Lubiprostone - Generic Drug Details

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What are the generic drug sources for lubiprostone and what is the scope of freedom to operate?

Lubiprostone is the generic ingredient in one branded drug marketed by Sucampo Pharma Llc and is included in one NDA. There are sixteen patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Lubiprostone has two hundred and sixteen patent family members in twenty-eight countries.

There are ten drug master file entries for lubiprostone. Four suppliers are listed for this compound.

Summary for lubiprostone

International Patents:	216
US Patents:	16
Tradenames:	1
Applicants:	1
NDAs:	1
Drug Master File Entries:	10
Suppliers / Packagers:	4
Bulk Api Vendors:	87
Clinical Trials:	44
Patent Applications:	1,860
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for lubiprostone
What excipients (inactive ingredients) are in lubiprostone?	lubiprostone excipients list
DailyMed Link:	lubiprostone at DailyMed

Recent Clinical Trials for lubiprostone

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Rajavithi Hospital	Phase 4
Braintree Laboratories	Phase 3
Takeda	Phase 2

See all lubiprostone clinical trials

Pharmacology for lubiprostone

Drug Class	Chloride Channel Activator
Mechanism of Action	Chloride Channel Activators

Medical Subject Heading (MeSH) Categories for lubiprostone

Chloride Channel Agonists

Paragraph IV (Patent) Challenges for LUBIPROSTONE

Tradename	Dosage	Ingredient	NDA	Submissiondate
AMITIZA	CAPSULE;ORAL	lubiprostone	021908	2012-08-20

US Patents and Regulatory Information for lubiprostone

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Sucampo Pharma Llc	AMITIZA	lubiprostone	CAPSULE;ORAL	021908-001	Jan 31, 2006		RX	Yes	Yes	Start Trial	Start Trial		Y		Start Trial
Sucampo Pharma Llc	AMITIZA	lubiprostone	CAPSULE;ORAL	021908-001	Jan 31, 2006		RX	Yes	Yes	Start Trial	Start Trial	Y			Start Trial
Sucampo Pharma Llc	AMITIZA	lubiprostone	CAPSULE;ORAL	021908-002	Apr 29, 2008		RX	Yes	No	Start Trial	Start Trial	Y			Start Trial
Sucampo Pharma Llc	AMITIZA	lubiprostone	CAPSULE;ORAL	021908-002	Apr 29, 2008		RX	Yes	No	Start Trial	Start Trial	Y			Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

Expired US Patents for lubiprostone

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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	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	021908-001	Jan 31, 2006	Start Trial	Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

International Patents for lubiprostone

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Country	Patent Number	Estimated Expiration
Mexico	PA03001959	Start Trial
Japan	4684334	Start Trial
Japan	2013049688	Start Trial
Taiwan	I298256	Start Trial
>Country	>Patent Number	>Estimated Expiration

Supplementary Protection Certificates for lubiprostone

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1315485	122015000080	Germany	Start Trial	PRODUCT NAME: LUBIPROSTON, ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; NAT. REGISTRATION NO/DATE: 92699.00.00 20150519; FIRST REGISTRATION: VEREINIGTES KOENIGREICH PL 21341/0003 20120910
1315485	2015/028	Ireland	Start Trial	PRODUCT NAME: LUBIPROSTONE AND PHARMACEUTICALLY ACCEPTABLE SALTS FOR LUBIPROSTONE.; NAT REGISTRATION NO/DATE: PA148/002/001 20150213; FIRST REGISTRATION NO/DATE: PL21341/0003-0001 20120910
1315485	300757	Netherlands	Start Trial	PRODUCT NAME: LUBIPROSTON; NATIONAL REGISTRATION NO/DATE: RVG 115891; FIRST REGISTRATION NO/DATE: PL21341/0003 20120910
1315485	2015C/048	Belgium	Start Trial	PRODUCT NAME: LUBIPROSTONE; AUTHORISATION NUMBER AND DATE: PL21341/0003 20150317
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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