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AFREZZA Drug Profile

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Which patents cover Afrezza, and what substitute generic drugs are available?

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

This drug has three hundred and seventy-five patent family members in twenty-six countries.

The generic ingredient in AFREZZA is insulin recombinant human. There are thirty-eight drug master file entries for this compound. Seven suppliers are listed for this compound. Additional details are available on the insulin recombinant human profile page.

Summary for Tradename: AFREZZA

Patents:32
Applicants:1
NDAs:1
Suppliers / Packagers: see list2
Clinical Trials: see list4
Formulation / Manufacturing:see details
Drug Prices:see details
DailyMed Link:AFREZZA at DailyMed

Pharmacology for Tradename: AFREZZA

Ingredient-typeInsulin
Drug ClassInsulin
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Mannkind
AFREZZA
insulin recombinant human
POWDER;INHALATION022472-003Apr 17, 2015RXYesNo8,258,095► Subscribe ► Subscribe
Mannkind
AFREZZA
insulin recombinant human
POWDER;INHALATION022472-003Apr 17, 2015RXYesNo8,734,845► SubscribeY ► Subscribe
Mannkind
AFREZZA
insulin recombinant human
POWDER;INHALATION022472-002Jun 27, 2014RXYesYes8,258,095► Subscribe ► Subscribe
Mannkind
AFREZZA
insulin recombinant human
POWDER;INHALATION022472-001Jun 27, 2014RXYesNo9,283,193► SubscribeY ► Subscribe
Mannkind
AFREZZA
insulin recombinant human
POWDER;INHALATION022472-003Apr 17, 2015RXYesNo8,215,300► 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;INHALATION022472-002Jun 27, 20146,663,898► Subscribe
Mannkind
AFREZZA
insulin recombinant human
POWDER;INHALATION022472-001Jun 27, 20146,071,497► Subscribe
Mannkind
AFREZZA
insulin recombinant human
POWDER;INHALATION022472-002Jun 27, 20148,133,514► Subscribe
Mannkind
AFREZZA
insulin recombinant human
POWDER;INHALATION022472-001Jun 27, 20148,133,514► Subscribe
Mannkind
AFREZZA
insulin recombinant human
POWDER;INHALATION022472-002Jun 27, 20146,071,497► 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
9,006,175Potentiation of glucose elimination► Subscribe
9,078,866Method for treating hyperglycemia with GLP-1► Subscribe
8,420,604Method of drug formulation of compositions comprising crystalline microparticle surfaces► Subscribe
7,799,344Method of drug formulation based on increasing the affinity of crystalline microparticle surfaces for 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
BrazilPI1013154► Subscribe
South Korea101438839► Subscribe
South Korea20160022404► Subscribe
South Korea20140072138► Subscribe
European Patent Office1196430► 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
/2005Austria► SubscribePRODUCT NAME: NOVOMIX 50 - SUSPENSION, ENTHALTEND LOESLICHES INSULIN ASPART UND PROTAMINKRISTALLISIERTES INSULIN ASPART IM VERHAELTNIS 50:50; REGISTRATION NO/DATE: EU/1/00/142/011 - EU/1/00/142/016 20051005
C0085France► SubscribePRODUCT NAME: LIRAGLUTIDE ET INSULINE DEGLUDEC; REGISTRATION NO/DATE: EU/1/14/947 20140918
226Luxembourg► SubscribePRODUCT NAME: COMBINATION D'INSULINE DEGLUDEC ET INSULINE ASPARTE SOUS TOUTES LES FORMES PROTEGEES PAR LE BREVET DE BASE; FIRST REGISTRATION DATE: 20130121
2107069/02Switzerland► SubscribePRODUCT NAME: INSULIN DEGLUDEC + INSULIN ASPART; REGISTRATION NO/DATE: SWISSMEDIC 62648 12.09.2013
00160Netherlands► SubscribePRODUCT NAME: INSULINE DETEMIRUM; NAT. REGISTRATION NO/DATE: EU/1/04/278/001EU/1/04/278/002EU/1/04/278/003EU/1/04/278/005EU/1/04/278/004EU/1/04/278/006EU/1/04/278/007EU/1/04/278/008EU/1/04/278/009 2004010601; FIRST REGISTRATION: 563705637156372EU/1/04/278/001 T/M -/009 2003101110
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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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