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Serving hundreds of leading biopharmaceutical companies globally:

Queensland Health
QuintilesIMS
Covington
McKesson
Citi
Argus Health
Mallinckrodt
Moodys
Cerilliant

Generated: May 22, 2018

DrugPatentWatch Database Preview

EXUBERA Drug Profile

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When do Exubera patents expire, and what generic alternatives are available?

Exubera is a drug marketed by Pfizer and is included in one NDA. There are four patents protecting this drug.

This drug has three hundred and thirty-four patent family members in fifty-eight countries.

The generic ingredient in EXUBERA 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 EXUBERA
International Patents:334
US Patents:4
Applicants:1
NDAs:1
Clinical Trials: 25
Formulation / Manufacturing:see details
DailyMed Link:EXUBERA at DailyMed
Drug patent expirations by year for EXUBERA

US Patents and Regulatory Information for EXUBERA

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Pfizer EXUBERA insulin recombinant human POWDER;INHALATION 021868-001 Jan 27, 2006 DISCN No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Pfizer EXUBERA insulin recombinant human POWDER;INHALATION 021868-002 Jan 27, 2006 DISCN No No ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Pfizer EXUBERA insulin recombinant human POWDER;INHALATION 021868-001 Jan 27, 2006 DISCN No No ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Pfizer EXUBERA insulin recombinant human POWDER;INHALATION 021868-002 Jan 27, 2006 DISCN No 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 EXUBERA

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Pfizer EXUBERA insulin recombinant human POWDER;INHALATION 021868-001 Jan 27, 2006 ➤ Sign Up ➤ Sign Up
Pfizer EXUBERA insulin recombinant human POWDER;INHALATION 021868-001 Jan 27, 2006 ➤ Sign Up ➤ Sign Up
Pfizer EXUBERA insulin recombinant human POWDER;INHALATION 021868-002 Jan 27, 2006 ➤ Sign Up ➤ Sign Up
Pfizer EXUBERA insulin recombinant human POWDER;INHALATION 021868-001 Jan 27, 2006 ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Premature patent expiration for: EXUBERA

Expiration due to failure to pay maintenance fee

Patent Number Tradename Expiration Date
➤ Sign Up EXUBERA ➤ Sign Up

Non-Orange Book US Patents for EXUBERA

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
6,165,463 Dispersible antibody compositions and methods for their preparation and use ➤ Sign Up
7,097,827 Devices, compositions and methods for the pulmonary delivery of aerosolized medicaments ➤ Sign Up
5,814,607 Pulmonary delivery of active fragments of parathyroid hormone ➤ Sign Up
8,173,168 Dispersible macromolecule compositions and methods for their preparation and use ➤ Sign Up
Patent No. Title Estimated Patent Expiration

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Supplementary Protection Certificates for EXUBERA

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
C/GB04/036 United Kingdom ➤ Sign Up PRODUCT NAME: INSULIN DETEMIR, NEB29- TETRADECANOYL- DES(B30) HUMAN INSULIN; NATL REGISTRATION NO/DATE: EU/1/04/278/001-009 20040601; FIRST REGISTRATION: CH 56370, 56311, 56372 20031110
C0009 France ➤ Sign Up PRODUCT NAME: INSULINE GLULISINE; REGISTRATION NO/DATE IN FRANCE: EU/1/04/258/001 DU 20040927; REGISTRATION NO/DATE AT EEC: EU/1/04/285/001 DU 20040927
2017000040 Germany ➤ Sign Up PRODUCT NAME: SCHNELL-WIRKENDES INSULIN ASPART; REGISTRATION NO/DATE: EU/1/16/1160 20170109
00021 Netherlands ➤ Sign Up PRODUCT NAME: INSULINE ASPART EN GEKRISTALLISEERD PROTAMINE-INSULINE ASPART; NAT. REGISTRATION NO/DATE: EU/1/00/142/001 20000801; FIRST REGISTRATION: 55414015541502 2000230623
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Mallinckrodt
Healthtrust
Citi
Fish and Richardson
Dow
McKinsey
Colorcon
Chinese Patent Office
Medtronic

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