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FABHALTA Drug Patent Profile

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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 five patents protecting this drug.

This drug has eighty-five patent family members in thirty-nine 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

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Summary for FABHALTA

International Patents:	85
US Patents:	5
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

Drug patent expirations by year for FABHALTA

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

Generic Entry Date for FABHALTA^: ⤷ Sign Up* 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.

US Patents and Regulatory Information for FABHALTA

FABHALTA is protected by five US patents and three FDA Regulatory Exclusivities.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of FABHALTA is ⤷ Sign Up.

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

Piperidinyl-indole derivatives complement factor B inhibitors and uses thereof
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF PRIMARY IMMUNOGLOBULIN A NEPHROPATHY (IGAN)

Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up

Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF PRIMARY IMMUNOGLOBULIN A NEPHROPATHY (IGAN)

Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF PAROXYSMAL NOCTURNAL HEMOGLOBINURIA (PNH) BY ADMINISTRATION OF 200 MG OF IPTACOPAN TWICE DAILY

Piperidinyl-indole derivatives complement factor B inhibitors and uses thereof
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up

FDA Regulatory Exclusivity protecting FABHALTA

NEW CHEMICAL ENTITY
Exclusivity Expiration: ⤷ Sign Up

TREATMENT OF ADULTS WITH PAROXYSMAL NOCTURNAL HEMOGLOBINURIA (PNH)
Exclusivity Expiration: ⤷ Sign Up

FOR THE REDUCTION OF PROTEINURIA IN ADULTS WITH PRIMARY IMMUNOGLOBULIN A NEPHROPATHY (IGAN) AT RISK OF RAPID DISEASE PROGRESSION, GENERALLY A URINE PROTEIN-TO-CREATININE RATIO (UPCR)>/= 1.5 G/G
Exclusivity Expiration: ⤷ Sign Up

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Glossary

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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				⤷ 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 FABHALTA

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

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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
>Country	>Patent Number	>Title	>Estimated Expiration