Fanapt is a drug owned by Vanda Pharmaceuticals Inc. It is protected by 10 US drug patents filed from 2013 to 2015. Out of these, 9 drug patents are active and 1 has expired. Fanapt's patents have been open to challenges since 06 May, 2013. Based on its patents and exclusivities, its generic launch date is estimated to be Dec 28, 2031. Details of Fanapt's patents and their expiration are given in the table below.
| Drug Patent Number | Drug Patent Title | Drug Patent Expiry | Status |
|---|---|---|---|
| These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| US9074254 | Method of predicting a predisposition to QT prolongation |
Dec, 2031
(7 years from now) | Active |
| US9074256 | Method of predicting a predisposition to QT prolongation |
Feb, 2031
(6 years from now) | Active |
| US9072742 | Method of predicting a predisposition to QT prolongation |
Jan, 2031
(6 years from now) | Active |
| US9074255 | Method of predicting a predisposition to QT prolongation |
Dec, 2030
(5 years from now) | Active |
| US8999638 | Method of treatment based on polymorphisms of the KCNQ1 gene |
Oct, 2030
(5 years from now) | Active |
| US8652776 | Prediction of QT prolongation based on SNP genotype |
Aug, 2030
(5 years from now) | Active |
| US9157121 | Method of treatment based on polymorphisms of the KCNQ1 gene |
Apr, 2030
(5 years from now) | Active |
| US8586610 | Methods for the administration of iloperidone |
Nov, 2027
(2 years from now) | Active |
| US9138432 | Methods for the administration of iloperidone |
Sep, 2025
(9 months from now) | Active |
| USRE39198 | Heteroarylpiperidines, pyrrolidines and piperazines and their use as antipsychotics and analgesics |
Nov, 2016
(8 years ago) |
Expired
|
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 Fanapt's patents.
Latest Legal Activities on Fanapt's Patents
Given below is the list of recent legal activities going on the following patents of Fanapt.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 8th Year, Large Entity | 13 Apr, 2023 | US9157121 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 22 Mar, 2023 | US9138432 (Litigated) |
| Payment of Maintenance Fee, 8th Year, Large Entity | 09 Jan, 2023 | US9072742 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 09 Jan, 2023 | US9074254 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 09 Jan, 2023 | US9074255 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 09 Jan, 2023 | US9074256 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 19 May, 2021 | US8586610 (Litigated) |
| Payment of Maintenance Fee, 4th Year, Large Entity | 15 Apr, 2019 | US9157121 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 22 Mar, 2019 | US9138432 (Litigated) |
| Payment of Maintenance Fee, 4th Year, Large Entity | 07 Jan, 2019 | US9074256 |
While patent expiration is one way of estimating the generic date of a drug, if a patent gets invalidated somehow, the generic of the drug may arrive early. Being aware of all relevant patents can help in avoiding legal pitfalls. Given below are details of the litigation history of Fanapt and ongoing litigations to help you estimate the early arrival of Fanapt generic.
Fanapt's Litigations
Fanapt been subject to various legal proceedings, including patent litigations. The earliest legal proceeding was initiated on Feb 26, 2016, against patent number US9138432. The petitioner Roxane Laboratories, Inc., challenged the validity of this patent, with Vanda Pharmaceuticals Inc. as the respondent. Click below to track the latest information on how companies are challenging Fanapt's patents.
| Patent | Proceeding Filing Date | Status | Respondent | Petitioner |
|---|---|---|---|---|
 | ||||
| US9138432 | February, 2016 |
Terminated-Denied
(30 Aug, 2016) | Vanda Pharmaceuticals Inc. | Roxane Laboratories, Inc. |
FDA has granted some exclusivities to Fanapt. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Fanapt, 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 Fanapt.
Exclusivity Information
Fanapt holds 3 exclusivities out of which 2 have expired. Its last outstanding exclusivity is set to expire in 2027. Details of Fanapt's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | May 06, 2014 |
| M(M-180) | May 26, 2019 |
| New Indication(I-939) | Apr 02, 2027 |
US patents provide insights into the exclusivity only within the United States, but Fanapt 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 Fanapt's family patents as well as insights into ongoing legal events on those patents.
Fanapt's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Fanapt's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Dec 28, 2031 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Fanapt Generic API suppliers:
Iloperidone is the generic name for the brand Fanapt. 3 different companies have already filed for the generic of Fanapt, with Inventia having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Fanapt's generic
How can I launch a generic of Fanapt before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Fanapt's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Fanapt's sponsor is invalid, unenforceable, or will not be infringed by your generic product.
Given below are the details of the already filed Para IV certificates on Fanapt -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 1 mg, 2 mg, 4 mg, 6 mg, 8 mg, 10 mg, and 12 mg | 06 May, 2013 | 1 | 15 Nov, 2016 | Extinguished |
About Fanapt
Fanapt is a drug owned by Vanda Pharmaceuticals Inc. It is used for the acute treatment of adults with schizophrenia. Fanapt uses Iloperidone as an active ingredient. Fanapt was launched by Vanda Pharms Inc in 2009.
Approval Date:
Fanapt was approved by FDA for market use on 06 May, 2009.
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 Fanapt is 06 May, 2009, its NCE-1 date is estimated to be 06 May, 2013.
Active Ingredient:
Fanapt uses Iloperidone as the active ingredient. Check out other Drugs and Companies using Iloperidone ingredient
Treatment:
Fanapt is used for the acute treatment of adults with schizophrenia.
Dosage:
Fanapt is available in tablet form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 6MG | TABLET | Prescription | ORAL |
| 10MG | TABLET | Prescription | ORAL |
| 12MG | TABLET | Prescription | ORAL |
| 8MG | TABLET | Prescription | ORAL |
| 4MG | TABLET | Prescription | ORAL |
| 2MG | TABLET | Prescription | ORAL |
| 1MG | TABLET | Prescription | ORAL |