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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 patent protection?

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 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:	70
US Patents:	2
Tradenames:	1
Applicants:	1
NDAs:	1
Drug Master File Entries:	2
Suppliers / Packagers:	1
Bulk Api Vendors:	85
Clinical Trials:	37
Patent Applications:	580
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for riociguat
What excipients (inactive ingredients) are in riociguat?	riociguat excipients list
DailyMed Link:	riociguat at DailyMed

Recent Clinical Trials for riociguat

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

Sponsor	Phase
Bayer Yakuhin, Ltd.	Phase 2
National Hospital Organization Okayama Medical Center	Phase 2
Actelion	Phase 3

See all riociguat clinical trials

Pharmacology for riociguat

Drug Class	Soluble Guanylate Cyclase Stimulator
Mechanism of Action	Guanylate Cyclase Stimulators

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	204819-004	Oct 8, 2013		RX	Yes	No			Y	Y
Bayer Hlthcare	ADEMPAS	riociguat	TABLET;ORAL	204819-004	Oct 8, 2013		RX	Yes	No			Y	Y
Bayer Hlthcare	ADEMPAS	riociguat	TABLET;ORAL	204819-005	Oct 8, 2013		RX	Yes	Yes
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	204819-002	Oct 8, 2013		RX	Yes	No			Y	Y
Bayer Hlthcare	ADEMPAS	riociguat	TABLET;ORAL	204819-001	Oct 8, 2013		RX	Yes	No			Y	Y

Expired US Patents for riociguat

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

International Patents for riociguat

Country	Patent Number	Estimated Expiration
Nicaragua	201500110
European Patent Office	3760629
Croatia	P20041166
Israel	240397
Guatemala	200300101
Portugal	1506193
Mexico	2015010725

Supplementary Protection Certificates for riociguat

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1506193	36/2014	Austria		PRODUCT NAME: RIOCIGUAT; REGISTRATION NO/DATE: EU/1/13/907 20140331
1506193	515	Finland
1506193	132014902270282	Italy		PRODUCT NAME: RIOCIGUAT(ADEMPAS); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/13/907, 20140327
1506193	165 5014-2014	Slovakia		PRODUCT NAME: RIOCIGUAT; REGISTRATION NO/DATE: EU/1/13/907 20140327
1506193	2014/028	Ireland		PRODUCT NAME: RIOCIGUAT OR A SALT, ISOMER OR HYDRATE THEREOF; REGISTRATION NO/DATE: EU/1/13/907/001-015 20140327
1506193	C 2014 026	Romania		PRODUCT NAME: RIOCIGUAT4,6-DIAMINO-2-[1-(-FLUORBENZIL)-1H-PIRAZOLO[3,4-B]PIRIDIN-3-IL]-5-PIRIMIDINIL(METIL)CARBAMAT DEMETIL; NATIONAL AUTHORISATION NUMBER: EU/1/13/907; DATE OF NATIONAL AUTHORISATION: 20140327; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/13/907; DATE OF FIRST AUTHORISATION IN EEA: 20140327
1506193	S1400019	Hungary		PRODUCT NAME: RIOCIGUAT; REG. NO/DATE: EU/1/13/97 20140327