Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Last Updated: November 18, 2019

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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.

Recent Clinical Trials for riociguat

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SponsorPhase
University of ArizonaPhase 3
University of Colorado, DenverPhase 2
International CTEPH AssociationPhase 2

See all riociguat clinical trials

Recent Litigation for riociguat

Identify potential future generic entrants

District Court Litigation
Case NameDate
Adverio Pharma GmbH v. Teva Pharmaceuticals USA, Inc.2018-01-19
Adverio Pharma GmbH v. MSN Laboratories Private Limited2018-01-19
Adverio Pharma GmbH v. Alembic Pharmaceuticals Limited2018-01-09

See all riociguat litigation

Pharmacology for riociguat
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   Start Trial   Start Trial Y Y   Start Trial
Bayer Hlthcare ADEMPAS riociguat TABLET;ORAL 204819-002 Oct 8, 2013 RX Yes No   Start Trial   Start Trial   Start Trial
Bayer Hlthcare ADEMPAS riociguat TABLET;ORAL 204819-001 Oct 8, 2013 RX Yes No   Start Trial   Start Trial   Start Trial
Bayer Hlthcare ADEMPAS riociguat TABLET;ORAL 204819-003 Oct 8, 2013 RX Yes No   Start Trial   Start Trial Y Y   Start Trial
Bayer Hlthcare ADEMPAS riociguat TABLET;ORAL 204819-003 Oct 8, 2013 RX Yes No   Start Trial   Start Trial   Start Trial
Bayer Hlthcare ADEMPAS riociguat TABLET;ORAL 204819-005 Oct 8, 2013 RX Yes Yes   Start Trial   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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

Supplementary Protection Certificates for riociguat

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1506193 SPC/GB14/044 United Kingdom   Start Trial 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   Start Trial PRODUCT NAME: RIOCIGUAT; AUTHORISATION NUMBER AND DATE: EU/1/13/907 20140331
1506193 PA2014018,C1506193 Lithuania   Start Trial PRODUCT NAME: RIOCIGUATUM; REGISTRATION NO/DATE: EU/1/13/907/001 - EU/1/13/907/015 20140327
1506193 CR 2014 00028 Denmark   Start Trial PRODUCT NAME: RIOCIGUAT OG SALTE, ISOMERER OG HYDRATER HERAF; REG. NO/DATE: EU/1/13/907 20140327
1506193 C300659 Netherlands   Start Trial PRODUCT NAME: RIOCIGUAT, DESGEW ENST IN DE; REGISTRATION NO/DATE: EU/1/13/907 20140327
1506193 14C0032 France   Start Trial PRODUCT NAME: RIOCIGUAT,SES SELS,SES ISOMERES ET SES HYDRATES.; REGISTRATION NO/DATE: EU/1/13/907/001-015 20140327
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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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.