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

Get the Book: Make Better Decisions

Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

PDF eBook: Just $10 Get Print Book on Amazon

Serving leading biopharmaceutical companies globally:

Medtronic
Dow
Moodys
McKesson
Baxter
Mallinckrodt

Last Updated: October 20, 2019

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 022472

See Plans and Pricing

« Back to Dashboard

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-nine 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. Five 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:39
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:  Start TrialPatent 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:  Start TrialPatent Expiration:Aug 2, 2030Product Flag?YSubstance Flag?Delist Request?
Patent:  Start TrialPatent Expiration:Jun 12, 2029Product Flag?YSubstance Flag?Delist Request?

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   Start Trial   Start Trial
Mannkind AFREZZA insulin recombinant human POWDER;INHALATION 022472-001 Jun 27, 2014   Start Trial   Start Trial
Mannkind AFREZZA insulin recombinant human POWDER;INHALATION 022472-002 Jun 27, 2014   Start Trial   Start Trial
Mannkind AFREZZA insulin recombinant human POWDER;INHALATION 022472-001 Jun 27, 2014   Start Trial   Start Trial
Mannkind AFREZZA insulin recombinant human POWDER;INHALATION 022472-002 Jun 27, 2014   Start Trial   Start Trial
Mannkind AFREZZA insulin recombinant human POWDER;INHALATION 022472-002 Jun 27, 2014   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Complete Access Available with Subscription

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

Mallinckrodt
Colorcon
Express Scripts
Johnson and Johnson
Boehringer Ingelheim
AstraZeneca

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.