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HUMALOG KWIKPEN Drug Profile

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

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

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

Summary for Tradename: HUMALOG KWIKPEN

Patents:3
Applicants:2
NDAs:2
Suppliers / Packagers: see list3

Pharmacology for Tradename: HUMALOG KWIKPEN

Ingredient-typeInsulin
Drug ClassInsulin Analog

Clinical Trials for: HUMALOG KWIKPEN

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
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>
Lilly
HUMALOG KWIKPEN
insulin lispro recombinant
INJECTABLE;INJECTION020563-003Sep 6, 2007RXYes7,291,132<disabled>Y <disabled>
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Expired Patents for Tradename: HUMALOG KWIKPEN

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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, 20075,474,978<disabled>
Lilly
HUMALOG KWIKPEN
insulin lispro recombinant
INJECTABLE;INJECTION020563-003Sep 6, 20075,514,646<disabled>
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Non-Orange Book Patents for Tradename: HUMALOG KWIKPEN

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
6,906,028 Stable insulin formulations<disabled in preview>
7,427,275Medication dispensing apparatus with triple screw threads for mechanical advantage<disabled in preview>
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International Patent Family for Tradename: HUMALOG KWIKPEN

Country Document Number Estimated Expiration
Israel133348<disabled in preview>
Indonesia24310<disabled in preview>
New Zealand501382<disabled in preview>
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Supplementary Protection Certificates for Tradename: HUMALOG KWIKPEN

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
C/GB05/024United Kingdom<disabled>PRODUCT NAME: INSULIN GLULISINE OR A PHYSIOLOGICALLY TOLERABLE SALT THEREOF; REGISTRATION NO/DATE: EU/1/04/285/001 - 020 20040929
C0009France<disabled>PRODUCT NAME: INSULINE GLULISINE; REGISTRATION NO/DATE IN FRANCE: EU/1/04/258/001 DU 20040927; REGISTRATION NO/DATE AT EEC: EU/1/04/285/001 DU 20040927
60026Netherlands<disabled>PRODUCT NAME: INSULINUM LISPRUM, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT; REGISTRATION NO/DATE: EU/1/96/007/001 - EU/1/96/007/003 19960430
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