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DUAKLIR PRESSAIR Drug Patent Profile

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

Duaklir 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 DUAKLIR PRESSAIR is aclidinium bromide; formoterol fumarate. 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; formoterol fumarate profile page.

DrugPatentWatch^® Generic Entry Outlook for Duaklir Pressair

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 DUAKLIR PRESSAIR

International Patents:	156
US Patents:	4
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Drug Prices:	Drug price information for DUAKLIR PRESSAIR
What excipients (inactive ingredients) are in DUAKLIR PRESSAIR?	DUAKLIR PRESSAIR excipients list
DailyMed Link:	DUAKLIR PRESSAIR at DailyMed

See drug prices for DUAKLIR PRESSAIR

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

Constraining patent/regulatory exclusivity:

RE46417

NDA:

210595

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 DUAKLIR PRESSAIR

Drug Class	Anticholinergic beta2-Adrenergic Agonist
Mechanism of Action	Adrenergic beta2-Agonists Cholinergic Antagonists

US Patents and Regulatory Information for DUAKLIR PRESSAIR

DUAKLIR 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	DUAKLIR PRESSAIR	aclidinium bromide; formoterol fumarate	POWDER, METERED;INHALATION	210595-001	Mar 29, 2019		RX	Yes	Yes	RE46417		Y	Y
Covis	DUAKLIR PRESSAIR	aclidinium bromide; formoterol fumarate	POWDER, METERED;INHALATION	210595-001	Mar 29, 2019		RX	Yes	Yes	8,051,851		Y
Covis	DUAKLIR PRESSAIR	aclidinium bromide; formoterol fumarate	POWDER, METERED;INHALATION	210595-001	Mar 29, 2019		RX	Yes	Yes	10,085,974		Y

Expired US Patents for DUAKLIR PRESSAIR

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Covis	DUAKLIR PRESSAIR	aclidinium bromide; formoterol fumarate	POWDER, METERED;INHALATION	210595-001	Mar 29, 2019	7,750,023
Covis	DUAKLIR PRESSAIR	aclidinium bromide; formoterol fumarate	POWDER, METERED;INHALATION	210595-001	Mar 29, 2019	10,034,867
Covis	DUAKLIR PRESSAIR	aclidinium bromide; formoterol fumarate	POWDER, METERED;INHALATION	210595-001	Mar 29, 2019	9,056,100

International Patents for DUAKLIR PRESSAIR

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

Country	Patent Number	Title	Estimated Expiration
Uruguay	31687	NUEVA DOSIFICACION Y FORMULACION
South Korea	20180125055
Montenegro	02286	JEDINJENJE ZA INHALACIJU KOJE SADRŽI AKLIDINIJUM ZA LEČENJE HRONIČNE OPSTRUKTIVNE BOLESTI PLUĆA (INHALATION COMPOSITION CONTAINING ACLIDINIUM FOR TREATMENT OF CHRONIC OBSTRUCTIVE PULMONARY DISEASE)

Supplementary Protection Certificates for DUAKLIR PRESSAIR

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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	C 2013 002	Romania		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	92132	Luxembourg		PRODUCT NAME: SEL D ACLIDINIUM AVEC ANION D UN ACIDE MONO OU POLYVALENT PHARMACEUTIQUEMENT ACCEPTABLE PARTICULIEREMENT LE BROMURE D ACLIDINIUM

DUAKLIR PRESSAIR Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for DUAKLIR PRESSAIR

Introduction

DUAKLIR PRESSAIR, a combination inhalation powder containing aclidinium bromide and formoterol fumarate, has been a significant player in the treatment of Chronic Obstructive Pulmonary Disease (COPD). Here, we delve into the market dynamics and financial trajectory of this medication.

FDA Approval and Clinical Trials

DUAKLIR PRESSAIR received FDA approval in April 2019, marking a crucial milestone in its market entry. The approval was based on the results of the AMPLIFY clinical trial, which demonstrated the efficacy and safety of DUAKLIR PRESSAIR compared to its individual components and other treatments like Spiriva® Handihaler® (tiotropium)[1].

Market Entry and Commercialization

Following FDA approval, Circassia Pharmaceuticals Inc. and AstraZeneca collaborated for the commercialization of DUAKLIR PRESSAIR in the United States. This collaboration allowed Circassia to have exclusive US commercialization rights, leveraging AstraZeneca's extensive resources and expertise[1][4].

Global Presence

DUAKLIR PRESSAIR is approved and marketed globally under various brand names. Outside the US, the same inhaler is marketed as Genuair, highlighting its widespread acceptance and use[1][4].

