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Last Updated: January 24, 2021

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DUONEB Drug Profile

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Which patents cover Duoneb, and when can generic versions of Duoneb launch?

Duoneb is a drug marketed by Mylan Speciality Lp and is included in one NDA. There is one patent protecting this drug.

This drug has fifteen patent family members in eight countries.

The generic ingredient in DUONEB is albuterol sulfate; ipratropium bromide. There are thirty-eight drug master file entries for this compound. Twelve suppliers are listed for this compound. Additional details are available on the albuterol sulfate; ipratropium bromide profile page.

US ANDA Litigation and Generic Entry Outlook for Duoneb

There is one tentative approval for the generic drug (albuterol sulfate; ipratropium bromide), which indicates the potential for near-term generic launch.

Indicators of Generic Entry

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Summary for DUONEB
International Patents:15
US Patents:1
Applicants:1
NDAs:1
Clinical Trials: 2
Formulation / Manufacturing:see details
DailyMed Link:DUONEB at DailyMed
Drug patent expirations by year for DUONEB
Recent Clinical Trials for DUONEB

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

SponsorPhase
University Hospitals Cleveland Medical CenterPhase 1
Shin-hwar WuN/A

See all DUONEB clinical trials

Paragraph IV (Patent) Challenges for DUONEB
Tradename Dosage Ingredient NDA Submissiondate
DUONEB SOLUTION;INHALATION albuterol sulfate; ipratropium bromide 020950

US Patents and Regulatory Information for DUONEB

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Mylan Speciality Lp DUONEB albuterol sulfate; ipratropium bromide SOLUTION;INHALATION 020950-001 Mar 21, 2001 DISCN Yes No   Start Trial   Start Trial   Start Trial
>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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Serving leading biopharmaceutical companies globally:

Moodys
Mallinckrodt
Express Scripts
Merck
Dow
McKesson

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