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Deloitte
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Federal Trade Commission
Chinese Patent Office
Fish and Richardson
Medtronic
Queensland Health
AstraZeneca
Express Scripts

Generated: August 21, 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 forty drug master file entries for this compound. Five 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
Bulk Api Vendors: 1
Clinical Trials: 25
Formulation / Manufacturing:see details
DailyMed Link:EXUBERA at DailyMed
Drug patent expirations by year for EXUBERA
Generic Entry Opportunity Date for EXUBERA
Generic Entry Date for EXUBERA*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
POWDER;INHALATION

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

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 ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Pfizer EXUBERA insulin recombinant human POWDER;INHALATION 021868-002 Jan 27, 2006 DISCN No No ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Pfizer EXUBERA insulin recombinant human POWDER;INHALATION 021868-001 Jan 27, 2006 DISCN No No ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Pfizer EXUBERA insulin recombinant human POWDER;INHALATION 021868-002 Jan 27, 2006 DISCN No No ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Pfizer EXUBERA insulin recombinant human POWDER;INHALATION 021868-001 Jan 27, 2006 DISCN No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Pfizer EXUBERA insulin recombinant human POWDER;INHALATION 021868-001 Jan 27, 2006 DISCN No No ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
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 ➤ Try a Free Trial ➤ Try a Free Trial
Pfizer EXUBERA insulin recombinant human POWDER;INHALATION 021868-001 Jan 27, 2006 ➤ Try a Free Trial ➤ Try a Free Trial
Pfizer EXUBERA insulin recombinant human POWDER;INHALATION 021868-001 Jan 27, 2006 ➤ Try a Free Trial ➤ Try a Free Trial
Pfizer EXUBERA insulin recombinant human POWDER;INHALATION 021868-002 Jan 27, 2006 ➤ Try a Free Trial ➤ Try a Free Trial
Pfizer EXUBERA insulin recombinant human POWDER;INHALATION 021868-002 Jan 27, 2006 ➤ Try a Free Trial ➤ Try a Free Trial
Pfizer EXUBERA insulin recombinant human POWDER;INHALATION 021868-002 Jan 27, 2006 ➤ Try a Free Trial ➤ Try a Free Trial
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
➤ Try a Free Trial EXUBERA ➤ Try a Free Trial

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
5,997,848 Methods and compositions for pulmonary delivery of insulin ➤ Try a Free Trial
8,161,969 Dry powder dispersing apparatus and methods for their use ➤ Try a Free Trial
8,173,168 Dispersible macromolecule compositions and methods for their preparation and use ➤ Try a Free Trial
6,123,936 Methods and compositions for the dry powder formulation of interferons ➤ Try a Free Trial
5,814,607 Pulmonary delivery of active fragments of parathyroid hormone ➤ Try a Free Trial
6,407,236 Adenosine A3 receptor modulators ➤ Try a Free Trial
Patent No. Title Estimated Patent Expiration

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Supplementary Protection Certificates for EXUBERA

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2017020 Lithuania ➤ Try a Free Trial PRODUCT NAME: INSULINAS GLARGINAS + LIKSIZENATIDAS; REGISTRATION NO/DATE: EU/1/16/1157 20170111
C/GB04/036 United Kingdom ➤ Try a Free Trial 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
2209800/01 Switzerland ➤ Try a Free Trial PRODUCT NAME: INSULIN DEGLUDEC + LIRAGLUTIDE; REGISTRATION NO/DATE: SWISSMEDIC 65041 12.09.2014
00597 Netherlands ➤ Try a Free Trial PRODUCT NAME: INSULINE DEGLUDEC EN INSULINE ASPART; REGISTRATION NO/DATE: EU/1/12/806/001EU/1/12/806/004EU/1/12/806/005EU/1/12/806/007EU/1/12/806/008 2013210121
C/GB00/022 United Kingdom ➤ Try a Free Trial PRODUCT NAME: INSULIN GLARGINE (LANTUS) OPTIONALLY IN THE FORM OF ESTERS THEREOF OR PHYSIOLOGICALLY TOLERATED SALTS THEREOF.; REGISTERED: UK EU/1/00/134/001 20000609; UK EU/1/00/134/002 20000609; UK EU/1/00/134/003 20000609; UK EU/1/00/134/004 20000609; UK EU/1/00/134/005 20000609; UK EU/1/00/134/006 20000609; UK EU/1/00/134/007 20000609
C0020 France ➤ Try a Free Trial PRODUCT NAME: INSULIN DETEMIR; NAT. REGISTRATION NO/DATE: EU/1/04/278/001 20040601; FIRST REGISTRATION: LI - 56370 20031110
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Fish and Richardson
Baxter
Boehringer Ingelheim
Express Scripts
Federal Trade Commission
Moodys
QuintilesIMS
Cerilliant
Argus Health

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