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Serving leading biopharmaceutical companies globally:

Express Scripts
US Army
Chinese Patent Office
Cantor Fitzgerald

Generated: December 14, 2017

DrugPatentWatch Database Preview

ACCUNEB Drug Profile

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When do Accuneb patents expire, and when can generic versions of Accuneb launch?

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-seven drug master file entries for this compound. Forty-four suppliers are listed for this compound. Additional details are available on the albuterol sulfate profile page.

US Patents and Regulatory Information

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Patent Submitted Product Substance Delist Req. Exclusivity Expiration
Mylan Speciality LpACCUNEBalbuterol sulfateSOLUTION;INHALATION020949-002Apr 30, 2001ANRXYesYes► Subscribe► Subscribe► Subscribe► Subscribe
Mylan Speciality LpACCUNEBalbuterol sulfateSOLUTION;INHALATION020949-001Apr 30, 2001ANRXYesYes► Subscribe► Subscribe► Subscribe► Subscribe
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Paragraph IV (Patent) Challenges for ACCUNEB

Drugname Dosage Strength RLD Submissiondate
albuterol sulfateInhalation Solution0.021% and 0.042%Accuneb10/19/2005

International Patent Family for Tradename: ACCUNEB

Country Document Number Estimated Expiration
Australia3297502► Subscribe
New Zealand550304► Subscribe
Japan2003212764► Subscribe
European Patent Office1441709► Subscribe
Canada2464660► Subscribe
China100413494► Subscribe
China1720036► Subscribe
World Intellectual Property Organization (WIPO)03037317► Subscribe
Australia2006202584► Subscribe
Japan2006513129► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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Serving leading biopharmaceutical companies globally:

Farmers Insurance
Cantor Fitzgerald
US Army
Chinese Patent Office
US Department of Justice

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 verifification 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.

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