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 Astrazeneca and is included in one NDA. There are five patents protecting this drug.

This drug has one hundred and thirty-nine patent family members in forty-four countries.

The generic ingredient in DUAKLIR PRESSAIR is aclidinium bromide; formoterol fumarate. There is one drug master file entry 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:	139
US Patents:	5
Applicants:	1
NDAs:	1
Formulation / Manufacturing:	see details
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 Generic Entry Opportunity Date for DUAKLIR PRESSAIR

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.

Anatomical Therapeutic Chemical (ATC) Classes for DUAKLIR PRESSAIR

R03AC	Selective beta-2-adrenoreceptor agonists
R03A	ADRENERGICS, INHALANTS
R03	DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES
R	Respiratory system

R03BB	Anticholinergics
R03B	OTHER DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES, INHALANTS
R03	DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES
R	Respiratory system

R03CC	Selective beta-2-adrenoreceptor agonists
R03C	ADRENERGICS FOR SYSTEMIC USE
R03	DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES
R	Respiratory system

US Patents and Regulatory Information for DUAKLIR PRESSAIR

DUAKLIR PRESSAIR is protected by five US patents and one FDA Regulatory Exclusivity.

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 DUAKLIR PRESSAIR

FDA Regulatory Exclusivity protecting DUAKLIR PRESSAIR

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Astrazeneca	DUAKLIR PRESSAIR	aclidinium bromide; formoterol fumarate	POWDER, METERED;INHALATION	210595-001	Mar 29, 2019		RX	Yes	Yes			Y	Y
Astrazeneca	DUAKLIR PRESSAIR	aclidinium bromide; formoterol fumarate	POWDER, METERED;INHALATION	210595-001	Mar 29, 2019		RX	Yes	Yes			Y
Astrazeneca	DUAKLIR PRESSAIR	aclidinium bromide; formoterol fumarate	POWDER, METERED;INHALATION	210595-001	Mar 29, 2019		RX	Yes	Yes			Y
Astrazeneca	DUAKLIR PRESSAIR	aclidinium bromide; formoterol fumarate	POWDER, METERED;INHALATION	210595-001	Mar 29, 2019		RX	Yes	Yes			Y
Astrazeneca	DUAKLIR PRESSAIR	aclidinium bromide; formoterol fumarate	POWDER, METERED;INHALATION	210595-001	Mar 29, 2019		RX	Yes	Yes

Expired US Patents for DUAKLIR PRESSAIR

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Astrazeneca	DUAKLIR PRESSAIR	aclidinium bromide; formoterol fumarate	POWDER, METERED;INHALATION	210595-001	Mar 29, 2019
Astrazeneca	DUAKLIR PRESSAIR	aclidinium bromide; formoterol fumarate	POWDER, METERED;INHALATION	210595-001	Mar 29, 2019
Astrazeneca	DUAKLIR PRESSAIR	aclidinium bromide; formoterol fumarate	POWDER, METERED;INHALATION	210595-001	Mar 29, 2019
Astrazeneca	DUAKLIR PRESSAIR	aclidinium bromide; formoterol fumarate	POWDER, METERED;INHALATION	210595-001	Mar 29, 2019
Astrazeneca	DUAKLIR PRESSAIR	aclidinium bromide; formoterol fumarate	POWDER, METERED;INHALATION	210595-001	Mar 29, 2019

International Patents for DUAKLIR PRESSAIR

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

Country	Patent Number	Title	Estimated Expiration
Colombia	5200759	NUEVOS DERIVADOS DE QUINUCLIDINA Y COMPOSICIONES FARMACEUTICAS QUE LOS CONTIENEN
Germany	60001840
Turkey	200200768
South Africa	201003900	NOVEL DOSAGE AND FORMULATION
European Patent Office	2265257	COMPOSITION À INHALER COMPRENANT ACLIDINIUM POUR LE TRAITEMENT DE MALADIES RESPIRATOIRES OBSTRUCTIVES CHRONIQUES (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	92132	Luxembourg		PRODUCT NAME: SEL D ACLIDINIUM AVEC ANION D UN ACIDE MONO OU POLYVALENT PHARMACEUTIQUEMENT ACCEPTABLE PARTICULIEREMENT LE BROMURE D ACLIDINIUM
1200431	1/2013	Austria		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	2013/002	Ireland		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	2013C/001	Belgium		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	C01200431/01	Switzerland		PRODUCT NAME: ACLIDINIUM; REGISTRATION NO/DATE: SWISSMEDIC 62590 25.04.2013