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ACCUNEB Drug Profile

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Accuneb is a drug marketed by Mylan Speclt and is included in one NDA. It is available from one supplier. 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-two suppliers are listed for this compound. Additional details are available on the albuterol sulfate profile page.

Summary for Tradename: ACCUNEB

Suppliers / Packagers: see list1
Bulk Api Vendors: see list102
Clinical Trials: see list1
Patent Applications: see list12,301
Formulation / Manufacturing:see details
Drug Prices:see details
DailyMed Link:ACCUNEB at DailyMed

Pharmacology for Tradename: ACCUNEB

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Mylan Speclt
albuterol sulfate
SOLUTION;INHALATION020949-002Apr 30, 2001RXYesYes6,702,997► subscribe ► subscribe
Mylan Speclt
albuterol sulfate
SOLUTION;INHALATION020949-001Apr 30, 2001RXYesYes6,702,997► subscribe ► subscribe
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Paragraph IV activity 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
China100413494► subscribe
MexicoPA04003928► 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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