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Last Updated: March 28, 2020

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 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-four patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Insulin recombinant human has eight hundred and twenty-seven 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.

Recent Clinical Trials for insulin recombinant human

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SponsorPhase
Stefan FischliPhase 3
Tandem Diabetes Care, Inc.Phase 3
University Hospital Inselspital, BerneEarly Phase 1

See all insulin recombinant human clinical trials

Recent Litigation for insulin recombinant human

Identify potential future generic entrants

PTAB Litigation
PetitionerDate
2014-06-16

See all insulin recombinant human litigation

Pharmacology for insulin recombinant human
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   Start Trial   Start Trial Y   Start Trial
Mannkind AFREZZA insulin recombinant human POWDER;INHALATION 022472-001 Jun 27, 2014 RX Yes No   Start Trial   Start Trial Y   Start Trial
Mannkind AFREZZA insulin recombinant human POWDER;INHALATION 022472-002 Jun 27, 2014 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Mannkind AFREZZA insulin recombinant human POWDER;INHALATION 022472-001 Jun 27, 2014 RX Yes No   Start Trial   Start Trial Y   Start Trial
Mannkind AFREZZA insulin recombinant human POWDER;INHALATION 022472-003 Apr 17, 2015 RX Yes No   Start Trial   Start Trial Y   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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   Start Trial   Start Trial
Pfizer EXUBERA insulin recombinant human POWDER;INHALATION 021868-001 Jan 27, 2006   Start Trial   Start Trial
Pfizer EXUBERA insulin recombinant human POWDER;INHALATION 021868-002 Jan 27, 2006   Start Trial   Start Trial
Mannkind AFREZZA insulin recombinant human POWDER;INHALATION 022472-002 Jun 27, 2014   Start Trial   Start Trial
Mannkind AFREZZA insulin recombinant human POWDER;INHALATION 022472-003 Apr 17, 2015   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for insulin recombinant human

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0792290 04C0020 France   Start Trial PRODUCT NAME: INSULIN DETEMIR; NAT. REGISTRATION NO/DATE: EU/1/04/278/001 20040601; FIRST REGISTRATION: LI - 56370 20031110
2107069 2013/034 Ireland   Start Trial PRODUCT NAME: INSULIN DEGLUDEC; NAT REGISTRATION NO/DATE: EU/1/12/807-001, 004, 005, 007-009, 012, 013 015 20130121
2498802 CR 2017 00020 Denmark   Start Trial PRODUCT NAME: INSULIN GLARGINE/LIXISENATID; REG. NO/DATE: EU/1/16/1157/001-004 20170113
2107069 C02107069/01 Switzerland   Start Trial PRODUCT NAME: INSULIN DEGLUDEC; REGISTRATION NO/DATE: SWISSMEDIC 62563 12.03.2013
2107069 C300597 Netherlands   Start 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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Medtronic
McKinsey
Boehringer Ingelheim
McKesson
Express Scripts
Baxter

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 verification 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.