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NORVIR Drug Profile

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Norvir is a drug marketed by Abbvie and Abbott and is included in four NDAs. It is available from three suppliers. There are eleven patents protecting this drug and two Paragraph IV challenges.

This drug has seventy patent family members in thirty-one countries.

The generic ingredient in NORVIR is ritonavir. There are twenty-one drug master file entries for this compound. Three suppliers are listed for this compound. There are four tentative approvals for this compound. Additional details are available on the ritonavir profile page.

Clinical Trials for: NORVIR

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Abbvie
NORVIR
ritonavir
TABLET;ORAL022417-001Feb 10, 2010RXYes8,691,878*PED<disabled>Y<disabled>
Abbvie
NORVIR
ritonavir
TABLET;ORAL022417-001Feb 10, 2010RXYes6,703,403*PED<disabled>Y<disabled>
Abbvie
NORVIR
ritonavir
TABLET;ORAL022417-001Feb 10, 2010RXYes8,268,349*PED<disabled>Y<disabled>
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Expired Patents for Tradename: NORVIR

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Abbvie
NORVIR
ritonavir
CAPSULE;ORAL020945-001Jun 29, 19995,846,987*PED<disabled>
Abbvie
NORVIR
ritonavir
CAPSULE;ORAL020945-001Jun 29, 19995,635,523*PED<disabled>
Abbvie
NORVIR
ritonavir
TABLET;ORAL022417-001Feb 10, 20105,648,497*PED<disabled>
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Paragraph IV activity for: NORVIR

Drugname Dosage Strength RLD Submissiondate
ritonavirCapsules100 mgNorvir10/31/2012
ritonavirTablets100 mgNorvir12/21/2010

Non-Orange Book Patents for Tradename: NORVIR

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
8,333,990Solid pharmaceutical dosage form<disabled in preview>
9,255,092Polymorph of a pharmaceutical<disabled in preview>
8,025,899Solid pharmaceutical dosage form<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: NORVIR

Country Document Number Estimated Expiration
European Patent Office2130534<disabled in preview>
Portugal1293207<disabled in preview>
TaiwanI381840<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: NORVIR

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0674513Switzerland<disabled>PRODUCT NAME: LOPINAVIR UND RITONAVIR; REGISTRATION NO/DATE: IKS 55648 20001213
00060Netherlands<disabled>PRODUCT NAME: RITONAVIR, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AAN- VAARDBAAR ZOUT OF EEN FARMACEUTISCH AANVAARDBARE ESTER, EN LOPINAVIR; REGISTRATION NO/DATE: EU/1/01/172/001 - EU/1/01/172/003 20010320
C/GB01/044United Kingdom<disabled>PRODUCT NAME: THE COMBINATION OF THE ACTIVE INGREDIENTS RITONAVIR AND LOPINAVIR; REGISTERED: CH 55649 20001213; UK EU/1/01/172/001 20010320; UK EU/1/01/172/002 20010320; UK EU/1/01/172/003 20010320
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