-yl)-7-methoxy-8-methylquinolin-4-yloxy)-5-methyl-4,14-dioxo-1,2,3,3a,4,5,6,7,8,9,11a,12,12a,13,14,14a-hexadecahydrocyclopenta[c]cyclopropa[g][1,6]diaz
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
BDBM50336504
C38H47N5O7S2
CHEBI:134743
CHEMBL3137358
CHEMBL501849
cyclopenta[c]cyclopropa[g][1,6]diazacyclotetradecine-12a(1H)-carboxamide
D00TLP
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
TMC436
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 ➤ 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 ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

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Supplementary Protection Certificates for simeprevir sodium

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0140034 00151 Estonia ➤ Sign Up PRODUCT NAME: SIMEPREVIIR;REG NO/DATE: EU/1/14/924 16.05.2014
2014 00053 Denmark ➤ Sign Up PRODUCT NAME: SIMEPREVIR ELLER ET SALT DERAF, HERUNDER SIMEPREVIRNATRIUM; REG. NO/DATE: EU/1/14/924 20140514
2014036,C1912999 Lithuania ➤ Sign Up PRODUCT NAME: SIMEPREVIRAS; REGISTRATION NO/DATE: EU/1/14/924 20140514
90062-5 Sweden ➤ Sign Up PRODUCT NAME: SIMEPREVIR, OR A SALT THEREOF, INCLUDING SIMEPREVIR SODIUM; REG. NO/DATE: EU/1/14/924 20140516
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Colorcon
Moodys
Fish and Richardson
McKesson
Covington
UBS
Healthtrust
Harvard Business School
Accenture

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.