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Serving leading biopharmaceutical companies globally:

QuintilesIMS
Express Scripts
Accenture
Johnson and Johnson
Julphar
AstraZeneca
Farmers Insurance
Federal Trade Commission
Novartis
Baxter

Generated: February 21, 2018

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 sixteen patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Lopinavir; ritonavir has thirty-eight patent family members in twenty-five 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
➤ Sign Up➤ Sign Up200MG; 50MGTABLET; ORAL
➤ Sign Up➤ Sign Up200MG; 50MGTABLET; ORAL
➤ Sign Up➤ Sign Up200MG; 50MGTABLET; ORAL

US Patents and Regulatory Information for lopinavir; ritonavir

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 TABLET;ORAL 021906-001 Oct 28, 2005 RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Abbvie KALETRA lopinavir; ritonavir CAPSULE;ORAL 021226-001 Sep 15, 2000 DISCN No No ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Abbvie KALETRA lopinavir; ritonavir TABLET;ORAL 021906-002 Nov 9, 2007 RX Yes No ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Abbvie KALETRA lopinavir; ritonavir CAPSULE;ORAL 021226-001 Sep 15, 2000 DISCN No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Abbvie KALETRA lopinavir; ritonavir SOLUTION;ORAL 021251-001 Sep 15, 2000 AA RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Abbvie KALETRA lopinavir; ritonavir SOLUTION;ORAL 021251-001 Sep 15, 2000 AA RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Abbvie KALETRA lopinavir; ritonavir TABLET;ORAL 021906-001 Oct 28, 2005 RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Abbvie KALETRA lopinavir; ritonavir CAPSULE;ORAL 021226-001 Sep 15, 2000 DISCN No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Abbvie KALETRA lopinavir; ritonavir CAPSULE;ORAL 021226-001 Sep 15, 2000 DISCN No No ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Abbvie KALETRA lopinavir; ritonavir TABLET;ORAL 021906-002 Nov 9, 2007 RX Yes No ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

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Expired US Patents for lopinavir; ritonavir

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Abbvie KALETRA lopinavir; ritonavir SOLUTION;ORAL 021251-001 Sep 15, 2000 ➤ Sign Up ➤ Sign Up
Abbvie KALETRA lopinavir; ritonavir TABLET;ORAL 021906-001 Oct 28, 2005 ➤ Sign Up ➤ Sign Up
Abbvie KALETRA lopinavir; ritonavir SOLUTION;ORAL 021251-001 Sep 15, 2000 ➤ Sign Up ➤ Sign Up
Abbvie KALETRA lopinavir; ritonavir TABLET;ORAL 021906-001 Oct 28, 2005 ➤ Sign Up ➤ Sign Up
Abbvie KALETRA lopinavir; ritonavir CAPSULE;ORAL 021226-001 Sep 15, 2000 ➤ Sign Up ➤ Sign Up
Abbvie KALETRA lopinavir; ritonavir TABLET;ORAL 021906-001 Oct 28, 2005 ➤ Sign Up ➤ Sign Up
Abbvie KALETRA lopinavir; ritonavir CAPSULE;ORAL 021226-001 Sep 15, 2000 ➤ Sign Up ➤ Sign Up
Abbvie KALETRA lopinavir; ritonavir CAPSULE;ORAL 021226-001 Sep 15, 2000 ➤ Sign Up ➤ Sign Up
Abbvie KALETRA lopinavir; ritonavir TABLET;ORAL 021906-002 Nov 9, 2007 ➤ Sign Up ➤ Sign Up
Abbvie KALETRA lopinavir; ritonavir SOLUTION;ORAL 021251-001 Sep 15, 2000 ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Non-Orange Book US Patents for 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
8,895,051 Flavoring systems for pharmaceutical compositions and methods of making such compositions ➤ Sign Up
7,659,405 Polymorph of a pharmaceutical ➤ Sign Up
8,193,367 Polymorph of a pharmaceutical ➤ Sign Up
9,255,092 Polymorph of a pharmaceutical ➤ Sign Up
8,333,990 Solid pharmaceutical dosage form ➤ Sign Up
8,674,112 Polymorph of a pharmaceutical ➤ Sign Up
6,894,171 Polymorph of a pharmaceutical ➤ Sign Up
7,183,416 Polymorph of a pharmaceutical ➤ Sign Up
Patent No. Title Estimated Patent Expiration

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International Patents for lopinavir; ritonavir

Supplementary Protection Certificates for lopinavir; ritonavir

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
00060 Netherlands ➤ Sign Up PRODUCT 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/GB01/044 United Kingdom ➤ Sign Up PRODUCT 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
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Deloitte
Cipla
Boehringer Ingelheim
Healthtrust
Johnson and Johnson
Daiichi Sankyo
Fuji
Teva
Accenture

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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