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Serving leading biopharmaceutical companies globally:

US Department of Justice
Fuji
Farmers Insurance
Daiichi Sankyo
Healthtrust
Harvard Business School
Covington
Colorcon
Express Scripts
Cerilliant

Generated: December 17, 2017

DrugPatentWatch Database Preview

KALETRA Drug Profile

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When do Kaletra patents expire, 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.

US Patents and Regulatory Information

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
AbbvieKALETRAlopinavir; ritonavirTABLET;ORAL021906-001Oct 28, 2005RXYesYes► Subscribe► SubscribeY► Subscribe
AbbvieKALETRAlopinavir; ritonavirTABLET;ORAL021906-001Oct 28, 2005RXYesYes► Subscribe► Subscribe► Subscribe
AbbvieKALETRAlopinavir; ritonavirTABLET;ORAL021906-001Oct 28, 2005RXYesYes► Subscribe► SubscribeY► Subscribe
AbbvieKALETRAlopinavir; ritonavirTABLET;ORAL021906-001Oct 28, 2005RXYesYes► Subscribe► SubscribeY► Subscribe
AbbvieKALETRAlopinavir; ritonavirCAPSULE;ORAL021226-001Sep 15, 2000DISCNNoNo► Subscribe► Subscribe► Subscribe
AbbvieKALETRAlopinavir; ritonavirTABLET;ORAL021906-002Nov 9, 2007RXYesNo► Subscribe► SubscribeY► Subscribe
AbbvieKALETRAlopinavir; ritonavirTABLET;ORAL021906-002Nov 9, 2007RXYesNo► Subscribe► SubscribeY► Subscribe
AbbvieKALETRAlopinavir; ritonavirCAPSULE;ORAL021226-001Sep 15, 2000DISCNNoNo► Subscribe► SubscribeY► Subscribe
AbbvieKALETRAlopinavir; ritonavirTABLET;ORAL021906-001Oct 28, 2005RXYesYes► Subscribe► SubscribeY► Subscribe
AbbvieKALETRAlopinavir; ritonavirCAPSULE;ORAL021226-001Sep 15, 2000DISCNNoNo► Subscribe► SubscribeY► Subscribe
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Expired Patents for Tradename: KALETRA

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
AbbvieKALETRAlopinavir; ritonavirTABLET;ORAL021906-001Oct 28, 2005► Subscribe► Subscribe
AbbvieKALETRAlopinavir; ritonavirCAPSULE;ORAL021226-001Sep 15, 2000► Subscribe► Subscribe
AbbvieKALETRAlopinavir; ritonavirSOLUTION;ORAL021251-001Sep 15, 2000► Subscribe► Subscribe
AbbvieKALETRAlopinavir; ritonavirTABLET;ORAL021906-002Nov 9, 2007► Subscribe► Subscribe
AbbvieKALETRAlopinavir; ritonavirTABLET;ORAL021906-001Oct 28, 2005► Subscribe► Subscribe
AbbvieKALETRAlopinavir; ritonavirTABLET;ORAL021906-001Oct 28, 2005► Subscribe► Subscribe
AbbvieKALETRAlopinavir; ritonavirSOLUTION;ORAL021251-001Sep 15, 2000► Subscribe► Subscribe
AbbvieKALETRAlopinavir; ritonavirSOLUTION;ORAL021251-001Sep 15, 2000► Subscribe► Subscribe
AbbvieKALETRAlopinavir; ritonavirTABLET;ORAL021906-002Nov 9, 2007► Subscribe► Subscribe
AbbvieKALETRAlopinavir; ritonavirCAPSULE;ORAL021226-001Sep 15, 2000► 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
7,183,416Polymorph of a pharmaceutical► Subscribe
8,895,051Flavoring systems for pharmaceutical compositions and methods of making such compositions► Subscribe
8,333,990Solid pharmaceutical dosage form► Subscribe
5,914,332 Retroviral protease inhibiting compounds► Subscribe
7,659,405Polymorph of a pharmaceutical► Subscribe
8,193,367Polymorph of a pharmaceutical► Subscribe
6,894,171 Polymorph of a pharmaceutical► Subscribe
7,279,582Retroviral protease inhibiting compounds► Subscribe
8,674,112Polymorph of a pharmaceutical► Subscribe
7,968,707Retroviral 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
Japan2000502997► Subscribe
Argentina055734► Subscribe
Canada2598827► Subscribe
World Intellectual Property Organization (WIPO)9701349► Subscribe
Czech Republic294246► Subscribe
European Patent Office2283844► Subscribe
Canada2238977► Subscribe
Japan2000502085► Subscribe
Portugal1284140► Subscribe
Australia1342297► 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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Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
UBS
Novartis
Covington
US Army
Johnson and Johnson
Moodys
Express Scripts
Farmers Insurance
Cipla

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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