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Last Updated: February 25, 2024

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 Covis and is included in one NDA. There are four patents protecting this drug.

This drug has one hundred and fifty-six patent family members in forty-six 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.

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:156
US Patents:4
Applicants:1
NDAs:1
Finished Product Suppliers / Packagers: 2
Raw Ingredient (Bulk) Api Vendors: 56
Patent Applications: 377
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 Loss of Exclusivity (LOE) 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

TUDORZA PRESSAIR is protected by four US patents.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of TUDORZA PRESSAIR is ⤷  Try a Trial.

This potential generic entry date is based on patent ⤷  Try a Trial.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Patents protecting TUDORZA PRESSAIR

Dosage and formulation
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: MAINTENANCE TREATMENT OF CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD)

Dosage and formulation
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: MAINTENANCE TREATMENT OF CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD)

Inhaler for the administration of powdered pharmaceuticals, and a powder cartridge system for use with this inhaler
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Quinuclidine derivatives and their use as muscarinic M3 receptor ligands
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: MAINTENANCE TREATMENT OF CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD)

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Covis TUDORZA PRESSAIR aclidinium bromide POWDER, METERED;INHALATION 202450-001 Jul 23, 2012 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Covis TUDORZA PRESSAIR aclidinium bromide POWDER, METERED;INHALATION 202450-001 Jul 23, 2012 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Covis TUDORZA PRESSAIR aclidinium bromide POWDER, METERED;INHALATION 202450-001 Jul 23, 2012 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y Y ⤷  Try a Trial
Covis TUDORZA PRESSAIR aclidinium bromide POWDER, METERED;INHALATION 202450-001 Jul 23, 2012 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a 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
Covis TUDORZA PRESSAIR aclidinium bromide POWDER, METERED;INHALATION 202450-001 Jul 23, 2012 ⤷  Try a Trial ⤷  Try a Trial
Covis TUDORZA PRESSAIR aclidinium bromide POWDER, METERED;INHALATION 202450-001 Jul 23, 2012 ⤷  Try a Trial ⤷  Try a Trial
Covis TUDORZA PRESSAIR aclidinium bromide POWDER, METERED;INHALATION 202450-001 Jul 23, 2012 ⤷  Try a Trial ⤷  Try a Trial
Covis TUDORZA PRESSAIR aclidinium bromide POWDER, METERED;INHALATION 202450-001 Jul 23, 2012 ⤷  Try a Trial ⤷  Try a Trial
Covis TUDORZA PRESSAIR aclidinium bromide POWDER, METERED;INHALATION 202450-001 Jul 23, 2012 ⤷  Try a Trial ⤷  Try a Trial
Covis TUDORZA PRESSAIR aclidinium bromide POWDER, METERED;INHALATION 202450-001 Jul 23, 2012 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

EU/EMA Drug Approvals for TUDORZA PRESSAIR

Company Drugname Inn Product Number / Indication Status Generic Biosimilar Orphan Marketing Authorisation Marketing Refusal
Covis Pharma Europe B.V. Bretaris Genuair aclidinium bromide EMEA/H/C/002706
Bretaris Genuair is indicated as a maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (COPD).
Authorised no no no 2012-07-20
Covis Pharma Europe B.V. Eklira Genuair aclidinium bromide EMEA/H/C/002211
Eklira Genuair is indicated as a maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (COPD).
Authorised no no no 2012-07-20
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

International Patents for TUDORZA PRESSAIR

See the table below for patents covering TUDORZA PRESSAIR around the world.

Country Patent Number Title Estimated Expiration
Spain 2353018 ⤷  Try a Trial
Turkey 200200768 ⤷  Try a Trial
Hong Kong 1018011 ⤷  Try a Trial
Canada 2381165 NOUVEAUX DERIVES DE QUINUCLIDINE ET COMPOSITIONS MEDICALES LES CONTENANT (NOVEL QUINUCLIDINE DERIVATIVES AND MEDICINAL COMPOSITIONS CONTAINING THE SAME) ⤷  Try a Trial
Bulgaria 65565 ⤷  Try a Trial
Croatia P960294 PHARMACEUTICAL POWDER CARTRIDGE WITH INTEGRATED METERING DEVICE AND INHALER FOR POWDERED MEDICAMENTS ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for TUDORZA PRESSAIR

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1200431 1/2013 Austria ⤷  Try a Trial 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 ⤷  Try a Trial PRODUCT NAME: AKLIDINIUMSALT MED FARMACEUTISKT ACCEPTABEL ANJON AV EN- ELLER FLERVAERD SYRA, SPECIELLT AKLIDINIUMBROMID; REG. NO/DATE: EU/1/12/778/001 20120720
1200431 2013C/001 Belgium ⤷  Try a 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 SPC/GB13/006 United Kingdom ⤷  Try a 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 13C0001 France ⤷  Try a Trial 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 PA2013001 Lithuania ⤷  Try a 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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

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