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Insulin lispro recombinant - Generic Drug Details

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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 list3

Pharmacology for Ingredient: insulin lispro recombinant

Ingredient-typeInsulin
Drug ClassInsulin Analog

Clinical Trials for: 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
insulin lispro recombinant
INJECTABLE;INJECTION020563-001Jun 14, 1996RXYes<disabled><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, 2015RXYes6,034,054<disabled>Y <disabled>
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Expired Orange Book Patents for Generic Ingredient: insulin lispro recombinant

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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, 20075,514,646<disabled>
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>
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Non-Orange Book Patents for Generic Ingredient: insulin lispro recombinant

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>
6,906,028 Stable insulin formulations<disabled in preview>
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International Patent Family for Ingredient: insulin lispro recombinant

Country Document Number Estimated Expiration
Czech Republic9904451<disabled in preview>
European Patent Office1656170<disabled in preview>
China100531813<disabled in preview>
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Supplementary Protection Certificates for Tradename: INSULIN LISPRO RECOMBINANT

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
/2005Austria<disabled>PRODUCT NAME: NOVOMIX 50 - SUSPENSION, ENTHALTEND LOESLICHES INSULIN ASPART UND PROTAMINKRISTALLISIERTES INSULIN ASPART IM VERHAELTNIS 50:50; REGISTRATION NO/DATE: EU/1/00/142/011 - EU/1/00/142/016 20051005
/2005Austria<disabled>PRODUCT NAME: NOVOMIX 70 - SUSPENSION, ENTHALTEND LOESLICHES INSULIN ASPART UND PROTAMINKRISTALLISIERTES INSULIN ASPART IM VERHAELTNIS 70:30; REGISTRATION NO/DATE: EU/1/00/142/017 - EU/1/00/142/022 20051005
13/034Ireland<disabled>PRODUCT NAME: INSULIN DEGLUDEC; NATL. REGISTRATION NO/DATE: EU/1/12/807-001, 004, 005, 007-009, 012, 013 AND 015 20130121; FIRST REGISTRATION: EU/1/12/807-001, 004, 005, 007-009, 012, 013 AND 015 20130121
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