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Insulin lispro protamine recombinant; insulin lispro recombinant - Generic Drug Details

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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 list2

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 KWIKPEN
insulin lispro protamine recombinant; insulin lispro recombinant
INJECTABLE;INJECTION021017-002Sep 6, 2007RXYes7,291,132<disabled>Y <disabled>
Lilly
HUMALOG MIX 50/50 KWIKPEN
insulin lispro protamine recombinant; insulin lispro recombinant
INJECTABLE;INJECTION021018-002Sep 6, 2007RXYes7,291,132<disabled>Y <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 50/50
insulin lispro protamine recombinant; insulin lispro recombinant
INJECTABLE;INJECTION021018-001Dec 22, 19995,474,978<disabled>
Lilly
HUMALOG MIX 75/25 KWIKPEN
insulin lispro protamine recombinant; insulin lispro recombinant
INJECTABLE;INJECTION021017-002Sep 6, 20075,461,031<disabled>
Lilly
HUMALOG MIX 50/50 KWIKPEN
insulin lispro protamine recombinant; insulin lispro recombinant
INJECTABLE;INJECTION021018-002Sep 6, 20075,514,646<disabled>
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Non-Orange Book Patents for Generic Ingredient: insulin lispro protamine recombinant; 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>
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International Patent Family for Ingredient: insulin lispro protamine recombinant; insulin lispro recombinant

Country Document Number Estimated Expiration
World Intellectual Property Organization (WIPO)2005018721<disabled in preview>
South Africa200601093<disabled in preview>
Japan4718462<disabled in preview>
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Supplementary Protection Certificates for Tradename: INSULIN LISPRO PROTAMINE RECOMBINANT; INSULIN LISPRO RECOMBINANT

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
C0020France<disabled>PRODUCT NAME: INSULIN DETEMIR; NAT. REGISTRATION NO/DATE: EU/1/04/278/001 20040601; FIRST REGISTRATION: LI - 56370 20031110
C/GB00/027United Kingdom<disabled>PRODUCT NAME: INSULIN ASPART AND PROTAMINE (NOVOMIX 30); REGISTERED: CH 55414 01 20000623; CH 55415 02 20000623; CH 55416 02 20000623; UK EU/1/00/142/001-008 20000801
/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
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