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Last Updated: September 27, 2021

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TUDORZA PRESSAIR Drug Patent 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 five 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:5
Applicants:1
NDAs:1
Finished Product Suppliers / Packagers: 1
Raw Ingredient (Bulk) Api Vendors: 50
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 ⤷  Try it Free ⤷  Try it Free Y ⤷  Try it Free
Astrazeneca TUDORZA PRESSAIR aclidinium bromide POWDER, METERED;INHALATION 202450-001 Jul 23, 2012 RX Yes Yes ⤷  Try it Free ⤷  Try it Free Y ⤷  Try it Free
Astrazeneca TUDORZA PRESSAIR aclidinium bromide POWDER, METERED;INHALATION 202450-001 Jul 23, 2012 RX Yes Yes ⤷  Try it Free ⤷  Try it Free Y Y ⤷  Try it Free
Astrazeneca TUDORZA PRESSAIR aclidinium bromide POWDER, METERED;INHALATION 202450-001 Jul 23, 2012 RX Yes Yes ⤷  Try it Free ⤷  Try it Free Y ⤷  Try it Free
Astrazeneca TUDORZA PRESSAIR aclidinium bromide POWDER, METERED;INHALATION 202450-001 Jul 23, 2012 RX Yes Yes ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Astrazeneca TUDORZA PRESSAIR aclidinium bromide POWDER, METERED;INHALATION 202450-001 Jul 23, 2012 RX Yes Yes ⤷  Try it Free ⤷  Try it Free Y ⤷  Try it Free
>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 ⤷  Try it Free ⤷  Try it Free
Astrazeneca TUDORZA PRESSAIR aclidinium bromide POWDER, METERED;INHALATION 202450-001 Jul 23, 2012 ⤷  Try it Free ⤷  Try it Free
Astrazeneca TUDORZA PRESSAIR aclidinium bromide POWDER, METERED;INHALATION 202450-001 Jul 23, 2012 ⤷  Try it Free ⤷  Try it Free
Astrazeneca TUDORZA PRESSAIR aclidinium bromide POWDER, METERED;INHALATION 202450-001 Jul 23, 2012 ⤷  Try it Free ⤷  Try it Free
Astrazeneca TUDORZA PRESSAIR aclidinium bromide POWDER, METERED;INHALATION 202450-001 Jul 23, 2012 ⤷  Try it Free ⤷  Try it Free
Astrazeneca TUDORZA PRESSAIR aclidinium bromide POWDER, METERED;INHALATION 202450-001 Jul 23, 2012 ⤷  Try it Free ⤷  Try it Free
Astrazeneca TUDORZA PRESSAIR aclidinium bromide POWDER, METERED;INHALATION 202450-001 Jul 23, 2012 ⤷  Try it Free ⤷  Try it Free
>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 CA 2013 00002 Denmark ⤷  Try it Free
1200431 132013902117495 Italy ⤷  Try it Free PRODUCT NAME: BROMURO DI ACLIDINIO(EKLIRA GENUAIR E BRETARIS GENUAIR); AUTHORISATION NUMBER(S) AND DATE(S): BRETARIS G.: EU/1/12/781/001-002-003; EKLIRA G.:EU/1/12/778/001-002-003, 20120720
1200431 SPC/GB13/006 United Kingdom ⤷  Try it Free 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 13C0001 France ⤷  Try it Free 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 C 2013 002 Romania ⤷  Try it Free PRODUCT NAME: SAREDE ACLIDINIU CU UN ANION ACCEPTABIL FARMACEUTIC AL UNUI ACID MONO SAU POLIVALENT, IN SPECIAL BROMURA DEACLIDINIU; NATIONAL AUTHORISATION NUMBER: RO EU/1/12/778/001, RO EU/1/12/778/002, RO EU/1/12/778/003; DATE OF NATIONAL AUTHORISATION: 20120720; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EMEA EU/1/12/778/001, EMEA EU/1/12/778/002, EMEA EU/1/12/778/003; DATE OF FIRST AUTHORISATION IN EEA: 20120720
1200431 C300573 Netherlands ⤷  Try it Free PRODUCT 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
1200431 2013/002 Ireland ⤷  Try it Free 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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Moodys
McKesson
Colorcon
Medtronic
Express Scripts
Harvard Business School

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