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Medtronic
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Generated: October 23, 2017

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Lopinavir; ritonavir - Generic Drug Details

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What are the generic 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 Generic Name: lopinavir; ritonavir

US Patents:19
Tradenames:2
Applicants:2
NDAs:4
Drug Master File Entries: see list13
Suppliers / Packagers: see list10
Bulk Api Vendors: see list2
Clinical Trials: see list805
Patent Applications: see list11
Therapeutic Class:Antivirals
Drug Prices:see low prices
DailyMed Link:lopinavir; ritonavir at DailyMed

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 Product Substance Delist Req. Exclusivity Expiration
Abbvie
KALETRA
lopinavir; ritonavir
SOLUTION;ORAL021251-001Sep 15, 2000AARXYesYes► Subscribe► Subscribe ► Subscribe
Abbvie
KALETRA
lopinavir; ritonavir
TABLET;ORAL021906-001Oct 28, 2005RXYesYes► Subscribe► SubscribeY► Subscribe
Silarx Pharms Inc
LOPINAVIR AND RITONAVIR
lopinavir; ritonavir
SOLUTION;ORAL207407-001Dec 27, 2016AARXNoNo► Subscribe► Subscribe► Subscribe
Abbvie
KALETRA
lopinavir; ritonavir
TABLET;ORAL021906-002Nov 9, 2007RXYesNo► Subscribe► SubscribeY► Subscribe
Abbvie
KALETRA
lopinavir; ritonavir
TABLET;ORAL021906-002Nov 9, 2007RXYesNo► Subscribe► Subscribe ► Subscribe
Abbvie
KALETRA
lopinavir; ritonavir
SOLUTION;ORAL021251-001Sep 15, 2000AARXYesYes► Subscribe► Subscribe ► Subscribe
Abbvie
KALETRA
lopinavir; ritonavir
CAPSULE;ORAL021226-001Sep 15, 2000DISCNNoNo► Subscribe► SubscribeY► Subscribe
Abbvie
KALETRA
lopinavir; ritonavir
TABLET;ORAL021906-001Oct 28, 2005RXYesYes► Subscribe► SubscribeY► Subscribe
Abbvie
KALETRA
lopinavir; ritonavir
CAPSULE;ORAL021226-001Sep 15, 2000DISCNNoNo► Subscribe► Subscribe ► Subscribe
Abbvie
KALETRA
lopinavir; ritonavir
TABLET;ORAL021906-002Nov 9, 2007RXYesNo► 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
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;ORAL021906-001Oct 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
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
Abbvie
KALETRA
lopinavir; ritonavir
TABLET;ORAL021906-002Nov 9, 2007► 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
5,914,332 Retroviral protease inhibiting compounds► Subscribe
8,674,112Polymorph of a pharmaceutical► Subscribe
7,183,416Polymorph of a pharmaceutical► Subscribe
8,333,990Solid pharmaceutical dosage form► Subscribe
7,968,707Retroviral protease inhibiting compounds► Subscribe
8,895,051Flavoring systems for pharmaceutical compositions and methods of making such compositions► Subscribe
9,255,092Polymorph of a pharmaceutical► Subscribe
6,472,529 Retroviral protease inhibiting compounds► Subscribe
6,894,171 Polymorph of a pharmaceutical► Subscribe
7,659,405Polymorph 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
Hong Kong1053783► Subscribe
European Patent Office1284140► Subscribe
World Intellectual Property Organization (WIPO)2006091529► Subscribe
Hungary9901079► Subscribe
European Patent Office1293207► Subscribe
Germany69624136► Subscribe
Taiwan494097► Subscribe
Argentina077411► Subscribe
Australia6342096► Subscribe
TaiwanI292752► 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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For more information try a trial or see the database preview and plans and pricing

Serving leading biopharmaceutical companies globally:

Mallinckrodt
Chubb
Federal Trade Commission
US Army
McKesson
Teva
Dow
Fish and Richardson
AstraZeneca
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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