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TUDORZA PRESSAIR Drug Profile

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Tudorza Pressair is a drug marketed by Astrazeneca Pharms and is included in one NDA. It is available from two suppliers. There are eight patents protecting this drug.

This drug has one hundred and twenty-six patent family members in forty-one countries.

The generic ingredient in TUDORZA PRESSAIR is aclidinium bromide. There is one drug master file entry for this compound. Two suppliers are listed for this compound. Additional details are available on the aclidinium bromide profile page.

Summary for Tradename: TUDORZA PRESSAIR

Patents:8
Applicants:1
NDAs:1
Suppliers / Packagers: see list2
Drug Prices: :see details

Pharmacology for Tradename: TUDORZA PRESSAIR

Drug ClassAnticholinergic
Mechanism of ActionCholinergic Antagonists
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Astrazeneca Pharms
TUDORZA PRESSAIR
aclidinium bromide
POWDER, METERED;INHALATION202450-001Jul 23, 2012RXYes6,750,226► subscribeYY ► subscribe
Astrazeneca Pharms
TUDORZA PRESSAIR
aclidinium bromide
POWDER, METERED;INHALATION202450-001Jul 23, 2012RXYes6,071,498► subscribeY ► subscribe
Astrazeneca Pharms
TUDORZA PRESSAIR
aclidinium bromide
POWDER, METERED;INHALATION202450-001Jul 23, 2012RXYes9,333,195► subscribeY ► subscribe
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Expired Patents for Tradename: TUDORZA PRESSAIR

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Astrazeneca Pharms
TUDORZA PRESSAIR
aclidinium bromide
POWDER, METERED;INHALATION202450-001Jul 23, 20126,071,498► subscribe
Astrazeneca Pharms
TUDORZA PRESSAIR
aclidinium bromide
POWDER, METERED;INHALATION202450-001Jul 23, 20125,840,279► subscribe
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Non-Orange Book Patents for Tradename: TUDORZA PRESSAIR

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
8,129,405Quinuclidine derivatives and medicinal compositions containing the same► subscribe
8,513,279Quinuclidine derivatives and medicinal compositions containing the same► subscribe
7,109,210Quinuclidine derivatives and medicinal compositions containing the same► subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.

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International Patent Family for Tradename: TUDORZA PRESSAIR

Country Document Number Estimated Expiration
Portugal1200431► subscribe
Norway20070703► subscribe
European Patent Office0837710► 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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Supplementary Protection Certificates for Tradename: TUDORZA PRESSAIR

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
90002-2Sweden► subscribePRODUCT NAME: AKLIDINIUMSALT MED FARMACEUTISKT ACCEPTABEL ANJON AV EN- ELLER FLERVAERD SYRA, SPECIELLT AKLIDINIUMBROMID; REG. NO/DATE: EU/1/12/778/001 20120720
C0001France► subscribePRODUCT NAME: SEL D'ACLIDINIUM AVEC UN ANION PHARMACEUTIQUEMENT ACCEPTABLE D'UN ACIDE MONO OU POLYVALENT, EN PARTICULIER LE BROMURE D'ACLIDINIUM; REGISTRATION NO/DATE: EU/1/12/778/001-003 20120720
2013 00002Denmark► subscribe
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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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