Iptacopan hydrochloride - Generic Drug Details
✉ Email this page to a colleague
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 five patents protecting this compound. Additional information is available in the individual branded drug profile pages.Iptacopan hydrochloride has eighty-five patent family members in thirty-nine countries.
One supplier is listed for this compound.
Summary for iptacopan hydrochloride
| International Patents: | 85 |
| US Patents: | 5 |
| Tradenames: | 1 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Clinical Trials: | 13 |
| 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 | ⤷ Sign Up | ||||
| Novartis | FABHALTA | iptacopan hydrochloride | CAPSULE;ORAL | 218276-001 | Dec 5, 2023 | 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 iptacopan hydrochloride
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| El Salvador | 2016005137 | DERIVADOS DE PIPERIDINIL-INDOL COMO INHIBIDORES DEL FACTOR DE COMPLEMENTO B Y USOS DE LOS MISMOS | ⤷ Sign Up |
| Russian Federation | 2020111788 | НОВЫЕ ВАРИАНТЫ ПРИМЕНЕНИЯ ПРОИЗВОДНЫХ ПИПЕРИДИНИЛИНДОЛА | ⤷ Sign Up |
| South Korea | 102497487 | ⤷ Sign Up | |
| Spain | 2655855 | ⤷ Sign Up | |
| Chile | 2020000483 | Nuevos usos de derivados de piperidinil-indol. | ⤷ Sign Up |
| Mexico | 2023010751 | NUEVOS USOS DE DERIVADOS DE PIPERIDINIL-INDOL. (NOVEL USES OF PIPERIDINYL-INDOLE DERIVATIVES.) | ⤷ Sign Up |
| >Country | >Patent Number | >Title | >Estimated Expiration |
