Iptacopan hydrochloride - Generic Drug Details
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What are the generic sources for iptacopan hydrochloride and what is the scope of freedom to operate?
Iptacopan hydrochloride
is the generic ingredient in one branded drug marketed by Novartis and is included in one NDA. There are two patents protecting this compound. Additional information is available in the individual branded drug profile pages.Iptacopan hydrochloride has fifty-six patent family members in thirty-eight countries.
One supplier is listed for this compound.
Summary for iptacopan hydrochloride
| International Patents: | 56 |
| US Patents: | 2 |
| Tradenames: | 1 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Clinical Trials: | 12 |
| DailyMed Link: | iptacopan hydrochloride at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for iptacopan hydrochloride
Generic Entry Date for iptacopan hydrochloride*:
Constraining patent/regulatory exclusivity:
TREATMENT OF ADULTS WITH PAROXYSMAL NOCTURNAL HEMOGLOBINURIA (PNH) Dosage:
CAPSULE;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 iptacopan hydrochloride
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Novartis Pharmaceuticals | Phase 2 |
| Novartis Pharmaceuticals | Phase 1 |
| Novartis Pharmaceuticals | Phase 3 |
Anatomical Therapeutic Chemical (ATC) Classes for iptacopan hydrochloride
US Patents and Regulatory Information for iptacopan hydrochloride
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Novartis | FABHALTA | iptacopan hydrochloride | CAPSULE;ORAL | 218276-001 | Dec 5, 2023 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | Y | ⤷ Try a Trial | ||
| Novartis | FABHALTA | iptacopan hydrochloride | CAPSULE;ORAL | 218276-001 | Dec 5, 2023 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Novartis | FABHALTA | iptacopan hydrochloride | CAPSULE;ORAL | 218276-001 | Dec 5, 2023 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Novartis | FABHALTA | iptacopan hydrochloride | CAPSULE;ORAL | 218276-001 | Dec 5, 2023 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | Y | ⤷ Try a Trial | ||
| >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 iptacopan hydrochloride
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Australia | 2014290298 | Piperidinyl indole derivatives and their use as complement factor B inhibitors | ⤷ Try a Trial |
| Hong Kong | 1221217 | 哌啶基吲哚衍生物和它們作為補體因子 抑制劑的用途 (PIPERIDINYL INDOLE DERIVATIVES AND THEIR USE AS COMPLEMENT FACTOR INHIBITORS) | ⤷ Try a Trial |
| South Korea | 102242742 | ⤷ Try a Trial | |
| El Salvador | 2016005137 | DERIVADOS DE PIPERIDINIL-INDOL COMO INHIBIDORES DEL FACTOR DE COMPLEMENTO B Y USOS DE LOS MISMOS | ⤷ Try a Trial |
| Singapore | 11201600086P | PIPERIDINYL INDOLE DERIVATIVES AND THEIR USE AS COMPLEMENT FACTOR B INHIBITORS | ⤷ Try a Trial |
| >Country | >Patent Number | >Title | >Estimated Expiration |
