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Julphar
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Federal Trade Commission
AstraZeneca
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Generated: November 21, 2018

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Insulin susp isophane recombinant human - Generic Drug Details

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What are the generic drug sources for insulin susp isophane recombinant human and what is the scope of insulin susp isophane recombinant human patent protection?

Insulin susp isophane recombinant human is the generic ingredient in two branded drugs marketed by Lilly and Novo Nordisk Inc, and is included in two NDAs. There is one patent protecting this compound. Additional information is available in the individual branded drug profile pages.

There are forty drug master file entries for insulin susp isophane recombinant human. Four suppliers are listed for this compound.

Summary for insulin susp isophane recombinant human

US Patents and Regulatory Information for insulin susp isophane 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 N insulin susp isophane recombinant human INJECTABLE;INJECTION 018781-001 Oct 28, 1982 OTC Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Novo Nordisk Inc NOVOLIN N insulin susp isophane recombinant human INJECTABLE;INJECTION 019959-001 Jul 1, 1991 OTC 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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Supplementary Protection Certificates for insulin susp isophane recombinant human

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
00597 Netherlands ➤ Try a Free 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
C0023 France ➤ Try a Free Trial PRODUCT NAME: INSULIN GLARGINE; NAT. REGISTRATION NO/DATE: EU/0/00/134/001 20000609; FIRST REGISTRATION: EU/1/00/134/001 20000609
C0020 France ➤ Try a Free Trial PRODUCT NAME: INSULIN DETEMIR; NAT. REGISTRATION NO/DATE: EU/1/04/278/001 20040601; FIRST REGISTRATION: LI - 56370 20031110
00698 Netherlands ➤ Try a Free Trial PRODUCT NAME: INSULINE DEGLUDEC EN LIRAGLUTIDE; REGISTRATION NO/DATE: EU/1/14/94765041 2014120918
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Julphar
Mallinckrodt
Accenture
Cipla
Johnson and Johnson
Federal Trade Commission
AstraZeneca
US Department of Justice
McKinsey

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