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Insulin recombinant human - Generic Drug Details

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What are the generic drug sources, and freedom to operate, for insulin recombinant human?

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 seven hundred 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:38
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
DailyMed Link:insulin recombinant human at DailyMed

Pharmacology for Ingredient: insulin recombinant human

Ingredient-typeInsulin
Drug ClassInsulin
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Mannkind
AFREZZA
insulin recombinant human
POWDER;INHALATION022472-001Jun 27, 2014RXYesNo► Subscribe► Subscribe
Mannkind
AFREZZA
insulin recombinant human
POWDER;INHALATION022472-001Jun 27, 2014RXYesNo7,943,572► Subscribe ► Subscribe
Mannkind
AFREZZA
insulin recombinant human
POWDER;INHALATION022472-003Apr 17, 2015RXYesNo9,339,615► SubscribeY ► Subscribe
Mannkind
AFREZZA
insulin recombinant human
POWDER;INHALATION022472-002Jun 27, 2014RXYesYes9,446,133► SubscribeY ► Subscribe
Mannkind
AFREZZA
insulin recombinant human
POWDER;INHALATION022472-003Apr 17, 2015RXYesNo8,215,300► SubscribeY ► 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, 20148,394,414► Subscribe
Mannkind
AFREZZA
insulin recombinant human
POWDER;INHALATION022472-001Jun 27, 20146,906,030► Subscribe
Mannkind
AFREZZA
insulin recombinant human
POWDER;INHALATION022472-003Apr 17, 20158,394,414► Subscribe
Pfizer
EXUBERA
insulin recombinant human
POWDER;INHALATION021868-001Jan 27, 20065,740,794► Subscribe
Pfizer
EXUBERA
insulin recombinant human
POWDER;INHALATION021868-002Jan 27, 20066,592,904► 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
6,407,236 Adenosine A3 receptor modulators► Subscribe
6,123,936 Methods and compositions for the dry powder formulation of interferons► Subscribe
8,161,969Dry powder dispersing apparatus and methods for their use► Subscribe
6,681,767 Method and device for delivering aerosolized medicaments► Subscribe
6,309,671 Stable glassy state powder 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 recombinant human

Country Document Number Estimated Expiration
HungaryE028623► Subscribe
Cyprus1110253► Subscribe
JapanH07501231► Subscribe
World Intellectual Property Organization (WIPO)9407514► Subscribe
Canada2112674► 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
C0035France► SubscribePRODUCT NAME: INSULINE DEGLUDEC; REGISTRATION NO/DATE: EU/1/12/807/001 20130121
00596Netherlands► SubscribePRODUCT 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
C0085France► SubscribePRODUCT NAME: LIRAGLUTIDE ET INSULINE DEGLUDEC; REGISTRATION NO/DATE: EU/1/14/947 20140918
2004005Lithuania► SubscribePRODUCT NAME: INSULIN DETEMIR
2209800/01Switzerland► SubscribePRODUCT NAME: INSULIN DEGLUDEC + LIRAGLUTIDE; REGISTRATION NO/DATE: SWISSMEDIC 65041 12.09.2014
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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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