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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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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.

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International Patent Family for Tradename: HUMALOG KWIKPEN

Country Document Number Estimated Expiration
China1266371<disabled in preview>
Israel133348<disabled in preview>
Germany69834956<disabled in preview>
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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Supplementary Protection Certificates for Tradename: HUMALOG KWIKPEN

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
C/GB04/036United Kingdom<disabled>PRODUCT NAME: INSULIN DETEMIR, NEB29- TETRADECANOYL- DES(B30) HUMAN INSULIN; NATL REGISTRATION NO/DATE: EU/1/04/278/001-009 20040601; FIRST REGISTRATION: CH 56370, 56311, 56372 20031110
00596Netherlands<disabled>PRODUCT NAME: INSULINE DEGLUDEC; REGISTRATION NO/DATE: EU/1/12/807/001EU/1/12/807/004EU/1/12/807/005EU/1/12/807/007EU/1/12/807/008EU/1/12/807/009EU/1/12/807/012EU/1/12/807/013EU/1/12/807/015 2013210121
90036-0Sweden<disabled>PRODUCT NAME: KOMBINATION AV INSULIN DEGLUDEK OCH INSULIN ASPART; REG. NO/DATE: EU/1/12/806/001 20130121
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