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ELOXATIN Drug Profile

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Eloxatin is a drug marketed by Sanofi Aventis Us and is included in two NDAs. It is available from two suppliers. There are two patents protecting this drug and four Paragraph IV challenges.

This drug has twenty-four patent family members in fifteen countries.

The generic ingredient in ELOXATIN is oxaliplatin. There are twenty-six drug master file entries for this compound. Thirteen suppliers are listed for this compound. There are five tentative approvals for this compound. Additional details are available on the oxaliplatin profile page.

Summary for Tradename: ELOXATIN

Patents:2
Applicants:1
NDAs:2
Suppliers / Packagers: see list2

Pharmacology for Tradename: ELOXATIN

Clinical Trials for: ELOXATIN

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Sanofi Aventis Us
ELOXATIN
oxaliplatin
INJECTABLE;IV (INFUSION)021759-001Jan 31, 2005RXYes5,716,988*PED<disabled>Y<disabled>
Sanofi Aventis Us
ELOXATIN
oxaliplatin
INJECTABLE;IV (INFUSION)021492-001Aug 9, 2002DISCNNo5,420,319*PED<disabled>Y<disabled>
Sanofi Aventis Us
ELOXATIN
oxaliplatin
INJECTABLE;IV (INFUSION)021759-002Jan 31, 2005RXYes5,420,319*PED<disabled>Y<disabled>
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Expired Patents for Tradename: ELOXATIN

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Sanofi Aventis Us
ELOXATIN
oxaliplatin
INJECTABLE;IV (INFUSION)021759-002Jan 31, 20055,338,874*PED<disabled>
Sanofi Aventis Us
ELOXATIN
oxaliplatin
INJECTABLE;IV (INFUSION)021492-002Aug 9, 20025,338,874*PED<disabled>
Sanofi Aventis Us
ELOXATIN
oxaliplatin
INJECTABLE;IV (INFUSION)021492-001Aug 9, 20025,290,961*PED<disabled>
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Paragraph IV activity for: ELOXATIN

Drugname Dosage Strength RLD Submissiondate
oxaliplatinInjection5 mg/mL, 40 mL vialEloxatin3/23/2011
oxaliplatinInjection200 mg/40 mLEloxatin7/16/2007
oxaliplatinInjection5 mg/mL, 10 mL and 20 mL vialsEloxatin2/9/2007
oxaliplatinFor Injection50 mg/vial and 100 mg/vialEloxatin2/9/2007

International Patent Family for Tradename: ELOXATIN

Country Document Number Estimated Expiration
China1138541<disabled in preview>
JapanH06329692<disabled in preview>
South Korea100365171<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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