Fabhalta is a drug owned by Novartis Pharmaceuticals Corp. It is protected by 5 US drug patents filed from 2023 to 2024 out of which none have expired yet. Fabhalta's patents will be open to challenges from 06 December, 2027. Based on its patents and exclusivities, its generic launch date is estimated to be Jul 15, 2041. Details of Fabhalta's patents and their expiration are given in the table below.
| Drug Patent Number | Drug Patent Title | Drug Patent Expiry | Status |
|---|---|---|---|
| These drug patents protect the active ingredient(API) of the drug. Only drug patent owner can launch products that use this active ingredient until these patents expire. | |||
| US11603363 | Crystalline form of LNP023 |
May, 2041
(16 years from now) | Active |
| US9682968 | Piperidinyl-indole derivatives complement factor B inhibitors and uses thereof |
Jul, 2034
(9 years from now) | Active |
| These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| US11951101 | Methods of using factor B inhibitors |
Jul, 2041
(16 years from now) | Active |
| US11723901 | Uses of piperidinyl-indole derivatives |
Aug, 2038
(13 years from now) | Active |
| US10093663 | Piperidinyl-indole derivatives complement factor B inhibitors and uses thereof |
Jul, 2034
(9 years from now) | Active |
A patent's expiry date may change depending upon legal activities going on that patent. Critical activities like abandoning of a patent, term extension of a patent or amendment of its claims can increase or decrease the life of a patent hence affecting its expiry date and in turn affecting the generic launch date of that drug. Tracking these ongoing activities on a patent application helps to keep an eye on the latest developments in the patent process of the drug which can give an idea of how early a drug's generic could be available. The next section provides a list of recent legal activities on Fabhalta's patents.
Latest Legal Activities on Fabhalta's Patents
Given below is the list of recent legal activities going on the following patents of Fabhalta.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Amendment after Notice of Allowance (Rule 312) Critical | 01 Mar, 2024 | US11951101 |
| Mailing Corrected Notice of Allowability | 08 Jan, 2024 | US11951101 |
| Email Notification Critical | 08 Jan, 2024 | US11951101 |
| Corrected Notice of Allowability | 03 Jan, 2024 | US11951101 |
| Initial letter Re: PTE Application to regulating agency | 21 Dec, 2023 | US9682968 |
| Patent Term Extension Application under 35 USC 156 Filed | 19 Dec, 2023 | US9682968 |
| Email Notification Critical | 08 Dec, 2023 | US9682968 |
| Change in Power of Attorney (May Include Associate POA) Critical | 08 Dec, 2023 | US9682968 |
| Electronic Review Critical | 07 Dec, 2023 | US11951101 |
| Mail Notice of Allowance Critical | 07 Dec, 2023 | US11951101 |
FDA has granted several exclusivities to Fabhalta. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Fabhalta, regardless of the status of it's patents. These exclusivities hence play a crucial role in delaying the generic launch. Given below are details of the exclusivities granted to Fabhalta.
Exclusivity Information
Fabhalta holds 3 exclusivities out of which none have expired. Its last outstanding exclusivity is set to expire in 2030. Details of Fabhalta's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Indication(I-949) | Aug 07, 2027 |
| New Chemical Entity Exclusivity(NCE) | Dec 05, 2028 |
| Orphan Drug Exclusivity(ODE-456) | Dec 05, 2030 |
US patents provide insights into the exclusivity only within the United States, but Fabhalta is protected by patents in multiple countries. Understanding the full scope of patent protection is crucial in strategizing market entry. By looking at the broader patent landscape, you can identify markets with weaker patent protection which could be ideal generic entry points. The following section offers details on Fabhalta's family patents as well as insights into ongoing legal events on those patents.
Fabhalta's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Fabhalta's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Jul 15, 2041 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Fabhalta Generics:
There are no approved generic versions for Fabhalta as of now.
About Fabhalta
Fabhalta is a drug owned by Novartis Pharmaceuticals Corp. Fabhalta uses Iptacopan Hydrochloride as an active ingredient. Fabhalta was launched by Novartis in 2023.
Approval Date:
Fabhalta was approved by FDA for market use on 05 December, 2023.
NCE-1 date:
NCE-1 date also known as the four year date occurs four years after the original drug approval and marks the first opportunity for a generic manufacturer to file an ANDA with a Paragraph IV certification. This is the earliest point when generic competition might begin, provided the challenge is successful. Since the approval date for Fabhalta is 05 December, 2023, its NCE-1 date is estimated to be 06 December, 2027.
Active Ingredient:
Fabhalta uses Iptacopan Hydrochloride as the active ingredient. Check out other Drugs and Companies using Iptacopan Hydrochloride ingredient
Dosage:
Fabhalta is available in capsule form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| EQ 200MG BASE | CAPSULE | Prescription | ORAL |