Loxapine hydrochloride - Generic Drug Details
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What are the generic sources for loxapine hydrochloride and what is the scope of patent protection?
Loxapine hydrochloride
is the generic ingredient in two branded drugs marketed by Teva Branded Pharm and Actavis Labs Ut Inc, and is included in two NDAs. Additional information is available in the individual branded drug profile pages.There is one drug master file entry for loxapine hydrochloride.
Summary for loxapine hydrochloride
| US Patents: | 0 |
| Tradenames: | 2 |
| Applicants: | 2 |
| NDAs: | 2 |
| Drug Master File Entries: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 13 |
| Clinical Trials: | 25 |
| Patent Applications: | 584 |
| DailyMed Link: | loxapine hydrochloride at DailyMed |
Recent Clinical Trials for loxapine hydrochloride
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Assistance Publique - Hôpitaux de Paris | Phase 3 |
| Lariboisière-Saint Louis clinical research unit | Phase 3 |
| Lee's Pharmaceutical Limited | Phase 3 |
Anatomical Therapeutic Chemical (ATC) Classes for loxapine hydrochloride
US Patents and Regulatory Information for loxapine hydrochloride
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Actavis Labs Ut Inc | LOXITANE IM | loxapine hydrochloride | INJECTABLE;INJECTION | 018039-001 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Teva Branded Pharm | LOXITANE C | loxapine hydrochloride | CONCENTRATE;ORAL | 017658-001 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| >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 loxapine hydrochloride
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Teva Branded Pharm | LOXITANE C | loxapine hydrochloride | CONCENTRATE;ORAL | 017658-001 | Approved Prior to Jan 1, 1982 | ⤷ Sign Up | ⤷ Sign Up |
| Actavis Labs Ut Inc | LOXITANE IM | loxapine hydrochloride | INJECTABLE;INJECTION | 018039-001 | Approved Prior to Jan 1, 1982 | ⤷ Sign Up | ⤷ Sign Up |
| Teva Branded Pharm | LOXITANE C | loxapine hydrochloride | CONCENTRATE;ORAL | 017658-001 | Approved Prior to Jan 1, 1982 | ⤷ Sign Up | ⤷ Sign Up |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
