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EXUBERA Drug Profile

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Which patents cover Exubera, and what substitute generic drugs 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-five patent family members in fifty-seven countries.

The generic ingredient in EXUBERA is insulin recombinant human. There are thirty-eight drug master file entries for this compound. Seven 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 list4
Formulation / Manufacturing:see details
Drug Prices:see details
DailyMed Link:EXUBERA at DailyMed
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Pfizer
EXUBERA
insulin recombinant human
POWDER;INHALATION021868-001Jan 27, 2006DISCNNoNo6,257,233► Subscribe ► Subscribe
Pfizer
EXUBERA
insulin recombinant human
POWDER;INHALATION021868-002Jan 27, 2006DISCNNoNo6,685,967► SubscribeY ► Subscribe
Pfizer
EXUBERA
insulin recombinant human
POWDER;INHALATION021868-001Jan 27, 2006DISCNNoNo6,685,967► SubscribeY ► Subscribe
Pfizer
EXUBERA
insulin recombinant human
POWDER;INHALATION021868-002Jan 27, 2006DISCNNoNo6,582,728► SubscribeY ► Subscribe
Pfizer
EXUBERA
insulin recombinant human
POWDER;INHALATION021868-001Jan 27, 2006DISCNNoNo6,546,929► Subscribe ► 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, 20065,740,794► Subscribe
Pfizer
EXUBERA
insulin recombinant human
POWDER;INHALATION021868-002Jan 27, 20066,592,904► Subscribe
Pfizer
EXUBERA
insulin recombinant human
POWDER;INHALATION021868-002Jan 27, 20066,737,045► Subscribe
Pfizer
EXUBERA
insulin recombinant human
POWDER;INHALATION021868-001Jan 27, 20065,997,848► Subscribe
Pfizer
EXUBERA
insulin recombinant human
POWDER;INHALATION021868-001Jan 27, 20066,543,448► 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
6,231,851 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
8,161,969Dry powder dispersing apparatus and methods for their use► Subscribe
5,993,783 Method and apparatus for pulmonary administration of dry powder .alpha.1-antitrypsin► Subscribe
6,303,582 Compositions and methods for nucleic acid delivery to the lung► 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
World Intellectual Property Organization (WIPO)9741833► Subscribe
Poland344600► Subscribe
Canada2200727► Subscribe
Canada2444415► Subscribe
Turkey9802247► 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
226Luxembourg► SubscribePRODUCT NAME: COMBINATION D'INSULINE DEGLUDEC ET INSULINE ASPARTE SOUS TOUTES LES FORMES PROTEGEES PAR LE BREVET DE BASE; FIRST REGISTRATION DATE: 20130121
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
90042Netherlands► SubscribePRODUCT NAME: INSULIN ASPART; REGISTRATION NO/DATE: EU/1/99/119/001 - EU/1/99/119/005 19990907
00596Netherlands► SubscribePRODUCT NAME: INSULINE DEGLUDEC; REGISTRATION NO/DATE: EU/1/12/807/001EU/1/12/807/004EU/1/12/807/005EU/1/12/807/007EU/1/12/807/008EU/1/12/807/009EU/1/12/807/012EU/1/12/807/013EU/1/12/807/015 2013210121
90067-4Sweden► SubscribePRODUCT NAME: COMBINATION OF INSULIN DEGLUDEC AND LIRAGLUTIDE; REG. NO/DATE: EU/1/14/974 20140918
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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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