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KALETRA Drug Profile

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Kaletra is a drug marketed by Abbvie and is included in three NDAs. It is available from nine suppliers. There are twenty patents protecting this drug and two Paragraph IV challenges.

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

The generic ingredient in KALETRA is lopinavir; ritonavir. There are twelve drug master file entries for this compound. Nine suppliers are listed for this compound. There are six tentative approvals for this compound. Additional details are available on the lopinavir; ritonavir profile page.

Clinical Trials for: KALETRA

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Abbvie
KALETRA
lopinavir; ritonavir
SOLUTION;ORAL021251-001Sep 15, 2000RXYes6,911,214*PEDMay 28, 2022Y
Abbvie
KALETRA
lopinavir; ritonavir
CAPSULE;ORAL021226-001Sep 15, 2000DISCNNo6,521,651*PEDMay 7, 2018Y
Abbvie
KALETRA
lopinavir; ritonavir
CAPSULE;ORAL021226-001Sep 15, 2000DISCNNo6,037,157*PEDDec 26, 2016Y
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Expired Patents for Tradename: KALETRA

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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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Paragraph IV activity for: KALETRA

Drugname Dosage Strength RLD Submissiondate
lopinavir and ritonavirOral Solution80 mg/20 mg per mLKaletra6/19/2014
lopinavir and ritonavirTablets100 mg/25 mgKaletra12/23/2008

Non-Orange Book Patents for Tradename: KALETRA

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
9,255,092Polymorph of a pharmaceutical<disabled in preview>
6,313,296 Retroviral protease inhibiting compounds<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 Tradename: KALETRA

Country Document Number Estimated Expiration
South Africa9610475<disabled in preview>
Georgia, Republic ofP20105083<disabled in preview>
Israel124607<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: KALETRA

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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