Macitentan; tadalafil - Generic Drug Details

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What are the generic drug sources for macitentan; tadalafil and what is the scope of freedom to operate?

Macitentan; tadalafil is the generic ingredient in one branded drug marketed by Actelion and is included in one NDA. There are three patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Macitentan; tadalafil has ninety-four patent family members in thirty-two countries.

One supplier is listed for this compound.

Summary for macitentan; tadalafil

International Patents:	94
US Patents:	3
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Clinical Trials:	8
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for macitentan; tadalafil
DailyMed Link:	macitentan; tadalafil at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for macitentan; tadalafil

Generic Entry Date for macitentan; tadalafil^: ⤷ Sign Up* Constraining patent/regulatory exclusivity: CHRONIC TREATMENT OF ADULTS WITH PULMONARY ARTERIAL HYPERTENSION (PAH, WHO GROUP I AND WHO FUNCTIONAL CLASS (FC) II-III) 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.

Recent Clinical Trials for macitentan; tadalafil

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Janssen Research & Development, LLC	Phase 1
WorldCare Clinical	Phase 3
Almac Clinical Technologies	Phase 3

See all macitentan; tadalafil clinical trials

Pharmacology for macitentan; tadalafil

Drug Class	Endothelin Receptor Antagonist Phosphodiesterase 5 Inhibitor
Mechanism of Action	Endothelin Receptor Antagonists Phosphodiesterase 5 Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for macitentan; tadalafil

US Patents and Regulatory Information for macitentan; tadalafil

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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
Actelion	OPSYNVI	macitentan; tadalafil	TABLET;ORAL	218490-001	Mar 22, 2024		RX	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Actelion	OPSYNVI	macitentan; tadalafil	TABLET;ORAL	218490-002	Mar 22, 2024		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Actelion	OPSYNVI	macitentan; tadalafil	TABLET;ORAL	218490-002	Mar 22, 2024		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
Actelion	OPSYNVI	macitentan; tadalafil	TABLET;ORAL	218490-001	Mar 22, 2024		RX	Yes	No	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
Actelion	OPSYNVI	macitentan; tadalafil	TABLET;ORAL	218490-002	Mar 22, 2024		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ 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 macitentan; tadalafil

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Country	Patent Number	Title	Estimated Expiration
China	101511365	Therapeutic compositions comprising a specific endothelin receptor antagonist and a PDE5 inhibitor	⤷ Sign Up
World Intellectual Property Organization (WIPO)	02053557		⤷ Sign Up
Norway	20091254		⤷ Sign Up
Denmark	1928409		⤷ Sign Up
Brazil	PI0116237	"composto de sulfamida, composição farmacêutica contendo o mesmo e seu uso como medicamento antagonista de receptor de endotelina".	⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for macitentan; tadalafil

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1345920	CR 2014 00012	Denmark	⤷ Sign Up	PRODUCT NAME: MACITENTAN OG FARMACEUTISK ACCEPTABLE SALTE HERAF; REG. NO/DATE: EU/1/13/893 20131227
1345920	14C0017	France	⤷ Sign Up	PRODUCT NAME: MACITENTAN ET SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE: EU/1/13/893 20131220
1345920	132014902244514	Italy	⤷ Sign Up	PRODUCT NAME: MACITENTAN(OPSUMIT); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/13/893/001-002, 20131220
1345920	122014000056	Germany	⤷ Sign Up	PRODUCT NAME: MACITENTAN; REGISTRATION NO/DATE: EU/1/13/893/001-003 20131220
1345920	C01345920/01	Switzerland	⤷ Sign Up	PRODUCT NAME: MACITENTAN; REGISTRATION NO/DATE: SWISSMEDIC 61863 06.02.2014
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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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.