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Last Updated: January 25, 2021

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ACCUNEB Drug Profile

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When do Accuneb patents expire, and what generic alternatives are available?

Accuneb is a drug marketed by Mylan Speciality Lp and is included in one NDA. There is one patent protecting this drug and one Paragraph IV challenge.

This drug has twelve patent family members in eight countries.

The generic ingredient in ACCUNEB is albuterol sulfate. There are thirty-eight drug master file entries for this compound. Forty-one suppliers are listed for this compound. Additional details are available on the albuterol sulfate profile page.

US ANDA Litigation and Generic Entry Outlook for Accuneb

A generic version of ACCUNEB was approved as albuterol sulfate by SUN PHARM INDUSTRIES on December 5th, 1989.

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Drug patent expirations by year for ACCUNEB
Drug Prices for ACCUNEB

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Recent Clinical Trials for ACCUNEB

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SponsorPhase
University of FloridaPhase 4

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Paragraph IV (Patent) Challenges for ACCUNEB
Tradename Dosage Ingredient NDA Submissiondate
ACCUNEB SOLUTION;INHALATION albuterol sulfate 020949 2005-10-19

US Patents and Regulatory Information for ACCUNEB

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 ACCUNEB albuterol sulfate SOLUTION;INHALATION 020949-002 Apr 30, 2001 AN RX Yes Yes   Start Trial   Start Trial   Start Trial
Mylan Speciality Lp ACCUNEB albuterol sulfate SOLUTION;INHALATION 020949-001 Apr 30, 2001 AN RX Yes Yes   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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