ADEMPAS Drug Patent Profile

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 three patents protecting this drug and one Paragraph IV challenge.

This drug has sixty-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.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Adempas

A generic version of ADEMPAS was approved as riociguat by MSN on September 1^st, 2022.

Summary for ADEMPAS

International Patents:	69
US Patents:	3
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	101
Clinical Trials:	15
Patent Applications:	784
Drug Prices:	Drug price information for ADEMPAS
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ADEMPAS
What excipients (inactive ingredients) are in ADEMPAS?	ADEMPAS excipients list
DailyMed Link:	ADEMPAS at DailyMed

See drug prices for ADEMPAS

Recent Clinical Trials for ADEMPAS

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

Sponsor	Phase
Danish Headache Center	N/A
Dr Sudarshan Rajagopal	Phase 3
Actelion	Phase 3

See all ADEMPAS clinical trials

Pharmacology for ADEMPAS

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

Anatomical Therapeutic Chemical (ATC) Classes for ADEMPAS

C02KX	Antihypertensives for pulmonary arterial hypertension
C02K	OTHER ANTIHYPERTENSIVES
C02	ANTIHYPERTENSIVES
C	Cardiovascular system

Paragraph IV (Patent) Challenges for ADEMPAS

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
ADEMPAS	Tablets	riociguat	0.5 mg, 1 mg, 1.5 mg, 2 mg and 2.5 mg	204819	3	2017-10-10

US Patents and Regulatory Information for ADEMPAS

ADEMPAS is protected by five US patents.

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

Expired US Patents for ADEMPAS

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	204819-004	Oct 8, 2013
Bayer Hlthcare	ADEMPAS	riociguat	TABLET;ORAL	204819-005	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

EU/EMA Drug Approvals for ADEMPAS

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Bayer AG	Adempas	riociguat	EMEA/H/C/002737 Chronic thromboembolic pulmonary hypertension (CTEPH)Adempas is indicated for the treatment of adult patients with WHO Functional Class (FC) II to III with- inoperable CTEPH,- persistent or recurrent CTEPH after surgical treatment,to improve exercise capacity (see section 5.1).Pulmonary arterial hypertension (PAH)Adempas, as monotherapy or in combination with endothelin receptor antagonists, is indicated for thetreatment of adult patients with pulmonary arterial hypertension (PAH) with WHO Functional Class(FC) II to III to improve exercise capacity.Efficacy has been shown in a PAH population including aetiologies of idiopathic or heritable PAH orPAH associated with connective tissue disease (see section 5.1).	Authorised	no	no	no	2014-03-27

International Patents for ADEMPAS

When does loss-of-exclusivity occur for ADEMPAS?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Australia

Brazil

Canada

Chile

China

Costa Rica

Cuba

Dominican Republic

Eurasian Patent Organization

European Patent Office

Hong Kong

Japan

Mexico

Morocco

Nicaragua

Peru

Philippines

Singapore

South Korea

Tunisia

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering ADEMPAS around the world.

Country	Patent Number	Title	Estimated Expiration
Indonesia	28240
Ecuador	SP045414	"PIRAZOLPIRIDINAS SUSTITUIDAS CON CARBAMATO"
Russian Federation	2004136277	ЗАМЕЩЕННЫЕ КАРБАМАТНЫМИ ГРУППАМИ ПИРАЗОЛОПИРИДИНЫ
Luxembourg	92419
South Korea	101011864
Nicaragua	201500110	FORMAS DEL METIL {4,6-DIAMINO-2-[1-(2-FLUOROBENCIL)-1h-PIRAZOLO [4,3-B] PIRIDINO-3-IL]PIRIMIDINO-5-IL} METIL CARBAMATO
Japan	2016509039	メチル｛４，６−ジアミノ−２−［１−（２−フルオロベンジル）−１Ｈ−ピラゾロ［３，４−Ｂ］ピリジノ−３−イル］ピリミジノ−５−イル｝メチルカルバメートの形態

Supplementary Protection Certificates for ADEMPAS

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1506193	132014902270282	Italy		PRODUCT NAME: RIOCIGUAT(ADEMPAS); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/13/907, 20140327
1506193	515	Finland
1506193	300659	Netherlands		PRODUCT NAME: RIOCIGUAT, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT OF HYDRAAT; REGISTRATION NO/DATE: EU/1/13/907 20140331
1506193	165 5014-2014	Slovakia		PRODUCT NAME: RIOCIGUAT; REGISTRATION NO/DATE: EU/1/13/907 20140327
1506193	C01506193/01	Switzerland		PRODUCT NAME: RIOCIGUAT; REGISTRATION NO/DATE: SWISSMEDIC 62903 21.11.2013
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	92419	Luxembourg		PRODUCT NAME: RIOCIGUAT ET SES DERIVES PHARMACEUTIQUEMENT ACCEPTABLES(ADEMPAS)