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Details for Patent: 5,578,621

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Patent 5,578,621 protects ALINIA and is included in one NDA.

This patent has one hundred and twenty-one patent family members in forty-two countries.

Summary for Patent: 5,578,621

Title: Benzamide derivatives
Abstract:The present invention relates to a new compound of formula I ##STR1## with one of the symbols R.sub.1, R.sub.2, R.sub.3, R.sub.4 and R.sub.5 representing OH, whereas the remaining symbols represent H; to a pharmaceutical composition containing the said compound, and to the use of said compound as anti-parasital, anti-bacterial, anti-fungal agent. The Prior Art Nitrothiazole compound PH 5776 (2-(acetolyloxy)-N-(5-nitro 2-thiazolyl) benzamide) is a compound of formula II ##STR2## in which R.sub.1 =O--COCH3 R.sub.2 =R.sub.3 =R.sub.4 =R.sub.5 =H The preparation and uses of this compound are disclosed in U.S. Pat. No. 3,950,351, as well as in publication made by Applicant. In U.S. Pat. No. 3,950,351, the compound of formula II is prepared by reacting ##STR3## This reaction is not suitable for the preparation of pure compound of formula I ##STR4## in which one of the symbols R.sub.1, R.sub.2, R.sub.3, R.sub.4 and R.sub.5 represent OH, whereas the remaining symbols represent H. Moreover, contrary to what could be expected from the prior art, i.e. that the presence of an acyloxy group was necessary for rendering the compound active and efficient against bacteria, parasites, . . . , it has now been found that the compound of formula I ##STR5## with one of the symbols R.sub.1, R.sub.2, R.sub.3, R.sub.4 and R.sub.5 representing OH, whereas the remaining symbols represent H; had an excellent efficiency against parasites, bacteria, fungus although it does not contain an acyloxy group. The compound of formula I had a substantially immediate action against parasite, fungus, bacteria.
Inventor(s): Rossignol; Jean-Francois (Clearwater, FL)
Assignee:
Application Number:08/301,407
Patent Claim Types:
see list of patent claims
Composition; Compound; Use;
Patent PDF download available with subscription

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use
Romark
ALINIA
nitazoxanide
FOR SUSPENSION;ORAL021498-001Nov 22, 2002RXYes5,578,621<disabled>METHOD OF TREATING PARASITIC INFECTIONS
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Non-Orange Book Patents for Patent: 5,578,621

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
5,968,961 Pharmaceutical compositions of tizoxanide and nitazoxanide<disabled in preview>
6,117,894 Acid stabilized pharmaceutical compositions of tizoxanide and nitazoxanide<disabled in preview>
6,051,576 Means to achieve sustained release of synergistic drugs by conjugation<disabled in preview>
5,387,598 Composition and galenic formulation suitable for combatting affections of the lower abdomen<disabled in preview>
6,020,353 2-(hydroxy)-N-(5-nitro-2-thiazolyl) benzamide<disabled in preview>
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International Patent Family for Patent: 5,578,621

Country Document Number Publication Date Supplementary Protection Certificate SPC Country SPC Expiration
Australia756451Jan 16, 2003
Slovakia151199Jul 11, 2000
Hong Kong1025907Jun 10, 2005
Canada2418634Nov 12, 1998
Israel132516Mar 19, 2001
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ISSN: 2162-2639

Preferred citation:

Friedman, Y. Location of pharmaceutical innovation: 2000–2009 Nature Reviews Drug Discovery 9, 835–836 (2010).

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