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Details for Patent: 5,540,938

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Patent 5,540,938 protects AMPYRA and is included in one NDA. There has been one Paragraph IV challenge on Ampyra.

This patent has eighteen patent family members in fifteen countries.

Summary for Patent: 5,540,938

Title: Formulations and their use in the treatment of neurological diseases
Abstract:Pharmaceutical formulations comprise a mono- or di-aminopyridine active agent for administration on a once- or twice-daily basis for use in the treatment of neurological diseases, in particular multiple sclerosis and Alzheimer's disease. The formulations, which are suitable for oral or percutaneous administration of the active agent, include the active agent in a carrier effective to permit release of the mono- or di-aminopyridine at a rate allowing controlled absorption thereof over, on the average, not less than a 12 hour period and at a rate sufficient to achieve therapeutically effective blood levels over a period of 12-24 hours following administration.
Inventor(s): Masterson; Joseph G. (London, GB), Myers; Michael (Athlone, IE)
Assignee: Elan Corporation, plc (Athlone, IE)
Application Number:08/328,165
Patent Claim Types:
see list of patent claims
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
Acorda
AMPYRA
dalfampridine
TABLET, EXTENDED RELEASE;ORAL022250-001Jan 22, 2010RXYes5,540,938<disabled>IMPROVEMENT OF WALKING IN PATIENTS WITH MULTIPLE SCLEROSIS (MS)
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Non-Orange Book Patents for Patent: 5,540,938

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
5,370,879 Formulations and their use in the treatment of neurological diseases<disabled in preview>
5,580,580 Formulations and their use in the treatment of neurological diseases<disabled in preview>
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International Patent Family for Patent: 5,540,938

Country Document Number Publication Date Supplementary Protection Certificate SPC Country SPC Expiration
South Africa9108711Aug 26, 1992
European Patent Office0484186May 06, 199291894Luxembourg<disabled>
Canada2054822May 03, 1992
European Patent Office0484186May 06, 199211C0049France<disabled>
Austria188118Jan 15, 2000
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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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