You are 3 steps away
from making better decisions

Serving leading biopharmaceutical companies globally:

Johnson and Johnson
Express Scripts
Harvard Business School

Last Updated: January 25, 2021

DrugPatentWatch Database Preview

ACCUNEB Drug Profile

➤ Get the DrugPatentWatch Daily Briefing
» See Plans and Pricing

« Back to Dashboard

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.

  Start Trial

Drug patent expirations by year for ACCUNEB
Drug Prices for ACCUNEB

See drug prices for ACCUNEB

Recent Clinical Trials for ACCUNEB

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

University of FloridaPhase 4

See all ACCUNEB clinical trials

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

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

Serving leading biopharmaceutical companies globally:


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.