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Serving leading biopharmaceutical companies globally:

Daiichi Sankyo
Covington
US Army
Moodys
Fish and Richardson
Colorcon
Harvard Business School
Boehringer Ingelheim
Novartis
Dow

Generated: October 21, 2017

DrugPatentWatch Database Preview

KALETRA Drug Profile

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What is the patent landscape for Kaletra, and when can generic versions of Kaletra launch?

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-nine patent family members in thirty-four countries and two supplementary protection certificates in two countries.

The generic ingredient in KALETRA is lopinavir; ritonavir. There are thirteen drug master file entries for this compound. Ten suppliers are listed for this compound. Additional details are available on the lopinavir; ritonavir profile page.
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Abbvie
KALETRA
lopinavir; ritonavir
CAPSULE;ORAL021226-001Sep 15, 2000DISCNNoNo► Subscribe► SubscribeY► Subscribe
Abbvie
KALETRA
lopinavir; ritonavir
CAPSULE;ORAL021226-001Sep 15, 2000DISCNNoNo► Subscribe► SubscribeY► Subscribe
Abbvie
KALETRA
lopinavir; ritonavir
SOLUTION;ORAL021251-001Sep 15, 2000AARXYesYes► Subscribe► SubscribeY ► Subscribe
Abbvie
KALETRA
lopinavir; ritonavir
CAPSULE;ORAL021226-001Sep 15, 2000DISCNNoNo► Subscribe► SubscribeY► Subscribe
Abbvie
KALETRA
lopinavir; ritonavir
TABLET;ORAL021906-002Nov 9, 2007RXYesNo► Subscribe► Subscribe ► Subscribe
Abbvie
KALETRA
lopinavir; ritonavir
TABLET;ORAL021906-001Oct 28, 2005RXYesYes► Subscribe► SubscribeY► Subscribe
Abbvie
KALETRA
lopinavir; ritonavir
TABLET;ORAL021906-001Oct 28, 2005RXYesYes► Subscribe► SubscribeY► Subscribe
Abbvie
KALETRA
lopinavir; ritonavir
TABLET;ORAL021906-002Nov 9, 2007RXYesNo► Subscribe► SubscribeY► Subscribe
Abbvie
KALETRA
lopinavir; ritonavir
SOLUTION;ORAL021251-001Sep 15, 2000AARXYesYes► Subscribe► Subscribe ► Subscribe
Abbvie
KALETRA
lopinavir; ritonavir
TABLET;ORAL021906-002Nov 9, 2007RXYesNo► Subscribe► SubscribeY► 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
CAPSULE;ORAL021226-001Sep 15, 2000► Subscribe► Subscribe
Abbvie
KALETRA
lopinavir; ritonavir
TABLET;ORAL021906-002Nov 9, 2007► Subscribe► Subscribe
Abbvie
KALETRA
lopinavir; ritonavir
TABLET;ORAL021906-001Oct 28, 2005► Subscribe► Subscribe
Abbvie
KALETRA
lopinavir; ritonavir
CAPSULE;ORAL021226-001Sep 15, 2000► Subscribe► Subscribe
Abbvie
KALETRA
lopinavir; ritonavir
TABLET;ORAL021906-001Oct 28, 2005► Subscribe► Subscribe
Abbvie
KALETRA
lopinavir; ritonavir
CAPSULE;ORAL021226-001Sep 15, 2000► Subscribe► Subscribe
Abbvie
KALETRA
lopinavir; ritonavir
CAPSULE;ORAL021226-001Sep 15, 2000► Subscribe► Subscribe
Abbvie
KALETRA
lopinavir; ritonavir
SOLUTION;ORAL021251-001Sep 15, 2000► Subscribe► Subscribe
Abbvie
KALETRA
lopinavir; ritonavir
TABLET;ORAL021906-002Nov 9, 2007► Subscribe► Subscribe
Abbvie
KALETRA
lopinavir; ritonavir
TABLET;ORAL021906-001Oct 28, 2005► Subscribe► Subscribe
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Paragraph IV (Patent) Challenges 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
7,968,707Retroviral protease inhibiting compounds► Subscribe
8,895,051Flavoring systems for pharmaceutical compositions and methods of making such compositions► Subscribe
5,914,332 Retroviral protease inhibiting compounds► Subscribe
7,659,405Polymorph of a pharmaceutical► Subscribe
8,193,367Polymorph of a pharmaceutical► Subscribe
6,472,529 Retroviral protease inhibiting compounds► Subscribe
8,333,990Solid pharmaceutical dosage form► Subscribe
7,279,582Retroviral protease inhibiting compounds► Subscribe
6,894,171 Polymorph of a pharmaceutical► Subscribe
6,313,296 Retroviral protease inhibiting compounds► 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
European Patent Office1295874► Subscribe
Spain2173341► Subscribe
Australia2006216856► Subscribe
Mexico2007010275► Subscribe
Israel136661► Subscribe
Hungary9901079► Subscribe
Australia6342096► Subscribe
South Korea101429024► Subscribe
South Korea20070120619► Subscribe
New Zealand326132► 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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For more information try a trial or see the database preview and plans and pricing

Serving leading biopharmaceutical companies globally:

Citi
Express Scripts
Healthtrust
Harvard Business School
McKinsey
Mallinckrodt
Queensland Health
McKesson
Cerilliant
Colorcon

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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