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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 KWIKPEN
insulin lispro protamine recombinant; insulin lispro recombinant
INJECTABLE;INJECTION021018-002Sep 6, 2007RXYes7,291,132<disabled>Y <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
insulin lispro protamine recombinant; insulin lispro recombinant
INJECTABLE;INJECTION021018-001Dec 22, 1999RXYes<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 50/50 KWIKPEN
insulin lispro protamine recombinant; insulin lispro recombinant
INJECTABLE;INJECTION021018-002Sep 6, 20075,514,646<disabled>
Lilly
HUMALOG MIX 75/25 KWIKPEN
insulin lispro protamine recombinant; insulin lispro recombinant
INJECTABLE;INJECTION021017-002Sep 6, 20075,514,646<disabled>
Lilly
HUMALOG MIX 50/50
insulin lispro protamine recombinant; insulin lispro recombinant
INJECTABLE;INJECTION021018-001Dec 22, 19995,747,642<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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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 Ingredient: insulin lispro protamine recombinant; insulin lispro recombinant

Country Document Number Estimated Expiration
Australia2004266131<disabled in preview>
World Intellectual Property Organization (WIPO)2005018721<disabled in preview>
Japan2007502146<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: INSULIN LISPRO PROTAMINE RECOMBINANT; INSULIN LISPRO RECOMBINANT

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
00160Netherlands<disabled>PRODUCT NAME: INSULINE DETEMIRUM; NAT. REGISTRATION NO/DATE: EU/1/04/278/001EU/1/04/278/002EU/1/04/278/003EU/1/04/278/005EU/1/04/278/004EU/1/04/278/006EU/1/04/278/007EU/1/04/278/008EU/1/04/278/009 2004010601; FIRST REGISTRATION: 563705637156372EU/1/04/278/001 T/M -/009 2003101110
91022-0Sweden<disabled>PRODUCT NAME: N EPSILONB29 MYRISTOYL- ELLER N EPSILONB29 TETRADEKANOYL-DES(B30) HUMANT INSULIN
213Luxembourg<disabled>PRODUCT NAME: INSULINE DEGLUDEC SOUS TOUTES LES FORMES PROTEGEES PAR LE BREVET DE BASE
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