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Serving leading biopharmaceutical companies globally:

Cipla
Citi
Colorcon
Medtronic
Julphar
Argus Health
Farmers Insurance
UBS
US Department of Justice
Daiichi Sankyo

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

Insulin recombinant human has seven hundred and fifty-eight 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 022472-001 Jun 27, 2014 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 022472-003 Apr 17, 2015 RX Yes No ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Novo Nordisk Inc VELOSULIN BR insulin recombinant human INJECTABLE;INJECTION 021028-001 Jul 19, 1999 DISCN No No ➤ Sign Up ➤ Sign Up ➤ 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 022472-003 Apr 17, 2015 RX Yes No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Mannkind AFREZZA insulin recombinant human POWDER;INHALATION 022472-003 Apr 17, 2015 RX Yes No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Mannkind AFREZZA insulin recombinant human POWDER;INHALATION 022472-002 Jun 27, 2014 RX Yes Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
Mannkind AFREZZA insulin recombinant human POWDER;INHALATION 022472-001 Jun 27, 2014 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
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
Pfizer EXUBERA insulin recombinant human POWDER;INHALATION 021868-002 Jan 27, 2006 ➤ Sign Up ➤ Sign Up
Pfizer EXUBERA insulin recombinant human POWDER;INHALATION 021868-002 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
Mannkind AFREZZA insulin recombinant human POWDER;INHALATION 022472-002 Jun 27, 2014 ➤ Sign Up ➤ Sign Up
Pfizer EXUBERA insulin recombinant human POWDER;INHALATION 021868-001 Jan 27, 2006 ➤ Sign Up ➤ Sign Up
Mannkind AFREZZA insulin recombinant human POWDER;INHALATION 022472-001 Jun 27, 2014 ➤ 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
6,258,341 Stable glassy state powder formulations ➤ Sign Up
5,785,049 Method and apparatus for dispersion of dry powder medicaments ➤ Sign Up
7,422,013 Dry powder dispersing apparatus and methods for their use ➤ Sign Up
6,423,344 Dispersible macromolecule compositions and methods for their preparation and use ➤ Sign Up
8,671,937 Unit dose capsules and dry powder inhaler ➤ Sign Up
6,372,258 Methods of spray-drying a drug and a hydrophobic amino acid ➤ Sign Up
5,997,848 Methods and compositions for pulmonary delivery of insulin ➤ Sign Up
6,448,253 Adenosine A3 receptor modulators ➤ Sign Up
6,479,049 Methods and compositions for the dry powder formulation of interferons ➤ Sign Up
5,458,135 Method and device for delivering aerosolized medicaments ➤ Sign Up
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
/2004 Austria ➤ Sign Up PRODUCT NAME: INSULIN-DETEMIR UND PHARMAZEUTISCH ANNEHMBARE ZN-SALZE DAVON; NAT. REGISTRATION NO/DATE: EU/1/04/278/001-009 20040601; FIRST REGISTRATION: LI 56370 56371 56372 20031110
2017000040 Germany ➤ Sign Up PRODUCT NAME: SCHNELL-WIRKENDES INSULIN ASPART; REGISTRATION NO/DATE: EU/1/16/1160 20170109
2107069/02 Switzerland ➤ Sign Up PRODUCT NAME: INSULIN DEGLUDEC + INSULIN ASPART; REGISTRATION NO/DATE: SWISSMEDIC 62648 12.09.2013
2013000061 Germany ➤ Sign Up PRODUCT NAME: INSULIN DEGLUDEC IN ALLEN DURCH DAS BASISPATENT GESCHUETZTEN FORMEN; REGISTRATION NO/DATE: EU/1/12/807/001 EU/1/12/807/004-005 EU/1/12/807/007-009 EU/1/12/807/012-013 EU/1/12/807/015 20130121
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
/2005 Austria ➤ Sign Up PRODUCT NAME: NOVOMIX 50 - SUSPENSION, ENTHALTEND LOESLICHES INSULIN ASPART UND PROTAMINKRISTALLISIERTES INSULIN ASPART IM VERHAELTNIS 50:50; REGISTRATION NO/DATE: EU/1/00/142/011 - EU/1/00/142/016 20051005
0596 Netherlands ➤ Sign Up PRODUCT NAME: INSULINE DEGLUDEC; NATIONAL REGISTRATION NO/DATE: EU/1/12/807/004 20130123; FIRST REGISTRATION: EU EU/1/12/807/001 20130123
00596 Netherlands ➤ Sign Up 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
C0035 France ➤ Sign Up PRODUCT NAME: INSULINE DEGLUDEC; REGISTRATION NO/DATE: EU/1/12/807/001 20130121
/2005 Austria ➤ Sign Up PRODUCT NAME: NOVOMIX 70 - SUSPENSION, ENTHALTEND LOESLICHES INSULIN ASPART UND PROTAMINKRISTALLISIERTES INSULIN ASPART IM VERHAELTNIS 70:30; REGISTRATION NO/DATE: EU/1/00/142/017 - EU/1/00/142/022 20051005
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Federal Trade Commission
Cipla
Express Scripts
Citi
Chubb
Daiichi Sankyo
Teva
Cantor Fitzgerald
Chinese Patent Office

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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