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Serving hundreds of leading biopharmaceutical companies globally:

Moodys
Healthtrust
Mallinckrodt
Queensland Health
Chinese Patent Office
Teva
Medtronic
Argus Health
Daiichi Sankyo

Generated: August 17, 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 forty drug master file entries for insulin recombinant human. Five 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: 40
Suppliers / Packagers: 5
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 ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Mannkind AFREZZA insulin recombinant human POWDER;INHALATION 022472-001 Jun 27, 2014 RX Yes No ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Lilly HUMULIN 70/30 PEN insulin recombinant human; insulin susp isophane recombinant human INJECTABLE;INJECTION 019717-002 Aug 6, 1998 OTC Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Mannkind AFREZZA insulin recombinant human POWDER;INHALATION 022472-003 Apr 17, 2015 RX Yes No ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Mannkind AFREZZA insulin recombinant human POWDER;INHALATION 022472-001 Jun 27, 2014 RX Yes No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Mannkind AFREZZA insulin recombinant human POWDER;INHALATION 022472-003 Apr 17, 2015 RX Yes No ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Mannkind AFREZZA insulin recombinant human POWDER;INHALATION 022472-002 Jun 27, 2014 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
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
Mannkind AFREZZA insulin recombinant human POWDER;INHALATION 022472-001 Jun 27, 2014 ➤ Try a Free Trial ➤ Try a Free Trial
Mannkind AFREZZA insulin recombinant human POWDER;INHALATION 022472-002 Jun 27, 2014 ➤ Try a Free Trial ➤ Try a Free Trial
Mannkind AFREZZA insulin recombinant human POWDER;INHALATION 022472-003 Apr 17, 2015 ➤ Try a Free Trial ➤ Try a Free Trial
Pfizer EXUBERA insulin recombinant human POWDER;INHALATION 021868-001 Jan 27, 2006 ➤ Try a Free Trial ➤ Try a Free Trial
Pfizer EXUBERA insulin recombinant human POWDER;INHALATION 021868-002 Jan 27, 2006 ➤ Try a Free Trial ➤ Try a Free Trial
Mannkind AFREZZA insulin recombinant human POWDER;INHALATION 022472-001 Jun 27, 2014 ➤ Try a Free Trial ➤ Try a Free Trial
Pfizer EXUBERA insulin recombinant human POWDER;INHALATION 021868-002 Jan 27, 2006 ➤ Try a Free Trial ➤ Try a Free Trial
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
7,799,344 Method of drug formulation based on increasing the affinity of crystalline microparticle surfaces for active agents ➤ Try a Free Trial
7,803,404 Method of drug formulation based on increasing the affinity of active agents for crystalline microparticle surfaces ➤ Try a Free Trial
8,372,804 Delivery of active agents ➤ Try a Free Trial
8,377,869 Method of preventing adverse effects by GLP-1 ➤ Try a Free Trial
8,420,604 Method of drug formulation of compositions comprising crystalline microparticle surfaces ➤ Try a Free Trial
8,785,396 Method and composition for treating migraines ➤ Try a Free Trial
8,921,311 Method for treating hyperglycemia ➤ Try a Free Trial
Patent No. Title Estimated Patent Expiration

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International Patents for INSULIN RECOMBINANT HUMAN

Supplementary Protection Certificates for INSULIN RECOMBINANT HUMAN

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
C0009 France ➤ Try a Free Trial PRODUCT NAME: INSULINE GLULISINE; REGISTRATION NO/DATE IN FRANCE: EU/1/04/258/001 DU 20040927; REGISTRATION NO/DATE AT EEC: EU/1/04/285/001 DU 20040927
00596 Netherlands ➤ Try a Free Trial PRODUCT 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
C/GB05/024 United Kingdom ➤ Try a Free Trial PRODUCT NAME: INSULIN GLULISINE OR A PHYSIOLOGICALLY TOLERABLE SALT THEREOF; REGISTRATION NO/DATE: EU/1/04/285/001 - 020 20040929
213 Luxembourg ➤ Try a Free Trial PRODUCT NAME: INSULINE DEGLUDEC SOUS TOUTES LES FORMES PROTEGEES PAR LE BREVET DE BASE
2017020 Lithuania ➤ Try a Free Trial PRODUCT NAME: INSULINAS GLARGINAS + LIKSIZENATIDAS; REGISTRATION NO/DATE: EU/1/16/1157 20170111
2107069/02 Switzerland ➤ Try a Free Trial PRODUCT NAME: INSULIN DEGLUDEC + INSULIN ASPART; REGISTRATION NO/DATE: SWISSMEDIC 62648 12.09.2013
00597 Netherlands ➤ Try a Free Trial PRODUCT NAME: INSULINE DEGLUDEC EN INSULINE ASPART; REGISTRATION NO/DATE: EU/1/12/806/001EU/1/12/806/004EU/1/12/806/005EU/1/12/806/007EU/1/12/806/008 2013210121
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Julphar
Harvard Business School
Cipla
Dow
Argus Health
Cerilliant
US Army
Queensland Health
Covington

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