Aprocitentan - Generic Drug Details
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What are the generic sources for aprocitentan and what is the scope of freedom to operate?
Aprocitentan
is the generic ingredient in one branded drug marketed by Idorsia and is included in one NDA. There are five patents protecting this compound. Additional information is available in the individual branded drug profile pages.Aprocitentan has seventy-five patent family members in thirty countries.
One supplier is listed for this compound.
Summary for aprocitentan
| International Patents: | 75 |
| US Patents: | 5 |
| Tradenames: | 1 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Clinical Trials: | 8 |
| Patent Applications: | 42 |
| What excipients (inactive ingredients) are in aprocitentan? | aprocitentan excipients list |
| DailyMed Link: | aprocitentan at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for aprocitentan
Generic Entry Date for aprocitentan*:
Constraining patent/regulatory exclusivity:
NEW CHEMICAL ENTITY 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 aprocitentan
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Actelion | Phase 1 |
| Idorsia Pharmaceuticals Ltd. | Phase 1 |
| Janssen Biotech, Inc. | Phase 1 |
Anatomical Therapeutic Chemical (ATC) Classes for aprocitentan
US Patents and Regulatory Information for aprocitentan
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Idorsia | TRYVIO | aprocitentan | TABLET;ORAL | 217686-001 | Mar 19, 2024 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | Y | ⤷ Sign Up | ||
| Idorsia | TRYVIO | aprocitentan | TABLET;ORAL | 217686-001 | Mar 19, 2024 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Idorsia | TRYVIO | aprocitentan | TABLET;ORAL | 217686-001 | Mar 19, 2024 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Idorsia | TRYVIO | aprocitentan | TABLET;ORAL | 217686-001 | Mar 19, 2024 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ 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 aprocitentan
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| New Zealand | 583990 | { 5-(4-bromo-phenyl)-6-[2-(5-bromo-pyrimidin-2-yloxy)-ethoxy]-pyrimidin-4-yl} -sulfamide and salts thereof | ⤷ Sign Up |
| Japan | 2020508338 | ４−ピリミジンスルファミド誘導体の結晶形 | ⤷ Sign Up |
| Japan | 2023027305 | ４－ピリミジンスルファミド誘導体の結晶形 | ⤷ Sign Up |
| Brazil | 112019017644 | forma cristalina de {5-(4-bromo-fenil)-6-[2-(5-bromo-pirimidina-2-iloxi)-etoxi]-pirimidina-4-il}-sulfamida, composição farmacêutica, uso de uma forma cristalina do composto {5-(4-bromo-fenil)-6-[2-(5-bromo-pirimidina-2-iloxi)-etoxi]-pirimidina-4-il}-sulfamida, e, método de tratamento | ⤷ Sign Up |
| >Country | >Patent Number | >Title | >Estimated Expiration |
