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Details for Generic Name: insulin lispro protamine recombinant; insulin lispro recombinant

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Insulin lispro protamine recombinant; insulin lispro recombinant is the generic ingredient in six branded drugs marketed by Lilly and is included in two NDAs. There is one patent protecting this compound. Additional information is available in the individual branded drug profile pages.

This ingredient has twelve patent family members in nine countries.

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

Summary for Generic Name: insulin lispro protamine recombinant; insulin lispro recombinant

Tradenames:6
Patents:1
Applicants:1
NDAs:2
Drug Master File Entries: see list38
Suppliers / Packaging: see list9

Pharmacology for Ingredient: insulin lispro protamine recombinant; insulin lispro recombinant

Ingredient-typeInsulin
Drug ClassInsulin Analog

Clinical Trials for: insulin lispro protamine recombinant; insulin lispro recombinant

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Lilly
HUMALOG MIX 50/50
insulin lispro protamine recombinant; insulin lispro recombinant
INJECTABLE;INJECTION021018-001Dec 22, 1999RXYes<disabled><disabled>
Lilly
HUMALOG MIX 75/25 PEN
insulin lispro protamine recombinant; insulin lispro recombinant
INJECTABLE;INJECTION021017-003Dec 22, 1999DISCNNo<disabled><disabled>
Lilly
HUMALOG MIX 50/50 PEN
insulin lispro protamine recombinant; insulin lispro recombinant
INJECTABLE;INJECTION021018-003Dec 22, 1999DISCNNo<disabled><disabled>
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Expired Orange Book Patents for Generic Ingredient: insulin lispro protamine recombinant; insulin lispro recombinant

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Lilly
HUMALOG MIX 75/25
insulin lispro protamine recombinant; insulin lispro recombinant
INJECTABLE;INJECTION021017-001Dec 22, 19995,461,031<disabled>
Lilly
HUMALOG MIX 75/25 KWIKPEN
insulin lispro protamine recombinant; insulin lispro recombinant
INJECTABLE;INJECTION021017-002Sep 6, 20075,747,642<disabled>
Lilly
HUMALOG MIX 50/50 KWIKPEN
insulin lispro protamine recombinant; insulin lispro recombinant
INJECTABLE;INJECTION021018-002Sep 6, 20075,747,642<disabled>
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International Patent Family for Ingredient: insulin lispro protamine recombinant; insulin lispro recombinant

Country Document Number Publication Date
Australia2004266131Mar 03, 2005
European Patent Office1656170May 17, 2006
South Korea101121317Mar 09, 2012
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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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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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