You are 3 steps away
from making better decisions

Serving leading biopharmaceutical companies globally:

McKesson
Express Scripts
Medtronic
McKinsey
Harvard Business School
Mallinckrodt

Last Updated: March 30, 2020

DrugPatentWatch Database Preview

EXUBERA Drug Profile


Email this page to a colleague

» See Plans and Pricing

« Back to Dashboard

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

Indicators of Generic Entry

< Available with Subscription >

  Start Trial

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
9004-10-8
AERx
AERx [Insulin management system]
CCRIS 5464
CHEBI:5931
Dal-insulinum
Dalanated insulin [INN]
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 021868-002 Jan 27, 2006   Start Trial   Start Trial
Pfizer EXUBERA insulin recombinant human POWDER;INHALATION 021868-002 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
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
0792290 0491022-0 Sweden   Start Trial PRODUCT NAME: N EPSILONB29 MYRISTOYL- ELLER N EPSILONB29 TETRADEKANOYL-DES(B30) HUMANT INSULIN
2107069 92213 Luxembourg   Start Trial PRODUCT NAME: INSULINE DEGLUDEC SOUS TOUTES LES FORMES PROTEGEES PAR LE BREVET DE BASE; AUTHORISATION NUMBER AND DATE: EU/1/12/807/001-4-5-7-8-9-12-13-15 TRESIBA 20130123
0705275 C300021 Netherlands   Start Trial PRODUCT NAME: INSULINE ASPART EN GEKRISTALLISEERD PROTAMINE-INSULINE ASPART; NAT. REGISTRATION NO/DATE: EU/1/00/142/001 20000801; FIRST REGISTRATION: 55414015541502 2000230623
0792290 PA2004005 Lithuania   Start Trial PRODUCT NAME: INSULIN DETEMIR
2340033 300880 Netherlands   Start Trial PRODUCT NAME: SNELWERKENDE INSULIN ASPART; REGISTRATION NO/DATE: EU/1/16/1160 20170109
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

McKesson
Express Scripts
Medtronic
McKinsey
Harvard Business School
Mallinckrodt

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 verification 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.