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Serving leading biopharmaceutical companies globally:

Novartis
Johnson and Johnson
Cipla
McKinsey
Federal Trade Commission
Fish and Richardson
Daiichi Sankyo
Teva
Accenture
UBS

Generated: October 23, 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 forty patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Insulin recombinant human has seven hundred and forty-eight patent family members in sixty-one countries and forty supplementary protection certificates in twelve 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

US Patents:40
Tradenames:11
Applicants:4
NDAs:9
Drug Master File Entries: see list38
Suppliers / Packagers: see list7
Clinical Trials: see list11,764
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
Mannkind
AFREZZA
insulin recombinant human
POWDER;INHALATION022472-001Jun 27, 2014RXYesNo► Subscribe► SubscribeY ► Subscribe
Mannkind
AFREZZA
insulin recombinant human
POWDER;INHALATION022472-001Jun 27, 2014RXYesNo► Subscribe► SubscribeY ► Subscribe
Mannkind
AFREZZA
insulin recombinant human
POWDER;INHALATION022472-003Apr 17, 2015RXYesNo► Subscribe► Subscribe ► Subscribe
Mannkind
AFREZZA
insulin recombinant human
POWDER;INHALATION022472-001Jun 27, 2014RXYesNo► Subscribe► SubscribeY ► Subscribe
Pfizer
EXUBERA
insulin recombinant human
POWDER;INHALATION021868-001Jan 27, 2006DISCNNoNo► Subscribe► SubscribeY ► Subscribe
Mannkind
AFREZZA
insulin recombinant human
POWDER;INHALATION022472-003Apr 17, 2015RXYesNo► Subscribe► SubscribeY ► Subscribe
Mannkind
AFREZZA
insulin recombinant human
POWDER;INHALATION022472-002Jun 27, 2014RXYesYes► Subscribe► SubscribeY ► Subscribe
Novo Nordisk Inc
NOVOLIN R
insulin recombinant human
INJECTABLE;INJECTION019938-001Jun 25, 1991OTCYesYes► Subscribe► Subscribe► Subscribe
Mannkind
AFREZZA
insulin recombinant human
POWDER;INHALATION022472-003Apr 17, 2015RXYesNo► Subscribe► SubscribeY ► Subscribe
Mannkind
AFREZZA
insulin recombinant human
POWDER;INHALATION022472-002Jun 27, 2014RXYesYes► Subscribe► 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, 2014► Subscribe► Subscribe
Mannkind
AFREZZA
insulin recombinant human
POWDER;INHALATION022472-001Jun 27, 2014► Subscribe► Subscribe
Mannkind
AFREZZA
insulin recombinant human
POWDER;INHALATION022472-001Jun 27, 2014► Subscribe► Subscribe
Pfizer
EXUBERA
insulin recombinant human
POWDER;INHALATION021868-001Jan 27, 2006► Subscribe► Subscribe
Mannkind
AFREZZA
insulin recombinant human
POWDER;INHALATION022472-001Jun 27, 2014► Subscribe► Subscribe
Mannkind
AFREZZA
insulin recombinant human
POWDER;INHALATION022472-001Jun 27, 2014► Subscribe► Subscribe
Pfizer
EXUBERA
insulin recombinant human
POWDER;INHALATION021868-001Jan 27, 2006► Subscribe► Subscribe
Pfizer
EXUBERA
insulin recombinant human
POWDER;INHALATION021868-001Jan 27, 2006► Subscribe► Subscribe
Pfizer
EXUBERA
insulin recombinant human
POWDER;INHALATION021868-002Jan 27, 2006► Subscribe► Subscribe
Mannkind
AFREZZA
insulin recombinant human
POWDER;INHALATION022472-001Jun 27, 2014► Subscribe► 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
5,775,320 Method and device for delivering aerosolized medicaments► Subscribe
6,258,341 Stable glassy state powder formulations► Subscribe
8,671,937Unit dose capsules and dry powder inhaler► Subscribe
6,089,228 Apparatus and methods for dispersing dry powder medicaments► Subscribe
8,372,804Delivery of active agents► Subscribe
6,797,258 Compositions and methods for the pulmonary delivery of aerosolized macromolecules► Subscribe
5,458,135 Method and device for delivering aerosolized medicaments► Subscribe
5,997,848 Methods and compositions for pulmonary delivery of insulin► Subscribe
6,407,236 Adenosine A3 receptor modulators► Subscribe
7,799,344Method of drug formulation based on increasing the affinity of crystalline microparticle surfaces for active agents► 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
Denmark2280020► Subscribe
Brazil9507023► Subscribe
Argentina013854► Subscribe
Australia740760► Subscribe
Eurasian Patent Organization200100007► Subscribe
Canada2183577► Subscribe
European Patent Office2582421► Subscribe
Australia2010203573► Subscribe
Russian Federation2487731► Subscribe
Russian Federation2468832► 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
0596Netherlands► SubscribePRODUCT NAME: INSULINE DEGLUDEC; NATIONAL REGISTRATION NO/DATE: EU/1/12/807/004 20130123; FIRST REGISTRATION: EU EU/1/12/807/001 20130123
C0035France► SubscribePRODUCT NAME: INSULINE DEGLUDEC; REGISTRATION NO/DATE: EU/1/12/807/001 20130121
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
0885961/01Switzerland► SubscribePRODUCT NAME: INSULIN GLULISIN; REGISTRATION NUMBER/DATE: SWISSMEDIC 57013 02.05.2005
C0044Belgium► SubscribePRODUCT NAME: INSULIN-ASPART; NAT. REGISTRATION NO/DATE: EU/1/99/119/001 19990907; FIRST REGISTRATION: CH 55045 01 19990615
2013000062Germany► SubscribePRODUCT NAME: KOMBINATION VON INSULIN DEGLUDEC UND INSULIN ASPART IN ALLEN DURCH DAS BASISPATENT GESCHUETZTEN FORMEN; REGISTRATION NO/DATE: EU/1/12/806/001 EU/1/12/806/004-005 EU/1/12/806/007-008 20130121
90067-4Sweden► SubscribePRODUCT NAME: COMBINATION OF INSULIN DEGLUDEC AND LIRAGLUTIDE; REG. NO/DATE: EU/1/14/974 20140918
213Luxembourg► SubscribePRODUCT NAME: INSULINE DEGLUDEC SOUS TOUTES LES FORMES PROTEGEES PAR LE BREVET DE BASE
2014000114Germany► SubscribePRODUCT NAME: KOMBINATION VON INSULIN DEGLUDEC UND LIRAGLUTIDE; REGISTRATION NO/DATE: EU/1/14/947 20140918
91022-0Sweden► SubscribePRODUCT NAME: N EPSILONB29 MYRISTOYL- ELLER N EPSILONB29 TETRADEKANOYL-DES(B30) HUMANT INSULIN
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For more information try a trial or see the database preview and plans and pricing

Serving leading biopharmaceutical companies globally:

Chinese Patent Office
Fish and Richardson
US Army
Julphar
Merck
Cipla
Moodys
Teva
McKinsey
Express Scripts

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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