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Serving hundreds of leading biopharmaceutical companies globally:

Moodys
Cerilliant
Cipla
Federal Trade Commission
Daiichi Sankyo
Harvard Business School
Cantor Fitzgerald
Argus Health
Baxter

Generated: December 19, 2018

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

Insulin recombinant human has seven hundred and sixty-four 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.

Summary for insulin recombinant human
International Patents:764
US Patents:42
Tradenames:11
Applicants:4
NDAs:9
Drug Master File Entries: 40
Suppliers / Packagers: 5
Clinical Trials: 4,258
Formulation / Manufacturing:see details
DailyMed Link:insulin recombinant human at DailyMed
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 ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Mannkind AFREZZA insulin recombinant human POWDER;INHALATION 022472-003 Apr 17, 2015 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 022472-003 Apr 17, 2015 RX Yes No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Novo Nordisk Inc NOVOLIN R insulin recombinant human INJECTABLE;INJECTION 019938-001 Jun 25, 1991 OTC Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Mannkind AFREZZA insulin recombinant human POWDER;INHALATION 022472-003 Apr 17, 2015 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 022472-002 Jun 27, 2014 ➤ 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 021868-002 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
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 021868-002 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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International Patents for insulin recombinant human

Country Document Number Estimated Expiration
Russian Federation 2175556 ➤ Try a Free Trial
Canada 2274758 ➤ Try a Free Trial
Sweden 0003984 ➤ Try a Free Trial
Japan 4386936 ➤ Try a Free Trial
Denmark 2211842 ➤ Try a Free Trial
World Intellectual Property Organization (WIPO) 9300951 ➤ Try a Free Trial
Country Document Number Estimated Expiration

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Supplementary Protection Certificates for insulin recombinant human

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
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
/2004 Austria ➤ Try a Free Trial 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
2107069/02 Switzerland ➤ Try a Free Trial PRODUCT NAME: INSULIN DEGLUDEC + INSULIN ASPART; REGISTRATION NO/DATE: SWISSMEDIC 62648 12.09.2013
91020-8 0090020-9 Sweden ➤ Try a Free Trial PRODUCT NAME: LANTUS - INSULIN GLARGIN; REGISTRATION NO/DATE: EU/1/00/134/001 20000609
2013000062 Germany ➤ Try a Free Trial PRODUCT NAME: KOMBINATION VON INSULIN DEGLUDEC UND INSULIN ASPART IN ALLEN DURCH DAS BASISPATENT GESCHUETZTEN FORMEN; REGISTRATION NO/DATE: EU/1/12/806/001 EU/1/12/806/004-005 EU/1/12/806/007-008 20130121
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Moodys
Cerilliant
Cipla
Federal Trade Commission
Daiichi Sankyo
Harvard Business School
Cantor Fitzgerald
Argus Health
Baxter

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