DUAKLIR PRESSAIR Drug Patent Profile

Which patents cover Duaklir Pressair, and when can generic versions of Duaklir Pressair launch?

Duaklir Pressair is a drug marketed by Azurity and is included in one NDA. There are two patents protecting this drug.

This drug has seventy-two patent family members in thirty-six countries.

The generic ingredient in DUAKLIR PRESSAIR is aclidinium bromide; formoterol fumarate. 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; 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 March 13, 2029. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for DUAKLIR PRESSAIR

International Patents:	72
US Patents:	2
Applicants:	1
NDAs:	1

US Patents and Regulatory Information for DUAKLIR PRESSAIR

DUAKLIR PRESSAIR is protected by two US patents.

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
Azurity	DUAKLIR PRESSAIR	aclidinium bromide; formoterol fumarate	POWDER, METERED;INHALATION	210595-001	Mar 29, 2019		RX	Yes	Yes			Y
Azurity	DUAKLIR PRESSAIR	aclidinium bromide; formoterol fumarate	POWDER, METERED;INHALATION	210595-001	Mar 29, 2019		RX	Yes	Yes			Y

International Patents for DUAKLIR PRESSAIR

When does loss-of-exclusivity occur for DUAKLIR PRESSAIR?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Argentina

Australia

Brazil

Canada

Chile

China

Colombia

Croatia

Cyprus

Denmark

Ecuador

European Patent Office

Finland

Hong Kong

Hungary

Israel

Japan

Lithuania

Malaysia

Mexico

Montenegro

New Zealand

Peru

Poland

Portugal

Russian Federation

Serbia

Singapore

Slovenia

South Africa

South Korea

Spain

Taiwan

Ukraine

Uruguay

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

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

Country	Patent Number	Title	Estimated Expiration
Argentina	029760	DERIVADOS DE QUINUCLIDINA, PROCESO PARA PREPARAR DICHOS DERIVADOS, COMPUESTOS INTERMEDIARIOS UTILIZABLES EN DICHO PROCESO, COMPOSICIONES FARMACEUTICAS FORMULADAS CON DICHOS DERIVADOS Y USO DE DICHOS DERIVADOS PARA LA PRODUCCION DE MEDICAMENTOS PARA EL TRATAMIENTO DE ENFERMEDADES RESPIRATORIAS, URINA
Austria	235492
Australia	2005202144
Australia	6433000
Australia	779881
Bulgaria	106301
Bulgaria	65565

Supplementary Protection Certificates for DUAKLIR PRESSAIR

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1200431	CA 2013 00002	Denmark
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	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	1390002-2	Sweden		PRODUCT NAME: AKLIDINIUMSALT MED FARMACEUTISKT ACCEPTABEL ANJON AV EN- ELLER FLERVAERD SYRA, SPECIELLT AKLIDINIUMBROMID; REG. NO/DATE: EU/1/12/778/001 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	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	PA2013001,C1200431	Lithuania		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