Revenue and Financial Performance

In 2020, DUAKLIR PRESSAIR, along with Eklira (another COPD treatment), generated $143 million in revenue for AstraZeneca in the countries covered by their agreement. This revenue indicates a strong market presence and demand for these medications[2].

Transfer of Global Rights

In a significant financial move, AstraZeneca transferred the global rights for Eklira and Duaklir to Covis Pharma in 2021. Covis Pharma agreed to pay $270 million upon completion of the transaction and also committed to covering certain ongoing development costs. This transfer did not impact AstraZeneca’s financial guidance for 2021 but marked a new chapter in the commercialization strategy for DUAKLIR PRESSAIR[2].

Market Competition

The COPD treatment market is highly competitive, with several established brands and ongoing research into new therapies. DUAKLIR PRESSAIR competes with other long-acting muscarinic antagonists (LAMAs) and long-acting beta-agonists (LABAs), as well as combination therapies. Its unique inhaler design, such as the Pressair inhaler, which provides patient feedback, helps differentiate it in the market[1][4].

Clinical Efficacy and Patient Benefits

The AMPLIFY trial demonstrated that DUAKLIR PRESSAIR significantly improved lung function and reduced the use of rescue inhalers in patients with COPD. These benefits, combined with a comparable safety profile to its individual components, have been key factors in its market success[1].

Safety Profile and Adverse Reactions

While DUAKLIR PRESSAIR has shown a favorable safety profile, it is not without risks. Common adverse reactions include upper respiratory tract infections, headache, and back pain. It is also contraindicated in patients with severe hypersensitivity to milk proteins or its components and is not indicated for acute episodes of bronchospasm[1][3].

Regulatory Considerations

DUAKLIR PRESSAIR must be used with caution in patients with certain coexisting conditions, such as severe cardiovascular disorders, convulsive disorders, and narrow-angle glaucoma. These considerations are crucial for prescribers and patients to ensure safe and effective use[3].

Patient Feedback and Ease of Use

The Pressair inhaler, used for DUAKLIR PRESSAIR, is designed to be easy to use and provides a unique patient feedback mechanism. This design has been praised for its simplicity and effectiveness, enhancing patient compliance and satisfaction[4].

Future Outlook

The transfer of global rights to Covis Pharma marks a new era for DUAKLIR PRESSAIR. With continued investment in marketing and potential further development, the medication is poised to maintain its market presence. The ongoing need for effective COPD treatments ensures a stable demand for DUAKLIR PRESSAIR, contributing to its financial stability and growth.

Key Takeaways

• FDA Approval and Clinical Trials: DUAKLIR PRESSAIR was approved by the FDA in 2019 based on the AMPLIFY trial.
• Market Entry and Commercialization: Circassia and AstraZeneca collaborated for US commercialization.
• Global Presence: Marketed globally under various brand names.
• Revenue and Financial Performance: Generated $143 million in revenue for AstraZeneca in 2020.
• Transfer of Global Rights: Transferred to Covis Pharma in 2021 for $270 million.
• Market Competition: Competes with other COPD treatments but differentiated by its inhaler design.
• Clinical Efficacy and Patient Benefits: Improved lung function and reduced rescue inhaler use.
• Safety Profile and Adverse Reactions: Favorable safety profile but with specific contraindications and precautions.
• Regulatory Considerations: Must be used with caution in certain patient groups.
• Patient Feedback and Ease of Use: Designed for ease of use with a unique feedback mechanism.

FAQs

1. What is DUAKLIR PRESSAIR used for?

   • DUAKLIR PRESSAIR is used for the maintenance treatment of Chronic Obstructive Pulmonary Disease (COPD).

2. Who are the key players involved in the commercialization of DUAKLIR PRESSAIR?

   • Initially, Circassia Pharmaceuticals Inc. and AstraZeneca were involved. In 2021, the global rights were transferred to Covis Pharma.

3. What are the common adverse reactions associated with DUAKLIR PRESSAIR?

   • Common adverse reactions include upper respiratory tract infections, headache, and back pain.

4. What is unique about the Pressair inhaler used for DUAKLIR PRESSAIR?

   • The Pressair inhaler is easy to use and provides a unique patient feedback mechanism.

5. What was the financial impact of the transfer of global rights to Covis Pharma?

   • Covis Pharma paid $270 million to AstraZeneca upon completion of the transaction and will cover certain ongoing development costs.

Sources

1. US Food and Drug Administration Approves DUAKLIR® PRESSAIR® for Patients with Chronic Obstructive Pulmonary Disease (COPD) - Business Wire
2. AstraZeneca to transfer global rights for Eklira and Duaklir to Covis Pharma - AstraZeneca
3. DUAKLIR® PRESSAIR® - FDA Label
4. Duaklir significantly improves lung function in COPD patients - AstraZeneca