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Generated: June 24, 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 five 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. Five 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 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	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:	RX	Dosage:	CAPSULE;ORAL			Strength	24MCG
Approval Date:	Jan 31, 2006	TE:		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:	➤ Try a Free Trial	Patent Expiration:	Sep 5, 2020	Product Flag?		Substance Flag?		Delist Request?
Patented Use:	METHOD OF RELIEVING OR PREVENTING CONSTIPATION IN A HUMAN CONSTIPATED PATIENT
Patent:	➤ Try a Free Trial	Patent Expiration:	Sep 5, 2020	Product 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

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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	➤ Try a Free Trial	➤ Try a Free Trial
Sucampo Pharma Llc	AMITIZA	lubiprostone	CAPSULE;ORAL	021908-001	Jan 31, 2006	➤ Try a Free Trial	➤ Try a Free Trial
Sucampo Pharma Llc	AMITIZA	lubiprostone	CAPSULE;ORAL	021908-001	Jan 31, 2006	➤ Try a Free Trial	➤ Try a Free Trial
Sucampo Pharma Llc	AMITIZA	lubiprostone	CAPSULE;ORAL	021908-002	Apr 29, 2008	➤ Try a Free Trial	➤ Try a Free Trial
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 verifification 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.