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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 two patents protecting this drug. Additional details are available on the ADEMPAS profile page.

The generic ingredient in ADEMPAS is riociguat. One supplier is listed for this compound. Additional details are available on the riociguat profile page.

Summary for NDA: 204819

Bayer Hlthcare

Pharmacology for NDA: 204819

Mechanism of ActionGuanylate Cyclase Stimulators

Suppliers and Packaging for NDA: 204819

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TABLET;ORAL 204819 NDA Bayer HealthCare Pharmaceuticals Inc. 50419-250 50419-250-01 90 TABLET, FILM COATED in 1 BOTTLE (50419-250-01)
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

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength0.5MG
Approval Date:Oct 8, 2013TE:RLD:No
Patent:6,743,798Patent Expiration:Jul 16, 2019Product Flag?YSubstance Flag?YDelist Request?
Patent:7,173,037Patent Expiration:Apr 25, 2023Product Flag?YSubstance Flag?YDelist Request?
Regulatory Exclusivity Expiration:Oct 8, 2018
Regulatory Exclusivity Use:NEW CHEMICAL ENTITY

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.