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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.

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
Janssen Pharms
TABLET, ORALLY DISINTEGRATING;ORAL021444-002Apr 2, 2003RXYes5,648,093*PED<disabled>Y
Janssen Pharms
TABLET, ORALLY DISINTEGRATING;ORAL021444-003Apr 2, 2003RXNo5,648,093*PED<disabled>Y
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International Patent Family for Patent: 5,648,093

Country Document Number Publication Date
World Intellectual Property Organization (WIPO)9109591Jul 11, 1991
World Intellectual Property Organization (WIPO)9323017Nov 25, 1993
United States of America5120549Jun 09, 1992
United States of America5215756Jun 01, 1993
United States of America5330763Jul 19, 1994
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Preferred citation:

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

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