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Serving leading biopharmaceutical companies globally:

Federal Trade Commission
Chubb
Baxter
Fish and Richardson
Cantor Fitzgerald
Colorcon
McKinsey
McKesson
Fuji
Mallinckrodt

Generated: January 19, 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-one 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:421
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 ➤ Subscribe ➤ Subscribe ➤ Subscribe
Mannkind AFREZZA insulin recombinant human POWDER;INHALATION 022472-003 Apr 17, 2015 RX Yes No ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Mannkind AFREZZA insulin recombinant human POWDER;INHALATION 022472-002 Jun 27, 2014 RX Yes Yes ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Mannkind AFREZZA insulin recombinant human POWDER;INHALATION 022472-001 Jun 27, 2014 RX Yes No ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Mannkind AFREZZA insulin recombinant human POWDER;INHALATION 022472-003 Apr 17, 2015 RX Yes No ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Mannkind AFREZZA insulin recombinant human POWDER;INHALATION 022472-002 Jun 27, 2014 RX Yes Yes ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Mannkind AFREZZA insulin recombinant human POWDER;INHALATION 022472-003 Apr 17, 2015 RX Yes No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Mannkind AFREZZA insulin recombinant human POWDER;INHALATION 022472-002 Jun 27, 2014 RX Yes Yes ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Mannkind AFREZZA insulin recombinant human POWDER;INHALATION 022472-002 Jun 27, 2014 RX Yes Yes ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Mannkind AFREZZA insulin recombinant human POWDER;INHALATION 022472-003 Apr 17, 2015 RX Yes No ➤ Subscribe ➤ Subscribe ➤ Subscribe
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 022472-002 Jun 27, 2014 ➤ Subscribe ➤ Subscribe
Mannkind AFREZZA insulin recombinant human POWDER;INHALATION 022472-001 Jun 27, 2014 ➤ Subscribe ➤ Subscribe
Mannkind AFREZZA insulin recombinant human POWDER;INHALATION 022472-001 Jun 27, 2014 ➤ Subscribe ➤ Subscribe
Mannkind AFREZZA insulin recombinant human POWDER;INHALATION 022472-002 Jun 27, 2014 ➤ Subscribe ➤ Subscribe
Mannkind AFREZZA insulin recombinant human POWDER;INHALATION 022472-002 Jun 27, 2014 ➤ Subscribe ➤ Subscribe
Mannkind AFREZZA insulin recombinant human POWDER;INHALATION 022472-002 Jun 27, 2014 ➤ Subscribe ➤ Subscribe
Mannkind AFREZZA insulin recombinant human POWDER;INHALATION 022472-001 Jun 27, 2014 ➤ Subscribe ➤ Subscribe
Mannkind AFREZZA insulin recombinant human POWDER;INHALATION 022472-001 Jun 27, 2014 ➤ Subscribe ➤ Subscribe
Mannkind AFREZZA insulin recombinant human POWDER;INHALATION 022472-001 Jun 27, 2014 ➤ Subscribe ➤ Subscribe
Mannkind AFREZZA insulin recombinant human POWDER;INHALATION 022472-002 Jun 27, 2014 ➤ Subscribe ➤ Subscribe
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 ➤ Subscribe
9,006,175 Potentiation of glucose elimination ➤ Subscribe
8,377,869 Method of preventing adverse effects by GLP-1 ➤ Subscribe
9,089,497 Method of drug formulation based on increasing the affinity of active agents for crystalline microparticle surfaces ➤ Subscribe
8,372,804 Delivery of active agents ➤ Subscribe
7,799,344 Method of drug formulation based on increasing the affinity of crystalline microparticle surfaces for active agents ➤ Subscribe
8,921,311 Method for treating hyperglycemia ➤ Subscribe
8,420,604 Method of drug formulation of compositions comprising crystalline microparticle surfaces ➤ Subscribe
9,446,001 Increasing drug affinity for crystalline microparticle surfaces ➤ Subscribe
9,801,925 Potentiation of glucose elimination ➤ Subscribe
Patent No. Title Estimated Patent Expiration

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International Patents for AFREZZA

Supplementary Protection Certificates for AFREZZA

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
213 Luxembourg ➤ Subscribe PRODUCT NAME: INSULINE DEGLUDEC SOUS TOUTES LES FORMES PROTEGEES PAR LE BREVET DE BASE
C0085 France ➤ Subscribe PRODUCT NAME: LIRAGLUTIDE ET INSULINE DEGLUDEC; REGISTRATION NO/DATE: EU/1/14/947 20140918
13/034 Ireland ➤ Subscribe APPLICATION FOR EXTENSION OF THE DURATION OF A SUPPLEMENTARY PROTECTION CERTIFICATE 2013/034 IN JOURNAL NO. 2325 OF 25/01/2017 UNDER THE HEADING APPLICATION FOR EXTENSION OF THE DURATION OF A SUPPLEMENTARY PROTECTION CERTIFICATE, SPC NO. 2013/034 SHOULD HAVE APPEARED AS FOLLOWS, NOVO NORDISK A/S NOVO ALLE, 2880 BAGSVAERD, DENMARK (20/12/2016) PATENT NO: EP2107069; NOVEL INSULIN DERIVATIVES PRODUCT: INSULIN DEGLUDEC MARKET AUTHORISATION: EU: EU/1/12/807-001, 004, 005, 007-009, 012, 013 AND 015 (21/01/2013) ORIGINAL SPC EXPIRY DATE: 22/01/2028 1127 DESIGNS REGISTERED UNDER THE INDUSTRIAL DESIGNS ACT, 2001
2017 00013 Denmark ➤ Subscribe PRODUCT NAME: KOMBINATION AF INSULIN DEGLUDEC OG LIRAGLUTID; NAT. REG. NO/DATE: EU/1/14/947 20140922; FIRST REG. NO/DATE: CH 65041 20140912
00160 Netherlands ➤ Subscribe PRODUCT 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
90042 Netherlands ➤ Subscribe PRODUCT NAME: INSULIN ASPART; REGISTRATION NO/DATE: EU/1/99/119/001 - EU/1/99/119/005 19990907
60026 Netherlands ➤ Subscribe PRODUCT 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/GB05/024 United Kingdom ➤ Subscribe PRODUCT NAME: INSULIN GLULISINE OR A PHYSIOLOGICALLY TOLERABLE SALT THEREOF; REGISTRATION NO/DATE: EU/1/04/285/001 - 020 20040929
91022-0 Sweden ➤ Subscribe PRODUCT NAME: N EPSILONB29 MYRISTOYL- ELLER N EPSILONB29 TETRADEKANOYL-DES(B30) HUMANT INSULIN
/2004 Austria ➤ Subscribe PRODUCT NAME: INSULIN-DETEMIR UND PHARMAZEUTISCH ANNEHMBARE ZN-SALZE DAVON; NAT. REGISTRATION NO/DATE: EU/1/04/278/001-009 20040601; FIRST REGISTRATION: LI 56370 56371 56372 20031110
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 leading biopharmaceutical companies globally:

Federal Trade Commission
US Army
AstraZeneca
Julphar
Merck
Chubb
Fish and Richardson
Medtronic
Express Scripts

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