LOXAPINE - Generic Drug Details
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What are the generic drug sources for loxapine and what is the scope of patent protection?
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 |
| 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 |
Recent Clinical Trials for LOXAPINE
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Lariboisière-Saint Louis clinical research unit | Phase 3 |
| Assistance Publique - Hôpitaux de Paris | Phase 3 |
| Lee's Pharmaceutical Limited | Phase 3 |
Medical Subject Heading (MeSH) Categories for LOXAPINE
Anatomical Therapeutic Chemical (ATC) Classes 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Elite Labs Inc | LOXAPINE SUCCINATE | loxapine succinate | CAPSULE;ORAL | 076868-004 | Aug 4, 2005 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Teva Branded Pharm | LOXITANE | loxapine succinate | TABLET;ORAL | 017525-007 | Approved Prior to Jan 1, 1982 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Teva Branded Pharm | LOXITANE | loxapine succinate | TABLET;ORAL | 017525-006 | Approved Prior to Jan 1, 1982 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Teva Branded Pharm | LOXITANE | loxapine succinate | CAPSULE;ORAL | 017525-004 | Approved Prior to Jan 1, 1982 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Rising | LOXAPINE SUCCINATE | loxapine succinate | CAPSULE;ORAL | 076762-002 | Nov 1, 2004 | 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
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Alexza Pharms | ADASUVE | loxapine | POWDER;INHALATION | 022549-001 | Dec 21, 2012 | ⤷ Sign Up | ⤷ Sign Up |
| Alexza Pharms | ADASUVE | loxapine | POWDER;INHALATION | 022549-001 | Dec 21, 2012 | ⤷ Sign Up | ⤷ Sign Up |
| Alexza Pharms | ADASUVE | loxapine | POWDER;INHALATION | 022549-001 | Dec 21, 2012 | ⤷ Sign Up | ⤷ Sign Up |
| Alexza Pharms | ADASUVE | loxapine | POWDER;INHALATION | 022549-001 | Dec 21, 2012 | ⤷ Sign Up | ⤷ Sign Up |
| Alexza Pharms | ADASUVE | loxapine | POWDER;INHALATION | 022549-001 | Dec 21, 2012 | ⤷ Sign Up | ⤷ Sign Up |
| >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 |
|---|---|---|---|
| Germany | 60227659 | ⤷ Sign Up | |
| World Intellectual Property Organization (WIPO) | 02098389 | ⤷ Sign Up | |
| Germany | 60228703 | ⤷ Sign Up | |
| New Zealand | 529420 | Delivery of antihistamines through an inhalation route | ⤷ Sign Up |
| Hong Kong | 1068293 | An aerosol forming device for use in inhalation therapy | ⤷ Sign Up |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for LOXAPINE
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1389098 | 1390040-2 | Sweden | ⤷ Sign Up | PRODUCT NAME: LOXAPIN; REG. NO/DATE: EU/1/13/823/001 20130220 |
| 1389098 | C01389098/01 | Switzerland | ⤷ Sign Up | PRODUCT NAME: LOXAPINUM; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 65461 13.12.2016 |
| 1389098 | 473 | Finland | ⤷ Sign Up | |
| 1389098 | CA 2013 00046 | Denmark | ⤷ Sign Up | PRODUCT NAME: LOXAPIN; REG. NO/DATE: EU/1/13/823/001-002 20130220 |
| 1389098 | 132013902184784 | Italy | ⤷ Sign Up | PRODUCT NAME: LOXAPINA(ADASUVE); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/13/823/001-002, 20130220 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
