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Serving hundreds of leading biopharmaceutical companies globally:

Chubb
Cantor Fitzgerald
US Department of Justice
US Army
Cipla
Accenture
Baxter
UBS
Dow

Generated: June 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-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
Lilly HUMULIN 50/50 insulin recombinant human; insulin susp isophane recombinant human INJECTABLE;INJECTION 020100-001 Apr 29, 1992 DISCN No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Pfizer EXUBERA insulin recombinant human POWDER;INHALATION 021868-001 Jan 27, 2006 DISCN No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ 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 022472-002 Jun 27, 2014 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial ➤ 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
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
Pfizer EXUBERA insulin recombinant human POWDER;INHALATION 021868-001 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
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
2017000040 Germany ➤ Try a Free Trial PRODUCT NAME: SCHNELL-WIRKENDES INSULIN ASPART; REGISTRATION NO/DATE: EU/1/16/1160 20170109
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
C0085 France ➤ Try a Free Trial PRODUCT NAME: LIRAGLUTIDE ET INSULINE DEGLUDEC; REGISTRATION NO/DATE: EU/1/14/947 20140918
90042 Netherlands ➤ Try a Free Trial PRODUCT NAME: INSULIN ASPART; REGISTRATION NO/DATE: EU/1/99/119/001 - EU/1/99/119/005 19990907
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Merck
AstraZeneca
Colorcon
Boehringer Ingelheim
Deloitte
Cipla
Daiichi Sankyo
Julphar
Covington

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.