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Last Updated: May 27, 2022

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 three suppliers. There are nine 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:9
Pharmacology for NDA: 021908
Mechanism of Action Chloride Channel Activators
Medical Subject Heading (MeSH) Categories for 021908
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)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength24MCG
Approval Date:Jan 31, 2006TE:ABRLD:Yes
Patent:See Plans and PricingPatent Expiration:Dec 4, 2022Product Flag?Substance Flag?Delist Request?
Patented Use:METHOD FOR TREATING OPIOID-INDUCED CONSTIPATION
Patent:See Plans and PricingPatent Expiration:Aug 30, 2022Product Flag?Substance Flag?Delist Request?
Patented Use:METHOD FOR TREATING CONSTIPATION BY OPENING CIC CHANNELS IN A MAMMALIAN SUBJECT
Patent:See Plans and PricingPatent Expiration:Aug 30, 2022Product Flag?Substance Flag?Delist Request?
Patented Use:METHOD FOR TREATING CONSTIPATION IN A PATIENT WITH OPIOID-INDUCED CONSTIPATION BY OPENING CIC CHANNELS

Expired US Patents for NDA 021908

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