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 three patents protecting this compound. Additional information is available in the individual branded drug profile pages.Iptacopan hydrochloride has fifty-seven patent family members in thirty-eight countries.
One supplier is listed for this compound.
Summary for iptacopan hydrochloride
International Patents: | 57 |
US Patents: | 3 |
Tradenames: | 1 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 1 |
Clinical Trials: | 12 |
Patent Applications: | 8 |
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 | ⤷ Sign Up | ⤷ Sign Up | Y | Y | ⤷ Sign Up | ||
Novartis | FABHALTA | iptacopan hydrochloride | CAPSULE;ORAL | 218276-001 | Dec 5, 2023 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Novartis | FABHALTA | iptacopan hydrochloride | CAPSULE;ORAL | 218276-001 | Dec 5, 2023 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Novartis | FABHALTA | iptacopan hydrochloride | CAPSULE;ORAL | 218276-001 | Dec 5, 2023 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Novartis | FABHALTA | iptacopan hydrochloride | CAPSULE;ORAL | 218276-001 | Dec 5, 2023 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | 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 iptacopan hydrochloride
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
New Zealand | 754317 | Piperidinyl indole derivatives and their use as complement factor b inhibitors | ⤷ Sign Up |
Guatemala | 201600007 | DERIVADOS DE PIPERIDINIL-INDOL COMO INHIBIDORES DEL FACTOR DE COMPLEMENTO B Y USOS DE LOS MISMOS | ⤷ Sign Up |
Spain | 2655855 | ⤷ Sign Up | |
Slovenia | 3022192 | ⤷ Sign Up | |
Malaysia | 187454 | PIPERIDINYL INDOLE DERIVATIVES AND THEIR USE AS COMPLEMENT FACTOR B INHIBITORS | ⤷ Sign Up |
World Intellectual Property Organization (WIPO) | 2021234544 | ⤷ Sign Up | |
Canada | 2917839 | DERIVES DE PIPERIDINYL-INDOLE ET LEUR UTILISATION EN TANT QU'INHIBITEURS DU FACTEUR B DU COMPLEMENT (PIPERIDINYL INDOLE DERIVATIVES AND THEIR USE AS COMPLEMENT FACTOR B INHIBITORS) | ⤷ Sign Up |
>Country | >Patent Number | >Title | >Estimated Expiration |