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Last Updated: March 19, 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 two branded drugs marketed by Apotex, Aurobindo Pharma Ltd, Zydus, and Actelion, and is included in four 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
⤷  Try a Trial⤷  Try a Trial10MGTABLET; ORAL
⤷  Try a Trial⤷  Try a Trial10MGTABLET; ORAL
⤷  Try a Trial⤷  Try a Trial10MGTABLET;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 ⤷  Try a Trial ⤷  Try a Trial Y Y ⤷  Try a Trial
Aurobindo Pharma Ltd MACITENTAN macitentan TABLET;ORAL 211198-001 Apr 18, 2023 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Apotex MACITENTAN macitentan TABLET;ORAL 211195-001 Jan 9, 2024 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Actelion OPSUMIT macitentan TABLET;ORAL 204410-001 Oct 18, 2013 AB RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
>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

Supplementary Protection Certificates for macitentan

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1345920 502 Finland ⤷  Try a Trial
1345920 122014000056 Germany ⤷  Try a Trial PRODUCT NAME: MACITENTAN; REGISTRATION NO/DATE: EU/1/13/893/001-003 20131220
1345920 300672 Netherlands ⤷  Try a Trial PRODUCT NAME: MACITENTAN, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT; REGISTRATION NO/DATE: EU/1/13/893/001-003 20131220
1345920 CR 2014 00012 Denmark ⤷  Try a Trial PRODUCT NAME: MACITENTAN OG FARMACEUTISK ACCEPTABLE SALTE HERAF; REG. NO/DATE: EU/1/13/893 20131227
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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