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Last Updated: October 19, 2019

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 021536

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NDA 021536 describes LEVEMIR PENFILL, which is a drug marketed by Novo Nordisk Inc and is included in one NDA. It is available from three suppliers. There is one patent protecting this drug. Additional details are available on the LEVEMIR PENFILL profile page.

The generic ingredient in LEVEMIR PENFILL is insulin detemir recombinant. There are forty drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the insulin detemir recombinant profile page.
Summary for 021536
Tradename:LEVEMIR PENFILL
Applicant:Novo Nordisk Inc
Ingredient:insulin detemir recombinant
Patents:23
Formulation / Manufacturing:see details
Pharmacology for NDA: 021536
Ingredient-typeInsulin
Medical Subject Heading (MeSH) Categories for 021536
Suppliers and Packaging for NDA: 021536
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
LEVEMIR insulin detemir recombinant INJECTABLE;SUBCUTANEOUS 021536 NDA Novo Nordisk 0169-3687 0169-3687-12 1 VIAL, GLASS in 1 CARTON (0169-3687-12) > 10 mL in 1 VIAL, GLASS
LEVEMIR FLEXPEN insulin detemir recombinant INJECTABLE;SUBCUTANEOUS 021536 NDA Novo Nordisk 0169-3687 0169-3687-12 1 VIAL, GLASS in 1 CARTON (0169-3687-12) > 10 mL in 1 VIAL, GLASS

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;SUBCUTANEOUSStrength1000 UNITS/10ML (100 UNITS/ML)
Approval Date:Jun 16, 2005TE:RLD:Yes
Patent:  Start TrialPatent Expiration:Jun 16, 2019Product Flag?YSubstance Flag?YDelist Request?
Patented Use:LEVEMIR IS A LONG-ACTING BASAL INSULIN ANALOG THAT IS INDICATED IN THE TREATMENT OF PATIENTS WITH DIABETES MELLITUS

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;SUBCUTANEOUSStrength300 UNITS/3ML (100 UNITS/ML)
Approval Date:Jun 16, 2005TE:RLD:No
Patent:  Start TrialPatent Expiration:Jun 16, 2019Product Flag?YSubstance Flag?YDelist Request?
Patented Use:LEVEMIR IS A LONG-ACTING BASAL INSULIN ANALOG THAT IS INDICATED IN THE TREATMENT OF PATIENTS WITH DIABETES MELLITUS
Patent:  Start TrialPatent Expiration:Jan 28, 2019Product Flag?YSubstance Flag?Delist Request?

Expired US Patents for NDA 021536

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Novo Nordisk Inc LEVEMIR INNOLET insulin detemir recombinant INJECTABLE;SUBCUTANEOUS 021536-003 Jun 16, 2005   Start Trial   Start Trial
Novo Nordisk Inc LEVEMIR FLEXPEN insulin detemir recombinant INJECTABLE;SUBCUTANEOUS 021536-002 Jun 16, 2005   Start Trial   Start Trial
Novo Nordisk Inc LEVEMIR insulin detemir recombinant INJECTABLE;SUBCUTANEOUS 021536-001 Jun 16, 2005   Start Trial   Start Trial
Novo Nordisk Inc LEVEMIR FLEXPEN insulin detemir recombinant INJECTABLE;SUBCUTANEOUS 021536-002 Jun 16, 2005   Start Trial   Start Trial
Novo Nordisk Inc LEVEMIR FLEXPEN insulin detemir recombinant INJECTABLE;SUBCUTANEOUS 021536-002 Jun 16, 2005   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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