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Last Updated: February 7, 2025

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. 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:156
US Patents:4
Applicants:1
NDAs:1
Finished Product Suppliers / Packagers: 1
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 ⤷  Free Trial.

This potential generic entry date is based on patent ⤷  Free 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.

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 ⤷  Free Trial ⤷  Free Trial Y ⤷  Free Trial
Covis TUDORZA PRESSAIR aclidinium bromide POWDER, METERED;INHALATION 202450-001 Jul 23, 2012 RX Yes Yes ⤷  Free Trial ⤷  Free Trial Y ⤷  Free Trial
Covis TUDORZA PRESSAIR aclidinium bromide POWDER, METERED;INHALATION 202450-001 Jul 23, 2012 RX Yes Yes ⤷  Free Trial ⤷  Free Trial Y Y ⤷  Free Trial
Covis TUDORZA PRESSAIR aclidinium bromide POWDER, METERED;INHALATION 202450-001 Jul 23, 2012 RX Yes Yes ⤷  Free Trial ⤷  Free Trial Y ⤷  Free 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 ⤷  Free Trial ⤷  Free Trial
Covis TUDORZA PRESSAIR aclidinium bromide POWDER, METERED;INHALATION 202450-001 Jul 23, 2012 ⤷  Free Trial ⤷  Free Trial
Covis TUDORZA PRESSAIR aclidinium bromide POWDER, METERED;INHALATION 202450-001 Jul 23, 2012 ⤷  Free Trial ⤷  Free Trial
Covis TUDORZA PRESSAIR aclidinium bromide POWDER, METERED;INHALATION 202450-001 Jul 23, 2012 ⤷  Free Trial ⤷  Free Trial
Covis TUDORZA PRESSAIR aclidinium bromide POWDER, METERED;INHALATION 202450-001 Jul 23, 2012 ⤷  Free Trial ⤷  Free Trial
Covis TUDORZA PRESSAIR aclidinium bromide POWDER, METERED;INHALATION 202450-001 Jul 23, 2012 ⤷  Free Trial ⤷  Free 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
Germany 602005023690 ⤷  Free Trial
Canada 2225396 CARTOUCHE DE POUDRE PHARMACEUTIQUE AVEC APPAREIL DE DOSAGE INTEGRE ET INHALATEUR POUR MEDICAMENTS EN POUDRE (PHARMACEUTICAL POWDER CARTRIDGE WITH INTEGRATED METERING DEVICE AND INHALER FOR POWDERED MEDICAMENTS) ⤷  Free Trial
European Patent Office 1200431 DERIVES DE QUINUCLIDINE ET LEUR UTILISATION COMME LIGANDS DES RECEPTEURS M3 MUSCARINIQUES (QUINUCLIDINE DERIVATIVES AND THEIR USE AS MUSCARINIC M3 RECEPTORS LIGANDS) ⤷  Free Trial
Denmark 1616592 ⤷  Free Trial
Russian Federation 2005121162 ⤷  Free Trial
Poland 204024 ⤷  Free 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 1390002-2 Sweden ⤷  Free 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 2013/002 Ireland ⤷  Free 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 SPC/GB13/006 United Kingdom ⤷  Free 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 2013C/001 Belgium ⤷  Free 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 PA2013001 Lithuania ⤷  Free 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 1/2013 Austria ⤷  Free 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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

Market Dynamics and Financial Trajectory for TUDORZA PRESSAIR

Introduction

TUDORZA PRESSAIR, an anticholinergic medication containing aclidinium bromide, is used for the long-term maintenance treatment of bronchospasm associated with chronic obstructive pulmonary disease (COPD). Here, we delve into the market dynamics and financial trajectory of this drug.

Market Acquisition and Integration

In 2015, AstraZeneca acquired the rights to Actavis' branded respiratory business in the US and Canada, including TUDORZA PRESSAIR and Daliresp, for an initial consideration of $600 million plus low single-digit royalties above a certain revenue threshold. This acquisition strengthened AstraZeneca's respiratory franchise globally and added immediate revenues with long-term growth potential[1].

Product Performance and Revenue

The acquisition of TUDORZA PRESSAIR and Daliresp brought significant revenue to AstraZeneca. In 2014, these products had combined annual sales in the US of approximately $230 million. This addition broadened the treatment options and formulations available to patients and physicians, enhancing AstraZeneca's market presence in the respiratory sector[1].

