ILOPERIDONE Drug Patent Profile
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When do Iloperidone patents expire, and when can generic versions of Iloperidone launch?
Iloperidone is a drug marketed by Inventia, Lupin Ltd, and Taro. and is included in three NDAs.
The generic ingredient in ILOPERIDONE 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.
Summary for ILOPERIDONE
Recent Clinical Trials for ILOPERIDONE
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Vanda Pharmaceuticals | Phase 2 |
| Melissa Delbello | Phase 4 |
| Patient-Centered Outcomes Research Institute | Phase 4 |
Pharmacology for ILOPERIDONE
| Drug Class | Atypical Antipsychotic |
Anatomical Therapeutic Chemical (ATC) Classes for ILOPERIDONE
Paragraph IV (Patent) Challenges for ILOPERIDONE
| 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 ILOPERIDONE
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Inventia | ILOPERIDONE | iloperidone | TABLET;ORAL | 207231-001 | Nov 28, 2016 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Taro | ILOPERIDONE | iloperidone | TABLET;ORAL | 207098-004 | Jul 22, 2019 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Inventia | ILOPERIDONE | iloperidone | TABLET;ORAL | 207231-007 | Nov 28, 2016 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Inventia | ILOPERIDONE | iloperidone | TABLET;ORAL | 207231-004 | Nov 28, 2016 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Lupin Ltd | ILOPERIDONE | iloperidone | TABLET;ORAL | 206890-005 | May 5, 2022 | DISCN | No | 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 |
EU/EMA Drug Approvals for ILOPERIDONE
| 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 |
