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Ritonavir - Generic Drug Details

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Ritonavir is the generic ingredient in two branded drugs marketed by Abbvie, Roxane, and Abbott, and is included in five NDAs. There are eleven patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

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

There are twenty-one drug master file entries for ritonavir. Three suppliers are listed for this compound. There are four tentative approvals for this compound.

Summary for Generic Name: ritonavir

Tradenames:2
Patents:11
Applicants:3
NDAs:5
Drug Master File Entries: see list21
Suppliers / Packaging: see list3
Therapeutic Class:Antivirals
Formulation / Manufacturing:see details

Tentative approvals for RITONAVIR

Applicant Application No. Form Dosage
<disabled><disabled>TABLET;ORAL100MG
<disabled><disabled>TABLET;ORAL100MG
<disabled><disabled>TABLET; ORAL25MG

Clinical Trials for: ritonavir

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, 2010RXYes7,364,752*PED<disabled>Y<disabled>
Abbvie
NORVIR
ritonavir
SOLUTION;ORAL020659-001Mar 1, 1996RXYes6,703,403*PED<disabled>Y<disabled>
Abbvie
NORVIR
ritonavir
TABLET;ORAL022417-001Feb 10, 2010RXYes6,703,403*PED<disabled>Y<disabled>
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Expired Orange Book Patents for Generic Ingredient: ritonavir

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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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Non-Orange Book Patents for Generic Ingredient: ritonavir

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
6,458,818 Pharmaceutical composition<disabled in preview>
7,183,416Polymorph of a pharmaceutical<disabled in preview>
6,894,171 Polymorph of a pharmaceutical<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 Ingredient: ritonavir

Country Document Number Estimated Expiration
Canada2224738<disabled in preview>
Denmark1293207<disabled in preview>
European Patent Office1210941<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: RITONAVIR

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
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
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
0674513Switzerland<disabled>PRODUCT NAME: LOPINAVIR UND RITONAVIR; REGISTRATION NO/DATE: IKS 55648 20001213
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