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Generated: November 20, 2018

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ADEMPAS Drug Profile

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Which patents cover Adempas, 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.

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
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.

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)
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
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 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 ➤ 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
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 204819-001 Oct 8, 2013 RX Yes No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Bayer Hlthcare ADEMPAS riociguat TABLET;ORAL 204819-003 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 ➤ 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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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 ➤ Sign Up

Supplementary Protection Certificates for ADEMPAS

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
419 Luxembourg ➤ Sign Up PRODUCT NAME: RIOCIGUAT ET SES DERIVES PHARMACEUTIQUEMENT ACCEPTABLES(ADEMPAS)
5 Finland ➤ Sign Up
00659 Netherlands ➤ Sign Up PRODUCT NAME: RIOCIGUAT, DESGEW ENST IN DE; REGISTRATION NO/DATE: EU/1/13/907 20140327
0140015 00109 Estonia ➤ Sign Up PRODUCT NAME: RIOTSIGUAAT;REG NO/DATE: K(2014)2152 (LOPLIK) 31.03.2014
/2014 Austria ➤ Sign Up PRODUCT NAME: RIOCIGUAT; REGISTRATION NO/DATE: EU/1/13/907 20140331
2014 00028 Denmark ➤ Sign Up PRODUCT NAME: RIOCIGUAT OG SALTE, ISOMERER OG HYDRATER HERAF; REG. NO/DATE: EU/1/13/907 20140327
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Healthtrust
Cipla
Chinese Patent Office
Citi
Express Scripts
Federal Trade Commission
UBS
Chubb
Teva

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