Details for New Drug Application (NDA): 022522

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NDA 022522 describes DALIRESP, which is a drug marketed by Astrazeneca and is included in one NDA. It is available from one supplier. There are three patents protecting this drug and two Paragraph IV challenges. Additional details are available on the DALIRESP profile page.

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.

Summary for 022522

Tradename:	DALIRESP
Applicant:	Astrazeneca
Ingredient:	roflumilast
Patents:	3

Pharmacology for NDA: 022522

Mechanism of Action	Phosphodiesterase 4 Inhibitors

Suppliers and Packaging for NDA: 022522

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
DALIRESP	roflumilast	TABLET;ORAL	022522	NDA	AstraZeneca Pharmaceuticals LP	0310-0088	0310-0088-28	1 BLISTER PACK in 1 BOX, UNIT-DOSE (0310-0088-28) / 28 TABLET in 1 BLISTER PACK
DALIRESP	roflumilast	TABLET;ORAL	022522	NDA	AstraZeneca Pharmaceuticals LP	0310-0088	0310-0088-39	10 BLISTER PACK in 1 BOX, UNIT-DOSE (0310-0088-39) / 2 TABLET in 1 BLISTER PACK

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	500MCG
Approval Date:	Feb 28, 2011	TE:	AB	RLD:	Yes
Patent:	8,536,206	Patent Expiration:	Mar 8, 2024	Product Flag?		Substance Flag?		Delist Request?
Patented Use:	TREATMENT TO REDUCE THE RISK OF COPD EXACERBATIONS IN PATIENTS WITH SEVERE COPD ASSOCIATED WITH CHRONIC BRONCHITIS AND A HISTORY OF EXACERBATIONS
Patent:	8,604,064	Patent Expiration:	Mar 8, 2024	Product Flag?		Substance Flag?		Delist Request?
Patented Use:	TREATMENT TO REDUCE THE RISK OF COPD EXACERBATIONS IN PATIENTS WITH SEVERE COPD ASSOCIATED WITH CHRONIC BRONCHITIS AND A HISTORY OF EXACERBATIONS
Patent:	8,618,142	Patent Expiration:	Mar 8, 2024	Product Flag?	Y	Substance Flag?		Delist Request?

Expired US Patents for NDA 022522

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Astrazeneca	DALIRESP	roflumilast	TABLET;ORAL	022522-001	Feb 28, 2011	9,468,598	⤷ Subscribe
Astrazeneca	DALIRESP	roflumilast	TABLET;ORAL	022522-001	Feb 28, 2011	8,604,064	⤷ Subscribe
Astrazeneca	DALIRESP	roflumilast	TABLET;ORAL	022522-002	Jan 23, 2018	8,618,142	⤷ Subscribe
Astrazeneca	DALIRESP	roflumilast	TABLET;ORAL	022522-002	Jan 23, 2018	5,712,298	⤷ Subscribe
Astrazeneca	DALIRESP	roflumilast	TABLET;ORAL	022522-001	Feb 28, 2011	5,712,298	⤷ Subscribe
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