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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

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	204819-003	Oct 8, 2013		RX	Yes	No			Y	Y
Bayer Hlthcare	ADEMPAS	riociguat	TABLET;ORAL	204819-005	Oct 8, 2013		RX	Yes	Yes			Y	Y
Bayer Hlthcare	ADEMPAS	riociguat	TABLET;ORAL	204819-004	Oct 8, 2013		RX	Yes	No			Y	Y
Bayer Hlthcare	ADEMPAS	riociguat	TABLET;ORAL	204819-002	Oct 8, 2013		RX	Yes	No
Bayer Hlthcare	ADEMPAS	riociguat	TABLET;ORAL	204819-003	Oct 8, 2013		RX	Yes	No
Bayer Hlthcare	ADEMPAS	riociguat	TABLET;ORAL	204819-004	Oct 8, 2013		RX	Yes	No
Bayer Hlthcare	ADEMPAS	riociguat	TABLET;ORAL	204819-003	Oct 8, 2013		RX	Yes	No

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International Patents for riociguat

Country	Document Number	Estimated Expiration
Spain	2268363
Norway	329105
Bulgaria	105177
Malaysia	133392
Spain	2255288
Guatemala	200300101
Indonesia	28240

Supplementary Protection Certificates for riociguat

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
5 5014-2014	Slovakia		PRODUCT NAME: RIOCIGUAT; REGISTRATION NO/DATE: EU/1/13/907 20140327
/2014	Austria		PRODUCT NAME: RIOCIGUAT; REGISTRATION NO/DATE: EU/1/13/907 20140331
0140015 00109	Estonia		PRODUCT NAME: RIOTSIGUAAT;REG NO/DATE: K(2014)2152 (LOPLIK) 31.03.2014
0659	Netherlands		PRODUCT NAME: RIOCIGUAT, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT OF HYDRAAT; REGISTRATION NO/DATE: EU/1/13/907 20140331
5	Finland
14/028	Ireland		PRODUCT NAME: RIOCIGUAT OR A SALT, ISOMER OR HYDRATE THEREOF; REGISTRATION NO/DATE: EU/1/13/907/001-015 20140327
2014018,C1506193	Lithuania		PRODUCT NAME: RIOCIGUATUM; REGISTRATION NO/DATE: EU/1/13/907/001 - EU/1/13/907/015 20140327