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 two branded drugs marketed by Sucampo Pharma Llc, Amneal, Anchen Pharms, Dr Reddys, and Teva Pharms Usa Inc, and is included in five NDAs. There are nine patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Lubiprostone has one hundred and thirty patent family members in twenty-four countries.

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

Summary for lubiprostone

International Patents:	130
US Patents:	9
Tradenames:	2
Applicants:	5
NDAs:	5
Drug Master File Entries:	10
Finished Product Suppliers / Packagers:	5
Raw Ingredient (Bulk) Api Vendors:	114
Clinical Trials:	46
Patent Applications:	2,365
Drug Prices:	Drug price trends for lubiprostone
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

See drug prices for lubiprostone

Recent Clinical Trials for lubiprostone

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

Sponsor	Phase
Alexandria University	Phase 3
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh	Phase 4
Rajavithi Hospital	Phase 4

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	Strength	NDA	ANDAs Submitted	Submissiondate
AMITIZA	Capsules	lubiprostone	8 mcg and 24 mcg	021908	1	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	021908-002	Apr 29, 2008	AB	RX	Yes	No	See Plans and Pricing	See Plans and Pricing	Y			See Plans and Pricing
Sucampo Pharma Llc	AMITIZA	lubiprostone	CAPSULE;ORAL	021908-001	Jan 31, 2006	AB	RX	Yes	Yes	See Plans and Pricing	See Plans and Pricing				See Plans and Pricing
Sucampo Pharma Llc	AMITIZA	lubiprostone	CAPSULE;ORAL	021908-001	Jan 31, 2006	AB	RX	Yes	Yes	See Plans and Pricing	See Plans and Pricing	Y			See Plans and Pricing
Sucampo Pharma Llc	AMITIZA	lubiprostone	CAPSULE;ORAL	021908-001	Jan 31, 2006	AB	RX	Yes	Yes	See Plans and Pricing	See Plans and Pricing	Y			See Plans and Pricing
Sucampo Pharma Llc	AMITIZA	lubiprostone	CAPSULE;ORAL	021908-002	Apr 29, 2008	AB	RX	Yes	No	See Plans and Pricing	See Plans and Pricing	Y			See Plans and Pricing
>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	021908-001	Jan 31, 2006	See Plans and Pricing	See Plans and Pricing
Sucampo Pharma Llc	AMITIZA	lubiprostone	CAPSULE;ORAL	021908-001	Jan 31, 2006	See Plans and Pricing	See Plans and Pricing
Sucampo Pharma Llc	AMITIZA	lubiprostone	CAPSULE;ORAL	021908-002	Apr 29, 2008	See Plans and Pricing	See Plans and Pricing
Sucampo Pharma Llc	AMITIZA	lubiprostone	CAPSULE;ORAL	021908-001	Jan 31, 2006	See Plans and Pricing	See Plans and Pricing
Sucampo Pharma Llc	AMITIZA	lubiprostone	CAPSULE;ORAL	021908-002	Apr 29, 2008	See Plans and Pricing	See Plans and Pricing
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

International Patents for lubiprostone

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Country	Patent Number	Title	Estimated Expiration
Mexico	2007002602	DERIVADOS DE PROSTAGLANDINA PARA EL TRATAMIENTO DE TRASTORNOS GASTROINTESTINALES. (PROSTAGLANDIN DERIVATIVES FOR TREATING GASTROINTESTINAL DISORDER.)	See Plans and Pricing
Japan	4889219		See Plans and Pricing
Portugal	2298314		See Plans and Pricing
Argentina	098997	UNIDAD DE DOSIFICACIÓN QUE COMPRENDE UN ANÁLOGO DE PROSTAGLANDINA PARA EL TRATAMIENTO DE LA CONSTIPACIÓN	See Plans and Pricing
Spain	2603381		See Plans and Pricing
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for lubiprostone

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1315485	132016000025193	Italy	See Plans and Pricing	PRODUCT NAME: LUBIPROSTONE O UN SUO SALE FARMACEUTICAMENTE ACCETTABILE(AMITIZA); AUTHORISATION NUMBER(S) AND DATE(S): PL 21341/0003, 20120910;043833019-021, 20150526
1315485	2015/028	Ireland	See Plans and Pricing	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	2015C/048	Belgium	See Plans and Pricing	PRODUCT NAME: LUBIPROSTONE; AUTHORISATION NUMBER AND DATE: PL21341/0003 20150317
2298314	92826	Luxembourg	See Plans and Pricing	PRODUCT NAME: LUBIPROSTONE, INCLUANT LES SELS PHARMACEUTIQUEMENT ACCEPTABLES, LES ESTERS OU LES AMIDES DE LA LUBIPROSTONE. FIRST REGISTRATION: 20120910
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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