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KALETRA Drug Profile

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Which patents cover Kaletra, and what substitute generic drugs are available?

Kaletra is a drug marketed by Abbvie and is included in three NDAs. There are nineteen patents protecting this drug and two Paragraph IV challenges.

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

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

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Abbvie
KALETRA
lopinavir; ritonavir
CAPSULE;ORAL021226-001Sep 15, 2000DISCNNoNo7,432,294*PED► SubscribeY► Subscribe
Abbvie
KALETRA
lopinavir; ritonavir
CAPSULE;ORAL021226-001Sep 15, 2000DISCNNoNo6,458,818*PED► SubscribeY► Subscribe
Abbvie
KALETRA
lopinavir; ritonavir
SOLUTION;ORAL021251-001Sep 15, 2000RXYesYes8,501,219► SubscribeY ► Subscribe
Abbvie
KALETRA
lopinavir; ritonavir
CAPSULE;ORAL021226-001Sep 15, 2000DISCNNoNo6,521,651*PED► SubscribeY► Subscribe
Abbvie
KALETRA
lopinavir; ritonavir
TABLET;ORAL021906-002Nov 9, 2007RXYesNo6,037,157*PED► Subscribe ► Subscribe
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Expired Patents for Tradename: KALETRA

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Abbvie
KALETRA
lopinavir; ritonavir
TABLET;ORAL021906-001Oct 28, 20055,541,206*PED► Subscribe
Abbvie
KALETRA
lopinavir; ritonavir
TABLET;ORAL021906-001Oct 28, 20055,846,987*PED► Subscribe
Abbvie
KALETRA
lopinavir; ritonavir
SOLUTION;ORAL021251-001Sep 15, 20005,674,882*PED► Subscribe
Abbvie
KALETRA
lopinavir; ritonavir
TABLET;ORAL021906-002Nov 9, 20075,648,497*PED► Subscribe
Abbvie
KALETRA
lopinavir; ritonavir
SOLUTION;ORAL021251-001Sep 15, 20005,541,206*PED► Subscribe
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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
7,659,405Polymorph of a pharmaceutical► Subscribe
5,914,332 Retroviral protease inhibiting compounds► Subscribe
7,968,707Retroviral protease inhibiting compounds► Subscribe
8,895,051Flavoring systems for pharmaceutical compositions and methods of making such compositions► Subscribe
6,894,171 Polymorph of a pharmaceutical► Subscribe
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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
Israel122546► Subscribe
Eurasian Patent Organization200701790► Subscribe
South Korea20070114294► Subscribe
Georgia, Republic ofP20105083► Subscribe
Japan3170292► Subscribe
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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► SubscribePRODUCT 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► SubscribePRODUCT 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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