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Generated: August 24, 2017

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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 six 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:6
Applicants:1
NDAs:1
Drug Master File Entries: see list1
Suppliers / Packagers: see list2
Bulk Api Vendors: see list22
Clinical Trials: see list276
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, 2012RXYesYes► Subscribe► SubscribeY ► Subscribe
Astrazeneca Pharms
TUDORZA PRESSAIR
aclidinium bromide
POWDER, METERED;INHALATION202450-001Jul 23, 2012RXYesYes► Subscribe► Subscribe► Subscribe
Astrazeneca Pharms
TUDORZA PRESSAIR
aclidinium bromide
POWDER, METERED;INHALATION202450-001Jul 23, 2012RXYesYes► Subscribe► SubscribeY ► Subscribe
Astrazeneca Pharms
TUDORZA PRESSAIR
aclidinium bromide
POWDER, METERED;INHALATION202450-001Jul 23, 2012RXYesYes► Subscribe► SubscribeY ► Subscribe
Astrazeneca Pharms
TUDORZA PRESSAIR
aclidinium bromide
POWDER, METERED;INHALATION202450-001Jul 23, 2012RXYesYes► Subscribe► SubscribeYY ► Subscribe
Astrazeneca Pharms
TUDORZA PRESSAIR
aclidinium bromide
POWDER, METERED;INHALATION202450-001Jul 23, 2012RXYesYes► Subscribe► SubscribeYY ► Subscribe
Astrazeneca Pharms
TUDORZA PRESSAIR
aclidinium bromide
POWDER, METERED;INHALATION202450-001Jul 23, 2012RXYesYes► Subscribe► SubscribeY ► 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, 2012► Subscribe► Subscribe
Astrazeneca Pharms
TUDORZA PRESSAIR
aclidinium bromide
POWDER, METERED;INHALATION202450-001Jul 23, 2012► Subscribe► 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
8,129,405Quinuclidine derivatives and medicinal compositions containing the same► Subscribe
8,513,279Quinuclidine derivatives and medicinal compositions containing the same► Subscribe
6,750,226 Quinuclidine derivatives and their use as muscarinic M3 receptor ligands► Subscribe
8,802,699Quinuclidine derivatives and medicinal compositions containing the same► Subscribe
7,358,260Quinuclidine derivatives and medicinal compositions containing the same► Subscribe
7,196,098Quinuclidine 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
7,750,023Quinuclidine 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 Ingredient: aclidinium bromide

Country Document Number Estimated Expiration
Australia6433000► Subscribe
South Korea101214823► Subscribe
China1272334► Subscribe
Czech Republic20020121► Subscribe
Hungary0202100► Subscribe
Estonia04915► Subscribe
Czech Republic304292► Subscribe
Russian Federation2306312► Subscribe
Ukraine93031► Subscribe
South Africa200200232► 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
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
2013001,C1200431Lithuania► SubscribePRODUCT NAME: ACLIDINII BROMIDUM; REGISTRATION NO/DATE: EU/1/12/778/001 - EU/1/12/778/003, 2012 07 20 EU/1/12/781/001 - EU/1/12/781/003 20120720
1200431/01Switzerland► SubscribePRODUCT NAME: ACLIDINIUM; REGISTRATION NO/DATE: SWISSMEDIC 62590 25.04.2013
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
1Finland► Subscribe
2013 00002Denmark► Subscribe
132Luxembourg► SubscribePRODUCT NAME: SEL D ACLIDINIUM AVEC ANION D UN ACIDE MONO OU POLYVALENT PHARMACEUTIQUEMENT ACCEPTABLE PARTICULIEREMENT LE BROMURE D ACLIDINIUM
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
2013001Lithuania► SubscribePRODUCT NAME: ACLIDINII BROMIDUM; REGISTRATION NO/DATE: EU/1/12/778/001 - EU/1/12/778/003, 2012 07 20 EU/1/12/781/001 - EU/1/12/781/003 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
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For more information try a trial or see the database preview and plans and pricing

Serving 500+ biopharmaceutical companies globally:

Covington
Cerilliant
Healthtrust
Chubb
Colorcon
US Army
Daiichi Sankyo
McKesson
Boehringer Ingelheim
Merck

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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