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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 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-nine 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:	79
US Patents:	2
Tradenames:	1
Applicants:	1
NDAs:	1
Drug Master File Entries:	2
Suppliers / Packagers:	1
Bulk Api Vendors:	76
Clinical Trials:	34
Patent Applications:	132
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for riociguat
DailyMed Link:	riociguat at DailyMed

Recent Clinical Trials for riociguat

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
University of Arizona	Phase 3
University of Colorado, Denver	Phase 2
International CTEPH Association	Phase 2

See all riociguat clinical trials

Recent Litigation for riociguat

Identify potential future generic entrants

District Court Litigation

Case Name	Date
Adverio Pharma GmbH v. Teva Pharmaceuticals USA, Inc.	2018-01-19
Adverio Pharma GmbH v. MSN Laboratories Private Limited	2018-01-19
Adverio Pharma GmbH v. Alembic Pharmaceuticals Limited	2018-01-09

See all riociguat litigation

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)

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

BCP04750

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

D09572

DB08931

EX-A2023

FT-0760451

GTPL5257

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

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

NCGC00379065-03

PB25734

Q-4478

QCR-167

Riociguat (BAY 63-2521)

Riociguat (JAN/USAN/INN)

Riociguat [USAN:INN:JAN]

Riociguat,CAS:625115-55-1

riociguatum

RU3FE2Y4XI

s8135

SCHEMBL245457

ST1171165

UNII-RU3FE2Y4XI

WXXSNCNJFUAIDG-UHFFFAOYSA-N

X6629

ZINC3819392

Paragraph IV (Patent) Challenges for RIOCIGUAT

Tradename	Dosage	Ingredient	NDA	Submissiondate
ADEMPAS	TABLET;ORAL	riociguat	204819	2017-10-10

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	204819-001	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	204819-001	Oct 8, 2013		RX	Yes	No
Bayer Hlthcare	ADEMPAS	riociguat	TABLET;ORAL	204819-003	Oct 8, 2013		RX	Yes	No			Y	Y
Bayer Hlthcare	ADEMPAS	riociguat	TABLET;ORAL	204819-003	Oct 8, 2013		RX	Yes	No
Bayer Hlthcare	ADEMPAS	riociguat	TABLET;ORAL	204819-005	Oct 8, 2013		RX	Yes	Yes

Expired US Patents for riociguat

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Bayer Hlthcare	ADEMPAS	riociguat	TABLET;ORAL	204819-005	Oct 8, 2013
Bayer Hlthcare	ADEMPAS	riociguat	TABLET;ORAL	204819-001	Oct 8, 2013
Bayer Hlthcare	ADEMPAS	riociguat	TABLET;ORAL	204819-002	Oct 8, 2013
Bayer Hlthcare	ADEMPAS	riociguat	TABLET;ORAL	204819-003	Oct 8, 2013
Bayer Hlthcare	ADEMPAS	riociguat	TABLET;ORAL	204819-004	Oct 8, 2013

International Patents for riociguat

Country	Patent Number	Estimated Expiration
Hungary	0103815
Norway	20045277
Japan	2002521483
Honduras	1999000125
New Zealand	509599
Austria	313543

Supplementary Protection Certificates for riociguat

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1506193	SPC/GB14/044	United Kingdom		PRODUCT NAME: RIOCIGUAT, I.E. METHYL N-(4,6-DIAMINO-2-(1-(2-FLUOROBENZYL)-1H-PYRAZOLO (3,4-B)PYRIDIN-3-YL)-5-PYRIMIDINYL(METHYL)CARBAMATE,OR A PHARMACEUTICALLY ACCEPTABLE SALT OR HYDRATE THEREOF.; REGISTERED: UK EU/1/13/907 20140331
1506193	2014C/030	Belgium		PRODUCT NAME: RIOCIGUAT; AUTHORISATION NUMBER AND DATE: EU/1/13/907 20140331
1506193	PA2014018,C1506193	Lithuania		PRODUCT NAME: RIOCIGUATUM; REGISTRATION NO/DATE: EU/1/13/907/001 - EU/1/13/907/015 20140327
1506193	CR 2014 00028	Denmark		PRODUCT NAME: RIOCIGUAT OG SALTE, ISOMERER OG HYDRATER HERAF; REG. NO/DATE: EU/1/13/907 20140327
1506193	C300659	Netherlands		PRODUCT NAME: RIOCIGUAT, DESGEW ENST IN DE; REGISTRATION NO/DATE: EU/1/13/907 20140327
1506193	14C0032	France		PRODUCT NAME: RIOCIGUAT,SES SELS,SES ISOMERES ET SES HYDRATES.; REGISTRATION NO/DATE: EU/1/13/907/001-015 20140327