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Generated: April 25, 2019

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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.

Insulin susp isophane recombinant human has thirteen patent family members in nine countries.

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
International Patents:13
US Patents:1
Tradenames:2
Applicants:2
NDAs:2
Drug Master File Entries: 40
Suppliers / Packagers: 4
Clinical Trials: 8
DailyMed Link:insulin susp isophane recombinant human at DailyMed

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
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
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
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

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2498802 122017000039 Germany ➤ Try a Free Trial PRODUCT NAME: SULIQUA (FIRMENEIGENER NAME DES MEDIZINISCHEN PRODUKTS) BZW. WIRKSTOFFZUSAMMENSETZUNG UMFASSEND INSULIN GLARGIN / LIXISENATID UND IHRE PHARMAZEUTISCH ANNEHMBAREN SALZE (INTERNATIONALER, NICHT FIRMENEIGENER NAME); REGISTRATION NO/DATE: EU/1/16/1157 20170111
0792290 28/2004 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 2013/034 Ireland ➤ Try a Free Trial PRODUCT NAME: INSULIN DEGLUDEC; NAT REGISTRATION NO/DATE: EU/1/12/807-001, 004, 005, 007-009, 012, 013 015 20130121
0792290 C300160 Netherlands ➤ Try a Free Trial PRODUCT NAME: INSULINE DETEMIRUM; NAT. REGISTRATION NO/DATE: EU/1/04/278/001EU/1/04/278/002EU/1/04/278/003EU/1/04/278/005EU/1/04/278/004EU/1/04/278/006EU/1/04/278/007EU/1/04/278/008EU/1/04/278/009 2004010601; FIRST REGISTRATION: 563705637156372EU/1/04/278/001 T/M -/009 2003101110
0885961 SZ 2/2005 Austria ➤ Try a Free Trial PRODUCT NAME: INSULIN GLULISINE
Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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