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Generated: March 23, 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. Six 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
Synonyms for EXUBERA
11081-38-2
37243-75-7
37294-43-2
57126-42-8
69090-47-7
8049-67-0
8049-95-4
88026-11-3
88026-12-4
9004-10-8
9045-63-0
9045-65-2
9045-66-3
9045-67-4
9066-39-1
9066-40-4
AERx
AERx [Insulin management system]
CCRIS 5464
CHEBI:5931
Dal-insulinum
Decurvon
Dermulin
EINECS 232-672-8
Endopancrine
HMR 4006
HSDB 3102
Humilin
Iletin
Imusay-131
Injectable insulini neutrale
Insular
insulin (recombinant)
INSULIN INJECTION
Insulin recombinant
insulin-human
Insulin, dalanated
Insulin, dalanated [USAN:INN]
Insulina dalanatada
Insulina dalanatada [INN-Spanish]
Insulina iniettabile neutra
Insulina iniettabile neutra [DCIT]
Insulini injectio neutralis
Insulini injectio neutralis [INN-Latin]
Insulinum dalanatum
Insulinum dalanatum [INN-Latin]
Insulyl
Intesulin B
Inyectable neutro de insulina
Inyectable neutro de insulina [INN-Spanish]
Iszilin
Musulin
S.N. 44
Solute neutre injectable d'insuline
Solute neutre injectable d'insuline [INN-French]

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

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2107069 C300596 Netherlands ➤ Sign Up PRODUCT 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
2107069 300596 Netherlands ➤ Sign Up PRODUCT NAME: INSULINE DEGLUDEC; NATIONAL REGISTRATION NO/DATE: EU/1/12/807/004 20130123; FIRST REGISTRATION: EU EU/1/12/807/001 20130123
2107069 31/2013 Austria ➤ Sign Up PRODUCT NAME: INSULIN DEGLUDEC UND BELIEBIGE ZN2+-KOMPLEXE DAVON; REGISTRATION NO/DATE: EU/1/12/807/001, EU/1/12/807/004, EU/1/12/807/005, EU/1/12/807/007, EU/1/12/807/008, EU/1/12/807/009, EU/1/12/807/012, EU/1/12/807/013, EU/1/12/807/015 (MITTEILUNG) 20130123
2107069 2013C/035 Belgium ➤ Sign Up PRODUCT NAME: TRESIBA-INSULINE DEGLUDEC; AUTHORISATION NUMBER AND DATE: EU/1/12/807/001 20130121
0705275 32/2000 Austria ➤ Sign Up PRODUCT NAME: INSULIN ASPART/PROTAMIN; NAT. REGISTRATION NO/DATE: EU/1/00/142/001-008 20000801; FIRST REGISTRATION: LI 55414-55416 20000623
2498802 PA2017020 Lithuania ➤ Sign Up PRODUCT NAME: INSULINAS GLARGINAS + LIKSIZENATIDAS; REGISTRATION NO/DATE: EU/1/16/1157 20170111
0368187 SZ 34/2000 Austria ➤ Sign Up PRODUCT NAME: LANTUS - INSULIN GLARGIN
Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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