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Generated: December 16, 2017

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 and forty-two supplementary protection certificates in twelve 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 EXUBERA

Drug patent expirations by year for EXUBERA

US Patents and Regulatory Information

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
PfizerEXUBERAinsulin recombinant humanPOWDER;INHALATION021868-001Jan 27, 2006DISCNNoNo► Subscribe► SubscribeY► Subscribe
PfizerEXUBERAinsulin recombinant humanPOWDER;INHALATION021868-002Jan 27, 2006DISCNNoNo► Subscribe► Subscribe► Subscribe
PfizerEXUBERAinsulin recombinant humanPOWDER;INHALATION021868-001Jan 27, 2006DISCNNoNo► Subscribe► Subscribe► Subscribe
PfizerEXUBERAinsulin recombinant humanPOWDER;INHALATION021868-002Jan 27, 2006DISCNNoNo► Subscribe► Subscribe► Subscribe
PfizerEXUBERAinsulin recombinant humanPOWDER;INHALATION021868-001Jan 27, 2006DISCNNoNo► Subscribe► SubscribeY► Subscribe
PfizerEXUBERAinsulin recombinant humanPOWDER;INHALATION021868-001Jan 27, 2006DISCNNoNo► Subscribe► Subscribe► Subscribe
PfizerEXUBERAinsulin recombinant humanPOWDER;INHALATION021868-002Jan 27, 2006DISCNNoNo► Subscribe► SubscribeY► Subscribe
PfizerEXUBERAinsulin recombinant humanPOWDER;INHALATION021868-002Jan 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
PfizerEXUBERAinsulin recombinant humanPOWDER;INHALATION021868-001Jan 27, 2006► Subscribe► Subscribe
PfizerEXUBERAinsulin recombinant humanPOWDER;INHALATION021868-002Jan 27, 2006► Subscribe► Subscribe
PfizerEXUBERAinsulin recombinant humanPOWDER;INHALATION021868-001Jan 27, 2006► Subscribe► Subscribe
PfizerEXUBERAinsulin recombinant humanPOWDER;INHALATION021868-002Jan 27, 2006► Subscribe► Subscribe
PfizerEXUBERAinsulin recombinant humanPOWDER;INHALATION021868-002Jan 27, 2006► Subscribe► Subscribe
PfizerEXUBERAinsulin recombinant humanPOWDER;INHALATION021868-001Jan 27, 2006► Subscribe► Subscribe
PfizerEXUBERAinsulin recombinant humanPOWDER;INHALATION021868-002Jan 27, 2006► Subscribe► Subscribe
PfizerEXUBERAinsulin recombinant humanPOWDER;INHALATION021868-001Jan 27, 2006► Subscribe► Subscribe
PfizerEXUBERAinsulin recombinant humanPOWDER;INHALATION021868-001Jan 27, 2006► Subscribe► Subscribe
PfizerEXUBERAinsulin recombinant humanPOWDER;INHALATION021868-001Jan 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
5,740,794 Apparatus and methods for dispersing dry powder medicaments► Subscribe
5,458,135 Method and device for delivering aerosolized medicaments► Subscribe
7,470,698Adenosine A3 receptor modulators► Subscribe
5,780,014 Method and apparatus for pulmonary administration of dry powder alpha 1-antitrypsin► Subscribe
6,681,767 Method and device for delivering aerosolized medicaments► Subscribe
6,258,341 Stable glassy state powder formulations► Subscribe
6,303,582 Compositions and methods for nucleic acid delivery to the lung► Subscribe
6,231,851 Methods and compositions for the dry powder formulation of interferons► Subscribe
6,514,496 Dispersible antibody compositions and methods for their preparation and use► Subscribe
6,165,463 Dispersible antibody compositions and methods for their preparation and use► 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
South Korea100384353► Subscribe
Canada2274758► Subscribe
Norway20063519► Subscribe
Czech Republic9500803► Subscribe
New Zealand281112► Subscribe
Australia662919► Subscribe
European Patent Office0846009► Subscribe
Australia4090599► Subscribe
Sweden0003984► Subscribe
Australia6248299► 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
0885961/01Switzerland► SubscribePRODUCT NAME: INSULIN GLULISIN; REGISTRATION NUMBER/DATE: SWISSMEDIC 57013 02.05.2005
C0009France► SubscribePRODUCT 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
2/2005Austria► SubscribePRODUCT NAME: INSULIN GLULISINE
C/GB05/024United Kingdom► SubscribePRODUCT NAME: INSULIN GLULISINE OR A PHYSIOLOGICALLY TOLERABLE SALT THEREOF; REGISTRATION NO/DATE: EU/1/04/285/001 - 020 20040929
2013000062Germany► SubscribePRODUCT NAME: KOMBINATION VON INSULIN DEGLUDEC UND INSULIN ASPART IN ALLEN DURCH DAS BASISPATENT GESCHUETZTEN FORMEN; REGISTRATION NO/DATE: EU/1/12/806/001 EU/1/12/806/004-005 EU/1/12/806/007-008 20130121
2004005Lithuania► SubscribePRODUCT NAME: INSULIN DETEMIR
2017000040Germany► SubscribePRODUCT NAME: SCHNELL-WIRKENDES INSULIN ASPART; REGISTRATION NO/DATE: EU/1/16/1160 20170109
13/34Ireland► SubscribePRODUCT: INSULIN DEGLUDEC IN ALL ITS FORMS AS THEY ARE PROTECTED BY THE BASIC PATENTS; REGISTRATION NO/DATE: IRELAND EU/1/12/807-001, 004, 005, 007-009, 012, 013 AND 015 / 21/01/2013
60026Netherlands► SubscribePRODUCT 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
91022-0Sweden► SubscribePRODUCT NAME: N EPSILONB29 MYRISTOYL- ELLER N EPSILONB29 TETRADEKANOYL-DES(B30) HUMANT INSULIN
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Serving leading biopharmaceutical companies globally:

Queensland Health
Chinese Patent Office
Moodys
Dow
Federal Trade Commission
Argus Health
Cipla
Chubb
Novartis
Farmers Insurance

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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