Clinical Trials and Efficacy

TUDORZA PRESSAIR has demonstrated strong efficacy in clinical trials. It has shown statistically significant improvements in bronchodilation as measured by changes in forced expiratory volume (FEV1) compared to placebo. The Phase IV ASCENT trial further supported its efficacy by reducing the annual rate of moderate or severe COPD exacerbations and demonstrating cardiovascular safety in patients with cardiovascular risk factors[3][4].

Safety Profile

The safety profile of TUDORZA PRESSAIR is well-documented. Clinical trials have identified common adverse reactions such as headache, nasopharyngitis, cough, and diarrhea. The drug has also been shown to be non-inferior to placebo in terms of major adverse cardiovascular events (MACE), which is crucial for patients with COPD who often have comorbid cardiovascular conditions[3].

Global Availability

TUDORZA PRESSAIR, also marketed as Eklira and Bretaris, is available in more than 50 countries. This widespread availability underscores its global market reach and the demand for effective COPD treatments[4].

Financial Performance

The financial performance of TUDORZA PRESSAIR has seen fluctuations. In 2018, the drug reported revenues of $95 million, which represented a decline of 19% compared to the previous year. Despite this, the drug remains a significant contributor to AstraZeneca's respiratory portfolio[5].

Market Trends and Competition

The respiratory market is highly competitive, with several other treatments available for COPD. However, TUDORZA PRESSAIR's unique formulation and delivery system, using the PRESSAIR inhaler, differentiate it from other products. The drug's ability to reduce exacerbations and demonstrate cardiovascular safety has helped it maintain a strong market position[4].

Impact on AstraZeneca's Financials

The acquisition of TUDORZA PRESSAIR has been part of AstraZeneca's broader strategy to strengthen its respiratory franchise. This move, along with other acquisitions and product launches, has contributed to AstraZeneca's overall financial growth. For instance, in Q1 2019, AstraZeneca reported a 14% growth in product sales, partly driven by the success of its respiratory and other therapeutic areas[2].

Future Outlook

Given the ongoing demand for effective COPD treatments and the drug's proven efficacy and safety, TUDORZA PRESSAIR is expected to continue playing a significant role in AstraZeneca's respiratory portfolio. However, market dynamics, including competition and regulatory changes, will continue to influence its financial trajectory.

Key Takeaways

  • Acquisition and Integration: AstraZeneca acquired TUDORZA PRESSAIR as part of Actavis' branded respiratory business in 2015.
  • Revenue Contribution: The drug added immediate revenues and long-term growth potential to AstraZeneca's portfolio.
  • Clinical Efficacy: TUDORZA PRESSAIR has demonstrated significant improvements in bronchodilation and reduction in COPD exacerbations.
  • Safety Profile: The drug has a well-documented safety profile, including cardiovascular safety.
  • Global Reach: Available in over 50 countries, highlighting its global market presence.
  • Financial Performance: Reported revenues of $95 million in 2018, despite a decline from the previous year.
  • Market Trends: Remains competitive in the respiratory market due to its unique formulation and delivery system.

FAQs

Q: What is TUDORZA PRESSAIR used for?

TUDORZA PRESSAIR is used for the long-term maintenance treatment of bronchospasm associated with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema.

Q: Who acquired the rights to TUDORZA PRESSAIR in 2015?

AstraZeneca acquired the rights to TUDORZA PRESSAIR from Actavis in 2015.

Q: What was the initial consideration for the acquisition of TUDORZA PRESSAIR?

The initial consideration for the acquisition was $600 million plus low single-digit royalties above a certain revenue threshold.

Q: How has TUDORZA PRESSAIR performed in clinical trials?

TUDORZA PRESSAIR has demonstrated statistically significant improvements in bronchodilation and a reduction in COPD exacerbations. It has also shown cardiovascular safety in patients with cardiovascular risk factors.

Q: What is the current global availability of TUDORZA PRESSAIR?

TUDORZA PRESSAIR is available in more than 50 countries worldwide.

Sources

  1. AstraZeneca Press Release: AstraZeneca to acquire rights to Actavis' branded respiratory business in the US and Canada.
  2. AstraZeneca Q1 2019 Results: Q1 2019 Results announcement.
  3. FDA Label: TUDORZA PRESSAIR label.
  4. AstraZeneca Press Release: Tudorza reduces exacerbations and demonstrates cardiovascular safety in COPD patients.
  5. PharmaCompass: Annual Sales Report for TUDORZA PRESSAIR.

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