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FABHALTA Drug Patent Profile

Which patents cover Fabhalta, and when can generic versions of Fabhalta launch?

Fabhalta is a drug marketed by Novartis and is included in one NDA. There are two patents protecting this drug.

This drug has fifty-six patent family members in thirty-eight countries.

The generic ingredient in FABHALTA is iptacopan hydrochloride. One supplier is listed for this compound. Additional details are available on the iptacopan hydrochloride profile page.

DrugPatentWatch^® Generic Entry Outlook for Fabhalta

Fabhalta will be eligible for patent challenges on December 5, 2027. This date may extended up to six months if a pediatric exclusivity extension is applied to the drug's patents.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be December 5, 2030. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for FABHALTA

International Patents:	56
US Patents:	2
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Drug Prices:	Drug price information for FABHALTA
What excipients (inactive ingredients) are in FABHALTA?	FABHALTA excipients list
DailyMed Link:	FABHALTA at DailyMed

See drug prices for FABHALTA

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for FABHALTA

Constraining patent/regulatory exclusivity:

TREATMENT OF ADULTS WITH PAROXYSMAL NOCTURNAL HEMOGLOBINURIA (PNH)

NDA:

218276

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.

Anatomical Therapeutic Chemical (ATC) Classes for FABHALTA

L04AJ	Complement inhibitors
L04A	IMMUNOSUPPRESSANTS
L04	IMMUNOSUPPRESSANTS
L	Antineoplastic and immunomodulating agents

US Patents and Regulatory Information for FABHALTA

FABHALTA is protected by two US patents and two FDA Regulatory Exclusivities.

This potential generic entry date is based on TREATMENT OF ADULTS WITH PAROXYSMAL NOCTURNAL HEMOGLOBINURIA (PNH).

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Patents protecting FABHALTA

FDA Regulatory Exclusivity protecting FABHALTA

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			Y	Y
Novartis	FABHALTA	iptacopan hydrochloride	CAPSULE;ORAL	218276-001	Dec 5, 2023		RX	Yes	Yes
Novartis	FABHALTA	iptacopan hydrochloride	CAPSULE;ORAL	218276-001	Dec 5, 2023		RX	Yes	Yes			Y	Y
Novartis	FABHALTA	iptacopan hydrochloride	CAPSULE;ORAL	218276-001	Dec 5, 2023		RX	Yes	Yes

International Patents for FABHALTA

See the table below for patents covering FABHALTA around the world.

Country	Patent Number	Title	Estimated Expiration
Australia	2014290298	Piperidinyl indole derivatives and their use as complement factor B inhibitors
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)
South Korea	102242742
El Salvador	2016005137	DERIVADOS DE PIPERIDINIL-INDOL COMO INHIBIDORES DEL FACTOR DE COMPLEMENTO B Y USOS DE LOS MISMOS
Singapore	11201600086P	PIPERIDINYL INDOLE DERIVATIVES AND THEIR USE AS COMPLEMENT FACTOR B INHIBITORS
Cuba	20160006	DERIVADOS DE PIPERIDINIL-INDOL COMO INHIBIDORES DE FACTOR DE COMPLEMENTO B