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Profile for Tradename: HUMALOG KWIKPEN

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Humalog Kwikpen is a drug marketed by Eli Lilly And Co and Lilly and is included in two NDAs. It is available from three suppliers. There are three patents protecting this drug.

This drug has forty-eight patent family members in thirty-one countries.

The generic ingredient in HUMALOG KWIKPEN is insulin lispro recombinant. There are thirty-eight drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the insulin lispro recombinant profile page.

Summary for Tradename: HUMALOG KWIKPEN

Patents:3
Applicants:2
NDAs:2
Suppliers / Packagers: see list13
2013 Sales:$879,632,000

Pharmacology for Tradename: HUMALOG KWIKPEN

Ingredient-typeInsulin
Drug ClassInsulin Analog

Clinical Trials for: HUMALOG KWIKPEN

The DURABLE Trial: Evaluating the Durability of Starter Insulin Regimens in Patients With Type 2 Diabetes (IOOV)
Status: Completed Condition: Diabetes Mellitus, Type 2

Insulin Lispro 6 Days Versus Insulin Aspart 6 Days in Pump Use
Status: Completed Condition: Diabetes Mellitus, Type 1

A Study of Insulin Lispro With BioChaperone Excipient in Healthy Participants
Status: Completed Condition: Healthy Participants

Immunogenicity Study of Wockhardt's Insulin Lispro/Lispro Mix Basal Bolus Regimen in Type 1 Diabetics
Status: Withdrawn Condition: Type I Diabetes

A Study of Lispro Formulations in Healthy Participants
Status: Completed Condition: Healthy Volunteers

A Study of LY2605541 and Insulin Lispro Mixture in Healthy Participants
Status: Completed Condition: Healthy Volunteers

Bioequivalence of Two Lispro Formulations
Status: Completed Condition: Healthy Volunteers

Liquid Meal Study With Insulin Lispro With/Without Recombinant Human Hyaluronidase PH20 (rHuPH20) and Regular Human Insulin With rHuPH20 to Compare Pharmacokinetics, Postprandial Glycemic Response, and Optimal Insulin Dose in Participants With Type 2 Diabetes Mellitus (T2DM)
Status: Completed Condition: Diabetes Mellitus, Type 2

Lispro Mid Mixture (MM) Intensive Mixture Therapy With Progressive Dose-Titration of Lispro Low Mixture (LM) or Biphasic Insulin Aspart 30/70 (S019)
Status: Completed Condition: Diabetes Mellitus, Type 2

Safety and Efficacy Study of Insulin Lispro Versus Insulin Aspart in Participants With Type 2 Diabetes on Insulin Pump Therapy
Status: Completed Condition: Type 2 Diabetes Mellitus

Courtesy of ClinicalTrials.org
See more clinical trials for this drug
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Eli Lilly And Co
HUMALOG KWIKPEN
insulin lispro recombinant
SOLUTION;SUBCUTANEOUS205747-001May 26, 2015RXYes6,551,992<disabled>Y <disabled>
Eli Lilly And Co
HUMALOG KWIKPEN
insulin lispro recombinant
SOLUTION;SUBCUTANEOUS205747-001May 26, 2015RXYes6,034,054<disabled>Y <disabled>
Lilly
HUMALOG KWIKPEN
insulin lispro recombinant
INJECTABLE;INJECTION020563-003Sep 6, 2007RXYes7,291,132<disabled>Y <disabled>
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Expired Patents for Tradename: HUMALOG KWIKPEN

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Lilly
HUMALOG KWIKPEN
insulin lispro recombinant
INJECTABLE;INJECTION020563-003Sep 6, 20075,474,978<disabled>
Lilly
HUMALOG KWIKPEN
insulin lispro recombinant
INJECTABLE;INJECTION020563-003Sep 6, 20075,514,646<disabled>
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Non-Orange Book Patents for Tradename: HUMALOG KWIKPEN

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
6,906,028 Stable insulin formulations<disabled in preview>
7,427,275Medication dispensing apparatus with triple screw threads for mechanical advantage<disabled in preview>
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International Patent Family for Tradename: HUMALOG KWIKPEN

Country Document Number Publication Date
Ukraine61109Aug 15, 2000
European Patent Office1656170May 17, 2006
Hong Kong1030747Sep 07, 2007
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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 information. There is no warranty that the information contained herein is error free. 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.

Copyright 2002-2016 thinkBiotech LLC
ISSN: 2162-2639

Preferred citation:

Friedman, Y. Location of pharmaceutical innovation: 2000–2009 Nature Reviews Drug Discovery 9, 835–836 (2010).

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