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Details for Patent: 5,648,093

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Patent 5,648,093 protects PROPULSID QUICKSOLV, ZELAPAR, and RISPERDAL, and is included in three NDAs. There have been two Paragraph IV challenges on Risperdal. There is one tentative approval for the compound protected by this patent. Additional details are available via the generic ingredient links below.

Protection for RISPERDAL has been extended six months for pediatric studies, as indicated by the *PED designation in the table below.

This patent has fifty-three patent family members in thirty countries.

Summary for Patent: 5,648,093

Title: Pharmaceutical and other dosage forms
Abstract:A fast dissolving, solid dosage form defined by a matrix containing gelatin, pectin and/or soy fiber protein and one or more amino acids having from about 2 to 12 carbon atoms is disclosed.
Inventor(s): Gole; Dilip J. (Ann Arbor, MI), Levinson; R. Saul (Chesterfield, MO), Wilkinson; Paul K. (Ann Arbor, MI), Davies; J. Desmond (Grosse Pointe Farms, MI)
Assignee: Janssen Pharmaceutica Inc. (Piscataway, NJ)
Application Number:08/447,253
Patent Claim Types:
see list of patent claims
Composition; Formulation; Compound; Dosage form;
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
Janssen Pharma
cisapride monohydrate
TABLET, ORALLY DISINTEGRATING;ORAL020767-001Nov 7, 1997DISCNNo5,648,093<disabled>
Valeant Pharm Intl
selegiline hydrochloride
TABLET, ORALLY DISINTEGRATING;ORAL021479-001Jun 14, 2006RXYes5,648,093<disabled>Y
Janssen Pharms
TABLET, ORALLY DISINTEGRATING;ORAL021444-001Apr 2, 2003RXNo5,648,093*PED<disabled>Y
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Non-Orange Book Patents for Patent: 5,648,093

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
5,120,549 United States Patent: 5120549   ( 1<disabled in preview>
5,558,880 Pharmaceutical and other dosage forms<disabled in preview>
5,215,756 Preparation of pharmaceutical and other matrix systems by solid-state dissolution<disabled in preview>
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International Patent Family for Patent: 5,648,093

Country Document Number Publication Date Supplementary Protection Certificate SPC Country SPC Expiration
JapanH07508019Sep 07, 1995
Slovakia280129Aug 06, 1999
El Salvador1998000062Nov 05, 1998
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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 information. There is no warranty that the information contained herein is error free. 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.

Copyright 2002-2016 thinkBiotech LLC
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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