FLUPHENAZINE HYDROCHLORIDE Drug Patent Profile
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When do Fluphenazine Hydrochloride patents expire, and what generic alternatives are available?
Fluphenazine Hydrochloride is a drug marketed by Ani Pharms, Pharm Assoc, Fresenius Kabi Usa, Ajanta Pharma Ltd, Amneal, Apotex, Aurobindo Pharma Ltd, Dr Reddys, Glenmark Pharms Ltd, Lannett Co Inc, MSN, Novitium Pharma, Prasco, Sandoz, Taro, Torrent, Twi Pharms, Upsher Smith Labs, Watson Labs, Zameer Pharms, and Zydus. and is included in twenty-seven NDAs.
The generic ingredient in FLUPHENAZINE HYDROCHLORIDE is fluphenazine hydrochloride. There are nineteen drug master file entries for this compound. Twenty-seven suppliers are listed for this compound. Additional details are available on the fluphenazine hydrochloride profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Fluphenazine Hydrochloride
A generic version of FLUPHENAZINE HYDROCHLORIDE was approved as fluphenazine hydrochloride by FRESENIUS KABI USA on April 16th, 1987.
Summary for FLUPHENAZINE HYDROCHLORIDE
| US Patents: | 0 |
| Applicants: | 21 |
| NDAs: | 27 |
| Finished Product Suppliers / Packagers: | 27 |
| Raw Ingredient (Bulk) Api Vendors: | 145 |
| Clinical Trials: | 12 |
| Patent Applications: | 3,133 |
| Formulation / Manufacturing: | see details |
| DailyMed Link: | FLUPHENAZINE HYDROCHLORIDE at DailyMed |
Recent Clinical Trials for FLUPHENAZINE HYDROCHLORIDE
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Janssen Scientific Affairs, LLC | |
| Technische Universität München | Phase 4 |
| Hannover Medical School | Phase 3 |
Pharmacology for FLUPHENAZINE HYDROCHLORIDE
| Drug Class | Phenothiazine |
Anatomical Therapeutic Chemical (ATC) Classes for FLUPHENAZINE HYDROCHLORIDE
US Patents and Regulatory Information for FLUPHENAZINE HYDROCHLORIDE
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Watson Labs | FLUPHENAZINE HYDROCHLORIDE | fluphenazine hydrochloride | TABLET;ORAL | 088527-001 | Dec 18, 1987 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Novitium Pharma | FLUPHENAZINE HYDROCHLORIDE | fluphenazine hydrochloride | TABLET;ORAL | 214674-004 | Mar 1, 2021 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Lannett Co Inc | FLUPHENAZINE HYDROCHLORIDE | fluphenazine hydrochloride | TABLET;ORAL | 089743-004 | Aug 25, 1988 | AB | RX | No | Yes | ⤷ 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 |
