FANAPT Drug Patent Profile
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Which patents cover Fanapt, and when can generic versions of Fanapt launch?
Fanapt is a drug marketed by Vanda Pharms Inc and is included in one NDA. There are nine patents protecting this drug and one Paragraph IV challenge.
This drug has fifty-nine patent family members in eight countries.
The generic ingredient in FANAPT is iloperidone. There are eight drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the iloperidone profile page.
DrugPatentWatch® Generic Entry Outlook for Fanapt
Fanapt was eligible for patent challenges on May 6, 2013.
There have been nine patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.
There is one tentative approval for the generic drug (iloperidone), which indicates the potential for near-term generic launch.
Indicators of Generic Entry
Summary for FANAPT
| International Patents: | 59 |
| US Patents: | 9 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 128 |
| Clinical Trials: | 8 |
| Patent Applications: | 3,590 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for FANAPT |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for FANAPT |
| What excipients (inactive ingredients) are in FANAPT? | FANAPT excipients list |
| DailyMed Link: | FANAPT at DailyMed |
Recent Clinical Trials for FANAPT
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Vanda Pharmaceuticals | Phase 2 |
| University of Colorado, Denver | Phase 2 |
| Novartis Pharmaceuticals | Phase 2 |
Pharmacology for FANAPT
| Drug Class | Atypical Antipsychotic |
Anatomical Therapeutic Chemical (ATC) Classes for FANAPT
Paragraph IV (Patent) Challenges for FANAPT
| Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
|---|---|---|---|---|---|---|
| FANAPT | Tablets | iloperidone | 1 mg, 2 mg, 4 mg, 6 mg, 8 mg, 10 mg, and 12 mg | 022192 | 1 | 2013-05-06 |
US Patents and Regulatory Information for FANAPT
FANAPT is protected by nine US patents.
Patents protecting FANAPT
Methods for the administration of iloperidone
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: METHOD OF TREATING SCHIZOPHRENIA BY ADMINISTERING ILOPERIDONE TO A PATIENT BY REDUCING THE DOSE IN PATIENTS WHO ARE POOR METABOLIZERS OF CYP2D6
Prediction of QT prolongation based on SNP genotype
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: DOSAGE MODIFICATION TO REDUCE THE RISK ASSOCIATED WITH QT PROLONGATION NOT INDUCED BY OTHER DRUGS DURING TREATMENT WITH ILOPERIDONE
Method of treatment based on polymorphisms of the KCNQ1 gene
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: DOSAGE MODIFICATION TO REDUCE RISKS ASSOCIATED WITH QT PROLONGATION NOT INDUCED BY OTHER DRUGS DURING TREATMENT WITH ILOPERIDONE
Method of predicting a predisposition to QT prolongation
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: DOSAGE MODIFICATION TO REDUCE RISKS ASSOCIATED WITH QT PROLONGATION NOT INDUCED BY OTHER DRUGS DURING TREATMENT WITH ILOPERIDONE
Method of predicting a predisposition to QT prolongation
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: DOSAGE MODIFICATION TO REDUCE RISKS ASSOCIATED WITH QT PROLONGATION NOT INDUCED BY OTHER DRUGS DURING TREATMENT WITH ILOPERIDONE
Method of predicting a predisposition to QT prolongation
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: DOSAGE MODIFICATION TO REDUCE RISKS ASSOCIATED WITH QT PROLONGATION NOT INDUCED BY OTHER DRUGS DURING TREATMENT WITH ILOPERIDONE
Method of predicting a predisposition to QT prolongation
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: DOSAGE MODIFICATION TO REDUCE RISKS ASSOCIATED WITH QT PROLONGATION NOT INDUCED BY OTHER DRUGS DURING TREATMENT WITH ILOPERIDONE
Methods for the administration of iloperidone
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: METHOD OF TREATING SCHIZOPHRENIA BY ADMINISTERING ILOPERIDONE TO A PATIENT BY REDUCING THE DOSE IN PATIENTS WHO ARE BEING TREATED WITH FLUOXETINE
Method of treatment based on polymorphisms of the KCNQ1 gene
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: DOSAGE MODIFICATION TO REDUCE RISKS ASSOCIATED WITH QT PROLONGATION NOT INDUCED BY OTHER DRUGS DURING TREATMENT WITH ILOPERIDONE
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Vanda Pharms Inc | FANAPT | iloperidone | TABLET;ORAL | 022192-005 | May 6, 2009 | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Vanda Pharms Inc | FANAPT | iloperidone | TABLET;ORAL | 022192-004 | May 6, 2009 | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Vanda Pharms Inc | FANAPT | iloperidone | TABLET;ORAL | 022192-006 | May 6, 2009 | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Vanda Pharms Inc | FANAPT | iloperidone | TABLET;ORAL | 022192-007 | May 6, 2009 | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
Expired US Patents for FANAPT
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Vanda Pharms Inc | FANAPT | iloperidone | TABLET;ORAL | 022192-001 | May 6, 2009 | ⤷ Try a Trial | ⤷ Try a Trial |
| Vanda Pharms Inc | FANAPT | iloperidone | TABLET;ORAL | 022192-005 | May 6, 2009 | ⤷ Try a Trial | ⤷ Try a Trial |
| Vanda Pharms Inc | FANAPT | iloperidone | TABLET;ORAL | 022192-002 | May 6, 2009 | ⤷ Try a Trial | ⤷ Try a Trial |
| Vanda Pharms Inc | FANAPT | iloperidone | TABLET;ORAL | 022192-006 | May 6, 2009 | ⤷ Try a Trial | ⤷ Try a Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
EU/EMA Drug Approvals for FANAPT
| Company | Drugname | Inn | Product Number / Indication | Status | Generic | Biosimilar | Orphan | Marketing Authorisation | Marketing Refusal |
|---|---|---|---|---|---|---|---|---|---|
| Vanda Pharmaceuticals Ltd | Fanaptum | iloperidone | EMEA/H/C/004149 Treatment of schizophrenia |
Refused | no | no | no | 2018-01-15 | |
| >Company | >Drugname | >Inn | >Product Number / Indication | >Status | >Generic | >Biosimilar | >Orphan | >Marketing Authorisation | >Marketing Refusal |
International Patents for FANAPT
See the table below for patents covering FANAPT around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Poland | 285247 | ⤷ Try a Trial | |
| European Patent Office | 2198048 | PRÉDICTION DE LA PROLONGATION DU QT EN FONCTION DU GÉNOTYPE SNP (PREDICTION OF QT PROLONGATION BASED ON SNP GENOTYPE) | ⤷ Try a Trial |
| Czech Republic | 9603628 | ⤷ Try a Trial | |
| Romania | 120341 | DERIVAŢI SUBSTITUIŢI DE PIPERIDINĂ, COMPOZIŢII FARMACEUTICE CARE ÎI CONŢIN ŞI UTILIZAREA ACESTORA CA ANTIPSIHOTICE ŞI ANALGEZICE (SUBSTITUTED PIPERIDINE DERIVATIVES, PHARMACEUTICAL COMPOSITIONS CONTAINING THE SAME AND USE THEREOF AS ANTIPSYCHOTIC AND ANALGESIC AGENTS) | ⤷ Try a Trial |
| >Country | >Patent Number | >Title | >Estimated Expiration |
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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. 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.
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