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Rofecoxib - Generic Drug Details

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Rofecoxib is the generic ingredient in one branded drug marketed by Merck and is included in two NDAs. There are two patents protecting this compound. Additional information is available in the individual branded drug profile pages.

This ingredient has forty-seven patent family members in thirty-six countries.

There are two drug master file entries for rofecoxib.

Summary for Generic Name: rofecoxib

Tradenames:1
Patents:2
Applicants:1
NDAs:2
Drug Master File Entries: see list2
Formulation / Manufacturing:see details

Clinical Trials for: rofecoxib

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Merck
VIOXX
rofecoxib
TABLET;ORAL021042-003Feb 25, 2000DISCNNo5,691,374*PED<disabled> <disabled>
Merck
VIOXX
rofecoxib
TABLET;ORAL021042-001May 20, 1999DISCNNo6,063,811*PED<disabled>Y<disabled>
Merck
VIOXX
rofecoxib
SUSPENSION;ORAL021052-001May 20, 1999DISCNNo5,691,374*PED<disabled> <disabled>
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Expired Orange Book Patents for Generic Ingredient: rofecoxib

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Merck
VIOXX
rofecoxib
SUSPENSION;ORAL021052-002May 20, 19996,239,173*PED<disabled>
Merck
VIOXX
rofecoxib
TABLET;ORAL021042-001May 20, 19995,691,374*PED<disabled>
Merck
VIOXX
rofecoxib
SUSPENSION;ORAL021052-002May 20, 19995,691,374*PED<disabled>
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International Patent Family for Ingredient: rofecoxib

Country Document Number Estimated Expiration
European Patent Office0910368<disabled in preview>
Czech Republic9803738<disabled in preview>
Argentina012014<disabled in preview>
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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