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Serving 500+ biopharmaceutical companies globally:

Mallinckrodt
Cipla
US Department of Justice
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Colorcon
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Queensland Health
Cerilliant

Generated: September 21, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 022472

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NDA 022472 describes AFREZZA, which is a drug marketed by Mannkind and is included in one NDA. It is available from two suppliers. There are thirty-five patents protecting this drug. Additional details are available on the AFREZZA profile page.

The generic ingredient in AFREZZA 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: 022472

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:35
Formulation / Manufacturing:see details

Pharmacology for NDA: 022472

Ingredient-typeInsulin

Suppliers and Packaging for NDA: 022472

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
AFREZZA
insulin recombinant human
POWDER;INHALATION 022472 NDA Sanofi-Aventis U.S. LLC 0024-5874 0024-5874-90 90 POWDER, METERED in 1 PACKAGE (0024-5874-90)
AFREZZA
insulin recombinant human
POWDER;INHALATION 022472 NDA Sanofi-Aventis U.S. LLC 0024-5882 0024-5882-36 90 PACKAGE in 1 CARTON (0024-5882-36) > 1 KIT in 1 PACKAGE * 30 POWDER, METERED in 1 BLISTER PACK * 60 POWDER, METERED in 1 BLISTER PACK

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:POWDER;INHALATIONStrength4 UNITS/INH
Approval Date:Jun 27, 2014TE:RLD:Yes
Regulatory Exclusivity Expiration:Jun 27, 2017
Regulatory Exclusivity Use:NEW PRODUCT
Patent:► SubscribePatent Expiration:Jun 29, 2020Product Flag?YSubstance Flag?Delist Request?
Patented Use:ADMINISTRATION OF A COMPOSITION COMPRISING INSULIN COMPLEXED WITH A DIKETOPIPERAZINE.
Patent:► SubscribePatent Expiration:Jun 29, 2020Product Flag?Substance Flag?Delist Request?
Patented Use:ADMINISTRATION OF A COMPOSITION COMPRISING INSULIN COMPLEXED WITH MICROPARTICLES OF A DIKETOPIPERAZINE.

Expired Orange Book Patents for NDA: 022472



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Serving 500+ biopharmaceutical companies globally:

Argus Health
Cantor Fitzgerald
Dow
QuintilesIMS
Healthtrust
Citi
Moodys
Boehringer Ingelheim
Chubb
Teva

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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