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Serving leading biopharmaceutical companies globally:

Cerilliant
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Generated: December 12, 2017

DrugPatentWatch Database Preview

Lopinavir; ritonavir - Generic Drug Details

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What are the generic drug sources for lopinavir; ritonavir and what is the scope of lopinavir; ritonavir freedom to operate?

Lopinavir; ritonavir
is the generic ingredient in two branded drugs marketed by Abbvie and Silarx Pharms Inc, and is included in four NDAs. There are nineteen patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Lopinavir; ritonavir has one hundred and thirty-nine patent family members in thirty-four countries and two supplementary protection certificates in two countries.

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

Summary for lopinavir; ritonavir

Tentative approvals for LOPINAVIR; RITONAVIR

Applicant Application No. Strength Dosage Form
u► Subscribe200MG; 50MGTABLET; ORAL
u► Subscribe200MG; 50MGTABLET; ORAL
u► Subscribe200MG; 50MGTABLET; ORAL
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Patent Submitted Product Substance Delist Req. Exclusivity Expiration
AbbvieKALETRAlopinavir; ritonavirCAPSULE;ORAL021226-001Sep 15, 2000DISCNNoNo► Subscribe► Subscribe► Subscribe► Subscribe
AbbvieKALETRAlopinavir; ritonavirTABLET;ORAL021906-002Nov 9, 2007RXYesNo► Subscribe► Subscribe► SubscribeY► Subscribe
AbbvieKALETRAlopinavir; ritonavirTABLET;ORAL021906-001Oct 28, 2005RXYesYes► Subscribe► Subscribe► SubscribeY► Subscribe
AbbvieKALETRAlopinavir; ritonavirCAPSULE;ORAL021226-001Sep 15, 2000DISCNNoNo► Subscribe► Subscribe► SubscribeY► Subscribe
AbbvieKALETRAlopinavir; ritonavirTABLET;ORAL021906-001Oct 28, 2005RXYesYes► Subscribe► Subscribe► Subscribe► Subscribe
AbbvieKALETRAlopinavir; ritonavirSOLUTION;ORAL021251-001Sep 15, 2000AARXYesYes► Subscribe► Subscribe► SubscribeY► Subscribe
AbbvieKALETRAlopinavir; ritonavirTABLET;ORAL021906-001Oct 28, 2005RXYesYes► Subscribe► Subscribe► Subscribe► Subscribe
AbbvieKALETRAlopinavir; ritonavirCAPSULE;ORAL021226-001Sep 15, 2000DISCNNoNo► Subscribe► Subscribe► Subscribe► Subscribe
AbbvieKALETRAlopinavir; ritonavirTABLET;ORAL021906-001Oct 28, 2005RXYesYes► Subscribe► Subscribe► Subscribe► Subscribe
AbbvieKALETRAlopinavir; ritonavirTABLET;ORAL021906-001Oct 28, 2005RXYesYes► Subscribe► Subscribe► SubscribeY► Subscribe
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Expired Orange Book Patents for Generic Ingredient: lopinavir; ritonavir

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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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
7,659,405Polymorph of a pharmaceutical► Subscribe
6,894,171 Polymorph of a pharmaceutical► Subscribe
8,674,112Polymorph of a pharmaceutical► Subscribe
5,914,332 Retroviral protease inhibiting compounds► Subscribe
8,333,990Solid pharmaceutical dosage form► Subscribe
7,183,416Polymorph of a pharmaceutical► Subscribe
8,895,051Flavoring systems for pharmaceutical compositions and methods of making such compositions► Subscribe
7,279,582Retroviral protease inhibiting compounds► Subscribe
7,968,707Retroviral protease inhibiting compounds► Subscribe
8,193,367Polymorph 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 Ingredient: lopinavir; ritonavir

Country Document Number Estimated Expiration
World Intellectual Property Organization (WIPO)9701349► Subscribe
Georgia, Republic ofP20105083► Subscribe
Argentina055734► Subscribe
Japan5597689► Subscribe
World Intellectual Property Organization (WIPO)9721685► Subscribe
Mexico9710403► Subscribe
Ukraine89220► Subscribe
Ukraine89220► Subscribe
European Patent Office0876353► 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: LOPINAVIR; RITONAVIR

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:

Fish and Richardson
QuintilesIMS
Baxter
McKesson
Argus Health
US Department of Justice
Chinese Patent Office
Deloitte
UBS
Boehringer Ingelheim

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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