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Boehringer Ingelheim
Colorcon
Argus Health
Healthtrust
Accenture
Deloitte
Federal Trade Commission
Fuji
UBS
Medtronic

Generated: February 19, 2018

DrugPatentWatch Database Preview

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 six 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 nine drug master file entries for this compound. Six 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
Therapeutic Class:Gastrointestinal Agents
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 Lake Erie Medical DBA Quality Care Products LLC 35356-500 N 35356-500-60
AMITIZA lubiprostone CAPSULE;ORAL 021908 NDA Physicians Total Care, Inc. 54868-5971 E 54868-5971-0

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength24MCG
Approval Date:Jan 31, 2006TE:RLD:Yes
Patent:➤ Sign UpPatent Expiration:Sep 5, 2020Product Flag?Substance Flag?Delist Request?
Patented Use:METHOD OF RELIEVING OR PREVENTING CONSTIPATION IN A HUMAN CONSTIPATED PATIENT
Patent:➤ Sign UpPatent Expiration:Sep 5, 2020Product Flag?Substance Flag?Delist Request?
Patented Use:METHOD OF RELIEVING OR PREVENTING CONSTIPATION IN A HUMAN PATIENT WITH OPIOID-INDUCED CONSTIPATION
Patent:➤ Sign UpPatent Expiration:Oct 16, 2020Product Flag?YSubstance Flag?Delist Request?

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 021908-002 Apr 29, 2008 ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Medtronic
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Cipla
McKinsey
Dow
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Johnson and Johnson

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