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Last Updated: July 16, 2024

Details for New Drug Application (NDA): 217686


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NDA 217686 describes TRYVIO, which is a drug marketed by Idorsia and is included in one NDA. It is available from one supplier. There are five patents protecting this drug. Additional details are available on the TRYVIO profile page.

The generic ingredient in TRYVIO is aprocitentan. One supplier is listed for this compound. Additional details are available on the aprocitentan profile page.
Summary for 217686
Tradename:TRYVIO
Applicant:Idorsia
Ingredient:aprocitentan
Patents:5
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 217686
Generic Entry Date for 217686*:
Constraining patent/regulatory exclusivity:
NEW CHEMICAL ENTITY
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.

Suppliers and Packaging for NDA: 217686
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TRYVIO aprocitentan TABLET;ORAL 217686 NDA Idorsia Pharmaceuticals Ltd 80491-8012 80491-8012-3 1 BOTTLE in 1 CARTON (80491-8012-3) / 30 TABLET, FILM COATED in 1 BOTTLE
TRYVIO aprocitentan TABLET;ORAL 217686 NDA Idorsia Pharmaceuticals Ltd 80491-8012 80491-8012-8 1 BLISTER PACK in 1 CARTON (80491-8012-8) / 10 TABLET, FILM COATED in 1 BLISTER PACK (80491-8012-7)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength12.5MG
Approval Date:Mar 19, 2024TE:RLD:Yes
Regulatory Exclusivity Expiration:Mar 22, 2029
Regulatory Exclusivity Use:NEW CHEMICAL ENTITY
Patent:⤷  Sign UpPatent Expiration:Feb 26, 2038Product Flag?YSubstance Flag?YDelist Request?
Patent:⤷  Sign UpPatent Expiration:Nov 6, 2037Product Flag?Substance Flag?Delist Request?
Patented Use:TREATMENT OF HYPERTENSION IN COMBINATION WITH OTHER ANTIHYPERTENSIVE DRUGS, INCLUDING AN ANGIOTENSIN RECEPTOR BLOCKER, TO LOWER BLOOD PRESSURE IN ADULT PATIENTS WHO ARE NOT ADEQUATELY CONTROLLED ON OTHER DRUGS

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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.