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Details for Patent: 8,518,421

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Patent 8,518,421 protects ABILIFY and is included in one NDA. There have been three Paragraph IV challenges on Abilify. There are four tentative approvals for the compound protected by this patent. Additional details are available via the generic ingredient links below.

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

Summary for Patent: 8,518,421

Title:Flashmelt oral dosage formulation
Abstract: There is provided granules for the production of flash-melt pharmaceutical oral dosage forms. In addition to one or more medicaments, the granules are composed of an excipient combination consisting of a superdisintegrant, a dispersing agent, a distributing agent, and a binder and may also include other conventional ingredients such as sweetening and flavoring agents. The subject granules are advantageous in that they are stable and can be prepared without the aid of solvents and without the need for special environments or handling. Dosage forms, especially tablets, prepared therefrom on conventional equipment disintegrate in the mouth in under about twenty five seconds.
Inventor(s): Kothari; Sanjeev H. (Princeton, NJ), Desai; Divyakant S. (West Windsor, NJ)
Assignee: Bristol-Myers Squibb Company (Princeton, NJ)
Application Number:13/108,193
Patent Claim Types:
see list of patent claims
Composition; Dosage form;
Patent Metrics:
Source: PatentQuant.com
Field: Pharmaceuticals
Back Citations: 0th percentile
Forward Citations: 2nd percentile

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use
TABLET, ORALLY DISINTEGRATING;ORAL021729-002Jun 7, 2006DISCNNo8,518,421*PEDJul 24, 2021Y
TABLET, ORALLY DISINTEGRATING;ORAL021729-003Jun 7, 2006DISCNNo8,518,421*PEDJul 24, 2021Y
TABLET, ORALLY DISINTEGRATING;ORAL021729-004Jun 7, 2006DISCNNo8,518,421*PEDJul 24, 2021Y
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