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Serving 500+ biopharmaceutical companies globally:

Chubb
Cantor Fitzgerald
Julphar
Johnson and Johnson
US Army
Mallinckrodt
UBS
Deloitte
McKesson
Queensland Health

Generated: June 27, 2017

DrugPatentWatch Database Preview

Insulin recombinant human - Generic Drug Details

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What are the generic sources for insulin recombinant human and what is the scope of insulin recombinant human freedom to operate?

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-nine patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Insulin recombinant human has seven hundred and eight patent family members in sixty-one countries.

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

Summary for Generic Name: insulin recombinant human

Tradenames:11
Patents:39
Applicants:4
NDAs:9
Drug Master File Entries: see list38
Suppliers / Packagers: see list6
Clinical Trials: see list11,440
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 TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Lilly
HUMULIN BR
insulin recombinant human
INJECTABLE;INJECTION019529-001Apr 28, 1986DISCNNoNo► Subscribe► Subscribe
Mannkind
AFREZZA
insulin recombinant human
POWDER;INHALATION022472-003Apr 17, 2015RXYesNo8,156,936► SubscribeY ► Subscribe
Mannkind
AFREZZA
insulin recombinant human
POWDER;INHALATION022472-003Apr 17, 2015RXYesNo8,729,019► SubscribeY ► Subscribe
Mannkind
AFREZZA
insulin recombinant human
POWDER;INHALATION022472-001Jun 27, 2014RXYesNo9,192,675► SubscribeY ► Subscribe
Mannkind
AFREZZA
insulin recombinant human
POWDER;INHALATION022472-002Jun 27, 2014RXYesYes7,943,178► 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;INHALATION022472-002Jun 27, 20147,276,534► Subscribe
Pfizer
EXUBERA
insulin recombinant human
POWDER;INHALATION021868-001Jan 27, 20066,423,344► Subscribe
Pfizer
EXUBERA
insulin recombinant human
POWDER;INHALATION021868-002Jan 27, 20066,051,256► Subscribe
Pfizer
EXUBERA
insulin recombinant human
POWDER;INHALATION021868-001Jan 27, 20066,592,904► Subscribe
Pfizer
EXUBERA
insulin recombinant human
POWDER;INHALATION021868-002Jan 27, 2006RE37872► 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
8,420,604Method of drug formulation of compositions comprising crystalline microparticle surfaces► Subscribe
6,089,228 Apparatus and methods for dispersing dry powder medicaments► Subscribe
9,662,461Dry powder drug delivery system and methods► Subscribe
6,123,936 Methods and compositions for the dry powder formulation of interferons► Subscribe
8,785,396Method and composition for treating migraines► 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
African Regional IP Organization (ARIPO)200001997► Subscribe
Russian Federation2010109856► Subscribe
China1138531► Subscribe
Mexico343841► Subscribe
Georgia, Republic ofP20032985► 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
60026Netherlands► SubscribePRODUCT NAME: INSULINUM LISPRUM, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT; REGISTRATION NO/DATE: EU/1/96/007/001 - EU/1/96/007/003 19960430
2209800/01Switzerland► SubscribePRODUCT NAME: INSULIN DEGLUDEC + LIRAGLUTIDE; REGISTRATION NO/DATE: SWISSMEDIC 65041 12.09.2014
13/034Ireland► SubscribeAPPLICATION FOR EXTENSION OF THE DURATION OF A SUPPLEMENTARY PROTECTION CERTIFICATE 2013/034 IN JOURNAL NO. 2325 OF 25/01/2017 UNDER THE HEADING APPLICATION FOR EXTENSION OF THE DURATION OF A SUPPLEMENTARY PROTECTION CERTIFICATE, SPC NO. 2013/034 SHOULD HAVE APPEARED AS FOLLOWS, NOVO NORDISK A/S NOVO ALLE, 2880 BAGSVAERD, DENMARK (20/12/2016) PATENT NO: EP2107069; NOVEL INSULIN DERIVATIVES PRODUCT: INSULIN DEGLUDEC MARKET AUTHORISATION: EU: EU/1/12/807-001, 004, 005, 007-009, 012, 013 AND 015 (21/01/2013) ORIGINAL SPC EXPIRY DATE: 22/01/2028 1127 DESIGNS REGISTERED UNDER THE INDUSTRIAL DESIGNS ACT, 2001
00021Netherlands► SubscribePRODUCT NAME: INSULINE ASPART EN GEKRISTALLISEERD PROTAMINE-INSULINE ASPART; NAT. REGISTRATION NO/DATE: EU/1/00/142/001 20000801; FIRST REGISTRATION: 55414015541502 2000230623
C/GB05/024United Kingdom► SubscribePRODUCT NAME: INSULIN GLULISINE OR A PHYSIOLOGICALLY TOLERABLE SALT THEREOF; REGISTRATION NO/DATE: EU/1/04/285/001 - 020 20040929
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For more information try a trial or see the database preview and plans and pricing

Serving 500+ biopharmaceutical companies globally:

Moodys
Accenture
Harvard Business School
Deloitte
QuintilesIMS
Fuji
Dow
Healthtrust
Queensland Health
Cerilliant

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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