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Last Updated: January 18, 2020

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AFREZZA Drug Profile

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Which patents cover Afrezza, and when can generic versions of Afrezza launch?

Afrezza is a drug marketed by Mannkind and is included in one NDA. There are thirty-nine patents protecting this drug.

This drug has four hundred and sixty-three patent family members in twenty-seven countries.

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.

US ANDA Litigation and Generic Entry Outlook for Afrezza

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Afrezza was eligible for patent challenges on December 31st, 1968.

Summary for AFREZZA
Drug patent expirations by year for AFREZZA
Drug Prices for AFREZZA

See drug prices for AFREZZA

Recent Clinical Trials for AFREZZA

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
DexCom, Inc.Phase 4
Diabetes and Glandular Disease ClinicPhase 4
Yale UniversityPhase 1

See all AFREZZA clinical trials

Pharmacology for AFREZZA
Drug ClassInsulin

US Patents and Regulatory Information for AFREZZA

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Mannkind AFREZZA insulin recombinant human POWDER;INHALATION 022472-002 Jun 27, 2014 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Mannkind AFREZZA insulin recombinant human POWDER;INHALATION 022472-003 Apr 17, 2015 RX Yes No   Start Trial   Start Trial   Start Trial
Mannkind AFREZZA insulin recombinant human POWDER;INHALATION 022472-002 Jun 27, 2014 RX Yes Yes   Start Trial   Start Trial   Start Trial
Mannkind AFREZZA insulin recombinant human POWDER;INHALATION 022472-001 Jun 27, 2014 RX Yes No   Start Trial   Start Trial Y   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for AFREZZA

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

Supplementary Protection Certificates for AFREZZA

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2209800 1490067-4 Sweden   Start Trial PRODUCT NAME: COMBINATION OF INSULIN DEGLUDEC AND LIRAGLUTIDE; REG. NO/DATE: EU/1/14/974 20140918
2107069 2013/34 Ireland   Start Trial PRODUCT: INSULIN DEGLUDEC IN ALL ITS FORMS AS THEY ARE PROTECTED BY THE BASIC PATENTS; REGISTRATION NO/DATE: IRELAND EU/1/12/807-001, 004, 005, 007-009, 012, 013 AND 015 / 21/01/2013
0368187 SZ 34/2000 Austria   Start Trial PRODUCT NAME: LANTUS - INSULIN GLARGIN
0368187 SPC/GB00/022 United Kingdom   Start Trial PRODUCT NAME: INSULIN GLARGINE (LANTUS) OPTIONALLY IN THE FORM OF ESTERS THEREOF OR PHYSIOLOGICALLY TOLERATED SALTS THEREOF.; REGISTERED: UK EU/1/00/134/001 20000609; UK EU/1/00/134/002 20000609; UK EU/1/00/134/003 20000609; UK EU/1/00/134/004 20000609; UK EU/1/00/134/005 20000609; UK EU/1/00/134/006 20000609; UK EU/1/00/134/007 20000609
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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

Serving leading biopharmaceutical companies globally:

Moodys
Mallinckrodt
Boehringer Ingelheim
Baxter
McKinsey
Dow

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