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Generated: October 19, 2018

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OLYSIO Drug Profile

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Which patents cover Olysio, and what generic alternatives are available?

Olysio is a drug marketed by Janssen Prods and is included in one NDA. There are nine patents protecting this drug.

The generic ingredient in OLYSIO is simeprevir sodium. There is one drug master file entry for this compound. Additional details are available on the simeprevir sodium profile page.

Drug patent expirations by year for OLYSIO
Generic Entry Opportunity Date for OLYSIO
Generic Entry Date for OLYSIO*:
Constraining patent/regulatory exclusivity:
NDA:
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 OLYSIO
Synonyms for OLYSIO
(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
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
SCHEMBL826061
SIMEPREVIR
Simeprevir sodium
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 OLYSIO

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 ➤ 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 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

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Supplementary Protection Certificates for OLYSIO

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
90064-1 Sweden ➤ Sign Up PRODUCT NAME: SIMEPREVIR, OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, INCLUDING SIMEPREVIR SODIUM; REG. NO/DATE: EU/1/14/924 20140516
0140034 00151 Estonia ➤ Sign Up PRODUCT NAME: SIMEPREVIIR;REG NO/DATE: EU/1/14/924 16.05.2014
00697 Netherlands ➤ Sign Up PRODUCT NAME: SIMEPREVIR, OF EEN ZOUT DAARVAN, WAARONDER SIMEPREVIRNATRIUM; REGISTRATION NO/DATE: EU/1/14/924 20140514
2014036,C1912999 Lithuania ➤ Sign Up PRODUCT NAME: SIMEPREVIRAS; REGISTRATION NO/DATE: EU/1/14/924 20140514
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

McKesson
Covington
Citi
Healthtrust
UBS
Federal Trade Commission
Dow
Cerilliant
Deloitte

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