Details for New Drug Application (NDA): 204819

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NDA 204819 describes ADEMPAS, which is a drug marketed by Bayer Hlthcare and is included in one NDA. It is available from one supplier. There are three patents protecting this drug and one Paragraph IV challenge. Additional details are available on the ADEMPAS profile page.

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.

Summary for 204819

Tradename:	ADEMPAS
Applicant:	Bayer Hlthcare
Ingredient:	riociguat
Patents:	3

Pharmacology for NDA: 204819

Mechanism of Action	Guanylate Cyclase Stimulators

Suppliers and Packaging for NDA: 204819

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
ADEMPAS	riociguat	TABLET;ORAL	204819	NDA	Bayer HealthCare Pharmaceuticals Inc.	50419-250	50419-250-01	90 TABLET, FILM COATED in 1 BOTTLE (50419-250-01)
ADEMPAS	riociguat	TABLET;ORAL	204819	NDA	Bayer HealthCare Pharmaceuticals Inc.	50419-250	50419-250-03	2 BLISTER PACK in 1 PACKAGE (50419-250-03) / 21 TABLET, FILM COATED in 1 BLISTER PACK

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	0.5MG
Approval Date:	Oct 8, 2013	TE:	AB	RLD:	Yes
Patent:	⤷ Sign Up	Patent Expiration:	Feb 18, 2034	Product Flag?	Y	Substance Flag?	Y	Delist Request?
Patented Use:	TREATMENT OF ADULTS WITH PERSISTENT/RECURRENT CHRONIC THROMBOEMBOLIC PULMONARY HYPERTENSION (CTEPH), (WHO GROUP 4) AFTER SURGICAL TREATMENT, OR INOPERABLE CTEPH, TO IMPROVE EXERCISE CAPACITY AND WHO FUNCTIONAL CLASS
Patent:	⤷ Sign Up	Patent Expiration:	Feb 18, 2034	Product Flag?	Y	Substance Flag?	Y	Delist Request?
Patented Use:	TREATMENT OF ADULTS WITH PULMONARY HYPERTENSION (PAH), (WHO GROUP 1), TO IMPROVE EXERCISE CAPACITY, WHO FUNCTIONAL CLASS AND TO DELAY CLINICAL WORSENING
Patent:	⤷ Sign Up	Patent Expiration:	Feb 18, 2034	Product Flag?	Y	Substance Flag?	Y	Delist Request?
Patented Use:	TREATMENT OF ADULTS WITH PERSISTENT/RECURRENT CHRONIC THROMBOEMBOLIC PULMONARY HYPERTENSION (CTEPH), (WHO GROUP 4) AFTER SURGICAL TREATMENT, OR INOPERABLE CTEPH, TO IMPROVE EXERCISE CAPACITY AND WHO FUNCTIONAL CLASS

Expired US Patents for NDA 204819

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Bayer Hlthcare	ADEMPAS	riociguat	TABLET;ORAL	204819-004	Oct 8, 2013	⤷ Sign Up	⤷ Sign Up
Bayer Hlthcare	ADEMPAS	riociguat	TABLET;ORAL	204819-001	Oct 8, 2013	⤷ Sign Up	⤷ Sign Up
Bayer Hlthcare	ADEMPAS	riociguat	TABLET;ORAL	204819-005	Oct 8, 2013	⤷ Sign Up	⤷ Sign Up
Bayer Hlthcare	ADEMPAS	riociguat	TABLET;ORAL	204819-003	Oct 8, 2013	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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