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Last Updated: July 10, 2020

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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 is one patent 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:1
Generic Entry Opportunity Date for 204819
Generic Entry Date for 204819*:
Constraining patent/regulatory exclusivity:
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 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
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
Paragraph IV (Patent) Challenges for 204819
Tradename Dosage Ingredient NDA Submissiondate
ADEMPAS TABLET;ORAL riociguat 204819 2017-10-10

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength0.5MG
Approval Date:Oct 8, 2013TE:RLD:Yes
Regulatory Exclusivity Expiration:Oct 8, 2020
Regulatory Exclusivity Use:TREATMENT OF ADULTS WITH PULMONARY ARTERIAL HYPERTENSION (PAH) WHO GROUP 1, TO IMPROVE EXERCISE CAPACITY, WHO FUNCTIONAL CLASS AND TO DELAY CLINICAL WORSENING.
Patent:  Start TrialPatent Expiration:Dec 4, 2026Product Flag?YSubstance Flag?YDelist Request?

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength1MG
Approval Date:Oct 8, 2013TE:RLD:Yes
Regulatory Exclusivity Expiration:Oct 8, 2020
Regulatory Exclusivity Use:TREATMENT OF ADULTS WITH PULMONARY ARTERIAL HYPERTENSION (PAH) WHO GROUP 1, TO IMPROVE EXERCISE CAPACITY, WHO FUNCTIONAL CLASS AND TO DELAY CLINICAL WORSENING.

Expired US Patents for NDA 204819

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Bayer Hlthcare ADEMPAS riociguat TABLET;ORAL 204819-001 Oct 8, 2013   Start Trial   Start Trial
Bayer Hlthcare ADEMPAS riociguat TABLET;ORAL 204819-005 Oct 8, 2013   Start Trial   Start Trial
Bayer Hlthcare ADEMPAS riociguat TABLET;ORAL 204819-002 Oct 8, 2013   Start Trial   Start Trial
Bayer Hlthcare ADEMPAS riociguat TABLET;ORAL 204819-003 Oct 8, 2013   Start Trial   Start Trial
Bayer Hlthcare ADEMPAS riociguat TABLET;ORAL 204819-004 Oct 8, 2013   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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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 verification 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.