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Loxapine - Generic Drug Details

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Loxapine is the generic ingredient in five branded drugs marketed by Alexza Pharms, Actavis Labs Ut Inc, Watson Labs, Mylan, Elite Labs Inc, and Lannett Holdings Inc, and is included in eleven NDAs. There are seventeen patents protecting this compound. Additional information is available in the individual branded drug profile pages.

This ingredient has two hundred and fourteen patent family members in eighteen countries.

There are eight drug master file entries for loxapine. One supplier is listed for this compound.

Summary for Generic Name: loxapine

Tradenames:5
Patents:17
Applicants:6
NDAs:11
Drug Master File Entries: see list8
Suppliers / Packaging: see list1
Formulation / Manufacturing:see details
Drug Prices:see low prices
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Lannett Holdings Inc
LOXAPINE SUCCINATE
loxapine succinate
CAPSULE;ORAL090695-002Sep 26, 2011RXNo► subscribe► subscribe
Actavis Labs Ut Inc
LOXITANE
loxapine succinate
CAPSULE;ORAL017525-004Approved Prior to Jan 1, 1982DISCNNo► subscribe► subscribe
Actavis Labs Ut Inc
LOXITANE C
loxapine hydrochloride
CONCENTRATE;ORAL017658-001Approved Prior to Jan 1, 1982DISCNNo► subscribe► subscribe
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Non-Orange Book Patents for Generic Ingredient: loxapine

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
7,087,218Delivery of diazepam through an inhalation route► subscribe
6,805,854 Delivery of sumatriptan, frovatriptan or naratriptan through an inhalation route► subscribe
7,449,172Delivery of antiemetics through an inhalation route► subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.

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International Patent Family for Ingredient: loxapine

Country Document Number Estimated Expiration
World Intellectual Property Organization (WIPO)02094234► subscribe
Germany60239604► subscribe
Czech Republic20033223► subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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Supplementary Protection Certificates for Tradename: LOXAPINE

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
00609Netherlands► subscribePRODUCT NAME: LOXAPINE; REGISTRATION NO/DATE: EU/1/13/823/001-002 20130220
0609Netherlands► subscribePRODUCT NAME: LOXAPINE; REGISTRATION NO/DATE: EU/1/13/823/001-002 20130220
2013 00046Denmark► subscribePRODUCT NAME: LOXAPIN; REG. NO/DATE: EU/1/13/823/001-002 20130220
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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