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Last Updated: October 14, 2019

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ADEMPAS Drug Profile

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When do Adempas patents expire, and what generic alternatives are available?

Adempas is a drug marketed by Bayer Hlthcare and is included in one NDA. There are two patents protecting this drug and one Paragraph IV challenge.

This drug has seventy-nine patent family members in forty-three countries.

The generic ingredient in ADEMPAS is riociguat. There are two drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the riociguat profile page.

Drug patent expirations by year for ADEMPAS
Drug Prices for ADEMPAS

See drug prices for ADEMPAS

Generic Entry Opportunity Date for ADEMPAS
Generic Entry Date for ADEMPAS*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
TABLET;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.

Recent Clinical Trials for ADEMPAS

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

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

See all ADEMPAS clinical trials

Recent Litigation for ADEMPAS

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 ADEMPAS litigation

Pharmacology for ADEMPAS
Synonyms for ADEMPAS
[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 (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
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

US Patents and Regulatory Information for ADEMPAS

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

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Bayer Hlthcare ADEMPAS riociguat TABLET;ORAL 204819-005 Oct 8, 2013   See Pricing   See Pricing
Bayer Hlthcare ADEMPAS riociguat TABLET;ORAL 204819-001 Oct 8, 2013   See Pricing   See Pricing
Bayer Hlthcare ADEMPAS riociguat TABLET;ORAL 204819-002 Oct 8, 2013   See Pricing   See Pricing
Bayer Hlthcare ADEMPAS riociguat TABLET;ORAL 204819-003 Oct 8, 2013   See Pricing   See Pricing
Bayer Hlthcare ADEMPAS riociguat TABLET;ORAL 204819-004 Oct 8, 2013   See Pricing   See Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration
Paragraph IV (Patent) Challenges for ADEMPAS
Drugname Dosage Strength RLD Date
➤ Subscribe Tablets 0.5 mg, 1 mg,1.5 mg, 2 mg and2.5 mg ➤ Subscribe   See Pricing

Supplementary Protection Certificates for ADEMPAS

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1506193 1490030-2 Sweden   See Pricing PRODUCT NAME: RIOCIGUAT OCH SALTER, ISOMERER OCH HYDRATER DAERAV; REG. NO/DATE: EU/1/13/907 20140327
1506193 2014C/030 Belgium   See Pricing PRODUCT NAME: RIOCIGUAT; AUTHORISATION NUMBER AND DATE: EU/1/13/907 20140331
1506193 S1400019 Hungary   See Pricing PRODUCT NAME: RIOCIGUAT; REG. NO/DATE: EU/1/13/97 20140327
1506193 300659 Netherlands   See Pricing PRODUCT NAME: RIOCIGUAT, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT OF HYDRAAT; REGISTRATION NO/DATE: EU/1/13/907 20140331
1506193 122014000041 Germany   See Pricing PRODUCT NAME: RIOCIGUAT SOWIE SALZE, ISOMERE UND HYDRATE DAVON; REGISTRATION NO/DATE: EU/1/13/907 20140327
1506193 14C0032 France   See Pricing 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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