Last Updated: July 18, 2026

IPTACOPAN HYDROCHLORIDE - Generic Drug Details

Name: IPTACOPAN HYDROCHLORIDE Generic Launch, Drug Patent, and Exclusivity Dataset
Creator: DrugPatentWatch
License: https://www.drugpatentwatch.com/terms.php

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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 eight patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Iptacopan hydrochloride has one hundred and twenty-three patent family members in forty-three countries.

One supplier is listed for this compound.

Summary for IPTACOPAN HYDROCHLORIDE

International Patents:	123
US Patents:	8
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Clinical Trials:	20
Patent Applications:	18
DailyMed Link:	IPTACOPAN HYDROCHLORIDE at DailyMed

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

Generic Entry Date for IPTACOPAN HYDROCHLORIDE^: ⤷ Start Trial* Constraining patent/regulatory exclusivity: 11,603,363 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
Peking University People's Hospital	NA
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology	NA
Fujian Medical University Union Hospital	NA

See all IPTACOPAN HYDROCHLORIDE clinical trials

Pharmacology for IPTACOPAN HYDROCHLORIDE

Drug Class	Complement Factor B Inhibitor
Mechanism of Action	Complement Factor B Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for IPTACOPAN HYDROCHLORIDE

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

US Patents and Regulatory Information for IPTACOPAN HYDROCHLORIDE

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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	11,603,363	⤷ Start Trial	Y	Y		⤷ Start Trial
Novartis	FABHALTA	iptacopan hydrochloride	CAPSULE;ORAL	218276-001	Dec 5, 2023		RX	Yes	Yes	⤷ Start Trial	⤷ Start Trial				⤷ Start Trial
Novartis	FABHALTA	iptacopan hydrochloride	CAPSULE;ORAL	218276-001	Dec 5, 2023		RX	Yes	Yes	10,093,663	⤷ Start Trial				⤷ Start 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

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Country	Patent Number	Title	Estimated Expiration
Argentina	096904		⤷ Start Trial
Argentina	132461		⤷ Start Trial
Australia	2014290298		⤷ Start Trial
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for IPTACOPAN HYDROCHLORIDE

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
3022192	C20240032	Finland	⤷ Start Trial
3022192	2490029-2	Sweden	⤷ Start Trial	PRODUCT NAME: IPTACOPAN OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REG. NO/DATE: EU/1/24/1802 20240521
3022192	LUC00358	Luxembourg	⤷ Start Trial	PRODUCT NAME: IPTACOPAN OU UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; AUTHORISATION NUMBER AND DATE: EU/1/24/1802 20240521
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.