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Last Updated: January 18, 2020

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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 three 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.

US ANDA Litigation and Generic Entry Outlook for Exubera

  Start Trial

Exubera was eligible for patent challenges on December 31st, 1968.

Summary for EXUBERA
International Patents:334
US Patents:3
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
Recent Clinical Trials for EXUBERA

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Mannkind CorporationPhase 3
PfizerN/A
Mannkind CorporationPhase 2

See all EXUBERA clinical trials

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   Start Trial   Start Trial   Start Trial
Pfizer EXUBERA insulin recombinant human POWDER;INHALATION 021868-002 Jan 27, 2006 DISCN No No   Start Trial   Start Trial   Start Trial
Pfizer EXUBERA insulin recombinant human POWDER;INHALATION 021868-001 Jan 27, 2006 DISCN No No   Start Trial   Start Trial   Start Trial
Pfizer EXUBERA insulin recombinant human POWDER;INHALATION 021868-001 Jan 27, 2006 DISCN No No   Start Trial   Start Trial Y   Start Trial
Pfizer EXUBERA insulin recombinant human POWDER;INHALATION 021868-002 Jan 27, 2006 DISCN No No   Start Trial   Start Trial Y   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for EXUBERA

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Pfizer EXUBERA insulin recombinant human POWDER;INHALATION 021868-001 Jan 27, 2006   Start Trial   Start Trial
Pfizer EXUBERA insulin recombinant human POWDER;INHALATION 021868-001 Jan 27, 2006   Start Trial   Start Trial
Pfizer EXUBERA insulin recombinant human POWDER;INHALATION 021868-001 Jan 27, 2006   Start Trial   Start Trial
Pfizer EXUBERA insulin recombinant human POWDER;INHALATION 021868-001 Jan 27, 2006   Start Trial   Start Trial
Pfizer EXUBERA insulin recombinant human POWDER;INHALATION 021868-002 Jan 27, 2006   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Premature patent expiration for: EXUBERA

Expiration due to failure to pay maintenance fee

Patent Number Tradename Expiration Date
  Start Trial EXUBERA   Start Trial

Supplementary Protection Certificates for EXUBERA

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2209800 1490067-4 Sweden   Start Trial PRODUCT NAME: COMBINATION OF INSULIN DEGLUDEC AND LIRAGLUTIDE; REG. NO/DATE: EU/1/14/974 20140918
2107069 2013/34 Ireland   Start Trial PRODUCT: 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
0368187 SZ 34/2000 Austria   Start Trial PRODUCT NAME: LANTUS - INSULIN GLARGIN
0368187 SPC/GB00/022 United Kingdom   Start Trial PRODUCT NAME: INSULIN GLARGINE (LANTUS) OPTIONALLY IN THE FORM OF ESTERS THEREOF OR PHYSIOLOGICALLY TOLERATED SALTS THEREOF.; REGISTERED: UK EU/1/00/134/001 20000609; UK EU/1/00/134/002 20000609; UK EU/1/00/134/003 20000609; UK EU/1/00/134/004 20000609; UK EU/1/00/134/005 20000609; UK EU/1/00/134/006 20000609; UK EU/1/00/134/007 20000609
2498802 122017000039 Germany   Start Trial PRODUCT NAME: SULIQUA (FIRMENEIGENER NAME DES MEDIZINISCHEN PRODUKTS) BZW. WIRKSTOFFZUSAMMENSETZUNG UMFASSEND INSULIN GLARGIN / LIXISENATID UND IHRE PHARMAZEUTISCH ANNEHMBAREN SALZE (INTERNATIONALER, NICHT FIRMENEIGENER NAME); REGISTRATION NO/DATE: EU/1/16/1157 20170111
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Dow
Moodys
Baxter
AstraZeneca
Johnson and Johnson
Mallinckrodt

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