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Details for Generic Name: insulin lispro recombinant

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Insulin lispro recombinant is the generic ingredient in three branded drugs marketed by Eli Lilly And Co and Lilly, and is included in two NDAs. There are three patents protecting this compound. Additional information is available in the individual branded drug profile pages.

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

There are thirty-eight drug master file entries for insulin lispro recombinant. Three suppliers are listed for this compound.

Summary for Generic Name: insulin lispro recombinant

Tradenames:3
Patents:3
Applicants:2
NDAs:2
Drug Master File Entries: see list38
Suppliers / Packaging: see list13

Pharmacology for Ingredient: insulin lispro recombinant

Ingredient-typeInsulin
Drug ClassInsulin Analog

Clinical Trials for: insulin lispro recombinant

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

Pharmacokinetic and Glucodynamic Crossover Study of Subcutaneously (SC) Administered Insulin Lispro + Recombinant Human Hyaluronidase (rHuPH20) and Regular Human Insulin + rHuPH20 Compared to Insulin Lispro Alone
Status: Completed Condition: Diabetes Mellitus

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

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

CONSISTENT 1: Metabolic and Safety Outcomes of Hylenex Recombinant (Hyaluronidase Human Injection) Preadministered at CSII Infusion Site in Participants With Type 1 Diabetes Mellitus (T1DM)
Status: Active, not recruiting Condition: Type 1 Diabetes Mellitus

A Pharmacokinetic and Glucodynamic Study of Subcutaneously Administered Insulin Analogs With rHuPH20 Compared to Insulin Analogs Alone
Status: Completed Condition: Healthy

Safety Study of Subcutaneously-Injected Prandial INSULIN-PH20 NP Compared to Insulin Lispro Injection in Participants With Type 1 Diabetes Mellitus
Status: Completed Condition: Diabetes Mellitus, Type 1

Randomized, Double Blind, 2 Way Crossover Study of CSII With, Versus Without, Pretreatment With Human Hyaluronidase
Status: Completed Condition: Type 1 Diabetes Mellitus

Safety/Efficacy Study of Subcutaneously Injected Prandial Insulins Compared to Insulin Lispro Alone in Participants With Type 1 Diabetes Mellitus
Status: Completed Condition: Diabetes Mellitus, Type 1

Safety/Efficacy Study of Subcutaneously Injected Prandial Insulins Compared to Insulin Lispro Alone in Patients With Type 2 Diabetes Mellitus
Status: Completed Condition: Diabetes Mellitus, Type II

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>
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, 2015RXYes7,291,132<disabled>Y <disabled>
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Expired Orange Book Patents for Generic Ingredient: insulin lispro recombinant

These historical archives are available as an add-on to one-year subscriptions

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 PEN
insulin lispro recombinant
INJECTABLE;INJECTION020563-002Aug 6, 19985,474,978<disabled>
Lilly
HUMALOG PEN
insulin lispro recombinant
INJECTABLE;INJECTION020563-002Aug 6, 19985,514,646<disabled>
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International Patent Family for Ingredient: insulin lispro recombinant

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.

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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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