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Loxapine - Generic Drug Details
» See Plans and Pricing
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, Mylan, and Watson Labs, and is included in eleven NDAs. There are eighteen patents protecting this compound. Additional information is available in the individual branded drug profile pages.Loxapine has two hundred and twenty-six patent family members in twenty countries.
There are eight drug master file entries for loxapine. One supplier is listed for this compound.
Summary for loxapine
| International Patents: | 226 |
| US Patents: | 18 |
| Tradenames: | 5 |
| Applicants: | 7 |
| NDAs: | 11 |
| Drug Master File Entries: | 8 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 32 |
| Clinical Trials: | 24 |
| Patent Applications: | 6,683 |
| 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 |
Recent Clinical Trials for loxapine
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Lee's Pharmaceutical Limited | Phase 3 |
| Mount Sinai Hospital, Chicago | Phase 4 |
| University of Arkansas | Phase 4 |
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 | Start Trial | Start Trial | Y | Start Trial | |||
| Teva Branded Pharm | LOXITANE | loxapine succinate | CAPSULE;ORAL | 017525-003 | Approved Prior to Jan 1, 1982 | DISCN | Yes | No | Start Trial | Start Trial | Start Trial | ||||
| Teva Branded Pharm | LOXITANE | loxapine succinate | TABLET;ORAL | 017525-006 | Approved Prior to Jan 1, 1982 | DISCN | Yes | No | Start Trial | Start Trial | Start Trial | ||||
| Lannett Co Inc | LOXAPINE SUCCINATE | loxapine succinate | CAPSULE;ORAL | 090695-001 | Sep 26, 2011 | AB | RX | No | No | Start Trial | Start Trial | Start Trial | |||
| Watson Labs | LOXAPINE SUCCINATE | loxapine succinate | CAPSULE;ORAL | 072205-001 | Jun 15, 1988 | 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 |
International Patents for loxapine
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Mexico | PA03010702 | Start Trial |
| Hong Kong | 1085127 | Start Trial |
| Austria | 418330 | Start Trial |
| Canada | 2446917 | Start Trial |
| European Patent Office | 2052753 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for loxapine
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1389098 | SPC/GB13/055 | United Kingdom | Start Trial | PRODUCT NAME: LOXAPINE; REGISTERED: UK EU/1/13/823/001 20130220; UK EU/1/13/823/002 20130220 |
| 1389098 | C300609 | Netherlands | Start Trial | PRODUCT NAME: LOXAPINE; REGISTRATION NO/DATE: EU/1/13/823/001-002 20130220 |
| 1389098 | 2013C/054 | Belgium | Start Trial | PRODUCT NAME: ADASUVE-LOXAPINE; AUTHORISATION NUMBER AND DATE: EU/1/13/823/001 20130225 |
| 1389098 | C01389098/01 | Switzerland | Start Trial | PRODUCT NAME: LOXAPINUM; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 65461 13.12.2016 |
| 1389098 | 132013902184784 | Italy | Start Trial | 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 |
