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Profile for Tradename: HUMALOG

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

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

Summary for Tradename: HUMALOG

Patents:3
Applicants:2
NDAs:4
Suppliers / Packagers: see list11
2013 Sales:$1,184,189,000

Pharmacology for Tradename: HUMALOG

Ingredient-typeInsulin
Drug ClassInsulin Analog

Clinical Trials for: HUMALOG

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

Phase II Pharmacokinetics Study of Humalog and Humulin-R With and Without rHuPH20 in Type 1 Diabetes Mellitus
Status: Completed Condition: Type 1 Diabetes Mellitus

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Status: Withdrawn Condition: Type I Diabetes

Humalog® Mix50/50(tm) as a Treatment for Gestational Diabetes
Status: Completed Condition: Gestational Diabetes Mellitus

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 Double-blinded, Randomised, Two -Period Crossover Euglycemic Clamp Trial Investigating the Pharmacokinetics, Glucodynamics and Safety of BioChaperone Insulin Lispro and Insulin Lispro (Humalog®) in Subjects With Type 1 Diabetes
Status: Completed Condition: Diabetes Mellitus Type 1

A Trial to Compare the Pharmacodynamic and Pharmacokinetic Properties of Biochaperone® Combo With Humalog® Mix25 and With Simultaneous Injections of Humalog® and Lantus® in Subjects With Type 2 Diabetes
Status: Completed Condition: Type 2 Diabetes Mellitus

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

Pharmacokinetic (PK), Pharmacodynamic (PD), and Safety Study of Subcutaneously Administered Humalog® With and Without Recombinant Human Hyaluronidase (rHuPH20)and Humulin-R® With and Without rHuPH20
Status: Completed Condition: 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
Lilly
HUMALOG
insulin lispro recombinant
INJECTABLE;INJECTION020563-001Jun 14, 1996RXYes<disabled><disabled>
Eli Lilly And Co
HUMALOG KWIKPEN
insulin lispro recombinant
SOLUTION;SUBCUTANEOUS205747-001May 26, 2015RXYes7,291,132<disabled>Y <disabled>
Lilly
HUMALOG MIX 75/25 KWIKPEN
insulin lispro protamine recombinant; insulin lispro recombinant
INJECTABLE;INJECTION021017-002Sep 6, 2007RXYes7,291,132<disabled>Y <disabled>
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Expired Patents for Tradename: HUMALOG

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Lilly
HUMALOG
insulin lispro recombinant
INJECTABLE;INJECTION020563-001Jun 14, 19965,474,978<disabled>
Lilly
HUMALOG
insulin lispro recombinant
INJECTABLE;INJECTION020563-001Jun 14, 19965,514,646<disabled>
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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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