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PRELAY Drug Profile

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Prelay is a drug marketed by Sankyo and is included in one NDA. There are two patents protecting this drug.

This drug has forty-four patent family members in thirty-five countries.

The generic ingredient in PRELAY is troglitazone. Additional details are available on the troglitazone profile page.

Summary for Tradename: PRELAY

Patents:2
Applicants:1
NDAs:1

Clinical Trials for: PRELAY

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Sankyo
PRELAY
troglitazone
TABLET;ORAL020719-001Jan 29, 1997DISCNNo5,859,037<disabled> <disabled>
Sankyo
PRELAY
troglitazone
TABLET;ORAL020719-003Aug 4, 1997DISCNNo6,011,049<disabled> <disabled>
Sankyo
PRELAY
troglitazone
TABLET;ORAL020719-001Jan 29, 1997DISCNNo6,011,049<disabled> <disabled>
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Expired Patents for Tradename: PRELAY

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Sankyo
PRELAY
troglitazone
TABLET;ORAL020719-003Aug 4, 19975,104,888<disabled>
Sankyo
PRELAY
troglitazone
TABLET;ORAL020719-002Jan 29, 19974,572,912<disabled>
Sankyo
PRELAY
troglitazone
TABLET;ORAL020719-002Jan 29, 19975,602,133<disabled>
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Premature patent expiration for: PRELAY

Expiration due to failure to pay maintenance fee

Patent Number Tradename Expiration Date
5,859,037
PRELAY
January 12, 2011
6,011,049
PRELAY
January 04, 2012

Non-Orange Book Patents for Tradename: PRELAY

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
5,972,973 Sulfonylurea-glitazone combinations for diabetes<disabled in preview>
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International Patent Family for Tradename: PRELAY

Country Document Number Estimated Expiration
Canada2272478<disabled in preview>
South Africa9801343<disabled in preview>
Japan2002529417<disabled in preview>
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Supplementary Protection Certificates for Tradename: PRELAY

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
C/GB97/084United Kingdom<disabled>PRODUCT NAME: TROGLITAZONE, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT; REGISTERED: UK 10949/0277 19970729; UK 10949/0278 19970729; UK 10949/0279 19970729; UK 06384/0005 19970729; UK 06384/0006 19970729; UK 06384/0007 19970729
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