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Serving hundreds of leading biopharmaceutical companies globally:

Daiichi Sankyo
Mallinckrodt
Chinese Patent Office
Farmers Insurance
McKinsey
Cerilliant
Harvard Business School
Baxter
Johnson and Johnson

Generated: April 19, 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 sixty 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 ➤ 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
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
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
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 022472-001 Jun 27, 2014 ➤ 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
Mannkind AFREZZA insulin recombinant human POWDER;INHALATION 022472-001 Jun 27, 2014 ➤ 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
6,309,671 Stable glassy state powder formulations ➤ Try a Free Trial
5,775,320 Method and device for delivering aerosolized medicaments ➤ Try a Free Trial
6,797,258 Compositions and methods for the pulmonary delivery of aerosolized macromolecules ➤ Try a Free Trial
8,372,804 Delivery of active agents ➤ Try a Free Trial
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
0885961/01 Switzerland ➤ Try a Free Trial PRODUCT NAME: INSULIN GLULISIN; REGISTRATION NUMBER/DATE: SWISSMEDIC 57013 02.05.2005
2013000061 Germany ➤ Try a Free Trial 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
0880 Netherlands ➤ Try a Free Trial PRODUCT NAME: SNELWERKENDE INSULIN ASPART; REGISTRATION NO/DATE: EU/1/16/1160 20170109
00019 Netherlands ➤ Try a Free Trial PRODUCT NAME: INSULINE GLARGINE,DESGEWENST IN DE VORM VAN EEN FYSIOLOGISCH GESCHIKT ZOUT; REGISTRATION NO/DATE: EU/1/00/134/001 - 007 20000609
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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For more information try a trial or see the plans and pricing

Serving hundreds of leading biopharmaceutical companies globally:

Federal Trade Commission
Cipla
Julphar
McKesson
Chubb
US Army
Merck
UBS
AstraZeneca

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.