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Details for Patent: 6,413,549

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Patent 6,413,549 protects METOZOLV ODT and is included in one NDA. There has been one Paragraph IV challenge on Metozolv ODT.

This patent has four patent family members in three countries.

Summary for Patent: 6,413,549

Title: Fast-Dispersing solid oral dosage form containing coarse particles
Abstract:This invention is directed to an oral solid, rapidly disintegrating, freeze-dried dosage form containing coarse particles of a pharmaceutically active material which are uncoated or coated with a polymer or lipid material. Preferably, the oral dosage form comprises coarse particles having a size in the range of 50 micron to 400 micron. The oral solid rapidly disintegrating dosage form according to the present invention preferably disintegrates in the oral cavity in less than 10 seconds.
Inventor(s): Green; Richard (Wiltshire, GB), Kearney; Patrick (Swindon, GB)
Assignee: R. P. Scherer Corporation (Basking Ridge, NJ)
Application Number:09/335,177
Patent Claim Types:
see list of patent claims
Composition; Dosage form;
Patent Metrics:
Source: PatentQuant.com
Field: Pharmaceuticals
Back Citations: 3rd 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
Salix Pharms
METOZOLV ODT
metoclopramide hydrochloride
TABLET, ORALLY DISINTEGRATING;ORAL022246-001Sep 4, 2009RXYes6,413,549► subscribeY
Salix Pharms
METOZOLV ODT
metoclopramide hydrochloride
TABLET, ORALLY DISINTEGRATING;ORAL022246-002Sep 4, 2009DISCNNo6,413,549► subscribeY
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Non-Orange Book Patents for Patent: 6,413,549

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
5,976,577 Process for preparing fast dispersing solid oral dosage 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: 6,413,549

Country Document Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Australia8399298► subscribe
Japan2001509478► subscribe
Japan4943581► 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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