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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. Four 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 / Packagers: see list4
Clinical Trials: see list2,223
Drug Prices:see low prices
DailyMed Link:insulin lispro recombinant at DailyMed

Pharmacology for Ingredient: insulin lispro recombinant

Ingredient-typeInsulin
Drug ClassInsulin Analog
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Eli Lilly And Co
HUMALOG KWIKPEN
insulin lispro recombinant
SOLUTION;SUBCUTANEOUS205747-001May 26, 2015RXYesYes6,034,054► subscribeY ► subscribe
Lilly
HUMALOG
insulin lispro recombinant
INJECTABLE;INJECTION020563-001Jun 14, 1996RXYesYes► subscribe► subscribe
Lilly
HUMALOG KWIKPEN
insulin lispro recombinant
INJECTABLE;INJECTION020563-003Sep 6, 2007RXYesYes7,291,132► subscribeY ► subscribe
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Expired Orange Book Patents for Generic Ingredient: insulin lispro recombinant

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Lilly
HUMALOG
insulin lispro recombinant
INJECTABLE;INJECTION020563-001Jun 14, 19965,474,978► subscribe
Lilly
HUMALOG PEN
insulin lispro recombinant
INJECTABLE;INJECTION020563-002Aug 6, 19985,514,646► subscribe
Lilly
HUMALOG KWIKPEN
insulin lispro recombinant
INJECTABLE;INJECTION020563-003Sep 6, 20075,474,978► subscribe
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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► subscribe
6,906,028 Stable insulin formulations► subscribe
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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 recombinant

Country Document Number Estimated Expiration
Portugal884053► subscribe
Turkey9903036► subscribe
Canada2530263► subscribe
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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 RECOMBINANT

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
00597Netherlands► subscribePRODUCT NAME: INSULINE DEGLUDEC EN INSULINE ASPART; REGISTRATION NO/DATE: EU/1/12/806/001EU/1/12/806/004EU/1/12/806/005EU/1/12/806/007EU/1/12/806/008 2013210121
C0085France► subscribePRODUCT NAME: LIRAGLUTIDE ET INSULINE DEGLUDEC; REGISTRATION NO/DATE: EU/1/14/947 20140918
2107069/02Switzerland► subscribePRODUCT NAME: INSULIN DEGLUDEC + INSULIN ASPART; REGISTRATION NO/DATE: SWISSMEDIC 62648 12.09.2013
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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