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Insulin recombinant human - Generic Drug Details

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Insulin recombinant human is the generic ingredient in eleven branded drugs marketed by Novo Nordisk Inc, Lilly, Pfizer, and Mannkind, and is included in nine NDAs. There are thirty-seven patents protecting this compound. Additional information is available in the individual branded drug profile pages.

This ingredient has six hundred and eighty-eight patent family members in sixty countries.

There are thirty-eight drug master file entries for insulin recombinant human. Seven suppliers are listed for this compound.

Summary for Generic Name: insulin recombinant human

Tradenames:11
Patents:37
Applicants:4
NDAs:9
Drug Master File Entries: see list38
Suppliers / Packagers: see list7
Clinical Trials: see list4,613
Formulation / Manufacturing:see details
Drug Prices:see low prices

Pharmacology for Ingredient: insulin recombinant human

Ingredient-typeInsulin
Drug ClassInsulin
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Mannkind
AFREZZA
insulin recombinant human
POWDER;INHALATION022472-002Jun 27, 2014RXYes9,511,198► subscribe ► subscribe
Mannkind
AFREZZA
insulin recombinant human
POWDER;INHALATION022472-002Jun 27, 2014RXYes8,146,588► subscribeY ► subscribe
Mannkind
AFREZZA
insulin recombinant human
POWDER;INHALATION022472-002Jun 27, 2014RXYes7,943,572► subscribe ► subscribe
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Expired Orange Book Patents for Generic Ingredient: insulin recombinant human

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Mannkind
AFREZZA
insulin recombinant human
POWDER;INHALATION022472-001Jun 27, 20146,663,898► subscribe
Pfizer
EXUBERA
insulin recombinant human
POWDER;INHALATION021868-002Jan 27, 2006RE38385► subscribe
Pfizer
EXUBERA
insulin recombinant human
POWDER;INHALATION021868-001Jan 27, 20065,997,848► subscribe
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Non-Orange Book Patents for Generic Ingredient: insulin recombinant human

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
6,372,258 Methods of spray-drying a drug and a hydrophobic amino acid► subscribe
8,377,869Method of preventing adverse effects by GLP-1► subscribe
7,521,069Methods and compositions for pulmonary delivery of insulin► 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 recombinant human

Country Document Number Estimated Expiration
Colombia5011099► subscribe
China102438602► subscribe
Canada2253393► 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 RECOMBINANT HUMAN

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
13/34Ireland► subscribePRODUCT: INSULIN DEGLUDEC IN ALL ITS FORMS AS THEY ARE PROTECTED BY THE BASIC PATENTS; REGISTRATION NO/DATE: IRELAND EU/1/12/807-001, 004, 005, 007-009, 012, 013 AND 015 / 21/01/2013
2209800/01Switzerland► subscribePRODUCT NAME: INSULIN DEGLUDEC + LIRAGLUTIDE; REGISTRATION NO/DATE: SWISSMEDIC 65041 12.09.2014
00698Netherlands► subscribePRODUCT NAME: INSULINE DEGLUDEC EN LIRAGLUTIDE; REGISTRATION NO/DATE: EU/1/14/94765041 2014120918
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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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