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Generated: March 19, 2019

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 one supplier. There are thirty-seven patents protecting this drug. Additional details are available on the AFREZZA profile page.

The generic ingredient in AFREZZA is insulin recombinant human. There are forty 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 022472
Tradename:AFREZZA
Applicant:Mannkind
Ingredient:insulin recombinant human
Patents:37
Formulation / Manufacturing:see details
Pharmacology for NDA: 022472
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 Mannkind Corporation 47918-874 47918-874-90 90 POWDER, METERED in 1 PACKAGE (47918-874-90)
AFREZZA insulin recombinant human POWDER;INHALATION 022472 NDA Mannkind Corporation 47918-878 47918-878-90 90 POWDER, METERED in 1 PACKAGE (47918-878-90)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:POWDER;INHALATIONStrength4 UNITS/INH
Approval Date:Jun 27, 2014TE:RLD:Yes
Patent:➤ Sign UpPatent Expiration:Aug 11, 2029Product Flag?Substance Flag?Delist Request?
Patented Use:METHOD OF CONTROLLING GLYCEMIA IN A DIABETIC PATIENT WITH DELAYED OR PROLONGED FOOD ABSORPBTION BY ADMINISTERING 50 TO 75% OF A PREDETERMINED DOSE OF INSULIN-FDKP AT MEALTIME, AND ADMINISTERING REMAINDER OF DOSE 30-120 MINUTES AFTER BEGINNING OF MEAL
Patent:➤ Sign UpPatent Expiration:Jun 29, 2020Product Flag?YSubstance Flag?Delist Request?
Patented Use:ADMINISTRATION OF A COMPOSITION COMPRISING INSULIN COMPLEXED WITH A DIKETOPIPERAZINE.
Patent:➤ Sign UpPatent Expiration:Jun 29, 2020Product Flag?Substance Flag?Delist Request?
Patented Use:ADMINISTRATION OF A COMPOSITION COMPRISING INSULIN COMPLEXED WITH MICROPARTICLES OF A DIKETOPIPERAZINE.

Expired US Patents for NDA 022472

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Mannkind AFREZZA insulin recombinant human POWDER;INHALATION 022472-002 Jun 27, 2014 ➤ Sign Up ➤ Sign Up
Mannkind AFREZZA insulin recombinant human POWDER;INHALATION 022472-003 Apr 17, 2015 ➤ Sign Up ➤ Sign Up
Mannkind AFREZZA insulin recombinant human POWDER;INHALATION 022472-001 Jun 27, 2014 ➤ Sign Up ➤ Sign Up
Mannkind AFREZZA insulin recombinant human POWDER;INHALATION 022472-002 Jun 27, 2014 ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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