DANICOPAN - Generic Drug Details
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What are the generic sources for danicopan and what is the scope of freedom to operate?
Danicopan
is the generic ingredient in one branded drug marketed by Alexion Pharms Inc and is included in one NDA. There are two patents protecting this compound. Additional information is available in the individual branded drug profile pages.Danicopan has one hundred and seven patent family members in twenty-four countries.
One supplier is listed for this compound.
Summary for DANICOPAN
| International Patents: | 107 |
| US Patents: | 2 |
| Tradenames: | 1 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Clinical Trials: | 24 |
| Patent Applications: | 40 |
| What excipients (inactive ingredients) are in DANICOPAN? | DANICOPAN excipients list |
| DailyMed Link: | DANICOPAN at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for DANICOPAN
Generic Entry Date for DANICOPAN*:
Constraining patent/regulatory exclusivity:
TREATMENT OF EXTRAVASCULAR HEMOLYSIS (EVH) IN ADULTS WITH PAROXYSMAL NOCTURNAL HEMOGLOBINURIA (PNH) 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 DANICOPAN
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| National Institute of Allergy and Infectious Diseases (NIAID) | Phase 2 |
| Alexion Pharmaceuticals | Phase 3 |
| Celerion | Phase 1 |
Anatomical Therapeutic Chemical (ATC) Classes for DANICOPAN
US Patents and Regulatory Information for DANICOPAN
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Alexion Pharms Inc | VOYDEYA | danicopan | TABLET;ORAL | 218037-001 | Mar 29, 2024 | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Alexion Pharms Inc | VOYDEYA | danicopan | TABLET;ORAL | 218037-002 | Mar 29, 2024 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Alexion Pharms Inc | VOYDEYA | danicopan | TABLET;ORAL | 218037-001 | Mar 29, 2024 | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Alexion Pharms Inc | VOYDEYA | danicopan | TABLET;ORAL | 218037-001 | Mar 29, 2024 | RX | Yes | No | ⤷ 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 DANICOPAN
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Japan | 2018199714 | 補体媒介障害の治療のためのアリール化合物、ヘテロアリール化合物及び複素環式化合物 (ARYL, HETEROARYL AND HETEROCYCLIC COMPOUNDS FOR TREATMENT OF COMPLEMENT MEDIATED DISORDERS) | ⤷ Sign Up |
| Japan | 6537532 | ⤷ Sign Up | |
| Israel | 301427 | תרכובות אריל, הטרואריל והטרוציקליות לטיפול בהפרעות מתווכות משלימות (Aryl, heteroaryl, and heterocyclic compounds for treatment of complement mediated disorders) | ⤷ Sign Up |
| Mexico | 2016011037 | COMPUESTOS DE FOSFONATO PARA EL TRATAMIENTO DE TRASTORNOS MEDIADOS POR COMPLEMENTO. (PHOSPHONATE COMPOUNDS FOR TREATMENT OF COMPLEMENT MEDIATED DISORDERS.) | ⤷ Sign Up |
| >Country | >Patent Number | >Title | >Estimated Expiration |
