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Serving hundreds of leading biopharmaceutical companies globally:

Cerilliant
Accenture
Colorcon
QuintilesIMS
Express Scripts
Mallinckrodt
Daiichi Sankyo
Julphar
Chinese Patent Office

Generated: May 24, 2018

DrugPatentWatch Database Preview

INSULIN RECOMBINANT HUMAN - Generic Drug Details

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What are the generic drug sources for insulin recombinant human and what is the scope of insulin recombinant human patent protection?

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

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

There are thirty-nine drug master file entries for insulin recombinant human. Six suppliers are listed for this compound.
Summary for INSULIN RECOMBINANT HUMAN
International Patents:763
US Patents:41
Tradenames:11
Applicants:4
NDAs:9
Drug Master File Entries: 39
Suppliers / Packagers: 6
Clinical Trials: 4,097
Formulation / Manufacturing:see details
DailyMed Link:INSULIN RECOMBINANT HUMAN at DailyMed
Pharmacology for INSULIN RECOMBINANT HUMAN
Ingredient-typeInsulin
Drug ClassInsulin

US Patents and Regulatory Information for INSULIN RECOMBINANT HUMAN

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;INHALATION 022472-003 Apr 17, 2015 RX Yes No ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Mannkind AFREZZA insulin recombinant human POWDER;INHALATION 022472-003 Apr 17, 2015 RX Yes No ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Mannkind AFREZZA insulin recombinant human POWDER;INHALATION 022472-002 Jun 27, 2014 RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Mannkind AFREZZA insulin recombinant human POWDER;INHALATION 022472-001 Jun 27, 2014 RX Yes No ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

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Expired US Patents for INSULIN RECOMBINANT HUMAN

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Pfizer EXUBERA insulin recombinant human POWDER;INHALATION 021868-001 Jan 27, 2006 ➤ Sign Up ➤ Sign Up
Pfizer EXUBERA insulin recombinant human POWDER;INHALATION 021868-002 Jan 27, 2006 ➤ Sign Up ➤ Sign Up
Mannkind AFREZZA insulin recombinant human POWDER;INHALATION 022472-001 Jun 27, 2014 ➤ Sign Up ➤ Sign Up
Pfizer EXUBERA insulin recombinant human POWDER;INHALATION 021868-002 Jan 27, 2006 ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Non-Orange Book US Patents for 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
5,458,135 Method and device for delivering aerosolized medicaments ➤ Sign Up
6,737,045 Methods and compositions for the pulmonary delivery insulin ➤ Sign Up
6,921,825 Adenosine A3 receptor modulators ➤ Sign Up
6,901,929 Dry powder dispersing apparatus and methods for their use ➤ Sign Up
Patent No. Title Estimated Patent Expiration

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Supplementary Protection Certificates for INSULIN RECOMBINANT HUMAN

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
/2000 Austria ➤ Sign Up PRODUCT NAME: LANTUS - INSULIN GLARGIN; REGISTRATION NO/DATE: EU/1/00/134/001 - EU/1/00/134/007 20000609
226 Luxembourg ➤ Sign Up PRODUCT NAME: COMBINATION D'INSULINE DEGLUDEC ET INSULINE ASPARTE SOUS TOUTES LES FORMES PROTEGEES PAR LE BREVET DE BASE; FIRST REGISTRATION DATE: 20130121
C0035 France ➤ Sign Up PRODUCT NAME: INSULINE DEGLUDEC; REGISTRATION NO/DATE: EU/1/12/807/001 20130121
0885961/01 Switzerland ➤ Sign Up PRODUCT NAME: INSULIN GLULISIN; REGISTRATION NUMBER/DATE: SWISSMEDIC 57013 02.05.2005
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Baxter
Boehringer Ingelheim
QuintilesIMS
Chinese Patent Office
Cipla
McKesson
Daiichi Sankyo
Federal Trade Commission
Cantor Fitzgerald

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.