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Serving leading biopharmaceutical companies globally:

Accenture
Baxter
US Department of Justice
Citi
Fish and Richardson
Fuji
AstraZeneca
Chinese Patent Office
Medtronic
Federal Trade Commission

Generated: October 17, 2017

DrugPatentWatch Database Preview

Loxapine - Generic Drug Details

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What are the generic sources for loxapine and what is the scope of loxapine patent protection?

Loxapine
is the generic ingredient in five branded drugs marketed by Galen Uk , Actavis Labs Ut Inc, Watson Labs, Mylan, Elite Labs Inc, and Lannett Holdings Inc, 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-four patent family members in nineteen countries and six supplementary protection certificates in four countries.

There are eight drug master file entries for loxapine. Two suppliers are listed for this compound.

Summary for Generic Name: loxapine

US Patents:18
Tradenames:5
Applicants:6
NDAs:11
Drug Master File Entries: see list8
Suppliers / Packagers: see list2
Bulk Api Vendors: see list20
Clinical Trials: see list23
Patent Applications: see list5,136
Formulation / Manufacturing:see details
Drug Prices:see low prices
DailyMed Link:loxapine at DailyMed
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Galen Uk
ADASUVE
loxapine
POWDER;INHALATION022549-001Dec 21, 2012RXYesYes► Subscribe► SubscribeY ► Subscribe
Galen Uk
ADASUVE
loxapine
POWDER;INHALATION022549-001Dec 21, 2012RXYesYes► Subscribe► SubscribeY ► Subscribe
Actavis Labs Ut Inc
LOXITANE IM
loxapine hydrochloride
INJECTABLE;INJECTION018039-001Approved Prior to Jan 1, 1982DISCNNoNo► Subscribe► Subscribe► Subscribe
Lannett Holdings Inc
LOXAPINE SUCCINATE
loxapine succinate
CAPSULE;ORAL090695-004Sep 26, 2011ABRXNoNo► Subscribe► Subscribe► Subscribe
Lannett Holdings Inc
LOXAPINE SUCCINATE
loxapine succinate
CAPSULE;ORAL090695-002Sep 26, 2011ABRXNoNo► Subscribe► Subscribe► Subscribe
Galen Uk
ADASUVE
loxapine
POWDER;INHALATION022549-001Dec 21, 2012RXYesYes► Subscribe► SubscribeY ► Subscribe
Actavis Labs Ut Inc
LOXITANE
loxapine succinate
CAPSULE;ORAL017525-001Approved Prior to Jan 1, 1982DISCNYesNo► Subscribe► Subscribe► Subscribe
Watson Labs
LOXAPINE SUCCINATE
loxapine succinate
CAPSULE;ORAL072206-001Jun 15, 1988ABRXNoYes► Subscribe► Subscribe► Subscribe
Galen Uk
ADASUVE
loxapine
POWDER;INHALATION022549-001Dec 21, 2012RXYesYes► Subscribe► SubscribeY ► Subscribe
Actavis Labs Ut Inc
LOXITANE
loxapine succinate
CAPSULE;ORAL017525-002Approved Prior to Jan 1, 1982DISCNYesNo► Subscribe► 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
7,087,217Delivery of nonsteroidal antiinflammatory drugs through an inhalation route► Subscribe
7,011,819Delivery of rizatriptan or zolmitriptan through an inhalation route► Subscribe
7,498,019Delivery of compounds for the treatment of headache through an inhalation route► Subscribe
7,078,018Delivery of opioids through an inhalation route► Subscribe
6,737,043 Delivery of alprazolam, estazolam, midazolam or triazolam through an inhalation route► Subscribe
7,488,469Delivery of caffeine through an inhalation route► Subscribe
7,987,846Method and apparatus for vaporizing a compound► Subscribe
7,014,841Delivery of antiemetics through an inhalation route► Subscribe
6,805,853 Delivery of diazepam through an inhalation route► Subscribe
6,797,259 Delivery of muscle relaxants 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
Japan2010270138► Subscribe
Canada2526432► Subscribe
World Intellectual Property Organization (WIPO)02094229► Subscribe
Canada2507158► Subscribe
MexicoPA03011268► Subscribe
Germany60228232► Subscribe
Austria462421► Subscribe
World Intellectual Property Organization (WIPO)02094241► Subscribe
Spain2623467► Subscribe
Hungary0401008► 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
2013 00046Denmark► SubscribePRODUCT NAME: LOXAPIN; REG. NO/DATE: EU/1/13/823/001-002 20130220
2013 00046Denmark► SubscribePRODUCT NAME: LOXAPIN; REG. NO/DATE: EU/1/13/823/001-002 20130220
3Finland► Subscribe
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
90040-2Sweden► SubscribePRODUCT NAME: LOXAPIN; REG. NO/DATE: EU/1/13/823/001 20130220
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For more information try a trial or see the database preview and plans and pricing

Serving leading biopharmaceutical companies globally:

Cerilliant
Julphar
UBS
Cantor Fitzgerald
QuintilesIMS
Novartis
Chinese Patent Office
US Army
Mallinckrodt
Johnson and Johnson

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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