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Last Updated: November 12, 2024

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 ten suppliers. There are five 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. Sixteen 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:5
Pharmacology for NDA: 021908
Mechanism of ActionChloride 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 Endo USA, Inc. 0254-3028 0254-3028-02 60 CAPSULE, GELATIN COATED in 1 BOTTLE (0254-3028-02)
AMITIZA lubiprostone CAPSULE;ORAL 021908 NDA AUTHORIZED GENERIC Endo USA, 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:⤷  Sign UpPatent Expiration:Oct 25, 2027Product Flag?YSubstance Flag?Delist Request?
Patent:⤷  Sign UpPatent Expiration:Jan 23, 2027Product Flag?YSubstance Flag?Delist Request?
Patent:⤷  Sign UpPatent Expiration:Sep 1, 2025Product 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

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

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.