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Serving hundreds of leading biopharmaceutical companies globally:

Farmers Insurance
Mallinckrodt
Fuji
US Department of Justice
Deloitte
Covington
Cerilliant
McKinsey
Healthtrust

Generated: April 20, 2018

DrugPatentWatch Database Preview

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-five patents protecting this drug.

This drug has four hundred and twenty-six patent family members in twenty-six countries.

The generic ingredient in AFREZZA is insulin recombinant human. There are thirty-nine 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 AFREZZA
International Patents:426
US Patents:35
Applicants:1
NDAs:1
Suppliers / Packagers: 1
Clinical Trials: 7
Formulation / Manufacturing:see details
Drug Prices:see details
DailyMed Link:AFREZZA at DailyMed
Drug patent expirations by year for AFREZZA
Pharmacology for AFREZZA
Ingredient-typeInsulin
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 ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Mannkind AFREZZA insulin recombinant human POWDER;INHALATION 022472-003 Apr 17, 2015 RX Yes No ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Mannkind AFREZZA insulin recombinant human POWDER;INHALATION 022472-002 Jun 27, 2014 RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Mannkind AFREZZA insulin recombinant human POWDER;INHALATION 022472-001 Jun 27, 2014 RX Yes No ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

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Expired US Patents for AFREZZA

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

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Non-Orange Book US Patents for AFREZZA

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
8,671,937 Unit dose capsules and dry powder inhaler ➤ Sign Up
9,066,881 Method of drug formulation based on increasing the affinity of active agents for crystalline microparticle surfaces ➤ Sign Up
9,006,175 Potentiation of glucose elimination ➤ Sign Up
8,372,804 Delivery of active agents ➤ Sign Up
Patent No. Title Estimated Patent Expiration

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Supplementary Protection Certificates for AFREZZA

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2004005,C0792290 Lithuania ➤ Sign Up PRODUCT NAME: INSULIN DETEMIR; REGISTRATION NO/DATE: EU/1/04/278/001, EU/1/04/278/002, EU/1/04/278/003, EU/1/04/278/004, EU/1/04/278/005, EU/1/04/278/006, EU/1/04/278/007, EU/1/04/278/008, EU/1/04/278/00 20040601
2013000062 Germany ➤ Sign Up PRODUCT NAME: KOMBINATION VON INSULIN DEGLUDEC UND INSULIN ASPART IN ALLEN DURCH DAS BASISPATENT GESCHUETZTEN FORMEN; REGISTRATION NO/DATE: EU/1/12/806/001 EU/1/12/806/004-005 EU/1/12/806/007-008 20130121
C0020 France ➤ Sign Up PRODUCT NAME: INSULIN DETEMIR; NAT. REGISTRATION NO/DATE: EU/1/04/278/001 20040601; FIRST REGISTRATION: LI - 56370 20031110
C0035 France ➤ Sign Up PRODUCT NAME: INSULINE DEGLUDEC; REGISTRATION NO/DATE: EU/1/12/807/001 20130121
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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For more information try a trial or see the plans and pricing

Serving hundreds of leading biopharmaceutical companies globally:

Medtronic
QuintilesIMS
Covington
Colorcon
Harvard Business School
Daiichi Sankyo
Cerilliant
McKesson
Accenture

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.