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 seven 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
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Questions you can ask:
- What is the 5 year forecast for FANAPT?
- What are the global sales for FANAPT?
- What is Average Wholesale Price for FANAPT?
Summary for FANAPT
International Patents: | 59 |
US Patents: | 9 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 130 |
Clinical Trials: | 8 |
Patent Applications: | 3,567 |
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 |
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 and one FDA Regulatory Exclusivity.
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 for Free | ⤷ Try for Free | ⤷ Try for Free | ||||
Vanda Pharms Inc | FANAPT | iloperidone | TABLET;ORAL | 022192-004 | May 6, 2009 | RX | Yes | No | ⤷ Try for Free | ⤷ Try for Free | ⤷ Try for Free | ||||
Vanda Pharms Inc | FANAPT | iloperidone | TABLET;ORAL | 022192-005 | May 6, 2009 | RX | Yes | No | ⤷ Try for Free | ⤷ Try for Free | ⤷ Try for Free | ||||
>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 for Free | ⤷ Try for Free |
Vanda Pharms Inc | FANAPT | iloperidone | TABLET;ORAL | 022192-005 | May 6, 2009 | ⤷ Try for Free | ⤷ Try for Free |
Vanda Pharms Inc | FANAPT | iloperidone | TABLET;ORAL | 022192-002 | May 6, 2009 | ⤷ Try for Free | ⤷ Try for Free |
>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 |
---|---|---|---|
Japan | 6108633 | ⤷ Try for Free | |
Russian Federation | 2062776 | METHOD FOR PRODUCTION OF SUBSTITUTED N-(ARYL OXYALKYL)-HETEROARYL PIPERIDINE OR HETEROARYL PIPERAZINE | ⤷ Try for Free |
Canada | 2175212 | HETEROARYLPIPERIDINES, PYRROLIDINES ET PIPERAZINES ET LEUR UTILISATION COMME ANTIPSYCHOTIQUES ET ANALGESIQUES (HETEROARYLPIPERIDINES, PYRROLIDINES AND PIPERAZINES AND THEIR USE AS ANTIPSYCHOTICS AND ANALGETICS) | ⤷ Try for Free |
>Country | >Patent Number | >Title | >Estimated Expiration |
Market Dynamics and Financial Trajectory for FANAPT
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