ACCUNEB Drug Patent Profile

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Which patents cover Accuneb, 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 5^th, 1989.

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Summary for ACCUNEB

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	81
Clinical Trials:	1
Patent Applications:	5,404
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for ACCUNEB
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ACCUNEB
DailyMed Link:	ACCUNEB at DailyMed

Drug patent expirations by year for ACCUNEB

Recent Clinical Trials for ACCUNEB

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Sponsor	Phase
University of Florida

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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

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Glossary

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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		DISCN	Yes	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Mylan Speciality Lp	ACCUNEB	albuterol sulfate	SOLUTION;INHALATION	020949-001	Apr 30, 2001		DISCN	Yes	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
>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

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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	⤷ Try a Trial	⤷ Try a Trial
Mylan Speciality Lp	ACCUNEB	albuterol sulfate	SOLUTION;INHALATION	020949-001	Apr 30, 2001	⤷ Try a Trial	⤷ Try a Trial
>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.

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Country	Patent Number	Title	Estimated Expiration
Australia	3297502		⤷ Try a Trial
Japan	2006513129		⤷ Try a Trial
Australia	2002347948		⤷ Try a Trial
>Country	>Patent Number	>Title	>Estimated Expiration

Summary for ACCUNEB

Recent Clinical Trials for ACCUNEB

Paragraph IV (Patent) Challenges for ACCUNEB

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