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Last Updated: October 25, 2021

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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 2/Phase 3
Assistance Publique - Hôpitaux de ParisPhase 2/Phase 3
Janssen Pharmaceutical K.K.Phase 1

See all macitentan clinical trials

Generic filers with tentative approvals for MACITENTAN
Applicant Application No. Strength Dosage Form
⤷  Try it Free⤷  Try it Free10MGTABLET; ORAL
⤷  Try it Free⤷  Try it Free10MGTABLET;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 NDA Submissiondate
OPSUMIT TABLET;ORAL macitentan 204410 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 ⤷  Try it Free ⤷  Try it Free Y ⤷  Try it Free
Actelion OPSUMIT macitentan TABLET;ORAL 204410-001 Oct 18, 2013 RX Yes Yes ⤷  Try it Free ⤷  Try it Free Y ⤷  Try it Free
Actelion OPSUMIT macitentan TABLET;ORAL 204410-001 Oct 18, 2013 RX Yes Yes ⤷  Try it Free ⤷  Try it Free Y ⤷  Try it Free
Actelion OPSUMIT macitentan TABLET;ORAL 204410-001 Oct 18, 2013 RX Yes Yes ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Actelion OPSUMIT macitentan TABLET;ORAL 204410-001 Oct 18, 2013 RX Yes Yes ⤷  Try it Free ⤷  Try it Free Y Y ⤷  Try it Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Supplementary Protection Certificates for macitentan

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1345920 14C0017 France ⤷  Try it Free PRODUCT NAME: MACITENTAN ET SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE: EU/1/13/893 20131220
1345920 C300672 Netherlands ⤷  Try it Free PRODUCT NAME: MACITENTAN, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT; REGISTRATION NO/DATE: EU/1/13/893/001-003 20131220
1345920 1490025-2 Sweden ⤷  Try it Free PRODUCT NAME: MACITENTAN; REG. NO/DATE: EU/1/13/893 20131220
1345920 92381 Luxembourg ⤷  Try it Free PRODUCT NAME: MACITENTAN ET SES DERIVES PHARMACEUTIQUEMENT ACCEPTABLES(OPSUMIT)
1345920 C01345920/01 Switzerland ⤷  Try it Free PRODUCT NAME: MACITENTAN; REGISTRATION NO/DATE: SWISSMEDIC 61863 06.02.2014
>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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