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TUDORZA PRESSAIR Drug Patent Profile

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

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

See drug prices for TUDORZA PRESSAIR

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for TUDORZA PRESSAIR

Constraining patent/regulatory exclusivity:

RE46417

NDA:

202450

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 Class	Anticholinergic
Mechanism of Action	Cholinergic Antagonists

US Patents and Regulatory Information for TUDORZA PRESSAIR

TUDORZA PRESSAIR is protected by four US patents.

This potential generic entry date is based on patent RE46417.

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	10,085,974		Y
Covis	TUDORZA PRESSAIR	aclidinium bromide	POWDER, METERED;INHALATION	202450-001	Jul 23, 2012		RX	Yes	Yes	8,051,851		Y
Covis	TUDORZA PRESSAIR	aclidinium bromide	POWDER, METERED;INHALATION	202450-001	Jul 23, 2012		RX	Yes	Yes	RE46417		Y	Y

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	7,078,412
Covis	TUDORZA PRESSAIR	aclidinium bromide	POWDER, METERED;INHALATION	202450-001	Jul 23, 2012	10,034,867
Covis	TUDORZA PRESSAIR	aclidinium bromide	POWDER, METERED;INHALATION	202450-001	Jul 23, 2012	6,750,226

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

International Patents for TUDORZA PRESSAIR

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

Country	Patent Number	Title	Estimated Expiration
Australia	779881
Ecuador	SP10010300
Canada	2716724	NOUVEAU DOSAGE ET NOUVELLE FORMULATION (NOVEL DOSAGE AND FORMULATION)

Supplementary Protection Certificates for TUDORZA PRESSAIR

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1200431	13C0001	France		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	132013902117495	Italy		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	CA 2013 00002	Denmark

TUDORZA PRESSAIR Market Analysis and Financial Projection Experimental

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.