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Serving 500+ biopharmaceutical companies globally:

Deloitte
Baxter
US Department of Justice
Covington
Healthtrust
Cipla
Accenture
Dow
Merck
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Generated: August 20, 2017

DrugPatentWatch Database Preview

EXUBERA Drug Profile

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What is the patent landscape for Exubera, and what generic Exubera 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 twenty-seven patent family members in fifty-eight countries.

The generic ingredient in EXUBERA 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.

Summary for Tradename: EXUBERA

Patents:4
Applicants:1
NDAs:1
Clinical Trials: see list25
Formulation / Manufacturing:see details
Drug Prices:see details
DailyMed Link:EXUBERA at DailyMed
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;INHALATION021868-001Jan 27, 2006DISCNNoNo► Subscribe► SubscribeY ► Subscribe
Pfizer
EXUBERA
insulin recombinant human
POWDER;INHALATION021868-002Jan 27, 2006DISCNNoNo► Subscribe► Subscribe ► Subscribe
Pfizer
EXUBERA
insulin recombinant human
POWDER;INHALATION021868-001Jan 27, 2006DISCNNoNo► Subscribe► Subscribe ► Subscribe
Pfizer
EXUBERA
insulin recombinant human
POWDER;INHALATION021868-002Jan 27, 2006DISCNNoNo► Subscribe► Subscribe ► Subscribe
Pfizer
EXUBERA
insulin recombinant human
POWDER;INHALATION021868-001Jan 27, 2006DISCNNoNo► Subscribe► SubscribeY ► Subscribe
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Expired Patents for Tradename: EXUBERA

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Pfizer
EXUBERA
insulin recombinant human
POWDER;INHALATION021868-001Jan 27, 2006► Subscribe► Subscribe
Pfizer
EXUBERA
insulin recombinant human
POWDER;INHALATION021868-001Jan 27, 2006► Subscribe► Subscribe
Pfizer
EXUBERA
insulin recombinant human
POWDER;INHALATION021868-001Jan 27, 2006► Subscribe► Subscribe
Pfizer
EXUBERA
insulin recombinant human
POWDER;INHALATION021868-002Jan 27, 2006► Subscribe► Subscribe
Pfizer
EXUBERA
insulin recombinant human
POWDER;INHALATION021868-002Jan 27, 2006► Subscribe► Subscribe
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Premature patent expiration for: EXUBERA

Expiration due to failure to pay maintenance fee

Patent Number Tradename Expiration Date
► Subscribe
EXUBERA
► Subscribe

Non-Orange Book Patents for Tradename: 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
6,921,527 Composition for pulmonary administration comprising a drug and a hydrophobic amino acid► Subscribe
5,997,848 Methods and compositions for pulmonary delivery of insulin► Subscribe
7,422,013Dry powder dispersing apparatus and methods for their use► Subscribe
6,138,668 Method and device for delivering aerosolized medicaments► Subscribe
6,681,767 Method and device for delivering aerosolized medicaments► 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: EXUBERA

Country Document Number Estimated Expiration
New Zealand299241► Subscribe
Poland344600► Subscribe
Sweden522578► Subscribe
Portugal1082155► Subscribe
Hungary220472► 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: EXUBERA

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
C0020France► SubscribePRODUCT NAME: INSULIN DETEMIR; NAT. REGISTRATION NO/DATE: EU/1/04/278/001 20040601; FIRST REGISTRATION: LI - 56370 20031110
C/GB04/036United Kingdom► SubscribePRODUCT 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
00597Netherlands► SubscribePRODUCT 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/GB00/027United Kingdom► SubscribePRODUCT NAME: INSULIN ASPART AND PROTAMINE (NOVOMIX 30); REGISTERED: CH 55414 01 20000623; CH 55415 02 20000623; CH 55416 02 20000623; UK EU/1/00/142/001-008 20000801
2004005Lithuania► SubscribePRODUCT NAME: INSULIN DETEMIR
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For more information try a trial or see the database preview and plans and pricing

Serving 500+ biopharmaceutical companies globally:

McKesson
AstraZeneca
QuintilesIMS
Daiichi Sankyo
Cipla
Chinese Patent Office
Covington
Federal Trade Commission
Queensland Health
Fish and Richardson

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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