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Serving 500+ biopharmaceutical companies globally:

Accenture
Medtronic
QuintilesIMS
Federal Trade Commission
Chubb
Dow
Daiichi Sankyo
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Deloitte
Merck

Generated: June 27, 2017

DrugPatentWatch Database Preview

Aclidinium bromide - Generic Drug Details

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What are the generic sources for aclidinium bromide and what is the scope of aclidinium bromide freedom to operate?

Aclidinium bromide
is the generic ingredient in one branded drug marketed by Astrazeneca Pharms and is included in one NDA. There are seven patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Aclidinium bromide has seventy-nine patent family members in thirty-eight countries.

There is one drug master file entry for aclidinium bromide. Two suppliers are listed for this compound.

Summary for Generic Name: aclidinium bromide

Tradenames:1
Patents:7
Applicants:1
NDAs:1
Drug Master File Entries: see list1
Suppliers / Packagers: see list2
Bulk Api Vendors: see list22
Clinical Trials: see list271
Patent Applications: see list161
Drug Prices:see low prices
DailyMed Link:aclidinium bromide at DailyMed

Pharmacology for Ingredient: aclidinium bromide

Drug ClassAnticholinergic
Mechanism of ActionCholinergic Antagonists
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Astrazeneca Pharms
TUDORZA PRESSAIR
aclidinium bromide
POWDER, METERED;INHALATION202450-001Jul 23, 2012RXYesYes6,681,768► SubscribeY ► Subscribe
Astrazeneca Pharms
TUDORZA PRESSAIR
aclidinium bromide
POWDER, METERED;INHALATION202450-001Jul 23, 2012RXYesYes7,078,412► SubscribeYY ► Subscribe
Astrazeneca Pharms
TUDORZA PRESSAIR
aclidinium bromide
POWDER, METERED;INHALATION202450-001Jul 23, 2012RXYesYes8,051,851► SubscribeY ► Subscribe
Astrazeneca Pharms
TUDORZA PRESSAIR
aclidinium bromide
POWDER, METERED;INHALATION202450-001Jul 23, 2012RXYesYes9,056,100► SubscribeY ► Subscribe
Astrazeneca Pharms
TUDORZA PRESSAIR
aclidinium bromide
POWDER, METERED;INHALATION202450-001Jul 23, 2012RXYesYes6,750,226► SubscribeYY ► Subscribe
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Expired Orange Book Patents for Generic Ingredient: aclidinium bromide

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

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
7,358,260Quinuclidine derivatives and medicinal compositions containing the same► Subscribe
7,897,617Quinuclidine derivatives and medicinal compositions containing the same► Subscribe
7,109,210Quinuclidine derivatives and medicinal compositions containing the same► Subscribe
7,214,687Quinuclidine derivatives and medicinal compositions containing the same► Subscribe
RE46417Quinuclidine derivatives and their use as muscarinic M3 receptor ligands► 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 Ingredient: aclidinium bromide

Country Document Number Estimated Expiration
Austria235492► Subscribe
Spain2165768► Subscribe
Austria481996► Subscribe
Turkey200200768► Subscribe
Canada2572790► 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: ACLIDINIUM BROMIDE

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2013 00002Denmark► Subscribe
13/002Ireland► SubscribePRODUCT NAME: ACLIDINIUM SALT WITH A PHARMACEUTICALLY ACCEPTABLE ANION OF A MONO OR POLYVALENT ACID ESPECIALLY AS ACLIDINIUM BROMIDE; NAT REGISTRATION NO/DATE: EU/1/12/778/001-003 20120720; FIRST REGISTRATION NO/DATE: EU/1/12/781/001-003 20/07/2012 EUROPEAN UNION EU/1/12/778/001-003 20/07/2012 EUROPEAN UNION EU/1/12/781/001-003 20120720
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
00573Netherlands► SubscribePRODUCT NAME: ACLIDINIUMZOUT MET EEN FARMACEUTISCH AANVAARDBAAR ANION VAN EEN EEN- OF MEERWAARDIG ZUUR, IN HET BIJZONDER ACLIDINIUMBROMIDE; REGISTRATION NO/DATE: EU/1/12/778/001-003EU/1/12/781/001-003 2012200720
132Luxembourg► SubscribePRODUCT NAME: SEL D ACLIDINIUM AVEC ANION D UN ACIDE MONO OU POLYVALENT PHARMACEUTIQUEMENT ACCEPTABLE PARTICULIEREMENT LE BROMURE D ACLIDINIUM
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For more information try a trial or see the database preview and plans and pricing

Serving 500+ biopharmaceutical companies globally:

Fuji
US Army
Colorcon
Moodys
Julphar
Express Scripts
Accenture
Argus Health
Dow
Baxter

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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