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Lopinavir; ritonavir - Generic Drug Details

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Lopinavir; ritonavir is the generic ingredient in one branded drug marketed by Abbvie and is included in three NDAs. There are twenty patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

This ingredient has one hundred and thirty patent family members in thirty-four countries.

There are twelve drug master file entries for lopinavir; ritonavir. Nine suppliers are listed for this compound. There are six tentative approvals for this compound.

Summary for Generic Name: lopinavir; ritonavir

Tradenames:1
Patents:20
Applicants:1
NDAs:3
Drug Master File Entries: see list12
Suppliers / Packaging: see list9
Therapeutic Class:Antivirals
Formulation / Manufacturing:see details
Drug Prices:see low prices

Tentative approvals for LOPINAVIR; RITONAVIR

Applicant Application No. Form Dosage
<disabled><disabled>TABLET; ORAL200MG; 50MG
<disabled><disabled>TABLET; ORAL200MG; 50MG
<disabled><disabled>TABLET; ORAL100MG; 25MG

Clinical Trials for: lopinavir; ritonavir

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Abbvie
KALETRA
lopinavir; ritonavir
TABLET;ORAL021906-001Oct 28, 2005RXYes8,309,613*PEDJun 24, 2025Y
Abbvie
KALETRA
lopinavir; ritonavir
TABLET;ORAL021906-001Oct 28, 2005RXYes8,470,347*PEDMar 17, 2027Y
Abbvie
KALETRA
lopinavir; ritonavir
TABLET;ORAL021906-002Nov 9, 2007RXNo6,037,157*PEDDec 26, 2016Y
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Expired Orange Book Patents for Generic Ingredient: lopinavir; ritonavir

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Abbvie
KALETRA
lopinavir; ritonavir
SOLUTION;ORAL021251-001Sep 15, 20005,846,987*PED<disabled>
Abbvie
KALETRA
lopinavir; ritonavir
TABLET;ORAL021906-002Nov 9, 20076,284,767*PED<disabled>
Abbvie
KALETRA
lopinavir; ritonavir
TABLET;ORAL021906-002Nov 9, 20075,648,497*PED<disabled>
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Non-Orange Book Patents for Generic Ingredient: lopinavir; 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
8,895,051Flavoring systems for pharmaceutical compositions and methods of making such compositions<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: lopinavir; ritonavir

Country Document Number Estimated Expiration
Portugal882024<disabled in preview>
Israel185390<disabled in preview>
Guatemala200600295A<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: LOPINAVIR; RITONAVIR

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
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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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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