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Profile for Tradename: HUMALOG KWIKPEN

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Humalog Kwikpen is a drug marketed by Lilly and is included in one NDA. It is available from three suppliers. There is one patent protecting this drug.

This drug has eleven patent family members in nine countries.

The generic ingredient in HUMALOG KWIKPEN is insulin lispro recombinant. There are thirty-seven 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:1
Applicants:1
NDAs:1
Suppliers: see list3
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

A Study of 2 Different Forms of Insulin Lispro in Healthy Participants
Status: Completed Condition: Healthy Volunteers

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Status: Withdrawn Condition: Type I Diabetes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: Recruiting 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

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
Lilly
HUMALOG KWIKPEN
insulin lispro recombinant
INJECTABLE;INJECTION020563-003Sep 6, 2007RXYes7,291,132<disabled>Y<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
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
China1835774Sep 20, 2006
Australia2004266131Dec 16, 2010
Australia2004266131Mar 03, 2005
China100531813Aug 26, 2009
South Africa200601093Aug 26, 2009
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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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