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Last Updated: May 29, 2024

Macitentan - Generic Drug Details


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What are the generic 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, Zydus, and Actelion, and is included in five 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 four tentative approvals for this compound.

Summary for macitentan
Recent Clinical Trials for macitentan

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

SponsorPhase
Janssen, LPPhase 4
American Heart AssociationPhase 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 Up10MGTABLET; ORAL
⤷  Sign Up⤷  Sign Up10MGTABLET; ORAL
⤷  Sign Up⤷  Sign Up10MGTABLET;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
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

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Actelion OPSUMIT macitentan TABLET;ORAL 204410-001 Oct 18, 2013 AB RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y Y ⤷  Sign Up
Actelion OPSUMIT macitentan TABLET;ORAL 204410-001 Oct 18, 2013 AB RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Actelion OPSUMIT macitentan TABLET;ORAL 204410-001 Oct 18, 2013 AB RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Apotex MACITENTAN macitentan TABLET;ORAL 211195-001 Jan 9, 2024 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Actelion OPSUMIT macitentan TABLET;ORAL 204410-001 Oct 18, 2013 AB RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Actelion OPSUMIT macitentan TABLET;ORAL 204410-001 Oct 18, 2013 AB RX Yes Yes ⤷  Sign Up ⤷  Sign Up 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

EU/EMA Drug Approvals for macitentan

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

Country Patent Number Title Estimated Expiration
Israel 190072 תכשיר רוקחות יציב המכיל פירימידין-סולפאמיד ושימוש בו להכנת תרופה ביתר לחץ דם ריאתי עורקי (Stable pharmaceutical composition comprising a pyrimidine sulfamide and its use in the preparation of a medicament for treatment of pulmonary arterial hypertension) ⤷  Sign Up
China 101262847 Stable pharmaceutical composition comprising a pyrimidine-sulfamide ⤷  Sign Up
Brazil PI0116237 "composto de sulfamida, composição farmacêutica contendo o mesmo e seu uso como medicamento antagonista de receptor de endotelina". ⤷  Sign Up
Hungary 229403 NOVEL SULFAMIDES AND THEIR USE AS ENDOTHELIN RECEPTOR ANTAGONISTS ⤷  Sign Up
Norway 20091254 ⤷  Sign Up
Japan 2004517855 ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for macitentan

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1345920 300672 Netherlands ⤷  Sign Up PRODUCT NAME: MACITENTAN, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT; REGISTRATION NO/DATE: EU/1/13/893/001-003 20131220
1345920 14C0017 France ⤷  Sign Up PRODUCT NAME: MACITENTAN ET SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE: EU/1/13/893 20131220
1345920 2014/018 Ireland ⤷  Sign Up PRODUCT NAME: MACITENTAN, THE STEREOISOMERS AND THE PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF.; REGISTRATION NO/DATE: EU/1/13/893 20131220
1345920 CA 2014 00012 Denmark ⤷  Sign Up PRODUCT NAME: MACITENTAN OG FARMACEUTISK ACCEPTABLE SALTE HERAF; REG. 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 SPC/GB14/018 United Kingdom ⤷  Sign Up PRODUCT NAME: MACITENTAN, WHICH IS N-(5-(4-BROMOPHENYL)-6-(2((5-BROMOPYRIMIDIN-2-YL)OXY)ETHOXY)PYRIMIDIN-4-YL)-N'-PROPYLSULFURIC DIAMIDE; REGISTERED: UK EU/1/13/893 20131220
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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