MACITENTAN; TADALAFIL - Generic Drug Details
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What are the generic sources for macitentan; tadalafil and what is the scope of freedom to operate?
Macitentan; tadalafil
is the generic ingredient in one branded drug marketed by Actelion and is included in one NDA. There are three patents protecting this compound. Additional information is available in the individual branded drug profile pages.Macitentan; tadalafil has ninety-four patent family members in thirty-two countries.
One supplier is listed for this compound.
Summary for MACITENTAN; TADALAFIL
International Patents: | 94 |
US Patents: | 3 |
Tradenames: | 1 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 1 |
Clinical Trials: | 8 |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for MACITENTAN; TADALAFIL |
DailyMed Link: | MACITENTAN; TADALAFIL at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for MACITENTAN; TADALAFIL
Generic Entry Date for MACITENTAN; TADALAFIL*:
Constraining patent/regulatory exclusivity:
CHRONIC TREATMENT OF ADULTS WITH PULMONARY ARTERIAL HYPERTENSION (PAH, WHO GROUP I AND WHO FUNCTIONAL CLASS (FC) II-III) Dosage:
TABLET;ORAL |
*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.
Recent Clinical Trials for MACITENTAN; TADALAFIL
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Janssen Research & Development, LLC | Phase 1 |
WorldCare Clinical | Phase 3 |
Almac Clinical Technologies | Phase 3 |
Pharmacology for MACITENTAN; TADALAFIL
Drug Class | Endothelin Receptor Antagonist Phosphodiesterase 5 Inhibitor |
Mechanism of Action | Endothelin Receptor Antagonists Phosphodiesterase 5 Inhibitors |
Anatomical Therapeutic Chemical (ATC) Classes for MACITENTAN; TADALAFIL
US Patents and Regulatory Information for MACITENTAN; TADALAFIL
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 | 218490-001 | Mar 22, 2024 | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Actelion | OPSYNVI | macitentan; tadalafil | TABLET;ORAL | 218490-001 | Mar 22, 2024 | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
Actelion | OPSYNVI | macitentan; tadalafil | TABLET;ORAL | 218490-002 | Mar 22, 2024 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Actelion | OPSYNVI | macitentan; tadalafil | TABLET;ORAL | 218490-001 | Mar 22, 2024 | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | Y | ⤷ Sign Up | ||
Actelion | OPSYNVI | macitentan; tadalafil | TABLET;ORAL | 218490-002 | Mar 22, 2024 | 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 |
International Patents for MACITENTAN; TADALAFIL
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Taiwan | I388556 | ⤷ Sign Up | |
European Patent Office | 1693372 | ⤷ Sign Up | |
Slovenia | 2059246 | ⤷ Sign Up | |
Portugal | 1345920 | ⤷ Sign Up | |
Russian Federation | 2424805 | СТАБИЛЬНЫЕ ФАРМАЦЕВТИЧЕСКИЕ КОМПОЗИЦИИ, ВКЛЮЧАЮЩИЕ ПИРИМИДИНСУЛЬФАМИД (STABLE PHARMACEUTICAL PYRIMIDINSULFAMIDE-INCLUDING COMPOSITIONS) | ⤷ Sign Up |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for MACITENTAN; TADALAFIL
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
1345920 | 1490025-2 | Sweden | ⤷ Sign Up | PRODUCT NAME: MACITENTAN; REG. NO/DATE: EU/1/13/893 20131220 |
1345920 | 92381 | Luxembourg | ⤷ Sign Up | PRODUCT NAME: MACITENTAN ET SES DERIVES PHARMACEUTIQUEMENT ACCEPTABLES(OPSUMIT) |
1345920 | 502 | Finland | ⤷ Sign Up | |
1345920 | C300672 | 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 | 2014/018 | Ireland | ⤷ Sign Up | PRODUCT NAME: MACITENTAN, THE STEREOISOMERS AND THE PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF.; REGISTRATION NO/DATE: EU/1/13/893 20131220 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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