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, Alembic, Amneal, Apotex, Aurobindo Pharma Ltd, Breckenridge, Dr Reddys, Glenmark Pharms Ltd, Hetero Labs Ltd Iii, Lannett Co Inc, MSN, Novitium Pharma, Prasco, Rising, Sandoz, Taro, Torrent, Twi Pharms, Upsher Smith Labs, Watson Labs, Zameer Pharms, and Zydus Lifesciences. and is included in thirty NDAs.
The generic ingredient in FLUPHENAZINE HYDROCHLORIDE is fluphenazine hydrochloride. There is one drug master file entry for this compound. Twenty-nine 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.
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Questions you can ask:
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Summary for FLUPHENAZINE HYDROCHLORIDE
| US Patents: | 0 |
| Applicants: | 25 |
| NDAs: | 30 |
| Finished Product Suppliers / Packagers: | 29 |
| Raw Ingredient (Bulk) Api Vendors: | 145 |
| Clinical Trials: | 12 |
| Patent Applications: | 1,857 |
| 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Torrent | FLUPHENAZINE HYDROCHLORIDE | fluphenazine hydrochloride | TABLET;ORAL | 217094-003 | Jan 22, 2024 | DISCN | No | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | ||||
| Hetero Labs Ltd Iii | FLUPHENAZINE HYDROCHLORIDE | fluphenazine hydrochloride | TABLET;ORAL | 218769-004 | Nov 18, 2025 | AB | RX | No | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | |||
| Dr Reddys | FLUPHENAZINE HYDROCHLORIDE | fluphenazine hydrochloride | TABLET;ORAL | 214534-003 | Jan 7, 2021 | AB | RX | No | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | |||
| Zameer Pharms | FLUPHENAZINE HYDROCHLORIDE | fluphenazine hydrochloride | TABLET;ORAL | 215141-001 | Oct 20, 2021 | AB | RX | No | 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 |
