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Generated: January 24, 2019

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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

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 Y ➤ Sign Up
Pfizer EXUBERA insulin recombinant human POWDER;INHALATION 021868-002 Jan 27, 2006 DISCN No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Pfizer EXUBERA insulin recombinant human POWDER;INHALATION 021868-001 Jan 27, 2006 DISCN No No ➤ Sign Up ➤ Sign Up ➤ 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 021868-002 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 021868-001 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

Supplementary Protection Certificates for EXUBERA

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
90036-0 Sweden ➤ Sign Up PRODUCT NAME: KOMBINATION AV INSULIN DEGLUDEK OCH INSULIN ASPART; REG. NO/DATE: EU/1/12/806/001 20130121
2013000061 Germany ➤ Sign Up PRODUCT NAME: INSULIN DEGLUDEC IN ALLEN DURCH DAS BASISPATENT GESCHUETZTEN FORMEN; REGISTRATION NO/DATE: EU/1/12/807/001 EU/1/12/807/004-005 EU/1/12/807/007-009 EU/1/12/807/012-013 EU/1/12/807/015 20130121
226 Luxembourg ➤ Sign Up PRODUCT NAME: COMBINATION D'INSULINE DEGLUDEC ET INSULINE ASPARTE SOUS TOUTES LES FORMES PROTEGEES PAR LE BREVET DE BASE; FIRST REGISTRATION DATE: 20130121
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Moodys
AstraZeneca
Farmers Insurance
Johnson and Johnson
Merck
Express Scripts
Federal Trade Commission
Fish and Richardson
Cerilliant

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