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Last Updated: January 31, 2023

ACCUNEB Drug Patent 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.

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

DrugPatentWatch® 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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Paragraph IV (Patent) Challenges for ACCUNEB
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
ACCUNEB Inhalation Solution albuterol sulfate 0.021% 020949 1 2005-10-19
ACCUNEB Inhalation Solution albuterol sulfate 0.042% 020949 1 2004-04-06

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 See Plans and Pricing See Plans and Pricing See Plans and Pricing
Mylan Speciality Lp ACCUNEB albuterol sulfate SOLUTION;INHALATION 020949-001 Apr 30, 2001 DISCN Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
>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 ACCUNEB

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Mylan Speciality Lp ACCUNEB albuterol sulfate SOLUTION;INHALATION 020949-002 Apr 30, 2001 See Plans and Pricing See Plans and Pricing
Mylan Speciality Lp ACCUNEB albuterol sulfate SOLUTION;INHALATION 020949-001 Apr 30, 2001 See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for ACCUNEB

See the table below for patents covering ACCUNEB around the world.

Country Patent Number Title Estimated Expiration
Japan 2003212764 ALBUTEROL INHALATION SOLUTION, SYSTEM, KIT AND METHOD FOR RELIEVING SYMPTOMS OF PEDIATRIC ASTHMA See Plans and Pricing
Australia 2006202584 See Plans and Pricing
European Patent Office 1441709 See Plans and Pricing
Australia 3297502 See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

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Serving leading biopharmaceutical companies globally:

Moodys
AstraZeneca
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McKesson
Dow
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.