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Last Updated: March 7, 2021

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 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
Generic Entry Date for 021908*:
Constraining patent/regulatory exclusivity:
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 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 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:RXDosage:CAPSULE;ORALStrength24MCG
Approval Date:Jan 31, 2006TE: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:  Start TrialPatent Expiration:Sep 5, 2020Product Flag?Substance Flag?Delist Request?
Patented Use:METHOD OF RELIEVING OR PREVENTING CONSTIPATION IN A HUMAN CONSTIPATED PATIENT
Patent:  Start TrialPatent 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

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

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