Loxapine - Generic Drug Details
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What are the generic drug sources for loxapine and what is the scope of freedom to operate?
Loxapine
is the generic ingredient in five branded drugs marketed by Alexza Pharms, Teva Branded Pharm, Actavis Labs Ut Inc, Elite Labs Inc, Lannett Co Inc, Rising, and Watson Labs, and is included in eleven NDAs. There are five patents protecting this compound. Additional information is available in the individual branded drug profile pages.Loxapine has two hundred and twenty-seven patent family members in twenty-one countries.
There are eight drug master file entries for loxapine. One supplier is listed for this compound.
Summary for loxapine
| International Patents: | 227 |
| US Patents: | 5 |
| Tradenames: | 5 |
| Applicants: | 7 |
| NDAs: | 11 |
| Drug Master File Entries: | 8 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 52 |
| Clinical Trials: | 25 |
| Patent Applications: | 6,704 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price trends for loxapine |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for loxapine |
| What excipients (inactive ingredients) are in loxapine? | loxapine excipients list |
| DailyMed Link: | loxapine at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for loxapine
Generic Entry Date for loxapine*:
Constraining patent/regulatory exclusivity:
Dosage:
POWDER;INHALATION |
*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.
Recent Clinical Trials for loxapine
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 |
Medical Subject Heading (MeSH) Categories for loxapine
US Patents and Regulatory Information for loxapine
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Alexza Pharms | ADASUVE | loxapine | POWDER;INHALATION | 022549-001 | Dec 21, 2012 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
| Alexza Pharms | ADASUVE | loxapine | POWDER;INHALATION | 022549-001 | Dec 21, 2012 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
| Lannett Co Inc | LOXAPINE SUCCINATE | loxapine succinate | CAPSULE;ORAL | 090695-004 | Sep 26, 2011 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Teva Branded Pharm | LOXITANE | loxapine succinate | TABLET;ORAL | 017525-007 | Approved Prior to Jan 1, 1982 | DISCN | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Watson Labs | LOXAPINE SUCCINATE | loxapine succinate | CAPSULE;ORAL | 072205-001 | Jun 15, 1988 | AB | RX | 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 |
Expired US Patents for loxapine
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Alexza Pharms | ADASUVE | loxapine | POWDER;INHALATION | 022549-001 | Dec 21, 2012 | ⤷ Try a Trial | ⤷ Try a Trial |
| Alexza Pharms | ADASUVE | loxapine | POWDER;INHALATION | 022549-001 | Dec 21, 2012 | ⤷ Try a Trial | ⤷ Try a Trial |
| Alexza Pharms | ADASUVE | loxapine | POWDER;INHALATION | 022549-001 | Dec 21, 2012 | ⤷ Try a Trial | ⤷ Try a Trial |
| Alexza Pharms | ADASUVE | loxapine | POWDER;INHALATION | 022549-001 | Dec 21, 2012 | ⤷ Try a Trial | ⤷ Try a Trial |
| Alexza Pharms | ADASUVE | loxapine | POWDER;INHALATION | 022549-001 | Dec 21, 2012 | ⤷ Try a Trial | ⤷ Try a Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
EU/EMA Drug Approvals for loxapine
| Company | Drugname | Inn | Product Number / Indication | Status | Generic | Biosimilar | Orphan | Marketing Authorisation | Marketing Refusal |
|---|---|---|---|---|---|---|---|---|---|
| Ferrer Internacional S.A. | Adasuve | loxapine | EMEA/H/C/002400 Adasuve is indicated for the rapid control of mild-to-moderate agitation in adult patients with schizophrenia or bipolar disorder. Patients should receive regular treatment immediately after control of acute agitation symptoms. |
Authorised | no | no | no | 2013-02-20 | |
| >Company | >Drugname | >Inn | >Product Number / Indication | >Status | >Generic | >Biosimilar | >Orphan | >Marketing Authorisation | >Marketing Refusal |
International Patents for loxapine
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Austria | 401064 | ⤷ Try a Trial | |
| Japan | 2007516015 | ⤷ Try a Trial | |
| Austria | 404184 | ⤷ Try a Trial | |
| Canada | 2447210 | ADMINISTRATION D'AEROSOLS CONTENANT DE PETITES PARTICULES VIA UNE VOIE D'INHALATION (DELIVERY OF AEROSOLS CONTAINING SMALL PARTICLES THROUGH AN INHALATION ROUTE) | ⤷ Try a Trial |
| Mexico | PA03011268 | DISPOSITIVO FORMADOR DE AEROSOL PARA UTILIZARSE EN TERAPIA DE INHALACION. (AN AEROSOL FORMING DEVICE FOR USE IN INHALATION THERAPY.) | ⤷ Try a Trial |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for loxapine
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1389098 | CR 2013 00046 | Denmark | ⤷ Try a Trial | PRODUCT NAME: LOXAPIN; REG. NO/DATE: EU/1/13/823/001-002 20130220 |
| 1389098 | 300609 | Netherlands | ⤷ Try a Trial | PRODUCT NAME: LOXAPINE; REGISTRATION NO/DATE: EU/1/13/823/001-002 20130220 |
| 1389098 | CA 2013 00046 | Denmark | ⤷ Try a Trial | PRODUCT NAME: LOXAPIN; REG. NO/DATE: EU/1/13/823/001-002 20130220 |
| 1389098 | SPC/GB13/055 | United Kingdom | ⤷ Try a Trial | PRODUCT NAME: LOXAPINE; REGISTERED: UK EU/1/13/823/001 20130220; UK EU/1/13/823/002 20130220 |
| 1389098 | C01389098/01 | Switzerland | ⤷ Try a Trial | PRODUCT NAME: LOXAPINUM; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 65461 13.12.2016 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
