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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
Drug Prices:see low prices
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, 2000DISCNNo6,063,811*PED► subscribeY► subscribe
Merck
VIOXX
rofecoxib
TABLET;ORAL021042-001May 20, 1999DISCNNo6,063,811*PED► subscribeY► subscribe
Merck
VIOXX
rofecoxib
TABLET;ORAL021042-002May 20, 1999DISCNNo5,691,374*PED► subscribe ► subscribe
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Expired Orange Book Patents for Generic Ingredient: rofecoxib

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Merck
VIOXX
rofecoxib
TABLET;ORAL021042-003Feb 25, 20006,239,173*PED► subscribe
Merck
VIOXX
rofecoxib
TABLET;ORAL021042-003Feb 25, 20005,691,374*PED► subscribe
Merck
VIOXX
rofecoxib
SUSPENSION;ORAL021052-002May 20, 19996,239,173*PED► subscribe
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International Patent Family for Ingredient: rofecoxib

Country Document Number Estimated Expiration
Eurasian Patent Organization001596► subscribe
Indonesia16921► subscribe
Australia5642496► subscribe
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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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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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