Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

Get the Book: Make Better Decisions

Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

PDF eBook: Just $10 Get Print Book on Amazon

Serving leading biopharmaceutical companies globally:

Merck
Harvard Business School
McKesson
Medtronic
Dow
Moodys

Last Updated: December 11, 2019

DrugPatentWatch Database Preview

TUDORZA PRESSAIR Drug Profile

Join the DrugPatentWatch Referral Program
Get access to a free drug patent landscape report or a free one-month subscription

« Back to Dashboard

When do Tudorza Pressair patents expire, and when can generic versions of Tudorza Pressair launch?

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

This drug has one hundred and thirty-two 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. Two suppliers are listed for this compound. Additional details are available on the aclidinium bromide profile page.

US ANDA Litigation and Generic Entry Outlook for Tudorza Pressair

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

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

Summary for TUDORZA PRESSAIR
Drug patent expirations by year for TUDORZA PRESSAIR
Drug Prices for TUDORZA PRESSAIR

See drug prices for TUDORZA PRESSAIR

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
Synonyms for TUDORZA PRESSAIR
(3R)-3-((Hydroxydi(thiophen-2-yl)acetyl)oxy)-1-(3-phenoxypropyl)-1-azoniabicyclo(2.2.2)octane bromide
(3R)-3-(2-Hydroxy-2,2-di(thiophen-2-yl)acetoxy)-1-(3-phenoxypropyl)quinuclidin-1-ium bromide
(3R)-3-[2-hydroxy(di-2-thienyl)acetoxy]-1-(3-phenoxypropyl)-1-azoniabicyclo[2.2.2]octane bromide
(3R)-3-{[Hydroxy(di-2-thienyl)acetyl]oxy}-1-(3-phenoxypropyl)-1-azoniabicyclo[2.2.2]octane bromide
(R)-3-(2-hydroxy-2,2-di(thiophen-2-yl)acetoxy)-1-(3-phenoxypropyl)quinuclidin-1-ium bromide
1-Azoniabicyclo(2.2.2)octane, 3-((hydroxydi-2-thienylacetyl)oxy)-1-(3-phenoxypropyl)-, bromide, (3R)-
2195AH
3(R)-(2-hydroxy-2,2-dithien-2-ylacetoxy)-1-(3-phenoxypropyl)-1-azoniabicyclo[2.2.2]octane bromide
320345-99-1
AC-23963
Aclidinium (Bromide)
Aclidinium bromide
Aclidinium bromide (JAN/USAN/INN)
Aclidinium bromide [USAN:INN]
AKOS016010522
Bretaris
C26H30NO4S2.Br
CHEBI:65344
CHEMBL551466
CS-0896
D08837
DTXSID30185854
Eklira
Eklira genuair (TN)
FT-0649851
Genuair
HY-14144
J-018606
KRP-AB1102
KS-0000104H
LAS 34273
LAS W-330
LAS-34273
LAS-34273 Micronized
LAS-W-330
MolPort-027-836-029
MolPort-035-395-763
s4031
SB16809
SCHEMBL72694
SW219176-1
Tudorza pressair (TN)
UNII-UQW7UF9N91
UQW7UF9N91
W-5426
XLAKJQPTOJHYDR-QTQXQZBYSA-M

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
Circassia TUDORZA PRESSAIR aclidinium bromide POWDER, METERED;INHALATION 202450-001 Jul 23, 2012 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Circassia TUDORZA PRESSAIR aclidinium bromide POWDER, METERED;INHALATION 202450-001 Jul 23, 2012 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Circassia TUDORZA PRESSAIR aclidinium bromide POWDER, METERED;INHALATION 202450-001 Jul 23, 2012 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Circassia TUDORZA PRESSAIR aclidinium bromide POWDER, METERED;INHALATION 202450-001 Jul 23, 2012 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Circassia TUDORZA PRESSAIR aclidinium bromide POWDER, METERED;INHALATION 202450-001 Jul 23, 2012 RX Yes Yes   Start Trial   Start Trial Y Y   Start Trial
Circassia TUDORZA PRESSAIR aclidinium bromide POWDER, METERED;INHALATION 202450-001 Jul 23, 2012 RX Yes Yes   Start Trial   Start Trial Y Y   Start Trial
Circassia TUDORZA PRESSAIR aclidinium bromide POWDER, METERED;INHALATION 202450-001 Jul 23, 2012 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
>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
Circassia TUDORZA PRESSAIR aclidinium bromide POWDER, METERED;INHALATION 202450-001 Jul 23, 2012   Start Trial   Start Trial
Circassia TUDORZA PRESSAIR aclidinium bromide POWDER, METERED;INHALATION 202450-001 Jul 23, 2012   Start Trial   Start Trial
>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 C300573 Netherlands   Start Trial 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 C01200431/01 Switzerland   Start Trial PRODUCT NAME: ACLIDINIUM; REGISTRATION NO/DATE: SWISSMEDIC 62590 25.04.2013
1200431 SPC/GB13/006 United Kingdom   Start Trial 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 PA2013001,C1200431 Lithuania   Start Trial PRODUCT 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 2013C/001 Belgium   Start Trial 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 2013/002 Ireland   Start Trial 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 C 2013 002 Romania   Start Trial 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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

Dow
Merck
Medtronic
Boehringer Ingelheim
McKinsey
Johnson and Johnson

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.