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Last Updated: December 12, 2025

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 twelve suppliers. There are four 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. Twenty-one 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:	4

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 Health USA, LLC	0254-3028	0254-3028-02	60 CAPSULE, GELATIN COATED in 1 BOTTLE (0254-3028-02)
AMITIZA	lubiprostone	CAPSULE;ORAL	021908	NDA AUTHORIZED GENERIC	Par Health USA, LLC	0254-3029	0254-3029-02	60 CAPSULE, GELATIN COATED in 1 BOTTLE (0254-3029-02)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	24MCG
Approval Date:	Jan 31, 2006	TE:	AB	RLD:	Yes
Patent:	⤷ Get Started Free	Patent Expiration:	Oct 25, 2027	Product Flag?	Y	Substance Flag?		Delist Request?
Patent:	⤷ Get Started Free	Patent Expiration:	Jan 23, 2027	Product Flag?	Y	Substance Flag?		Delist Request?
Patent:	⤷ Get Started Free	Patent Expiration:	Sep 1, 2025	Product Flag?		Substance Flag?		Delist Request?
Patented Use:	METHOD FOR THE LONG TERM TREATMENT OF CHRONIC CONSTIPATION IN A HUMAN SUBJECT

Expired US Patents for NDA 021908

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

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