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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 four patents protecting this drug. Additional details are available on the EXUBERA profile page.

The generic ingredient in EXUBERA is insulin recombinant human. There are thirty-eight drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the insulin recombinant human profile page.

Summary for NDA: 021868

Tradename:
EXUBERA
Applicant:
Pfizer
Ingredient:
insulin recombinant human
Patents:4
Formulation / Manufacturing:see details

Summary for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:POWDER;INHALATIONStrength1MG/INH
Approval Date:Jan 27, 2006TE:RLD:No
Patent:6,582,728Patent Expiration:Jun 24, 2020Product Flag?YSubstance Flag?Delist Request?
Patent:6,685,967Patent Expiration:Sep 11, 2018Product Flag?YSubstance Flag?Delist Request?
Patent:6,257,233Patent Expiration:May 14, 2019Product Flag?Substance Flag?Delist Request?
Patented Use:METHOD OF ADMINISTERING INSULIN VIA INHALATION

Expired Orange Book Patents for NDA: 021868

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Pfizer
EXUBERA
insulin recombinant human
POWDER;INHALATION021868-002Jan 27, 20066,051,256► subscribe
Pfizer
EXUBERA
insulin recombinant human
POWDER;INHALATION021868-001Jan 27, 20065,740,794► subscribe
Pfizer
EXUBERA
insulin recombinant human
POWDER;INHALATION021868-002Jan 27, 20066,543,448► subscribe
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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