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 |
Generic filers with tentative approvals for MACITENTAN
Applicant | Application No. | Strength | Dosage Form |
⤷ Subscribe | ⤷ Subscribe | 10MG | TABLET; ORAL |
⤷ Subscribe | ⤷ Subscribe | 10MG | TABLET;ORAL |
⤷ Subscribe | ⤷ Subscribe | 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
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 | OPSYNVI | macitentan; tadalafil | TABLET;ORAL | 218490-002 | Mar 22, 2024 | RX | Yes | Yes | 10,946,015 | ⤷ Subscribe | Y | ⤷ Subscribe | |||
Actelion | OPSYNVI | macitentan; tadalafil | TABLET;ORAL | 218490-001 | Mar 22, 2024 | RX | Yes | No | ⤷ Subscribe | ⤷ Subscribe | ⤷ Subscribe | ||||
Zydus Lifesciences | MACITENTAN | macitentan | TABLET;ORAL | 211224-001 | Apr 6, 2021 | DISCN | No | No | ⤷ Subscribe | ⤷ Subscribe | ⤷ Subscribe | ||||
Actelion | OPSYNVI | macitentan; tadalafil | TABLET;ORAL | 218490-001 | Mar 22, 2024 | RX | Yes | No | ⤷ Subscribe | ⤷ Subscribe | ⤷ Subscribe | ||||
>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 |
---|---|---|---|
Morocco | 30704 | COMPOSITIONS THERAPEUTIQUES | ⤷ Subscribe |
Denmark | 2059246 | ⤷ Subscribe | |
Norway | 20032699 | ⤷ Subscribe | |
South Korea | 100819668 | ⤷ Subscribe | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for MACITENTAN
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
1345920 | SPC/GB14/018 | United Kingdom | ⤷ Subscribe | 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 |
1345920 | 14C0017 | France | ⤷ Subscribe | PRODUCT NAME: MACITENTAN ET SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE: EU/1/13/893 20131220 |
1345920 | 132014902244514 | Italy | ⤷ Subscribe | PRODUCT NAME: MACITENTAN(OPSUMIT); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/13/893/001-002, 20131220 |
1345920 | 1490025-2 | Sweden | ⤷ Subscribe | PRODUCT NAME: MACITENTAN; REG. NO/DATE: EU/1/13/893 20131220 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
MACITENTAN Market Analysis and Financial Projection Experimental
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