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Last Updated: January 30, 2023

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 two branded drugs marketed by Zydus and Actelion, and is included in two 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 two 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
See Plans and PricingSee Plans and Pricing10MGTABLET; ORAL
See Plans and PricingSee Plans and Pricing10MGTABLET;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 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Zydus MACITENTAN macitentan TABLET;ORAL 211224-001 Apr 6, 2021 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Actelion OPSUMIT macitentan TABLET;ORAL 204410-001 Oct 18, 2013 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Actelion OPSUMIT macitentan TABLET;ORAL 204410-001 Oct 18, 2013 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Actelion OPSUMIT macitentan TABLET;ORAL 204410-001 Oct 18, 2013 RX Yes Yes See Plans and Pricing See Plans and Pricing Y Y See Plans and Pricing
>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
Russian Federation 2462249 ТЕРАПЕВТИЧЕСКИЕ КОМПОЗИЦИИ, СОДЕРЖАЩИЕ СПЕЦИФИЧЕСКИЙ АНТАГОНИСТ РЕЦЕПТОРА ЭНДОТЕЛИНА И ИНГИБИТОР PDE5 (THERAPEUTIC COMPOSITIONS CONTAINING SPECIFIC ENDOTHELIN RECEPTOR ANTAGONIST AND PDE5 INHIBITOR) See Plans and Pricing
Croatia P20120957 See Plans and Pricing
South Africa 200303695 Novel sulfamides and their use as endothelin receptor antagonists. See Plans and Pricing
Brazil PI0715698 produto, composiÇço farmacÊutica que o contÉm e uso de composto See Plans and Pricing
South Korea 20080055897 STABLE PHARMACEUTICAL COMPOSITION COMPRISING A PYRIMIDINE-SULFAMIDE See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for macitentan

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1345920 132014902244514 Italy See Plans and Pricing PRODUCT NAME: MACITENTAN(OPSUMIT); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/13/893/001-002, 20131220
1345920 C300672 Netherlands See Plans and Pricing PRODUCT NAME: MACITENTAN, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT; REGISTRATION NO/DATE: EU/1/13/893/001-003 20131220
1345920 CA 2014 00012 Denmark See Plans and Pricing PRODUCT NAME: MACITENTAN OG FARMACEUTISK ACCEPTABLE SALTE HERAF; REG. NO/DATE: EU/1/13/893 20131220
1345920 2014/018 Ireland See Plans and Pricing PRODUCT NAME: MACITENTAN, THE STEREOISOMERS AND THE PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF.; REGISTRATION NO/DATE: EU/1/13/893 20131220
1345920 300672 Netherlands See Plans and Pricing PRODUCT NAME: MACITENTAN, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT; REGISTRATION NO/DATE: EU/1/13/893/001-003 20131220
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

McKinsey
McKesson
Boehringer Ingelheim
Express Scripts
Harvard Business School
Colorcon

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