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Serving leading biopharmaceutical companies globally:

Moodys
QuintilesIMS
McKesson
Novartis
Daiichi Sankyo
Queensland Health
Harvard Business School
Cantor Fitzgerald
US Department of Justice
Citi

Generated: November 18, 2017

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 nineteen patent family members in twenty-six countries and forty-two supplementary protection certificates in twelve countries.

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.

Pharmacology for AFREZZA

Ingredient-typeInsulin
Drug ClassInsulin
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;INHALATION022472-002Jun 27, 2014RXYesYes► Subscribe► SubscribeY ► Subscribe
Mannkind
AFREZZA
insulin recombinant human
POWDER;INHALATION022472-003Apr 17, 2015RXYesNo► Subscribe► SubscribeY ► Subscribe
Mannkind
AFREZZA
insulin recombinant human
POWDER;INHALATION022472-002Jun 27, 2014RXYesYes► Subscribe► Subscribe ► Subscribe
Mannkind
AFREZZA
insulin recombinant human
POWDER;INHALATION022472-001Jun 27, 2014RXYesNo► Subscribe► SubscribeY ► Subscribe
Mannkind
AFREZZA
insulin recombinant human
POWDER;INHALATION022472-003Apr 17, 2015RXYesNo► Subscribe► SubscribeY ► Subscribe
Mannkind
AFREZZA
insulin recombinant human
POWDER;INHALATION022472-002Jun 27, 2014RXYesYes► Subscribe► SubscribeY ► Subscribe
Mannkind
AFREZZA
insulin recombinant human
POWDER;INHALATION022472-003Apr 17, 2015RXYesNo► Subscribe► Subscribe► Subscribe
Mannkind
AFREZZA
insulin recombinant human
POWDER;INHALATION022472-002Jun 27, 2014RXYesYes► Subscribe► SubscribeY ► Subscribe
Mannkind
AFREZZA
insulin recombinant human
POWDER;INHALATION022472-002Jun 27, 2014RXYesYes► Subscribe► Subscribe ► Subscribe
Mannkind
AFREZZA
insulin recombinant human
POWDER;INHALATION022472-003Apr 17, 2015RXYesNo► Subscribe► SubscribeY ► Subscribe
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Expired Patents for Tradename: AFREZZA

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Mannkind
AFREZZA
insulin recombinant human
POWDER;INHALATION022472-001Jun 27, 2014► Subscribe► Subscribe
Mannkind
AFREZZA
insulin recombinant human
POWDER;INHALATION022472-001Jun 27, 2014► Subscribe► Subscribe
Mannkind
AFREZZA
insulin recombinant human
POWDER;INHALATION022472-002Jun 27, 2014► Subscribe► Subscribe
Mannkind
AFREZZA
insulin recombinant human
POWDER;INHALATION022472-001Jun 27, 2014► Subscribe► Subscribe
Mannkind
AFREZZA
insulin recombinant human
POWDER;INHALATION022472-002Jun 27, 2014► Subscribe► Subscribe
Mannkind
AFREZZA
insulin recombinant human
POWDER;INHALATION022472-003Apr 17, 2015► Subscribe► Subscribe
Mannkind
AFREZZA
insulin recombinant human
POWDER;INHALATION022472-002Jun 27, 2014► Subscribe► Subscribe
Mannkind
AFREZZA
insulin recombinant human
POWDER;INHALATION022472-002Jun 27, 2014► Subscribe► Subscribe
Mannkind
AFREZZA
insulin recombinant human
POWDER;INHALATION022472-001Jun 27, 2014► Subscribe► Subscribe
Mannkind
AFREZZA
insulin recombinant human
POWDER;INHALATION022472-002Jun 27, 2014► Subscribe► Subscribe
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Non-Orange Book Patents for Tradename: 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
8,921,311Method for treating hyperglycemia► Subscribe
9,078,866Method for treating hyperglycemia with GLP-1► Subscribe
7,803,404Method of drug formulation based on increasing the affinity of active agents for crystalline microparticle surfaces► Subscribe
9,006,175Potentiation of glucose elimination► Subscribe
8,785,396Method and composition for treating migraines► Subscribe
9,061,111Unit dose capsules and dry powder inhaler► Subscribe
9,066,881Method of drug formulation based on increasing the affinity of active agents for crystalline microparticle surfaces► Subscribe
9,630,930Diketopiperazine microparticles with defined specific surface areas► Subscribe
8,377,869Method of preventing adverse effects by GLP-1► Subscribe
8,372,804Delivery of active agents► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.

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International Patent Family for Tradename: AFREZZA

Country Document Number Estimated Expiration
Spain2570400► Subscribe
South Korea20100090692► Subscribe
European Patent Office2214647► Subscribe
Malaysia156306► Subscribe
Australia2013204305► Subscribe
Australia779986► Subscribe
Japan2016147883► Subscribe
European Patent Office1649886► Subscribe
Canada2601860► Subscribe
Portugal1808438► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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Supplementary Protection Certificates for Tradename: AFREZZA

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
/2000Austria► SubscribePRODUCT NAME: INSULIN ASPART/PROTAMIN; NAT. REGISTRATION NO/DATE: EU/1/00/142/001-008 20000801; FIRST REGISTRATION: LI 55414-55416 20000623
213Luxembourg► SubscribePRODUCT NAME: INSULINE DEGLUDEC SOUS TOUTES LES FORMES PROTEGEES PAR LE BREVET DE BASE
/2005Austria► SubscribePRODUCT NAME: NOVOMIX 70 - SUSPENSION, ENTHALTEND LOESLICHES INSULIN ASPART UND PROTAMINKRISTALLISIERTES INSULIN ASPART IM VERHAELTNIS 70:30; REGISTRATION NO/DATE: EU/1/00/142/017 - EU/1/00/142/022 20051005
0880Netherlands► SubscribePRODUCT NAME: SNELWERKENDE INSULIN ASPART; REGISTRATION NO/DATE: EU/1/16/1160 20170109
90036-0Sweden► SubscribePRODUCT NAME: KOMBINATION AV INSULIN DEGLUDEK OCH INSULIN ASPART; REG. NO/DATE: EU/1/12/806/001 20130121
13/34Ireland► SubscribePRODUCT: 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
60026Netherlands► SubscribePRODUCT NAME: INSULINUM LISPRUM, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT; REGISTRATION NO/DATE: EU/1/96/007/001 - EU/1/96/007/003 19960430
C/GB05/024United Kingdom► SubscribePRODUCT NAME: INSULIN GLULISINE OR A PHYSIOLOGICALLY TOLERABLE SALT THEREOF; REGISTRATION NO/DATE: EU/1/04/285/001 - 020 20040929
2013000061Germany► SubscribePRODUCT NAME: INSULIN DEGLUDEC IN ALLEN DURCH DAS BASISPATENT GESCHUETZTEN FORMEN; REGISTRATION NO/DATE: EU/1/12/807/001 EU/1/12/807/004-005 EU/1/12/807/007-009 EU/1/12/807/012-013 EU/1/12/807/015 20130121
C0044Belgium► SubscribePRODUCT NAME: INSULIN-ASPART; NAT. REGISTRATION NO/DATE: EU/1/99/119/001 19990907; FIRST REGISTRATION: CH 55045 01 19990615
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For more information try a trial or see the database preview and plans and pricing

Serving leading biopharmaceutical companies globally:

Dow
Queensland Health
Farmers Insurance
Merck
Julphar
Harvard Business School
US Department of Justice
Cipla
Mallinckrodt
Daiichi Sankyo

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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