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Last Updated: May 16, 2021

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TUDORZA PRESSAIR Drug Profile

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Which patents cover Tudorza Pressair, and when can generic versions of Tudorza Pressair launch?

Tudorza Pressair is a drug marketed by Astrazeneca and is included in one NDA. There are four patents protecting this drug.

This drug has one hundred and thirty-eight patent family members in forty-three countries.

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

DrugPatentWatch® Generic Entry Outlook for Tudorza Pressair

Tudorza Pressair was eligible for patent challenges on July 23, 2016.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be February 10, 2025. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

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Summary for TUDORZA PRESSAIR
International Patents:138
US Patents:4
Applicants:1
NDAs:1
Finished Product Suppliers / Packagers: 1
Raw Ingredient (Bulk) Api Vendors: 47
Patent Applications: 95
Drug Prices: Drug price information for TUDORZA PRESSAIR
What excipients (inactive ingredients) are in TUDORZA PRESSAIR?TUDORZA PRESSAIR excipients list
DailyMed Link:TUDORZA PRESSAIR at DailyMed
Drug patent expirations by year for TUDORZA PRESSAIR
Drug Prices for TUDORZA PRESSAIR

See drug prices for TUDORZA PRESSAIR

DrugPatentWatch® Estimated Generic Entry Opportunity Date for TUDORZA PRESSAIR
Generic Entry Date for TUDORZA PRESSAIR*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
POWDER, METERED;INHALATION

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Pharmacology for TUDORZA PRESSAIR
Drug ClassAnticholinergic
Mechanism of ActionCholinergic Antagonists

US Patents and Regulatory Information for TUDORZA PRESSAIR

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Astrazeneca TUDORZA PRESSAIR aclidinium bromide POWDER, METERED;INHALATION 202450-001 Jul 23, 2012 RX Yes Yes   Get Started for $10   Get Started for $10 Y   Get Started for $10
Astrazeneca TUDORZA PRESSAIR aclidinium bromide POWDER, METERED;INHALATION 202450-001 Jul 23, 2012 RX Yes Yes   Get Started for $10   Get Started for $10 Y   Get Started for $10
Astrazeneca TUDORZA PRESSAIR aclidinium bromide POWDER, METERED;INHALATION 202450-001 Jul 23, 2012 RX Yes Yes   Get Started for $10   Get Started for $10 Y Y   Get Started for $10
Astrazeneca TUDORZA PRESSAIR aclidinium bromide POWDER, METERED;INHALATION 202450-001 Jul 23, 2012 RX Yes Yes   Get Started for $10   Get Started for $10 Y   Get Started for $10
Astrazeneca TUDORZA PRESSAIR aclidinium bromide POWDER, METERED;INHALATION 202450-001 Jul 23, 2012 RX Yes Yes   Get Started for $10   Get Started for $10   Get Started for $10
>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 TUDORZA PRESSAIR

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Astrazeneca TUDORZA PRESSAIR aclidinium bromide POWDER, METERED;INHALATION 202450-001 Jul 23, 2012   Get Started for $10   Get Started for $10
Astrazeneca TUDORZA PRESSAIR aclidinium bromide POWDER, METERED;INHALATION 202450-001 Jul 23, 2012   Get Started for $10   Get Started for $10
Astrazeneca TUDORZA PRESSAIR aclidinium bromide POWDER, METERED;INHALATION 202450-001 Jul 23, 2012   Get Started for $10   Get Started for $10
Astrazeneca TUDORZA PRESSAIR aclidinium bromide POWDER, METERED;INHALATION 202450-001 Jul 23, 2012   Get Started for $10   Get Started for $10
Astrazeneca TUDORZA PRESSAIR aclidinium bromide POWDER, METERED;INHALATION 202450-001 Jul 23, 2012   Get Started for $10   Get Started for $10
Astrazeneca TUDORZA PRESSAIR aclidinium bromide POWDER, METERED;INHALATION 202450-001 Jul 23, 2012   Get Started for $10   Get Started for $10
Astrazeneca TUDORZA PRESSAIR aclidinium bromide POWDER, METERED;INHALATION 202450-001 Jul 23, 2012   Get Started for $10   Get Started for $10
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for TUDORZA PRESSAIR

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1200431 SPC/GB13/006 United Kingdom   Get Started for $10 PRODUCT NAME: ACLIDINIUM SALT WITH PHARMACEUTICALLY ACCEPTABLE ANION OF A MONO OR POLYVALENT ACID ESPECIALLY AS ACLIDINIUM BROMIDE; REGISTERED: UK EU/1/12/778/001 20120720; UK EU/1/12/778/002 20120720; UK EU/1/12/778/003 20120720; UK EU/1/12/781/001 20120720; UK EU/1/12/781/002 20120720; UK EU/1/12/781/003 20120720
1200431 2013C/001 Belgium   Get Started for $10 PRODUCT NAME: SEL D'ACLIDINIUM AVEC UN ANION PHARMACEUTIQUEMENT ACCEPTABLE D'UN ACIDE MONO OU POLYVALENT EN PARTICULIER LE BROMURE D'ACLIDINIUM; AUTHORISATION NUMBER AND DATE: EU/1/12/781/001 20120725
1200431 13C0001 France   Get Started for $10 PRODUCT 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
1200431 2013/002 Ireland   Get Started for $10 PRODUCT 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
1200431 92132 Luxembourg   Get Started for $10 PRODUCT NAME: SEL D ACLIDINIUM AVEC ANION D UN ACIDE MONO OU POLYVALENT PHARMACEUTIQUEMENT ACCEPTABLE PARTICULIEREMENT LE BROMURE D ACLIDINIUM
1200431 1/2013 Austria   Get Started for $10 PRODUCT NAME: ACLIDINIUMSALZ MIT EINEM PHARMAZEUTISCH ANNEHMBAREN ANION EINER MONO- ODER POLYVALENTEN SAEURE INSBESONDERE ALS ACLIDINIUMBROMID; REGISTRATION NO/DATE: EU/1/12/778/001-003 EU/1/12/781/001-003 20120720
1200431 1390002-2 Sweden   Get Started for $10 PRODUCT NAME: AKLIDINIUMSALT MED FARMACEUTISKT ACCEPTABEL ANJON AV EN- ELLER FLERVAERD SYRA, SPECIELLT AKLIDINIUMBROMID; REG. NO/DATE: EU/1/12/778/001 20120720
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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