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Details for New Drug Application (NDA): 021908

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NDA 021908 describes AMITIZA, which is a drug marketed by Sucampo Pharma Llc and is included in one NDA. It is available from four suppliers. There are sixteen patents protecting this drug and one Paragraph IV challenge. Additional details are available on the AMITIZA profile page.

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

Summary for 021908

Tradename:	AMITIZA
Applicant:	Sucampo Pharma Llc
Ingredient:	lubiprostone
Patents:	16

Generic Entry Opportunity Date for 021908

Dosage:

CAPSULE;ORAL

^*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 NDA: 021908

Mechanism of Action

Chloride Channel Activators

Medical Subject Heading (MeSH) Categories for 021908

Chloride Channel Agonists

Suppliers and Packaging for NDA: 021908

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
AMITIZA	lubiprostone	CAPSULE;ORAL	021908	NDA AUTHORIZED GENERIC	Par Pharmaceutical Inc.	0254-3028	0254-3028-02	60 CAPSULE, GELATIN COATED in 1 BOTTLE (0254-3028-02)
AMITIZA	lubiprostone	CAPSULE;ORAL	021908	NDA AUTHORIZED GENERIC	Par Pharmaceutical Inc.	0254-3029	0254-3029-02	60 CAPSULE, GELATIN COATED in 1 BOTTLE (0254-3029-02)

Paragraph IV (Patent) Challenges for 021908

Tradename	Dosage	Ingredient	NDA	Submissiondate
AMITIZA	CAPSULE;ORAL	lubiprostone	021908	2012-08-20

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	24MCG
Approval Date:	Jan 31, 2006	TE:		RLD:	Yes
Regulatory Exclusivity Expiration:	Apr 26, 2021
Regulatory Exclusivity Use:	REVISIONS TO SECTION 8.4 OF THE PRESCRIBING INFORMATION TO INCLUDE A SAFETY AND EFFICACY STUDY IN PEDIATRIC PATIENTS AGES >=6 YEARS TO
Patent:		Patent Expiration:	Sep 5, 2020	Product Flag?		Substance Flag?		Delist Request?
Patented Use:	METHOD OF RELIEVING OR PREVENTING CONSTIPATION IN A HUMAN CONSTIPATED PATIENT
Patent:		Patent Expiration:	Sep 5, 2020	Product Flag?		Substance Flag?		Delist Request?
Patented Use:	METHOD OF RELIEVING OR PREVENTING CONSTIPATION IN A HUMAN PATIENT WITH OPIOID-INDUCED CONSTIPATION

Expired US Patents for NDA 021908

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Sucampo Pharma Llc	AMITIZA	lubiprostone	CAPSULE;ORAL	021908-001	Jan 31, 2006
Sucampo Pharma Llc	AMITIZA	lubiprostone	CAPSULE;ORAL	021908-001	Jan 31, 2006
Sucampo Pharma Llc	AMITIZA	lubiprostone	CAPSULE;ORAL	021908-002	Apr 29, 2008
Sucampo Pharma Llc	AMITIZA	lubiprostone	CAPSULE;ORAL	021908-002	Apr 29, 2008
Sucampo Pharma Llc	AMITIZA	lubiprostone	CAPSULE;ORAL	021908-001	Jan 31, 2006
Sucampo Pharma Llc	AMITIZA	lubiprostone	CAPSULE;ORAL	021908-001	Jan 31, 2006

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