DALIRESP Drug Patent Profile

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

Daliresp is a drug marketed by Astrazeneca and is included in one NDA. There are three patents protecting this drug and two Paragraph IV challenges.

This drug has thirty-seven patent family members in twenty-nine countries.

The generic ingredient in DALIRESP is roflumilast. There are ten drug master file entries for this compound. Fourteen suppliers are listed for this compound. Additional details are available on the roflumilast profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Daliresp

A generic version of DALIRESP was approved as roflumilast by MYLAN on July 13^th, 2018.

Summary for DALIRESP

International Patents:	37
US Patents:	3
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	136
Clinical Trials:	17
Patent Applications:	5,683
Drug Prices:	Drug price information for DALIRESP
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for DALIRESP
What excipients (inactive ingredients) are in DALIRESP?	DALIRESP excipients list
DailyMed Link:	DALIRESP at DailyMed

See drug prices for DALIRESP

Recent Clinical Trials for DALIRESP

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Chiesi Farmaceutici S.p.A.	Phase 3
Johns Hopkins University	Phase 3
Patient-Centered Outcomes Research Institute	Phase 3

See all DALIRESP clinical trials

Pharmacology for DALIRESP

Drug Class	Phosphodiesterase 4 Inhibitor
Mechanism of Action	Phosphodiesterase 4 Inhibitors

Paragraph IV (Patent) Challenges for DALIRESP

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
DALIRESP	Tablets	roflumilast	250 mcg	022522	1	2019-01-25
DALIRESP	Tablets	roflumilast	500 mcg	022522	7	2015-03-02

US Patents and Regulatory Information for DALIRESP

DALIRESP is protected by three US patents.

Patents protecting DALIRESP

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Astrazeneca	DALIRESP	roflumilast	TABLET;ORAL	022522-002	Jan 23, 2018	AB	RX	Yes	No
Astrazeneca	DALIRESP	roflumilast	TABLET;ORAL	022522-001	Feb 28, 2011	AB	RX	Yes	Yes
Astrazeneca	DALIRESP	roflumilast	TABLET;ORAL	022522-002	Jan 23, 2018	AB	RX	Yes	No
Astrazeneca	DALIRESP	roflumilast	TABLET;ORAL	022522-002	Jan 23, 2018	AB	RX	Yes	No			Y

Expired US Patents for DALIRESP

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Astrazeneca	DALIRESP	roflumilast	TABLET;ORAL	022522-002	Jan 23, 2018
Astrazeneca	DALIRESP	roflumilast	TABLET;ORAL	022522-001	Feb 28, 2011
Astrazeneca	DALIRESP	roflumilast	TABLET;ORAL	022522-002	Jan 23, 2018
Astrazeneca	DALIRESP	roflumilast	TABLET;ORAL	022522-002	Jan 23, 2018

EU/EMA Drug Approvals for DALIRESP

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
AstraZeneca AB	Daxas	roflumilast	EMEA/H/C/001179 Daxas is indicated for maintenance treatment of severe chronic obstructive pulmonary disease (COPD) (FEV1 post-bronchodilator less than 50% predicted) associated with chronic bronchitis in adult patients with a history of frequent exacerbations as add-on to bronchodilator treatment.,	Authorised	no	no	no	2010-07-05
AstraZeneca AB	Libertek	roflumilast	EMEA/H/C/002399 Libertek is indicated for maintenance treatment of severe chronic obstructive pulmonary disease (COPD) (FEV1 post-bronchodilator less than 50% predicted) associated with chronic bronchitis in adult patients with a history of frequent exacerbations as add-on to bronchodilator treatment.	Withdrawn	no	no	no	2011-02-28
AstraZeneca AB	Daliresp	roflumilast	EMEA/H/C/002398 Daliresp is indicated for maintenance treatment of severe chronic obstructive pulmonary disease (COPD) (FEV1 post-bronchodilator less than 50% predicted) associated with chronic bronchitis in adult patients with a history of frequent exacerbations as add-on to bronchodilator treatment.	Withdrawn	no	no	no	2011-02-28

International Patents for DALIRESP

See the table below for patents covering DALIRESP around the world.

Country	Patent Number	Title	Estimated Expiration
Hungary	220041	Fluor-alkoxi-helyettesített benzamidszármazékok, eljárás előállításukra és ezeket a vegyületeket tartalmazó gyógyászati készítmények (FLUORALKOXY SUBSTITUTED BENZAMIDE DERIVATIVES, PROCESS FOR PRODUCING THEM AND PHARMACEUTICAL COMPOSITIONS CONTAINING THEM)
Peru	20030823	FORMA DE DOSIFICACION QUE CONTIENE UN INHIBIDOR DE LA PDE 4 COMO INGREDIENTE ACTIVO
Ukraine	84266	ДОЗИРОВАННАЯ ВРАЧЕБНАЯ ФОРМА В ВИДЕ ТАБЛЕТКИ ИЛИ ГРАНУЛЫ ДЛЯ ПЕРОРАЛЬНОГО ВВЕДЕНИЯ, КОТОРАЯ СОДЕРЖИТ ИНГИБИТОР PDE 4 И ПОЛИВИНИЛПИРОЛИДОН, СПОСОБЫ ЕЕ ПОЛУЧЕНИЯ И ПРИМЕНЕНИЯ;ДОЗОВАНА ЛІКАРСЬКА ФОРМА У ВИГЛЯДІ ТАБЛЕТКИ АБО ПЕЛЕТИ ДЛЯ ПЕРОРАЛЬНОГО ВВЕДЕННЯ, ЯКА МІСТИТЬ ІНГІБІТОР PDE 4 ТА ПОЛІВІНІЛПІРОЛІДОН, СПОСОБИ ЇЇ ОДЕРЖАННЯ ТА ЗАСТОСУВАННЯ (ORAL DOSAGE FORM CONTAINING A PDE 4 INHIBITOR AS AN ACTIVE INGREDIENT AND POLYVINYLPYROOLIDON AS EXCIPIENT, PROCESSES FOR THE PREPARATION AND USE THEREOF)
Norway	955211

Supplementary Protection Certificates for DALIRESP

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0706513	1090034-8	Sweden		PRODUCT NAME: ROFLUMILAST OCH SALTER DAERAV; REG. NO/DATE: EU/1/10/636/001 20100705
0706513	91709	Luxembourg		91709, EXPIRES: 20190702
0706513	C00706513/01	Switzerland		FORMER OWNER: NYCOMED GERMANY HOLDING GMBH, DE
0706513	10C0052	France		PRODUCT NAME: ROFLUMILAST, ROFLUMILAST-N-OXYDE ET LES SELS DE CES COMPOSES; NAT. REGISTRATION NO/DATE: EU/1/16/636/001 20100705; FIRST REGISTRATION: EU/1/10/636/001 20100705