TRYVIO Drug Patent Profile

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Which patents cover Tryvio, and when can generic versions of Tryvio launch?

Tryvio is a drug marketed by Idorsia and is included in one NDA. There are five patents protecting this drug.

This drug has seventy-five patent family members in thirty countries.

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

DrugPatentWatch^® Generic Entry Outlook for Tryvio

Tryvio will be eligible for patent challenges on March 22, 2028. This date may extended up to six months if a pediatric exclusivity extension is applied to the drug's patents.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be March 22, 2029. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

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Summary for TRYVIO

International Patents:	75
US Patents:	5
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Patent Applications:	22
What excipients (inactive ingredients) are in TRYVIO?	TRYVIO excipients list
DailyMed Link:	TRYVIO at DailyMed

Drug patent expirations by year for TRYVIO

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for TRYVIO

Generic Entry Date for TRYVIO^: ⤷ Sign Up* Constraining patent/regulatory exclusivity: NEW CHEMICAL ENTITY NDA: 217686 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.

US Patents and Regulatory Information for TRYVIO

TRYVIO is protected by five US patents and one FDA Regulatory Exclusivity.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of TRYVIO is ⤷ Sign Up.

This potential generic entry date is based on NEW CHEMICAL ENTITY.
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Patents protecting TRYVIO

Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up

Combinations of a 4-pyrimidinesulfamide derivative with active ingredients for the treatment of endothelin related diseases
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
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

Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF HYPERTENSION IN COMBINATION WITH OTHER ANTIHYPERTENSIVE DRUGS, TO LOWER BLOOD PRESSURE IN ADULT PATIENTS WHO ARE NOT ADEQUATELY CONTROLLED ON OTHER DRUGS

Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF HYPERTENSION IN COMBINATION WITH OTHER ANTIHYPERTENSIVE DRUGS, INCLUDING AN ANGIOTENSIN CONVERTING ENZYME INHIBITOR, TO LOWER BLOOD PRESSURE IN ADULT PATIENTS WHO ARE NOT ADEQUATELY CONTROLLED ON OTHER DRUGS

4-pyrimidinesulfamide derivative
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF HYPERTENSION IN COMBINATION WITH OTHER ANTIHYPERTENSIVE DRUGS, TO LOWER BLOOD PRESSURE IN ADULT PATIENTS WHO ARE NOT ADEQUATELY CONTROLLED ON OTHER DRUGS

FDA Regulatory Exclusivity protecting TRYVIO

NEW CHEMICAL ENTITY
Exclusivity Expiration: ⤷ Sign Up

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Idorsia	TRYVIO	aprocitentan	TABLET;ORAL	217686-001	Mar 19, 2024		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Idorsia	TRYVIO	aprocitentan	TABLET;ORAL	217686-001	Mar 19, 2024		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up	Y	Y		⤷ Sign Up
Idorsia	TRYVIO	aprocitentan	TABLET;ORAL	217686-001	Mar 19, 2024		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Idorsia	TRYVIO	aprocitentan	TABLET;ORAL	217686-001	Mar 19, 2024		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Idorsia	TRYVIO	aprocitentan	TABLET;ORAL	217686-001	Mar 19, 2024		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Idorsia	TRYVIO	aprocitentan	TABLET;ORAL	217686-001	Mar 19, 2024		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up	Y	Y		⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

International Patents for TRYVIO

See the table below for patents covering TRYVIO around the world.

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Country	Patent Number	Title	Estimated Expiration
Morocco	49664	COMBINAISONS D'UN DÉRIVÉ DE 4-PYRIMIDINESULFAMIDE AVEC DES PRINCIPES ACTIFS POUR LE TRAITEMENT DE MALADIES LIÉES À L'ENDOTHÉLINE	⤷ Sign Up
Morocco	47596	FORMES CRISTALLINES DU DÉRIVÉ 4-PYRIMIDINESULFAMIDE APROCITENTAN	⤷ Sign Up
Russian Federation	2485116	ПРОИЗВОДНЫЕ 4-ПИРИМИДИНСУЛЬФАМИДА (4-PYRIMIDINESULPHAMIDE DERIVATIVE)	⤷ Sign Up
Cyprus	1113255		⤷ Sign Up
Hong Kong	1144196	4-PYRIMIDINESULFAMIDE DERIVATIVE 4-	⤷ Sign Up
Chile	2020001762	Formas cristalinas del derivado de 4-pirimidinsulfamida de aprocitentán. (divisional solicitud 201902464)	⤷ Sign Up
European Patent Office	3658140	COMBINAISONS D'UN DÉRIVÉ DE 4-PYRIMIDINESULFAMIDE AVEC DES PRINCIPES ACTIFS POUR LE TRAITEMENT DE MALADIES LIÉES À L'ENDOTHÉLINE (COMBINATIONS OF A 4-PYRIMIDINESULFAMIDE DERIVATIVE WITH ACTIVE INGREDIENTS FOR THE TREATMENT OF ENDOTHELIN RELATED DISEASES)	⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration