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APIDRA Drug Profile

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Apidra is a drug marketed by Sanofi Aventis Us and is included in one NDA. It is available from one supplier. There are twelve patents protecting this drug.

This drug has eighty patent family members in thirty-nine countries.

The generic ingredient in APIDRA is insulin glulisine recombinant. There are thirty-eight drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the insulin glulisine recombinant profile page.

Summary for Tradename: APIDRA

Patents:12
Applicants:1
NDAs:1
Suppliers / Packagers: see list1

Pharmacology for Tradename: APIDRA

Ingredient-typeInsulin
Drug ClassInsulin Analog

Clinical Trials for: APIDRA

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Sanofi Aventis Us
APIDRA
insulin glulisine recombinant
INJECTABLE;IV (INFUSION), SUBCUTANEOUS021629-001Apr 16, 2004RXYes6,221,633<disabled>YY <disabled>
Sanofi Aventis Us
APIDRA SOLOSTAR
insulin glulisine recombinant
INJECTABLE;SUBCUTANEOUS021629-003Feb 24, 2009RXNo8,679,069<disabled>Y <disabled>
Sanofi Aventis Us
APIDRA
insulin glulisine recombinant
INJECTABLE;IV (INFUSION), SUBCUTANEOUS021629-002Dec 20, 2005RXYes7,696,162<disabled>Y <disabled>
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Non-Orange Book Patents for Tradename: APIDRA

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
7,205,276Zinc-free and low-zinc insulin preparations having improved stability<disabled in preview>
7,205,277Zinc-free and low-zinc insulin preparations having improved stability<disabled in preview>
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.

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International Patent Family for Tradename: APIDRA

Country Document Number Estimated Expiration
Cyprus1113318<disabled in preview>
Austria283919<disabled in preview>
Malaysia129417<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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Supplementary Protection Certificates for Tradename: APIDRA

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
90036-0Sweden<disabled>PRODUCT NAME: KOMBINATION AV INSULIN DEGLUDEK OCH INSULIN ASPART; REG. NO/DATE: EU/1/12/806/001 20130121
13/034Ireland<disabled>PRODUCT NAME: INSULIN DEGLUDEC; NATL. REGISTRATION NO/DATE: EU/1/12/807-001, 004, 005, 007-009, 012, 013 AND 015 20130121; FIRST REGISTRATION: EU/1/12/807-001, 004, 005, 007-009, 012, 013 AND 015 20130121
2005 00018Denmark<disabled>
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