Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Last Updated: November 12, 2019

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 021868

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NDA 021868 describes EXUBERA, which is a drug marketed by Pfizer and is included in one NDA. There are three patents protecting this drug. Additional details are available on the EXUBERA profile page.

The generic ingredient in EXUBERA is insulin recombinant human. There are forty drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the insulin recombinant human profile page.
Summary for 021868
Tradename:EXUBERA
Applicant:Pfizer
Ingredient:insulin recombinant human
Patents:3
Formulation / Manufacturing:see details

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:POWDER;INHALATIONStrength1MG/INH
Approval Date:Jan 27, 2006TE:RLD:No
Patent:  Start TrialPatent Expiration:May 14, 2019Product Flag?Substance Flag?Delist Request?
Patented Use:METHOD OF ADMINISTERING INSULIN VIA INHALATION
Patent:  Start TrialPatent Expiration:May 14, 2019Product Flag?Substance Flag?Delist Request?
Patented Use:METHOD OF ADMINISTERING INSULIN VIA INHALATION
Patent:  Start TrialPatent Expiration:Jun 24, 2020Product Flag?YSubstance Flag?Delist Request?

Expired US Patents for NDA 021868

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 021868-002 Jan 27, 2006   Start Trial   Start Trial
Pfizer EXUBERA insulin recombinant human POWDER;INHALATION 021868-002 Jan 27, 2006   Start Trial   Start Trial
Pfizer EXUBERA insulin recombinant human POWDER;INHALATION 021868-002 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
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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