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Serving leading biopharmaceutical companies globally:

Fish and Richardson
McKesson
Moodys
Dow
AstraZeneca
Baxter
Teva
Merck
Cerilliant
Citi

Generated: January 20, 2018

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 Lilly, Novo Nordisk Inc, Mannkind, and Pfizer, 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 fifty-six 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
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 ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Mannkind AFREZZA insulin recombinant human POWDER;INHALATION 022472-003 Apr 17, 2015 RX Yes No ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Mannkind AFREZZA insulin recombinant human POWDER;INHALATION 022472-003 Apr 17, 2015 RX Yes No ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Lilly HUMULIN 50/50 insulin recombinant human; insulin susp isophane recombinant human INJECTABLE;INJECTION 020100-001 Apr 29, 1992 DISCN No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Mannkind AFREZZA insulin recombinant human POWDER;INHALATION 022472-001 Jun 27, 2014 RX Yes No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Mannkind AFREZZA insulin recombinant human POWDER;INHALATION 022472-002 Jun 27, 2014 RX Yes Yes ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Mannkind AFREZZA insulin recombinant human POWDER;INHALATION 022472-003 Apr 17, 2015 RX Yes No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Mannkind AFREZZA insulin recombinant human POWDER;INHALATION 022472-001 Jun 27, 2014 RX Yes No ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Mannkind AFREZZA insulin recombinant human POWDER;INHALATION 022472-002 Jun 27, 2014 RX Yes Yes ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Mannkind AFREZZA insulin recombinant human POWDER;INHALATION 022472-001 Jun 27, 2014 RX Yes No ➤ Subscribe ➤ Subscribe ➤ Subscribe
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 022472-002 Jun 27, 2014 ➤ Subscribe ➤ Subscribe
Pfizer EXUBERA insulin recombinant human POWDER;INHALATION 021868-001 Jan 27, 2006 ➤ Subscribe ➤ Subscribe
Pfizer EXUBERA insulin recombinant human POWDER;INHALATION 021868-001 Jan 27, 2006 ➤ Subscribe ➤ Subscribe
Pfizer EXUBERA insulin recombinant human POWDER;INHALATION 021868-001 Jan 27, 2006 ➤ Subscribe ➤ Subscribe
Mannkind AFREZZA insulin recombinant human POWDER;INHALATION 022472-001 Jun 27, 2014 ➤ Subscribe ➤ Subscribe
Pfizer EXUBERA insulin recombinant human POWDER;INHALATION 021868-001 Jan 27, 2006 ➤ Subscribe ➤ Subscribe
Pfizer EXUBERA insulin recombinant human POWDER;INHALATION 021868-002 Jan 27, 2006 ➤ Subscribe ➤ Subscribe
Mannkind AFREZZA insulin recombinant human POWDER;INHALATION 022472-001 Jun 27, 2014 ➤ Subscribe ➤ Subscribe
Mannkind AFREZZA insulin recombinant human POWDER;INHALATION 022472-002 Jun 27, 2014 ➤ Subscribe ➤ Subscribe
Pfizer EXUBERA insulin recombinant human POWDER;INHALATION 021868-001 Jan 27, 2006 ➤ Subscribe ➤ Subscribe
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
6,258,341 Stable glassy state powder formulations ➤ Subscribe
6,737,045 Methods and compositions for the pulmonary delivery insulin ➤ Subscribe
6,019,968 Dispersible antibody compositions and methods for their preparation and use ➤ Subscribe
8,372,804 Delivery of active agents ➤ Subscribe
5,814,607 Pulmonary delivery of active fragments of parathyroid hormone ➤ Subscribe
7,097,827 Devices, compositions and methods for the pulmonary delivery of aerosolized medicaments ➤ Subscribe
7,271,171 Adenosine A.sub.3 receptor modulators ➤ Subscribe
6,589,560 Stable glassy state powder formulations ➤ Subscribe
9,078,866 Method for treating hyperglycemia with GLP-1 ➤ Subscribe
5,785,049 Method and apparatus for dispersion of dry powder medicaments ➤ Subscribe
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
90067-4 Sweden ➤ Subscribe PRODUCT NAME: COMBINATION OF INSULIN DEGLUDEC AND LIRAGLUTIDE; REG. NO/DATE: EU/1/14/974 20140918
0880 Netherlands ➤ Subscribe PRODUCT NAME: SNELWERKENDE INSULIN ASPART; REGISTRATION NO/DATE: EU/1/16/1160 20170109
2004005 Lithuania ➤ Subscribe PRODUCT NAME: INSULIN DETEMIR
90036-0 Sweden ➤ Subscribe PRODUCT NAME: KOMBINATION AV INSULIN DEGLUDEK OCH INSULIN ASPART; REG. NO/DATE: EU/1/12/806/001 20130121
226 Luxembourg ➤ Subscribe PRODUCT NAME: COMBINATION D'INSULINE DEGLUDEC ET INSULINE ASPARTE SOUS TOUTES LES FORMES PROTEGEES PAR LE BREVET DE BASE; FIRST REGISTRATION DATE: 20130121
2107069/01 Switzerland ➤ Subscribe PRODUCT NAME: INSULIN DEGLUDEC; REGISTRATION NO/DATE: SWISSMEDIC 62563 12.03.2013
0885961/01 Switzerland ➤ Subscribe PRODUCT NAME: INSULIN GLULISIN; REGISTRATION NUMBER/DATE: SWISSMEDIC 57013 02.05.2005
2014000114 Germany ➤ Subscribe PRODUCT NAME: KOMBINATION VON INSULIN DEGLUDEC UND LIRAGLUTIDE; REGISTRATION NO/DATE: EU/1/14/947 20140918
C0044 Belgium ➤ Subscribe PRODUCT NAME: INSULIN-ASPART; NAT. REGISTRATION NO/DATE: EU/1/99/119/001 19990907; FIRST REGISTRATION: CH 55045 01 19990615
C/GB04/036 United Kingdom ➤ Subscribe PRODUCT NAME: INSULIN DETEMIR, NEB29- TETRADECANOYL- DES(B30) HUMAN INSULIN; NATL REGISTRATION NO/DATE: EU/1/04/278/001-009 20040601; FIRST REGISTRATION: CH 56370, 56311, 56372 20031110
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving leading biopharmaceutical companies globally:

Healthtrust
Merck
Johnson and Johnson
Chinese Patent Office
Accenture
Teva
Citi
Colorcon
US Army

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