MACITENTAN - Generic Drug Details

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

Macitentan is the generic ingredient in three branded drugs marketed by Apotex, Aurobindo Pharma Ltd, Torrent, Zydus Lifesciences, and Actelion, and is included in six NDAs. There are five patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

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

There are ten drug master file entries for macitentan. One supplier is listed for this compound. There are three tentative approvals for this compound.

Summary for MACITENTAN

International Patents:	94
US Patents:	5
Tradenames:	3
Applicants:	5
NDAs:	6
Drug Master File Entries:	10
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	92
Clinical Trials:	57
Patent Applications:	876
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for MACITENTAN
What excipients (inactive ingredients) are in MACITENTAN?	MACITENTAN excipients list
DailyMed Link:	MACITENTAN at DailyMed

Recent Clinical Trials for MACITENTAN

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

Sponsor	Phase
American Heart Association	Phase 4
Janssen, LP	Phase 4
Janssen Pharmaceutical K.K.	Phase 3

See all MACITENTAN clinical trials

Generic filers with tentative approvals for MACITENTAN

Applicant	Application No.	Strength	Dosage Form
⤷ Sign Up	⤷ Sign Up	10MG	TABLET; ORAL
⤷ Sign Up	⤷ Sign Up	10MG	TABLET;ORAL
⤷ Sign Up	⤷ Sign Up	10MG	TABLET;ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for MACITENTAN

Drug Class	Endothelin Receptor Antagonist
Mechanism of Action	Endothelin Receptor Antagonists

Anatomical Therapeutic Chemical (ATC) Classes for MACITENTAN

C02KX	Antihypertensives for pulmonary arterial hypertension
C02K	OTHER ANTIHYPERTENSIVES
C02	ANTIHYPERTENSIVES
C	Cardiovascular system

Paragraph IV (Patent) Challenges for MACITENTAN

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
OPSUMIT	Tablets	macitentan	10 mg	204410	11	2017-10-18

US Patents and Regulatory Information for MACITENTAN

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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	Y			⤷ Sign Up
Actelion	OPSYNVI	macitentan; tadalafil	TABLET;ORAL	218490-002	Mar 22, 2024		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up	Y	Y		⤷ Sign Up
Actelion	OPSYNVI	macitentan; tadalafil	TABLET;ORAL	218490-002	Mar 22, 2024		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Zydus Lifesciences	MACITENTAN	macitentan	TABLET;ORAL	211224-001	Apr 6, 2021		DISCN	No	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	Y			⤷ Sign Up
Actelion	OPSYNVI	macitentan; tadalafil	TABLET;ORAL	218490-001	Mar 22, 2024		RX	Yes	No	⤷ 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

EU/EMA Drug Approvals for MACITENTAN

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Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Janssen-Cilag International N.V.	Opsumit	macitentan	EMEA/H/C/002697 Opsumit, as monotherapy or in combination, is indicated for the long-term treatment of pulmonary arterial hypertension (PAH) in adult patients of WHO Functional Class (FC) II to III.Efficacy has been shown in a PAH population including idiopathic and heritable PAH, PAH associated with connective tissue disorders, and PAH associated with corrected simple congenital heart disease.	Authorised	no	no	yes	2013-12-20
>Company	>Drugname	>Inn	>Product Number / Indication	>Status	>Generic	>Biosimilar	>Orphan	>Marketing Authorisation	>Marketing Refusal

International Patents for MACITENTAN

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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
Mexico	PA03004780	NUEVAS SULFAMIDAS. (NOVEL SULFAMIDES AND THEIR USE AS ENDOTHELIN RECEPTOR ANTAGONISTS.)	⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for MACITENTAN

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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
1345920	92381	Luxembourg	⤷ Sign Up	PRODUCT NAME: MACITENTAN ET SES DERIVES PHARMACEUTIQUEMENT ACCEPTABLES(OPSUMIT)
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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