Generic Fabhalta Availability
Last updated on May 7, 2025.
Fabhalta is a brand name of iptacopan, approved by the FDA in the following formulation(s):
FABHALTA (iptacopan hydrochloride - capsule;oral)
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Manufacturer: NOVARTIS
Approval date: December 5, 2023
Strength(s): EQ 200MG BASE [RLD]
Is there a generic version of Fabhalta available?
No. There is currently no therapeutically equivalent version of Fabhalta available in the United States.
Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Fabhalta. These medications may be counterfeit and potentially unsafe. If you purchase medications online, be sure you are buying from a reputable and valid online pharmacy. Ask your health care provider for advice if you are unsure about the online purchase of any medication.
See also: Generic Drug FAQ.
Related patents
Patents are granted by the U.S. Patent and Trademark Office at any time during a drug's development and may include a wide range of claims.
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Piperidinyl-indole derivatives complement factor B inhibitors and uses thereof
Patent 10,093,663
Issued: October 9, 2018
Inventor(s): Adams Christopher Michael & Capparelli Michael Paul & Ehara Takeru & Karki Rajeshri Ganesh & Mainolfi Nello & Zhang Chun
Assignee(s): Novartis AGThe present invention provides a compound of formula I:
Patent expiration dates:
- July 14, 2034✓
- July 14, 2034✓
- July 14, 2034
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Crystalline form of LNP023
Patent 11,603,363
Issued: March 14, 2023
Inventor(s): Jia; Zichen et al.
Assignee(s): Novartis AG (Basel, CH)Described herein is a crystalline hydrate form of LNP023 hydrochloride and to a process for its preparation. Furthermore, described herein is a pharmaceutical composition comprising the crystalline hydrate form of LNP023 hydrochloride, and at least one pharmaceutically acceptable excipient. The pharmaceutical composition described herein can be used to treat a disease and disorder mediated by complement activation.
Patent expiration dates:
- May 25, 2041✓✓
- May 25, 2041
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Uses of piperidinyl-indole derivatives
Patent 11,723,901
Issued: August 15, 2023
Inventor(s): Eder; Jörg et al.
Assignee(s): Novartis AG (Basel, CH)The present invention relates to the novel use of certain piperidinyl-indole derivatives in the treatment of patients suffering from renal diseases or disorders, and in particular for the treatment of patients suffering from C3G (C3 glomerulopathy) and IgAN (IgA nephropathy).
Patent expiration dates:
- August 30, 2038✓
- August 30, 2038
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Methods of using factor B inhibitors
Patent 11,951,101
Issued: April 9, 2024
Inventor(s): Baltcheva; Irina et al.
Assignee(s): Novartis AG (Basel, CH)Described herein are methods of treating paroxysmal nocturnal hemoglobinuria (PNH) with the Factor B inhibitor LNP023 or a pharmaceutically acceptable salt thereof, e.g. LNP023 hydrochloride.
Patent expiration dates:
- July 15, 2041✓
- July 15, 2041
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Piperidinyl-indole derivatives complement factor B inhibitors and uses thereof
Patent 9,682,968
Issued: June 20, 2017
Inventor(s): Adams Christopher Michael & Capparelli Michael Paul & Ehara Takeru & Karki Rajeshri Ganesh & Mainolfi Nello & Zhang Chun
Assignee(s): Novartis AGThe present invention provides a compound of formula I: (I) a method for manufacturing the compounds of the invention, and its therapeutic uses as inhibitors of the complement alternative pathway, in particular of Factor B. The present invention further provides a combination of pharmacologically active agents and a pharmaceutical composition.
Patent expiration dates:
- July 14, 2034✓✓
- July 14, 2034
Related exclusivities
Exclusivity is exclusive marketing rights granted by the FDA upon approval of a drug and can run concurrently with a patent or not. Exclusivity is a statutory provision and is granted to an NDA applicant if statutory requirements are met.
Exclusivity expiration dates:
- August 7, 2027 - 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
- March 20, 2028 - TREATMENT OF ADULTS WITH COMPLEMENT 3 GLOMERULOPATHY (C3G), TO REDUCE PROTEINURIA
- December 5, 2028 - NEW CHEMICAL ENTITY
- December 5, 2030 - TREATMENT OF ADULTS WITH PAROXYSMAL NOCTURNAL HEMOGLOBINURIA (PNH)
More about Fabhalta (iptacopan)
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- Drug class: selective immunosuppressants
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Glossary
| Term | Definition |
|---|---|
| Drug Patent | A drug patent is assigned by the U.S. Patent and Trademark Office and assigns exclusive legal right to the patent holder to protect the proprietary chemical formulation. The patent assigns exclusive legal right to the inventor or patent holder, and may include entities such as the drug brand name, trademark, product dosage form, ingredient formulation, or manufacturing process A patent usually expires 20 years from the date of filing, but can be variable based on many factors, including development of new formulations of the original chemical, and patent infringement litigation. |
| Drug Exclusivity | Exclusivity is the sole marketing rights granted by the FDA to a manufacturer upon the approval of a drug and may run simultaneously with a patent. Exclusivity periods can run from 180 days to seven years depending upon the circumstance of the exclusivity grant. |
| RLD | A Reference Listed Drug (RLD) is an approved drug product to which new generic versions are compared to show that they are bioequivalent. A drug company seeking approval to market a generic equivalent must refer to the Reference Listed Drug in its Abbreviated New Drug Application (ANDA). By designating a single reference listed drug as the standard to which all generic versions must be shown to be bioequivalent, FDA hopes to avoid possible significant variations among generic drugs and their brand name counterpart. |
Further information
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
