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FANAPT Drug 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-seven patent family members in eight countries.
The generic ingredient in FANAPT is iloperidone. There are eight drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the iloperidone profile page.
US ANDA Litigation and 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
Summary for FANAPT
| International Patents: | 57 |
| US Patents: | 9 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 108 |
| Clinical Trials: | 6 |
| Patent Applications: | 2,928 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for FANAPT |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for FANAPT |
| DailyMed Link: | FANAPT at DailyMed |
Recent Clinical Trials for FANAPT
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| University of Colorado, Denver | Phase 2 |
| Novartis Pharmaceuticals | Phase 2 |
| Novartis Pharmaceuticals | Phase 4 |
Pharmacology for FANAPT
| Drug Class | Atypical Antipsychotic |
Paragraph IV (Patent) Challenges for FANAPT
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| FANAPT | TABLET;ORAL | iloperidone | 022192 | 2013-05-06 |
US Patents and Regulatory Information for FANAPT
| 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 | Start Trial | Start Trial | Start Trial | ||||
| Vanda Pharms Inc | FANAPT | iloperidone | TABLET;ORAL | 022192-004 | May 6, 2009 | RX | Yes | No | Start Trial | Start Trial | Start Trial | ||||
| Vanda Pharms Inc | FANAPT | iloperidone | TABLET;ORAL | 022192-006 | May 6, 2009 | RX | Yes | No | Start Trial | Start Trial | Start Trial | ||||
| Vanda Pharms Inc | FANAPT | iloperidone | TABLET;ORAL | 022192-007 | May 6, 2009 | RX | Yes | No | Start Trial | Start Trial | Start Trial | ||||
| Vanda Pharms Inc | FANAPT | iloperidone | TABLET;ORAL | 022192-005 | May 6, 2009 | RX | Yes | No | Start Trial | Start Trial | Start 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 | Start Trial | Start Trial |
| Vanda Pharms Inc | FANAPT | iloperidone | TABLET;ORAL | 022192-005 | May 6, 2009 | Start Trial | Start Trial |
| Vanda Pharms Inc | FANAPT | iloperidone | TABLET;ORAL | 022192-007 | May 6, 2009 | Start Trial | Start Trial |
| Vanda Pharms Inc | FANAPT | iloperidone | TABLET;ORAL | 022192-003 | May 6, 2009 | Start Trial | Start Trial |
| Vanda Pharms Inc | FANAPT | iloperidone | TABLET;ORAL | 022192-004 | May 6, 2009 | Start Trial | Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for FANAPT
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| European Patent Office | 0963984 | Start Trial |
| Japan | 5800798 | Start Trial |
| Australia | 7938501 | Start Trial |
| Australia | 640653 | Start Trial |
| Japan | 2012522533 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
