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Details for Patent: 8,133,893

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Patent 8,133,893 protects DESYREL and OLEPTRO and is included in two NDAs. There has been one Paragraph IV challenge on Oleptro.

This patent has twenty-two patent family members in nineteen countries.

Summary for Patent: 8,133,893

Title:Trazodone and trazodone hydrochloride in purified form
Abstract: A process of production of trazodone or trazodone hydrochloride that comprises the steps of: (a) preparing an organic phase comprising trazodone in at least one organic solvent; (b) preparing an aqueous phase comprising at least one basic compound; (c) mixing said aqueous phase with said organic phase; (d) heating at a temperature of at least 40.degree. C. for at least 30 minutes; (e) recovering said trazodone; and, optionally, (f) treating said trazodone with hydrochloric acid to obtain trazodone hydrochloride. Trazodone or trazodone hydrochloride comprising less than 15 ppm of alkylating substances, and a pharmaceutical composition comprising said trazodone hydrochloride. ##STR00001##
Inventor(s): Marchetti; Marcello (Rome, IT), Iacoangeli; Tommaso (Rome, IT), Ciottoli; Giovanni Battista (Rome, IT), Biondi; Giuseppe (Castel Gandolfo, IT)
Assignee: Aziende Chimiche Riunite Angelini Francesco A.C.R.A.F. S.p.A. (Rome, IT)
Application Number:12/513,048
Patent Claim Types:
see list of patent claims
Compound; Composition; Use; Process;
Patent Metrics:
Source: PatentQuant.com
Field: Pharmaceuticals
Back Citations: 4th percentile
Forward Citations: 0th percentile

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use
Pragma Pharms Llc
DESYREL
trazodone hydrochloride
TABLET;ORAL018207-001Approved Prior to Jan 1, 1982DISCNNo8,133,893► subscribeYY
Pragma Pharms Llc
DESYREL
trazodone hydrochloride
TABLET;ORAL018207-002Approved Prior to Jan 1, 1982DISCNNo8,133,893► subscribeYY
Pragma Pharms Llc
DESYREL
trazodone hydrochloride
TABLET;ORAL018207-003Mar 25, 1985DISCNNo8,133,893► subscribeYY
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Foreign Priority and PCT Information for Patent: 8,133,893

Foriegn Application Priority Data
Foreign Country Foreign Patent Number Foreign Patent Date
ItalyMI2007A1603Aug 03, 2007
PCT Information
PCT FiledJuly 23, 2008PCT Application Number:PCT/EP2008/059640
PCT Publication Date:February 12, 2009PCT Publication Number: WO2009/019133

Non-Orange Book Patents for Patent: 8,133,893

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
8,314,236Trazodone and trazodone hydrochloride in purified form► 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 Patent: 8,133,893

Country Document Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Ukraine103597► subscribe
Slovenia2178850► subscribe
Portugal2178850► 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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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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