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Riociguat - Generic Drug Details

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What are the generic drug sources for riociguat and what is the scope of riociguat freedom to operate?
Riociguat is the generic ingredient in one branded drug marketed by Bayer Hlthcare and is included in one NDA. There are two patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Riociguat has seventy-eight patent family members in forty-three countries.

There are two drug master file entries for riociguat. One supplier is listed for this compound.

Summary for riociguat

International Patents:	78
US Patents:	2
Tradenames:	1
Applicants:	1
NDAs:	1
Drug Master File Entries:	2
Suppliers / Packagers:	1
Bulk Api Vendors:	65
Clinical Trials:	30
Patent Applications:	116
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for riociguat
DailyMed Link:	riociguat at DailyMed

Pharmacology for riociguat

Drug Class	Soluble Guanylate Cyclase Stimulator
Mechanism of Action	Guanylate Cyclase Stimulators

Synonyms for riociguat

[4,6-Diamino-2-[1-(2-fluorobenzyl)-1H-pyrazolo[3,4-b]pyridin-3-yl]pyrimidin-5-yl]methylcarbamic acid methyl ester
115R551
625115-55-1
AB0033159
AC-27647
ACN-036668
Adempas
Adempas (TN)
AK172141
AKOS015900718
AKOS032950011
AN-401
API0010348
AS-19299
BAY 63-2521
Bay 63-2521,Riociguat
BAY 63-2521; BAY 632521
BAY 63-2521;BAY 632521
BAY 632521
BAY-63-2521
BAY-632521
BCP0726000023
BCP9000382
C20H19FN8O2
Carbamic acid, (4,6-diamino-2-(1-((2-fluorophenyl)methyl)-1H-pyrazolo(3,4-b)pyridin-3-yl)-5-pyrimidinyl)methyl-, methyl ester
Carbamic acid, N-(4,6-diamino-2-(1-((2-fluorophenyl)methyl)-1H-pyrazolo(3,4-b)pyridin-3-yl)-5-pyrimidinyl)-N-methyl-, methyl ester
CHEBI:76018
CHEMBL2107834
CR0020
CS-0584
D04UKC
D09572
DB08931
FT-0760451
GTPL5257
HE067864
HE367522
HY-14779
I14-16377
KB-80378
KS-000006SQ
Methyl (4,6-diamino-2-(1-(2-fluorobenzyl)-1H-pyrazolo[3,4-b]pyridin-3-yl)pyrimidin-5-yl)(methyl)carbamate
methyl {4,6-diamino-2-[1-(2-fluorobenzyl)-1H-pyrazolo[3,4-b]pyridin-3-yl]pyrimidin-5-yl}methylcarbamate
Methyl 4,6-diamino-2-(1-(2-fluorobenzyl)-1H-pyrazolo(3,4-b)pyridin-3-yl)-5-pyrimidinyl(methyl)carbamate
methyl 4,6-diamino-2-(1-(2-fluorobenzyl)-1H-pyrazolo[3,4-b]pyridin-3-yl)pyrimidin-5-yl(methyl)carbamate
Methyl 4,6-diamino-2-[1-(2-fluorobenzyl)-1H-pyrazolo[3,4-b]pyridin-3-yl]-5-pyrimidinyl(methyl)carbamate
Methyl N-(4,6-diamino-2-{1-((2-fluorophenyl)methyl)-1H-pyrazolo(3,4-b)pyridin-3-yl}pyrimidin-5-yl)-N-methylcarbamate
methyl N-(4,6-diamino-2-{1-[(2-fluorophenyl)methyl]-1H-pyrazolo[3,4-b]pyridin-3-yl}pyrimidin-5-yl)-N-methylcarbamate
Methyl N-[4,6-Diamino-2-[1-[(2-fluorophenyl)methyl]-1H-pyrazolo[3,4-b]pyridin-3-yl]-5-pyrimidinyl]-N-methyl-carbaminate
methyl N-[4,6-diamino-2-[1-[(2-fluorophenyl)methyl]pyrazolo[3,4-b]pyridin-3-yl]pyrimidin-5-yl]-N-methyl-carbamate
MFCD19443708
MolPort-023-219-120
N-[4,6-Diamino-2-[1-[(2-fluorophenyl)methyl]-1H-pyrazolo[3,4-b]pyridin-3-yl]-5-pyrimidinyl]-N-methylcarbamic acid methyl ester
PB25734
Q-4478
QCR-167
Riociguat (BAY 63-2521)
Riociguat (JAN/INN)
Riociguat [USAN:INN:JAN]
Riociguat,CAS:625115-55-1
riociguatum
RU3FE2Y4XI
s8135
SCHEMBL245457
ST1171165
UNII-RU3FE2Y4XI
WXXSNCNJFUAIDG-UHFFFAOYSA-N
X6629
ZINC3819392

US Patents and Regulatory Information for riociguat

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Bayer Hlthcare	ADEMPAS	riociguat	TABLET;ORAL	204819-002	Oct 8, 2013		RX	Yes	No	➤ Sign Up	➤ Sign Up	Y	Y		➤ Sign Up
Bayer Hlthcare	ADEMPAS	riociguat	TABLET;ORAL	204819-002	Oct 8, 2013		RX	Yes	No	➤ Sign Up	➤ Sign Up				➤ Sign Up
Bayer Hlthcare	ADEMPAS	riociguat	TABLET;ORAL	204819-005	Oct 8, 2013		RX	Yes	Yes	➤ Sign Up	➤ Sign Up	Y	Y		➤ Sign Up
Bayer Hlthcare	ADEMPAS	riociguat	TABLET;ORAL	204819-005	Oct 8, 2013		RX	Yes	Yes	➤ 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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International Patents for riociguat

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Country	Document Number	Estimated Expiration
New Zealand	509599	➤ Sign Up
Portugal	1506193	➤ Sign Up
South Korea	101011864	➤ Sign Up
Norway	319073	➤ Sign Up
Country	Document Number	Estimated Expiration

Supplementary Protection Certificates for riociguat

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Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2014 00028	Denmark	➤ Sign Up	PRODUCT NAME: RIOCIGUAT OG SALTE, ISOMERER OG HYDRATER HERAF; REG. NO/DATE: EU/1/13/907 20140327
C0032	France	➤ Sign Up	PRODUCT NAME: RIOCIGUAT,SES SELS,SES ISOMERES ET SES HYDRATES.; REGISTRATION NO/DATE: EU/1/13/907/001-015 20140327
0659	Netherlands	➤ Sign Up	PRODUCT NAME: RIOCIGUAT, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT OF HYDRAAT; REGISTRATION NO/DATE: EU/1/13/907 20140331
90030-2	Sweden	➤ Sign Up	PRODUCT NAME: RIOCIGUAT OCH SALTER, ISOMERER OCH HYDRATER DAERAV; REG. NO/DATE: EU/1/13/907 20140327
Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description